December 4, 2024 • 52 mins
Unlock the secrets of dietary supplement regulations with our esteemed guest, Asa, a seasoned regulatory consultant with a background in clinical herbalism. Discover the intricacies of FDA oversight in the supplement industry and learn why the notion that dietary supplements are unregulated is a myth. Asa's journey from herbal studies in Boulder to advising companies on maintaining compliance provides unique perspectives and invaluable lessons for anyone navigating this complex field.
Gain a deeper understanding of the transformative impact of the Dietary Supplement Health and Education Act (DSHEA) and its role in shaping the herbal and dietary supplement industry. We explore the distinction between structure/function claims and disease claims, and how these affect marketing strategies. Delve into the evolution of labeling and marketing regulations, and consider potential legislative updates that could further refine the guidelines set by DSHEA over the past three decades.
Lastly, we tackle the challenges retailers face in complying with regulatory guidelines, particularly in the context of influencer marketing and digital platforms. Learn about the risks associated with unsubstantiated claims and how innovative tools like Apex Compliance software are helping companies stay in line with regulations. Through practical advice and expert insights, this episode equips businesses with the knowledge to market their health products ethically and legally.
Connect with us:
Email: info@naturalproductsmarketer.com
About Amanda Ballard
Amanda has worked in natural products marketing in the retail setting since 2016 and has a great understanding of the unique challenges and opportunities that retailers in this industry face. More than anything, she wants this industry to continue to boom and believes much of that success hinges on the ability of retailers to do well in their businesses and market their products effectively.
About Tina Smith
Since 2014, Tina has worked with multiple natural products businesses, discovering how to market their CBD products online, without having their payment processor shut them down, to letting customers talk about their health issues those products have helped them solve. She knows first hand how experts like you offer the best products and a superior customer experience, that is why she is committed to helping you find an easy way to grow your natural product business.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Asa Waldstein (00:00):
Well, the FDA has a pretty big job right.
Their mandate of their charteris to protect public safety, so
they oversee conventional foodsthat's meats, that's eggs,
that's dairy.
They oversee drugs.
Dietary supplements are just apart of this.
So they've got a pretty big job, to be fair.
Tina Smith (00:24):
Welcome to the Natural Products Marketer
Podcast.
I'm Tina and.
Amanda Ballard (00:28):
I'm Amanda and we're here to make marketing
easier for natural productsbusinesses, so you can reach
more people and change morelives.
Tina Smith (00:38):
Amanda, how did you hear about Asa?
Amanda Ballard (00:41):
LinkedIn.
I've seen your name pop upeverywhere.
I've also I have a lot ofindustry friends that are mutual
friends of yours.
I was actually talking withSarah Burden the other day and
she was like, oh my gosh, I wasjust talking with him, so I was.
I was telling her how excited Iwas for today's interview.
I think the first time I heardabout you was from Deborah Short
(01:04):
with Senpa.
She had dropped your name for apossible speaking engagement
and so I've heard about youthrough the grapevine many, many
times.
Asa Waldstein (01:14):
Wonderful.
I love it.
Yeah, small world, even thoughthe supplement industry is so
big, it's really not that bigand so it's great.
It's great to have colleagueslike that share some kind words.
And yeah, sarah is wonderful.
I just recently saw her at theSupply Side East and what's Up
with Subs event and it waspretty exciting because my
(01:35):
daughter is 23.
She's never been to anyindustry events.
She's an environmentalist.
She's going to go to gradschool and see Boulder here in
Coloradoado where we live in thefall.
She's never been to anyindustry world events at all.
So she came and met me for thetail end of the what's up with
subs event and it was so neatshe every by that time people
(01:58):
have been having a really goodtime, you know, drinking and
celebrating.
But she heard about warningletter wednesday, my weekly blog
post over and over and overagain.
Oh, like this is my daughternova.
Oh, yeah, we love warningletter wednesday.
She spoke to me at the end ofthe event because then we went
and spent three nights in newyork city having fun.
She said now I kind of get itbecause I'm I do warning letter
(02:22):
wednesday every week, every tTuesday night for Wednesday, for
the past two and a half plusyears whether we're in.
Africa or on vacation orwherever it may be.
So it kind of helped her seewhat her dad does and why I'm
always taking two hours off onher vacation to do Morning
Letter Wednesday and it was kindof a fun aside there, awesome
(02:43):
to do morning letter rides.
Tina Smith (02:44):
And it was kind of a fun aside there.
Awesome, we're really excitedto talk to you because so many
of our clients need you.
So many retailers have a lot ofquestions, and manufacturers
too, and they're questions thatwe either don't know how to
answer or we feel reallyuncomfortable answering because
they're compliance related.
So we want to make sure that wegive people the right
(03:08):
information from someone whoknows what they're talking about
.
So I would love to start withfirst just how you got into this
industry and what brought youinto compliance and regulatory
related to the supplements.
Asa Waldstein (03:23):
I love that question, thank you.
I followed my passion forherbal supplements and natural
healing into the dietarysupplement industry.
So, to back up even more, Icame out to Boulder.
I like cool places.
So I came out from Santa Cruzto Boulder, colorado, in the
late nineties to study clinicalherbalism.
So I participated in athree-year clinical herbalism
program I'm a certified clinicalherbalist and then participated
in a three-year clinicalherbalism program I'm a
(03:45):
certified clinical herbalist andthen in 2001, I started making
supplements because herbs arecool, I believe in natural
healing, that type of thing, andlittle did I know that this
whole dietary supplementindustry was going to grow up
around me.
So I kind of just followed mypassion for herbs into a dietary
supplement manufacturingenvironment.
And then it was just kind offate and serendipity.
(04:09):
I was actually pretty good atrunning dietary supplement
companies, formulating, talkingto customers, getting products
out the door in a compliantmanner.
And then I learned theregulations kind of from the
inside out.
So I've seen the implementationof laws such as GMPs for
dietary supplements, commonallergy and labeling law, to
(04:29):
name a few.
So I kind of learned them againfrom the inside out.
How do these regulations andlaws, how do they affect me as a
small business manager orsomeone who's helping to guide
different brands.
How do we make sense of them ina practical way?
How do we interpret theregulations in a way that's not
(04:49):
going to put us out of businessbut is actually going to make
sense and allow us to continueto do our jobs, make money, sell
great health giving products,but also stay in compliance?
So I did that for many yearsprobably about 17 years as a
dietary supplement manufacturerand marketer, and then I went
out on my own.
So I started my own regulatoryconsulting company about four
(05:12):
years ago, and what I love aboutthat is, instead of working
with one company, I get to workwith 30, 40, 50 different
companies and really understandthe nuances of regulatory
compliance and how it applies toall these different companies,
whether they're small, emergingbrands or the biggest of the big
companies as well.
Tina Smith (05:32):
Yeah, so one of the big misconceptions about the
supplement industry is that it'snot regulated, and we know that
that's not true.
It's very regulated, but youknow we hear a lot that the FDA
does not regulate supplementsand so you can't trust what's in
the bottle.
So tell us a little bit aboutthe regulations that are there
(05:53):
and how much regulation the FDAdoes have over the products.
Asa Waldstein (05:59):
Well, the FDA has a pretty big job, right?
They have to.
Their mandate of their charteris to protect public safety.
So they oversee conventionalfoods that's meats, that's eggs,
that's dairy.
They oversee drugs.
Dietary supplements are just apart of this.
So they've got a pretty big job, to be fair.
(06:20):
And so we're talking aboutdietary and herbal supplements
here.
So FDA inspects around 500dietary supplement manufacturing
facilities a year.
I've heard that there's overperhaps 10,000 dietary
supplement manufacturingfacilities in the US.
So 5%, that's not a very goodnumber.
So I really would like to seeFDA, I'd like to get some more
(06:45):
resources to FDA to do more GMPinspections.
So I think FDA is doing apretty good job with the
resources they have.
Um kind of on the critical side, I think FDA could certainly do
a better job at helping toremove drug spike ingredients
and drug spike ingredientproducts from the market
whenever they're found.
Again, it's a very, very smallsubset of dietary supplements.
(07:09):
Whenever they are found, I'dlike to see them removed with a
little more haste.
So of course we knowsupplements are regulated by the
FDA, and I'm just making up anumber here.
99.8% of them are probablypretty darn good.
They're made under a goodmanufacturing practice compliant
facility.
(07:30):
but then there's a select fewout there that I've talked about
with the drug spike ingredientsand that type of thing.
So dietary supplements yeah,they have a high level of safety
and you know I always lovehaving these type of
conversations.
And thank you for this question, tina, because educating about
the regulatory structure, theframework with dietary
(07:52):
supplements and actually howgenerally safe supplements are
when taken as directed, takingall the potential
contraindications in mind,really is an important topic to
get out to the broader public.
Amanda Ballard (08:07):
Yeah, that's really interesting and I'm glad
that you kind of clarified that.
You know, I think one of theprobably one of the bigger
questions we get beyond thatmore from a retail perspective.
I've been around the block acouple times now with different
retailers and the topic ofDeshaies comes up over and over
(08:27):
again.
So for the uninitiated, can youtell us a little bit about the
Deshaies Act and what that didto this industry back in the 90s
?
And I know from many of mypeers that have owned their own
health food stores since, youknow, the 70s, 80s, 90s.
(08:49):
This was a big deal for themand I can't necessarily share in
that experience.
And so they talk about Dachetall the time and how like, how
amazing it was that that gotpassed.
I'm like I can't relate to you.
What does this mean?
And then, what does it actuallymean to present day about what
we can and cannot say aboutsupplements?
Asa Waldstein (09:07):
Yeah, thank you for that.
So DSHEA, the DietarySupplement, Health and Education
Act.
We have so many acronyms in ourworld, it's good to spell about
every once in a while.
So there is a world beforeDSHEA and after.
DSHEA, the world before DSHEA is, there wasn't really a legal
way to sell and market herbaland dietary supplements.
I think to your point, amanda.
(09:28):
Companies were getting ratedfor selling products that
contain herbs like echinacea oreven vitamin C and things like
that.
So it's really just crazy tothink about, from what we look,
what it's like now, 30 yearslater, and what it was like
before 1994 when Deshaies passed.
So again, deshaies gave us alawful way to manufacture and
(09:50):
market herbal ingredients.
And so when we look at kind ofwhat Deshaies did, talking about
claims and how it helpedclarify some of what we can say,
deshaies helped clarify what isoff limits, so a disease claim,
and what is a structurefunction claim Allowable if we
have substantiation.
(10:13):
So I love the example ofinflammation.
Right, I run a regulatoryconsulting company.
I'm asked, hey, is inflammationa claim?
So here's a good example.
If we're talking about helpsupport a healthy inflammatory
response after exercisestructure function claim, we're
talking about the body.
It's a normal non-disease state.
I worked out too hard, I wentsnowboarding, I've got an
(10:35):
inflammatory response.
I'm helping to balance thatpretty low risk.
I'd consider that in thestructure function category in
my opinion, whereas the phrasechronic inflammation or helps
with chronic inflammation that'sdisease related.
You know that's diseaseadjacent.
So you can't have somethingthat's a normal life event that
goes on all the time that itcrosses that line from okay or
(10:59):
probably okay into disease claimcategory.
Another thing that Deshaies didwas it kind of put a stake in
the ground with ingredients, soanything marketed, or most
things marketed, before October15th 1994, when Deshaies passed.
I know that date becauseOctober 15th is the anniversary
(11:20):
of the first date that I hadwith my wife.
That's how I remember it.
Even though I'm a geek, I knowthis stuff.
I remember October 15th as adate, so anyway.
October 15th 1994, herbs andingredients were marketed before
then.
They're considered ODIs or olddietary ingredients and they're
most likely to be allowableunder this structure.
(11:40):
Anything marketed after thatDachet date is considered a new
dietary ingredient according toFDA regulations.
So if it's an NDI, a newdietary ingredient, companies
are supposed to go through thesafety procedures of proving
that ingredient safe.
Now I just wanted todemonstrate how unclear this is
(12:03):
and how complex it is at thesame time.
So let's take an ingredientlike turmeric.
Turmeric marketed forever andever, probably considered an old
dietary ingredient.
But if we take turmeric and wehighly, highly purify it, if
that purification was done andwas sold in the marketplace
after the disheies date, thenmaybe it needs to become be
(12:27):
considered a new dietaryingredient.
So as we're looking at kind ofDeshaies, the initial framework
there and how it affects ustoday, I also, of course, look
at labeling.
Right, I'm a regulatory person.
I look at labeling.
So when Deshaies was enacted,there was really no such thing
as the internet.
So when we look at so whenDeshaies was enacted, there was
really no such thing as theinternet.
So when we look at thecomplexities of Deshaies then
(12:49):
and Deshaies 30 years later,some of the regulations of
Deshaies don't really make sense.
So when we're unclear on how toadapt regulations for the world
we live in today, we look atwarning letters.
So that's why I love writingWarning Letter Wednesday, which
we talked about before we jumpedon today, and why it's
(13:11):
important to read FDA warningletter trends.
So I like to think of the adageof all marketing is an
extension of the label.
So if we wouldn't put somethingon the label, such as anxiety
support, we should be verycareful to not let it slip by in
any secondary form of marketing.
Hashtag social post, influencerpost, that type of thing.
(13:34):
So that really shows howDeshaies provided a framework.
But then we have to payattention to enforcement trends
as a way to interpret how thatmakes sense for our company.
And I did want to give a plugto APA, the American Herbal
Products Association, at ExpoWest.
They just posted a 30 years ofDachet video and I'll share it
(13:55):
with you, amanda and Tina.
If you can share it with thereaders here, I think that'd be
a great resource.
I think that'd be a greatresource.
It's a great video of Deshaies,what it was like before
Deshaies, how we got to where weare here in the herbal dietary
supplement industry.
Yeah, absolutely.
(14:24):
Now there is word on the streetthat they might start looking at
Deshaies again in thelegislature.
What would that mean?
I think that it could meanadapting some of the antiquated
verbiage that was part of theact before there was the
internet, for example, so thatcould be good.
It could also be helping tomaybe further define what is
(14:46):
education and what is a diseaseclaim.
So, for example, if we'retalking about a blog and we're
talking about an ingredient in ablog and that ingredient sold
in our product, is thateducation or is that labeling
According to FDA warning letterenforcement?
That's labeling, but it wouldhelp clarify some of those type
(15:06):
of things.
Also, there's this veryantiquated rule which drives me
bananas, that plaintiffattorneys have got a hold of and
we're all aware of that FDA orthat Deshaies disclaimer this
product has not been intended totreat, diagnose, cure, prevent
disease, so on and so forth.
Intended to treat, diagnose,cure, prevent disease, so on and
so forth.
Now, according to this DSHEAAct, that disclaimer needs to be
(15:29):
on every label panel.
It says label panel in therules every label panel where
that structure function claim isso, let's say that the product
supports joint health, on theprincipal or the main label
panel.
Now, according to the regs,we're supposed to put that to
shade disclaimer on that mainlabel panel and on the side
(15:51):
label panel for structurefunction claims.
It's so, bananas, that it'sleading to several lawsuits.
It's very silly.
Being able to update.
Things like that are important.
I also urge caution.
If we open up discussion wemight not get what we want.
So you know, bringing Deshaiesinto you know now, 2024 and
(16:17):
beyond, into more of a modernframework, I think, is not a bad
idea.
But we need to be vigilant ifwe open up that discussion to
make sure that we're not goingto lose any of the protections
provided by Dachet.
Tina Smith (16:30):
Yeah, I'm so curious about some of these things that
you're talking about,especially when it comes to
education materials like blogposts or webinars and that kind
of thing, when you start talkingabout scientific studies even.
Is that in compliance if yousell the product in your store
(16:52):
and you have a blog post aboutit, even if you don't point from
the blog post to the product?
Asa Waldstein (16:59):
I love this discussion.
I don't know about a brick andmortar type discussion.
We'll come back to that.
Secondly, but according againto FDA warning letter
enforcement, clinical citationsare considered marketing, so
they are considered labeling.
So let's say that we have ablog post about turmeric and
(17:22):
then we have a study citationabout turmeric and arthritis.
Now if we're not sellingturmeric on that website or
connected by the social media orlinked in some way pretty darn
low risk, probably in the fineto no risk category.
But if we are selling turmeric,then the FDA would probably
(17:43):
consider that a labeling andtherefore, citing that clinical
study is saying hey, theingredient turmeric in this
example that we have in ourproduct is being marketed for
arthritis.
So, citing clinical studies,even if we have all the research
in the world, we're still notallowed to make those disease
claims about our products oringredients, according to FDA.
(18:08):
Ftc is a little bit different.
Now, if it's a brick-and-mortarstore and they are maybe not
selling their product online butthey are educating online, but
they are selling that product intheir store, I can't think in
reality of a situation wherethat would occur Then it's
(18:30):
probably far enough that it'snot really risky, but it's all
about how linked it is.
Again, if it's on a website oron a social or YouTube and
that's linked to where peoplecan order products.
That's a common statement inwarning letters.
That's enough to build thatbridge from clinical research
into disease claims and the sameand I'm often asked this as
(18:53):
well the same is true for studycitations.
So study citations have beencited in some warning letters,
mostly related to COVID and CBD,because there was some initial
research about that.
So simply just having a studycitation with the ingredient in
the disease claim, that wasenough to attract a warning
(19:13):
letter in this COVID, cbd groupof warning letters from a year
or two ago.
So I don't think in real worldrisk that just study citations
are enough to tip the scale intowarning letter category unless
they're very high risk.
So just a quick closing thoughton that is a good best practice
(19:34):
if companies are using studycitations which I think is good
as long as we're being truthfuland not misleading is make sure
that the ingredient name or theproduct name and the disease
claim are not in that studycitation or that URL.
So if it was turmeric study forarthritis, maybe remove
turmeric or arthritis from there.
(19:55):
That greatly lowers the risk.
There's a hot tip for today.
Tina Smith (20:01):
Thank you.
I'm curious about what happensif you get a warning letter.
Yeah, warning letters.
Asa Waldstein (20:08):
we definitely want to avoid them.
So they're a public record.
They rank very high in searchengines like Google.
So it can be memorializedforever.
The name of the company and thepeople that are in charge
memorialize forever in warningletter history.
So because they're public, itcan lead to credit card
(20:29):
processing issues, insuranceissues.
It can also scare awaydistributors.
So it can scare awaydistributors.
It might be Whole Foods orwhatever it may be.
Warning letters can affect thatOn face value.
They require legal resources torespond to, and repeat warning
(20:49):
letters may perhaps lead toinjunction or seizure, although
that's very rare.
Companies have to be kind ofnot very nice, be jerks to do
that, really scurrying a lot,but it's possible.
So we always want to respond toa warning letter.
We should respond to warningletters.
It's possible.
So we always want to respond towarning letter.
We should respond to warningletters.
And again, we were kind ofmaybe there's more of a target
(21:10):
on companies back from the FDA,because repeat warning letters
do have a more seriousramification.
Now in this day and age in thesupplement industry there's so
much, there's so many mergersand acquisitions happening.
There's a lot of things likethat.
So the quickest way to scareaway M&A strategic alignment
investment is to get a warningletter.
(21:31):
Those folks with the cash.
They'd rather go to someoneelse that maybe doesn't have
that target on their back.
Now there's some reasons toavoid a warning letter, but one
of the main reasons is it alertsclass action attorneys.
So oftentimes plaintiffattorneys will use the warning
letter as the basis ofwrongdoing in the lawsuits, copy
and paste that warning letterinto the lawsuit and that can
(21:55):
lead to demand letters andlawsuits.
And that's very common Warningletters come out lots of demand
letters and lawsuits follow.
Amanda Ballard (22:02):
Interesting.
Have you seen any retailers getissued warning letters?
Asa Waldstein (22:10):
It's usually retailers that have an online
presence and so oftentimes it'smaybe retailers that are selling
products that are not compliant, such as there was a bunch of
ophthalmic so high productwarning letters.
I'm not picking on anycompanies like CBS, I think
(22:34):
Walgreens big giant nationalretailers got warning letters
for distributing these products.
Now they were distributing themonline, making it really easy
for an FDA inspector to justlook online and see that.
So retailers certainly do getwarning letters.
It's almost always for thedisease claims or the lack of
(22:54):
compliant product categorythat's being sold online.
Of course, we can't talk aboutretailers without talking about
Amazon.
Amazon continues to get betterand better.
Let's hope they're moving inmore, continue to move in more
compliant direction.
I believe they probably are,but Amazon, I think, has gotten
(23:15):
four warning letters over thepast 16 months or so.
So Amazon really is in thecrosshairs of FTA just because
they're so big and, according toGMP regulations, distributors
are responsible for thecompliance of the products they
distribute.
So I'm actually glad thatAmazon, who is a distributor
(23:36):
they're actually handling theproduct has been held
accountable for either thedisease claims or the compliance
of the products that they aredistributing, because according
to GMPs, all distributors arecompliant.
So I certainly feel like ifsmaller or medium-sized
distributors should comply withGMP distributor requirements
(23:58):
can't remember which subpart itis, then of course the biggest
one in the world, amazon shouldbe held accountable as well.
Tina Smith (24:05):
Yeah, so I'm just curious, based on that question,
you haven't heard about smallerindependent retailers receiving
these warning letters.
Asa Waldstein (24:16):
Yeah, so only if they're thank you for clarifying
that only if they're makingdisease claims, almost only if
they're making disease claims.
These might be smallerpractitioners.
These might be smallerindependent retailers.
These might even be farmer'smarket style cottage industries
(24:42):
that are selling their productsat farmer's markets.
They snap a picture of theirsign hey, our echinacea is great
for flu prevention.
Whatever it may be, they putthat online.
On that maybe I'm speakinghypotheticals on their instagram
or whatever it may be, thatinstagram links to a shopping
(25:02):
cart where customers can orderproducts.
That certainly, without a doubt, has attracted warning letters.
So there's a lot of thesesmaller retailers that, to be
honest, probably just don't knowany better.
I don't necessarily thinkthere's very much of any
malicious activity or deceptiveactivity.
They probably just don't knowany better.
(25:23):
Taking and copying if you goonto Google or AI or whatever it
may be and say what are thebenefits of echinacea, you're
going to get disease, disease,disease.
Taking and copying those overonto marketing doesn't
necessarily translate intocompliant copy.
Same thing with clinicalstudies, right?
So branded ingredients, otherclinical studies we go on PubMed
(25:45):
, I'll stay with echinaceastudies.
We go on PubMed, I'll stay withEchinacea.
There's lots of studies abouthelps with mitigation of flu
symptoms or whatever it may be,those don't necessarily
translate in compliant marketing, so a lot of these smaller
retailers don't know that.
I guess that's why we're havingthis discussion right to help
educate people about what iseducation and where education
(26:09):
crosses that line into marketing.
Amanda Ballard (26:12):
So what about customer testimonials?
So we recommend that to a lotof our clients to use their
customer testimonials in theirmarketing, just because it's you
know, it's they're saying it,not me, right?
So how does that in in theregulatory space?
Like you know, customer says oh, this helped me get rid of
whatever ailment that I'mdealing with.
(26:34):
How do we handle that?
Asa Waldstein (26:38):
It's a great question.
So testimonials that a companyadopts, post on social, puts in
a banner ad, curates in any way,interacts with, engages with,
those are considered pieces ofmarketing and therefore their
labeling.
So let's say there's atestimonial such as this product
(27:00):
worked great for my arthritis,a social wall or coming maybe an
Amazon review or testimonial orcoming in through a third-party
widget that's non-curated,non-compensated, on a website,
all right, the authority hasbeen pretty hands-off with that.
Now, if I as a company thenlike it or say thanks on social,
(27:25):
I've adopted that as mymarketing and therefore it's
labeling.
If I engage with a producttestimonial or review on my
website, then I've engaged withthe same thing with socials.
I've adopted it as my marketing.
If I take that and then put itin a banner ad I see this
(27:46):
mistake happening all the time.
Customer testimonials we'reexcited when we get testimonials
with companies.
We'll copy and paste them ontoInstagram or whatever it may be.
That's labeling and that'smarketing.
So anything we adopt asmarketing is again labeling.
I know I'm repeating myself,but it's important.
We must have substantiation forand we're responsible for that.
(28:08):
So we's kind of.
You know, we've we've kind ofunpacked this a little, a little
bit of where the gray area isand where the gray area crosses
that line into into marketing.
Tina Smith (28:22):
And I'm curious, you just use the word substantiated
.
We would have to be able tosubstantiate the claim.
What does that entail?
Like what would you to be ableto substantiate the claim?
What does that entail?
Like what would you need tohave to substantiate a claim?
Asa Waldstein (28:33):
Got it.
Just need to make sure that wehave some firm clinical data to
back up whatever we're saying.
So if a customer's, we'll stayon testimonials.
As an example, let's say acustomer says, hey, this product
helped me sleep eight hoursthrough the night, we better
have some data to back up thatour product can actually do that
(28:55):
, that that is a reproducibleresult in, I'll just say, the
majority of the population.
Now to take substantiation alittle deeper, and I don't want
to scare anybody out there, butthe gold standard is placebo,
controlled, randomized, blindedclinical trials.
So that is a well-powered studyof dozens and dozens of
(29:19):
individuals that don't know whatthey're taking.
If they're taking a placebo oran active product and it's
reproducible, that is veryexpensive to do.
On dietary supplements, whichis why a lot and it just doesn't
make sense because we're notsupplements are not drugs in
many cases.
So that's why a lot ofcompanies depend on the data
(29:40):
that's available, either throughbranded ingredient or, you know
, for example, pubmed.
So if there is a study on athousand milligrams of vitamin C
I'm making up these numbers, sodon't quote me on that A
thousand milligrams of vitamin Ctaken as a capsule twice a day
for immune support.
Let's say there's awell-powered study on PubMed
about just vitamin C.
(30:01):
Now companies oftentimes willuse that to build out their
substantiation dossier.
That's just a fancy word forthe packet.
So if our product has athousand milligrams of vitamin C
it's the same study population,the same form, like the capsule
then that probably helps ussubstantiate a claim of immune
support.
So it's kind of finding thedata out there, making sure like
(30:25):
matches, like animal studiesdon't necessarily they're not,
they're not the best.
We want to find human clinicaltrials on ingredients that we
can then use to prove theirproducts work.
We have data to back it up.
We're not just, you know,looking into a crystal ball and
saying, hey, this product'sreally good.
Let me make up a bunch ofclaims about it.
Amanda Ballard (30:46):
Basically, I mean a bunch of claims about it.
Basically, I mean, what I'mhearing is that retailers need
to be super careful in whatthey're engaging with online,
even if you know someoneliterally just comments on
Instagram this is my favoriteproduct you sell in your store.
I'm sleeping better than I'veever slept in my life and you
(31:08):
hit that like button next to itLike you are claiming that as a
factual statement.
Asa Waldstein (31:15):
Yep, it's true.
It's true, and with thatexample, that might be a
calculated risk on the company'spart because there's not any
disease words, high risk diseasewords there.
If there was word insomniathere, ding, ding, ding, we've
really elevated the risk.
It's all about you have to betruthful, not misleading, but it
(31:36):
is oftentimes all about thatrisk.
So, as we're working withretailers or whomever brands,
agencies, influencers, whateverit may be, it's great to educate
about this, especially withonline engagement.
Here's the best practices.
Here's a training.
(31:56):
I do this a lot in my supplementadvisor group, my consulting
company.
Here's the training about bestpractices for online and social
media engagement.
Here's your parameters.
Here's your do's and don'ts.
Here's some examples.
So then we know Oftentimes thecompany employee who's engaging
(32:18):
with social media.
They may be so far away,removed from regulatory or
compliance they may not have anyidea.
The name of the game isengagement in essentially all
industries except supplements.
What works in tech appareldoesn't necessarily translate
over here.
So making sure this frontlineperson that's the front and last
(32:40):
barrier to potential issues,making sure they're trained,
creating a company culture ofcompliance is really important
and it doesn't have to becomplicated.
It can be a 10-minute talk thatyour social media managers sign
off on, and just making surethat they're aware of this and
that there are some written downprocedures, do's and don'ts, is
(33:03):
usually a pretty good start.
Tina Smith (33:07):
So do you have examples of some of the biggest
offenses?
I know we've talked a littlebit about some of these, but
just to help us clarify a littlebit, like these are big don'ts,
these have really had bigconsequences.
Asa Waldstein (33:22):
Disease claims Disease claims.
So we've talked about sleepingthrough the night that's a lower
risk.
We're the night that's lowerrisk.
We're talking about insomniahigher risk.
We've talked about supports aninflammatory response after
exercise lower risk.
We're talking about chronicinflammation higher risk.
Joint support lower risk.
(33:44):
Arthritis higher risk.
Cardiovascular support maybelower risk.
Prevents heart attack higherrisk.
So you would kind of I likethis example structure function
to disease claims.
Disease claims really are theeasiest way to get in trouble
Now, because everything's anextension of label.
(34:06):
This is somewhat nuanced, sohashtag is considered marketing.
So let's say, we have acompliant post and we add
hashtag flu prevention, we'vetaken a perhaps compliant post
and made it non-compliant.
The same thing with claimstatements in a video text
overlay that type of thing.
(34:27):
So disease claims really arethe key.
Another thing that's not talkedabout very often but it's
important is making sure that wedon't compare our products to
drugs or saying our products arebetter than drugs.
Natural health fanatic, butsaying our herbal dietary
(34:54):
supplement works as good orbetter than drugs is a great way
to attract FDA attention.
We're just not allowed to sayit and the higher the
ramifications of someone nottaking their drug, the higher
risk it is.
So let's say we're talkingabout ibuprofen, maybe that's
not super high risk, but ifwe're talking about an SSRI,
some depression med, someonegoes off their depression med or
(35:17):
their statins or whatever maybethis can create a serious
health crisis.
So saying, hey, you knowproducts or opioid withdrawal is
another huge one that agenciesare paying a big, huge attention
to, or a lot of attention to,rather, so hey, this product
(35:37):
helps you get off opioids orthis product helps you not be on
your depression beds anymore,that would really tip the scale
into warning letter category.
So we've talked about FDA, ofcourse, but another thing that I
wanted to make everyone awareof is with plaintiff attorneys.
So there are a lot of statementsthat FDA and in some ways, ftc
don't pay that much attention tothat plaintiff attorneys really
do.
No artificial flavors, noartificial colors, all natural
(36:03):
made in the USA, although FTCreally does focus on that as
well.
These type of statements arelow-hanging fruit for plaintiff
attorneys.
So I can't tell you the numberof calls I get from clients and
prospective clients and justcolleagues in the industry
saying, hey, I was making anall-natural ingredients claim,
but I have citric acid in myproduct and I got a demand
(36:25):
letter for between $20,000 to$50,000.
What do I do?
You're making an all-naturalclaim, but you're using an
ingredient that's notall-natural.
Basically, settle up is kind ofhow it works, and the plaintiff
attorneys are really smart andthey understand that.
So being careful, not just onlyfrom a prevent warning letter
(36:46):
point of view, but preventingthese lawsuits, is also really
essential.
Amanda Ballard (36:50):
So what would you do in a situation because
this happens a lot, especiallywith TikTok being as influential
as it is you know customerswill come in.
Something starts trending, likeBerberine is nature's ozempic,
that was pretty recent.
Or I think for a while, gabba'snature's Adderall, or I think
(37:11):
for a while, gaba's Nature'sAdderall.
What do you do in thosesituations?
Because you're not saying thatas the retailer, customers are
coming in but it's a problem,and you're like, well, I know I
can't say that, but they'resaying it.
Should I make any sort ofstatement on this to say like,
hey, we can't say that, but someway to address a situation like
(37:33):
that in a compliant manner?
Asa Waldstein (37:36):
Customers that are non-compensated, meaning not
free samples, they're not paid.
Influencers or ambassadors canessentially say whatever the
heck they want.
And so if that's on TikTok, hey, I tried this new Burberry
product.
I lost all these pounds.
Nature's is epic Hashtag nomore obesity.
Ok, now if I as a companyengage with that, again back to
(38:00):
the liking and engaging.
I've adopted that in mymarketing.
Oftentimes it'll be brandambassadors, people that have
received free product,influencers, saying these types
of statements, and if the brandcan't say it, then the
influencer or ambassador can'tsay it as well, shouldn't be
able to say it, and so there'sno kind of loophole there other
(38:23):
than to state that if a customeris not receiving free product,
they're just passionate.
They can say essentiallywhatever the heck they want
about the product if the brand'snot paying them, compensating
them or engaging with theircontent.
Amanda Ballard (38:39):
So would that be something we'd have to be
cautious of?
So, like I mean, a customercould put out a story on their
Instagram and say, hey, I gotthis berberine at this store and
I've lost all this weight.
It's like Nature's Ozempic andthey tag the local health food
store that they, like you, haveno control over that.
Do you potentially get introuble for something like that?
Asa Waldstein (39:04):
I don't know if I would remove the tag or not.
It's probably best to removethe tag, but I'm not.
I will say I'm not aware of anyenforcement for just leaving
the tag on there and notengaging.
And so, as a business owner,that'd be a decision, a risk
reward decision.
I would, you know they would,they would have to make.
(39:25):
But again, I don't, I don'tthink that that would be
superbly risky.
You know, brands love thesetrue believer, passionate folks
that just get out there and singfrom the rooftops.
It can be an interesting wayfor customers to talk about
products in a way that brandscan't or shouldn't.
(39:47):
Brands can't or shouldn't.
But that being said, if thebrand is manipulating that in
any way, then that crosses thatline, that ethical and
regulatory line.
Tina Smith (39:59):
Yes, that's interesting.
So what if you do have a brandinfluencer?
You're paying someone.
You've given them guidelineslike please don't make the
following claims, but say youknow these other things about it
.
You're welcome to say that, butstay away from this.
And they do it anyway.
Then what do you do?
Do you ask them to take it down?
Like, how do you react?
Asa Waldstein (40:18):
Influencer contracts are essential because
they kind of handle.
They should lay out a fewthings Parameters of what the
influencer or ambassador can andcan't say and ramifications for
what happens.
So brands can't just say, hey,here's a contract, you sign it
(40:39):
and go nuts.
There should be some type ofreview that the brand does.
I review 50 posts from 10% ofour influencers once a quarter,
whatever it may be.
So the brand should have thatas part of their internal
documents.
That's really important.
Then, on the influencercontract, it should lay out what
the ramifications are.
What's the stick there?
(41:00):
So if influencers are makingserious disease claims or
anything out of line, thecompany does have the right to,
I'm sure, ask them to take downthe post.
If there are repeat issues,then the termination of contract
happens.
(41:20):
That's pretty common.
I know that brands are hesitantfor really high value
influencers to do that, butlet's hope it never comes to
that.
I've worked with giganticcompanies on their influencer
outreach and training programand I'm just making this up.
It may be after two offenses.
The influencer needs toparticipate in a complimentary
(41:45):
influencer best practicetraining program, of which I've
done several of those, so theyunderstand how to talk about the
products in their own authenticbrand voice without crossing
the line.
Another part of that influencercontract that I want to make
sure I didn't forget isdisclosing material connection.
Most of the enforcement withinfluencers is not related to
(42:06):
disease claims, yet it's relatedto not disclosing material
connection.
That would be, if there's animage that would be hashtag, ad
or sponsored or brand ambassador, whatever it may be above the
fold, not buried.
Disclosing material connectionis really important.
So we'd want to make sure thatthat's part of the influencer
contract.
(42:26):
Now, with the new FTC guidelineson disclosure, now with the new
FTA FTC, rather, guidelines ondisclosure, if an influencer is
making a statement or a benefitstatement out loud, verbally,
then the disclosure should alsobe verbally.
It's kind of bananas, I don'tnecessarily.
I mean, I understand it, butit's also difficult.
So let's say there's a story,an influencer, says hey, I took
(42:49):
this product.
Thanks so much.
You know it's helping my jointsbe better.
Hey, I took this product,thanks so much, it's helping my
joints be better and I'msleeping through the night.
Is it really fair to ask themto then say thanks to brand ABC
for being my sponsor here?
Is it fair to ask them to saythat in a 30 second video?
I don't know, but that's whatthe rules are.
However, the endorsement ismade, then the disclosure should
(43:12):
be made in the same way.
So I know I went a littlesidetracked, but I want to make
sure I didn't miss thatimportant point about influencer
disclosures as well.
Tina Smith (43:21):
No, that's awesome.
I mean, obviously we're sort ofnitpicking, going down rabbit
trails a little bit, but this iswhat you do every day and it's
really nice to have an expert tobe able to ask these questions.
So I'm curious what is ApexCompliance?
Because I feel like a lot ofour retailers and manufacturers
might be interested in thatservice.
Asa Waldstein (43:42):
Thank you.
Apex Compliance is my softwareas a service compliance program,
and what it does is it helpsfind and replace risky marketing
phrases on websites, videos orcontent before publishing, and
this really grew out of a needfor my own consulting practice.
So Supplement Advisor Group, myconsulting company, I was asked
(44:03):
to do website compliancereviews.
Hey, look at my website, tellme what's wrong, tell me what I
need to do.
Hey, look at my website, tellme what's wrong, tell me what I
need to do.
I went looking.
I've got a list of top top 50or 75 words that are trigger
words, disease words, insomnia.
We've talked about a lot ofthem cancer, alzheimer's, that
type of thing.
I went looking for a productthat would actually find, a
(44:25):
computer product that wouldactually search these websites
for these risky words and giveme a report.
Guess what?
There was none out there and soI invented it.
I had some programmers build mea program.
This was a kind of entry-levelproduct that worked well for my
own consulting company.
I type in the words, I cansearch the website.
It gives me a report.
(44:45):
I customize that, I give thatto the client.
Greatly reduces their onlinemarketing risk.
And then all my colleaguesstarted asking me for this, tina
.
They started to say, hey, can Ilicense it, can I buy this
product?
And that's when Apex Compliancewas born.
So I launched about nine and ahalf or 10 months ago or so.
(45:05):
So very new startup.
And again it's a subscriptionsoftware.
You can upload your videos,your podcasts, your content
before publishing blogs, socialposts.
It'll scan for risky words,give it a risk rating, suggest
low-risk alternatives.
There's AI powered.
I've trained the Apex AI oncompliance principles, wording,
letter trends, lawsuit trends,that type of thing.
(45:27):
And then a really new excitingfeature that we're launching
soon is with being able to scanfull YouTube channels.
So right now we can do YouTubevideos one by one.
Pretty soon, like in the nextweek or two or three, we'll be
able to put in a YouTube channeland I'll scan those top 250
videos on the YouTube I'm really, really excited about too.
(45:47):
So Apex is great for companiesthat are coming into the US that
might not understand thenuances of the regulatory
structure here, kind of forpeace of mind, and it's also
great for established brands,retailers, to make sure that
their online marketing iscompliant.
It's not going to come back andit should not come back and
bite them old blogs, ingredientstatements, whatever it may be.
(46:10):
But it's also really valuablefor streamlining that content
review process.
Before I post a blog, anysocial post run it through the
Apex engine and it should flagmany risky words.
So it cuts down on that backand forth between marketing to
regulatory, marketing toregulatory.
(46:31):
Hey come on, I've told youmarketing 10 times, we shouldn't
say this.
It cuts down that and saves alot of time, and so it's really
exciting.
I'm happy to announce that Apexhas been invited to VitaFoods
Geneva next month.
So it's VitaFoods Europe andGeneva biggest supplement trade
show in Europe, I believe and sowe are actually a top six
(46:52):
finalist in the new technologysolution category.
So little old Apex Complianceme.
You know I get to go pitch onbehalf of the small company
we're going up I should say thatin quotes because it's all fun
and games against five reallylarge companies for this startup
award.
So I get to be on stage inGeneva in just a few weeks, so
(47:15):
I'm excited to share that withyou today.
Amanda Ballard (47:18):
That's so awesome.
I can't help but just be justin awe of that whole program
just existing.
I think it's very, very neededespecially in the world that we
live in that's so digitalmarketing driven to be able to
be in compliance and just knowwhat we can say and what we
(47:40):
can't say and how to limit ourrisk.
I love that.
So thank you for that servicethat you're providing.
I think that's fantastic.
Asa Waldstein (47:48):
Thank you, and I did want to add that we just
launched an Amazon prohibitedword list so it helps scan for a
lot of the trigger words thatAmazon may.
That may lead to delistingingredients and more resources,
that type of thing, and it iscompletely customizable so
companies can add all naturalmade in the USA, whatever it may
be, and then use that use thatto that to search their content,
(48:12):
which is, you know, I made itfor the dietary supplement
industry but several industriesare using it law firms, that
type of thing as well.
Tina Smith (48:22):
Amazing.
Okay, so two things arounddisclaimers what disclaimer or
type of disclaimer do you thinkshould be on every retailers or
natural products manufacturerswebsite?
And second, what disclaimer dowe need to make about this being
legal advice on this podcastepisode.
Asa Waldstein (48:44):
Thank you for that.
So this is informationalpurposes only, does not
constitute any legal orregulatory advice.
We're just having an opendiscussion.
It's not specific to anyindividual's company.
So if you want referrals forlawyers or consultants, please
contact me and I'm happy to sendyou in the right direction.
Amanda Ballard (49:03):
That's my disclaimer.
Asa Waldstein (49:05):
The other disclaimer is where we talked
about the FDA to Shea disclaimerthese statements are not
intended to treat your diagnosedpreventive disease, so on and
so forth.
That's a good idea to have onwebsites to I'm using a lot of
air quotes here comply with thatdishe regulation that the
(49:25):
disclaimer must be on everylabel panel where the claim is
made.
It's a good idea, but I don'tknow how much it protects you.
For example, it doesn't allowus to say whatever we want.
We can't put a hey, this isinformational purposes only, not
approved by the FDA, and thensay turmeric's great for.
(49:46):
Alzheimer's if we sell turmeric,so it's not a get out of jail
free card.
They have to match.
So other than that, on websites, I don't know whatever makes
sense for your own, of course,terms and conditions.
Privacy policy, americans forDisability Act compliance is
(50:07):
really important.
A lot of small retailers andcompanies practitioners,
continue to get sued for theirwebsites not being ADA or
Americans for Disability Actcompliance and making sure that
your website is ADA compliant isreally essential to help avoid
some of these pesky lawsuits.
Amanda Ballard (50:24):
Well, I just really appreciate your time with
us today, asa, if people wantto get in touch with you or
learn more about Apex Complianceor your consulting business,
how can they get in touch withyou?
Asa Waldstein (50:36):
Sure.
Thank you for that.
Amanda Ballard (50:38):
I am really active on.
Asa Waldstein (50:39):
LinkedIn.
As some of you may know, Iwrite my weekly post-warning
letter Wednesday, which I postto it.
So connecting on LinkedIn is agreat way to find out what I'm
up to.
That's my name, Asa Waldstein,on LinkedIn, same as on Twitter
X, or you can visitasawaldsteincom.
That's my website and fromthere you should be able to
direct it to the Warning LetterWednesday, my consulting
(51:01):
services.
And then just to throw one moreURL at you
apexcomplianceprogramcom is ourstandalone website.
That's apexcomplianceprogramcom, for Apex Compliance.
But really connecting onLinkedIn, I'd love to chat with
any of the listeners here.
Through the Asa Waldsteinwebsite, you can set up a free
(51:21):
initial consult.
I don't care how big or smallyou are.
I'm happy to donate 15 minutesof my time to help point you in
the right direction, provide anyresources I can as well.
Tina Smith (51:33):
That's so generous of you.
Thank you so much.
I know that our listeners willappreciate that, and what I
imagine, though, is that we willalso get a lot of follow-up
questions from this, so what I'mhoping is that we can invite
you back once we have a fulllist of questions to ask you
again.
Asa Waldstein (51:48):
Yes, without a doubt.
You know my day in the life isI'm asked very, very, very, very
difficult questions, so evenvery large brands that when they
have hard ones, they send themover to me and so it's great.
It helps my, helps my brain,you know, work well.
So hard questions, easyquestions.
I look forward to theopportunity coming back on the
(52:10):
show and chatting with you aboutthis Awesome.
Thanks so much for your time,asa.
I look forward to theopportunity coming back on the
show and chatting with you aboutthis Awesome Thanks so much for
your time, Asa.
Amanda Ballard (52:15):
Have a good rest of your day.
Thank you so much.
Asa Waldstein (52:17):
Thanks so much.
Have a great day.
Amanda Ballard (52:20):
Thanks so much for listening to the Natural
Products Marketer Podcast.
We hope you found this episodeto be super helpful.
Make sure you check out theshow notes for any of those
valuable resources that wementioned on today's episode.
Tina Smith (52:30):
And, before you go, we would love for you to give us
a review.
Follow, like and subscribe onApple Podcasts, Spotify, YouTube
or wherever you're listeningtoday, and make sure you join us
for our next episode, where wegive you more marketing tips so
that you can reach more peopleand change more lives.
Well, the FDA has a pretty big job right.
Their mandate of their charteris to protect public safety, so
they oversee conventional foodsthat's meats, that's eggs,
that's dairy.
They oversee drugs.
Dietary supplements are just apart of this.
So they've got a pretty big job, to be fair.
Tina Smith (00:24):
Welcome to the Natural Products Marketer
Podcast.
I'm Tina and.
Amanda Ballard (00:28):
I'm Amanda and we're here to make marketing
easier for natural productsbusinesses, so you can reach
more people and change morelives.
Tina Smith (00:38):
Amanda, how did you hear about Asa?
Amanda Ballard (00:41):
LinkedIn.
I've seen your name pop upeverywhere.
I've also I have a lot ofindustry friends that are mutual
friends of yours.
I was actually talking withSarah Burden the other day and
she was like, oh my gosh, I wasjust talking with him, so I was.
I was telling her how excited Iwas for today's interview.
I think the first time I heardabout you was from Deborah Short
(01:04):
with Senpa.
She had dropped your name for apossible speaking engagement
and so I've heard about youthrough the grapevine many, many
times.
Asa Waldstein (01:14):
Wonderful.
I love it.
Yeah, small world, even thoughthe supplement industry is so
big, it's really not that bigand so it's great.
It's great to have colleagueslike that share some kind words.
And yeah, sarah is wonderful.
I just recently saw her at theSupply Side East and what's Up
with Subs event and it waspretty exciting because my
(01:35):
daughter is 23.
She's never been to anyindustry events.
She's an environmentalist.
She's going to go to gradschool and see Boulder here in
Coloradoado where we live in thefall.
She's never been to anyindustry world events at all.
So she came and met me for thetail end of the what's up with
subs event and it was so neatshe every by that time people
(01:58):
have been having a really goodtime, you know, drinking and
celebrating.
But she heard about warningletter wednesday, my weekly blog
post over and over and overagain.
Oh, like this is my daughternova.
Oh, yeah, we love warningletter wednesday.
She spoke to me at the end ofthe event because then we went
and spent three nights in newyork city having fun.
She said now I kind of get itbecause I'm I do warning letter
(02:22):
wednesday every week, every tTuesday night for Wednesday, for
the past two and a half plusyears whether we're in.
Africa or on vacation orwherever it may be.
So it kind of helped her seewhat her dad does and why I'm
always taking two hours off onher vacation to do Morning
Letter Wednesday and it was kindof a fun aside there, awesome
(02:43):
to do morning letter rides.
Tina Smith (02:44):
And it was kind of a fun aside there.
Awesome, we're really excitedto talk to you because so many
of our clients need you.
So many retailers have a lot ofquestions, and manufacturers
too, and they're questions thatwe either don't know how to
answer or we feel reallyuncomfortable answering because
they're compliance related.
So we want to make sure that wegive people the right
(03:08):
information from someone whoknows what they're talking about
.
So I would love to start withfirst just how you got into this
industry and what brought youinto compliance and regulatory
related to the supplements.
Asa Waldstein (03:23):
I love that question, thank you.
I followed my passion forherbal supplements and natural
healing into the dietarysupplement industry.
So, to back up even more, Icame out to Boulder.
I like cool places.
So I came out from Santa Cruzto Boulder, colorado, in the
late nineties to study clinicalherbalism.
So I participated in athree-year clinical herbalism
program I'm a certified clinicalherbalist and then participated
in a three-year clinicalherbalism program I'm a
(03:45):
certified clinical herbalist andthen in 2001, I started making
supplements because herbs arecool, I believe in natural
healing, that type of thing, andlittle did I know that this
whole dietary supplementindustry was going to grow up
around me.
So I kind of just followed mypassion for herbs into a dietary
supplement manufacturingenvironment.
And then it was just kind offate and serendipity.
(04:09):
I was actually pretty good atrunning dietary supplement
companies, formulating, talkingto customers, getting products
out the door in a compliantmanner.
And then I learned theregulations kind of from the
inside out.
So I've seen the implementationof laws such as GMPs for
dietary supplements, commonallergy and labeling law, to
(04:29):
name a few.
So I kind of learned them againfrom the inside out.
How do these regulations andlaws, how do they affect me as a
small business manager orsomeone who's helping to guide
different brands.
How do we make sense of them ina practical way?
How do we interpret theregulations in a way that's not
(04:49):
going to put us out of businessbut is actually going to make
sense and allow us to continueto do our jobs, make money, sell
great health giving products,but also stay in compliance?
So I did that for many yearsprobably about 17 years as a
dietary supplement manufacturerand marketer, and then I went
out on my own.
So I started my own regulatoryconsulting company about four
(05:12):
years ago, and what I love aboutthat is, instead of working
with one company, I get to workwith 30, 40, 50 different
companies and really understandthe nuances of regulatory
compliance and how it applies toall these different companies,
whether they're small, emergingbrands or the biggest of the big
companies as well.
Tina Smith (05:32):
Yeah, so one of the big misconceptions about the
supplement industry is that it'snot regulated, and we know that
that's not true.
It's very regulated, but youknow we hear a lot that the FDA
does not regulate supplementsand so you can't trust what's in
the bottle.
So tell us a little bit aboutthe regulations that are there
(05:53):
and how much regulation the FDAdoes have over the products.
Asa Waldstein (05:59):
Well, the FDA has a pretty big job, right?
They have to.
Their mandate of their charteris to protect public safety.
So they oversee conventionalfoods that's meats, that's eggs,
that's dairy.
They oversee drugs.
Dietary supplements are just apart of this.
So they've got a pretty big job, to be fair.
(06:20):
And so we're talking aboutdietary and herbal supplements
here.
So FDA inspects around 500dietary supplement manufacturing
facilities a year.
I've heard that there's overperhaps 10,000 dietary
supplement manufacturingfacilities in the US.
So 5%, that's not a very goodnumber.
So I really would like to seeFDA, I'd like to get some more
(06:45):
resources to FDA to do more GMPinspections.
So I think FDA is doing apretty good job with the
resources they have.
Um kind of on the critical side, I think FDA could certainly do
a better job at helping toremove drug spike ingredients
and drug spike ingredientproducts from the market
whenever they're found.
Again, it's a very, very smallsubset of dietary supplements.
(07:09):
Whenever they are found, I'dlike to see them removed with a
little more haste.
So of course we knowsupplements are regulated by the
FDA, and I'm just making up anumber here.
99.8% of them are probablypretty darn good.
They're made under a goodmanufacturing practice compliant
facility.
(07:30):
but then there's a select fewout there that I've talked about
with the drug spike ingredientsand that type of thing.
So dietary supplements yeah,they have a high level of safety
and you know I always lovehaving these type of
conversations.
And thank you for this question, tina, because educating about
the regulatory structure, theframework with dietary
(07:52):
supplements and actually howgenerally safe supplements are
when taken as directed, takingall the potential
contraindications in mind,really is an important topic to
get out to the broader public.
Amanda Ballard (08:07):
Yeah, that's really interesting and I'm glad
that you kind of clarified that.
You know, I think one of theprobably one of the bigger
questions we get beyond thatmore from a retail perspective.
I've been around the block acouple times now with different
retailers and the topic ofDeshaies comes up over and over
(08:27):
again.
So for the uninitiated, can youtell us a little bit about the
Deshaies Act and what that didto this industry back in the 90s
?
And I know from many of mypeers that have owned their own
health food stores since, youknow, the 70s, 80s, 90s.
(08:49):
This was a big deal for themand I can't necessarily share in
that experience.
And so they talk about Dachetall the time and how like, how
amazing it was that that gotpassed.
I'm like I can't relate to you.
What does this mean?
And then, what does it actuallymean to present day about what
we can and cannot say aboutsupplements?
Asa Waldstein (09:07):
Yeah, thank you for that.
So DSHEA, the DietarySupplement, Health and Education
Act.
We have so many acronyms in ourworld, it's good to spell about
every once in a while.
So there is a world beforeDSHEA and after.
DSHEA, the world before DSHEA is, there wasn't really a legal
way to sell and market herbaland dietary supplements.
I think to your point, amanda.
(09:28):
Companies were getting ratedfor selling products that
contain herbs like echinacea oreven vitamin C and things like
that.
So it's really just crazy tothink about, from what we look,
what it's like now, 30 yearslater, and what it was like
before 1994 when Deshaies passed.
So again, deshaies gave us alawful way to manufacture and
(09:50):
market herbal ingredients.
And so when we look at kind ofwhat Deshaies did, talking about
claims and how it helpedclarify some of what we can say,
deshaies helped clarify what isoff limits, so a disease claim,
and what is a structurefunction claim Allowable if we
have substantiation.
(10:13):
So I love the example ofinflammation.
Right, I run a regulatoryconsulting company.
I'm asked, hey, is inflammationa claim?
So here's a good example.
If we're talking about helpsupport a healthy inflammatory
response after exercisestructure function claim, we're
talking about the body.
It's a normal non-disease state.
I worked out too hard, I wentsnowboarding, I've got an
(10:35):
inflammatory response.
I'm helping to balance thatpretty low risk.
I'd consider that in thestructure function category in
my opinion, whereas the phrasechronic inflammation or helps
with chronic inflammation that'sdisease related.
You know that's diseaseadjacent.
So you can't have somethingthat's a normal life event that
goes on all the time that itcrosses that line from okay or
(10:59):
probably okay into disease claimcategory.
Another thing that Deshaies didwas it kind of put a stake in
the ground with ingredients, soanything marketed, or most
things marketed, before October15th 1994, when Deshaies passed.
I know that date becauseOctober 15th is the anniversary
(11:20):
of the first date that I hadwith my wife.
That's how I remember it.
Even though I'm a geek, I knowthis stuff.
I remember October 15th as adate, so anyway.
October 15th 1994, herbs andingredients were marketed before
then.
They're considered ODIs or olddietary ingredients and they're
most likely to be allowableunder this structure.
(11:40):
Anything marketed after thatDachet date is considered a new
dietary ingredient according toFDA regulations.
So if it's an NDI, a newdietary ingredient, companies
are supposed to go through thesafety procedures of proving
that ingredient safe.
Now I just wanted todemonstrate how unclear this is
(12:03):
and how complex it is at thesame time.
So let's take an ingredientlike turmeric.
Turmeric marketed forever andever, probably considered an old
dietary ingredient.
But if we take turmeric and wehighly, highly purify it, if
that purification was done andwas sold in the marketplace
after the disheies date, thenmaybe it needs to become be
(12:27):
considered a new dietaryingredient.
So as we're looking at kind ofDeshaies, the initial framework
there and how it affects ustoday, I also, of course, look
at labeling.
Right, I'm a regulatory person.
I look at labeling.
So when Deshaies was enacted,there was really no such thing
as the internet.
So when we look at so whenDeshaies was enacted, there was
really no such thing as theinternet.
So when we look at thecomplexities of Deshaies then
(12:49):
and Deshaies 30 years later,some of the regulations of
Deshaies don't really make sense.
So when we're unclear on how toadapt regulations for the world
we live in today, we look atwarning letters.
So that's why I love writingWarning Letter Wednesday, which
we talked about before we jumpedon today, and why it's
(13:11):
important to read FDA warningletter trends.
So I like to think of the adageof all marketing is an
extension of the label.
So if we wouldn't put somethingon the label, such as anxiety
support, we should be verycareful to not let it slip by in
any secondary form of marketing.
Hashtag social post, influencerpost, that type of thing.
(13:34):
So that really shows howDeshaies provided a framework.
But then we have to payattention to enforcement trends
as a way to interpret how thatmakes sense for our company.
And I did want to give a plugto APA, the American Herbal
Products Association, at ExpoWest.
They just posted a 30 years ofDachet video and I'll share it
(13:55):
with you, amanda and Tina.
If you can share it with thereaders here, I think that'd be
a great resource.
I think that'd be a greatresource.
It's a great video of Deshaies,what it was like before
Deshaies, how we got to where weare here in the herbal dietary
supplement industry.
Yeah, absolutely.
(14:24):
Now there is word on the streetthat they might start looking at
Deshaies again in thelegislature.
What would that mean?
I think that it could meanadapting some of the antiquated
verbiage that was part of theact before there was the
internet, for example, so thatcould be good.
It could also be helping tomaybe further define what is
(14:46):
education and what is a diseaseclaim.
So, for example, if we'retalking about a blog and we're
talking about an ingredient in ablog and that ingredient sold
in our product, is thateducation or is that labeling
According to FDA warning letterenforcement?
That's labeling, but it wouldhelp clarify some of those type
(15:06):
of things.
Also, there's this veryantiquated rule which drives me
bananas, that plaintiffattorneys have got a hold of and
we're all aware of that FDA orthat Deshaies disclaimer this
product has not been intended totreat, diagnose, cure, prevent
disease, so on and so forth.
Intended to treat, diagnose,cure, prevent disease, so on and
so forth.
Now, according to this DSHEAAct, that disclaimer needs to be
(15:29):
on every label panel.
It says label panel in therules every label panel where
that structure function claim isso, let's say that the product
supports joint health, on theprincipal or the main label
panel.
Now, according to the regs,we're supposed to put that to
shade disclaimer on that mainlabel panel and on the side
(15:51):
label panel for structurefunction claims.
It's so, bananas, that it'sleading to several lawsuits.
It's very silly.
Being able to update.
Things like that are important.
I also urge caution.
If we open up discussion wemight not get what we want.
So you know, bringing Deshaiesinto you know now, 2024 and
(16:17):
beyond, into more of a modernframework, I think, is not a bad
idea.
But we need to be vigilant ifwe open up that discussion to
make sure that we're not goingto lose any of the protections
provided by Dachet.
Tina Smith (16:30):
Yeah, I'm so curious about some of these things that
you're talking about,especially when it comes to
education materials like blogposts or webinars and that kind
of thing, when you start talkingabout scientific studies even.
Is that in compliance if yousell the product in your store
(16:52):
and you have a blog post aboutit, even if you don't point from
the blog post to the product?
Asa Waldstein (16:59):
I love this discussion.
I don't know about a brick andmortar type discussion.
We'll come back to that.
Secondly, but according againto FDA warning letter
enforcement, clinical citationsare considered marketing, so
they are considered labeling.
So let's say that we have ablog post about turmeric and
(17:22):
then we have a study citationabout turmeric and arthritis.
Now if we're not sellingturmeric on that website or
connected by the social media orlinked in some way pretty darn
low risk, probably in the fineto no risk category.
But if we are selling turmeric,then the FDA would probably
(17:43):
consider that a labeling andtherefore, citing that clinical
study is saying hey, theingredient turmeric in this
example that we have in ourproduct is being marketed for
arthritis.
So, citing clinical studies,even if we have all the research
in the world, we're still notallowed to make those disease
claims about our products oringredients, according to FDA.
(18:08):
Ftc is a little bit different.
Now, if it's a brick-and-mortarstore and they are maybe not
selling their product online butthey are educating online, but
they are selling that product intheir store, I can't think in
reality of a situation wherethat would occur Then it's
(18:30):
probably far enough that it'snot really risky, but it's all
about how linked it is.
Again, if it's on a website oron a social or YouTube and
that's linked to where peoplecan order products.
That's a common statement inwarning letters.
That's enough to build thatbridge from clinical research
into disease claims and the sameand I'm often asked this as
(18:53):
well the same is true for studycitations.
So study citations have beencited in some warning letters,
mostly related to COVID and CBD,because there was some initial
research about that.
So simply just having a studycitation with the ingredient in
the disease claim, that wasenough to attract a warning
(19:13):
letter in this COVID, cbd groupof warning letters from a year
or two ago.
So I don't think in real worldrisk that just study citations
are enough to tip the scale intowarning letter category unless
they're very high risk.
So just a quick closing thoughton that is a good best practice
(19:34):
if companies are using studycitations which I think is good
as long as we're being truthfuland not misleading is make sure
that the ingredient name or theproduct name and the disease
claim are not in that studycitation or that URL.
So if it was turmeric study forarthritis, maybe remove
turmeric or arthritis from there.
(19:55):
That greatly lowers the risk.
There's a hot tip for today.
Tina Smith (20:01):
Thank you.
I'm curious about what happensif you get a warning letter.
Yeah, warning letters.
Asa Waldstein (20:08):
we definitely want to avoid them.
So they're a public record.
They rank very high in searchengines like Google.
So it can be memorializedforever.
The name of the company and thepeople that are in charge
memorialize forever in warningletter history.
So because they're public, itcan lead to credit card
(20:29):
processing issues, insuranceissues.
It can also scare awaydistributors.
So it can scare awaydistributors.
It might be Whole Foods orwhatever it may be.
Warning letters can affect thatOn face value.
They require legal resources torespond to, and repeat warning
(20:49):
letters may perhaps lead toinjunction or seizure, although
that's very rare.
Companies have to be kind ofnot very nice, be jerks to do
that, really scurrying a lot,but it's possible.
So we always want to respond toa warning letter.
We should respond to warningletters.
It's possible.
So we always want to respond towarning letter.
We should respond to warningletters.
And again, we were kind ofmaybe there's more of a target
(21:10):
on companies back from the FDA,because repeat warning letters
do have a more seriousramification.
Now in this day and age in thesupplement industry there's so
much, there's so many mergersand acquisitions happening.
There's a lot of things likethat.
So the quickest way to scareaway M&A strategic alignment
investment is to get a warningletter.
(21:31):
Those folks with the cash.
They'd rather go to someoneelse that maybe doesn't have
that target on their back.
Now there's some reasons toavoid a warning letter, but one
of the main reasons is it alertsclass action attorneys.
So oftentimes plaintiffattorneys will use the warning
letter as the basis ofwrongdoing in the lawsuits, copy
and paste that warning letterinto the lawsuit and that can
(21:55):
lead to demand letters andlawsuits.
And that's very common Warningletters come out lots of demand
letters and lawsuits follow.
Amanda Ballard (22:02):
Interesting.
Have you seen any retailers getissued warning letters?
Asa Waldstein (22:10):
It's usually retailers that have an online
presence and so oftentimes it'smaybe retailers that are selling
products that are not compliant, such as there was a bunch of
ophthalmic so high productwarning letters.
I'm not picking on anycompanies like CBS, I think
(22:34):
Walgreens big giant nationalretailers got warning letters
for distributing these products.
Now they were distributing themonline, making it really easy
for an FDA inspector to justlook online and see that.
So retailers certainly do getwarning letters.
It's almost always for thedisease claims or the lack of
(22:54):
compliant product categorythat's being sold online.
Of course, we can't talk aboutretailers without talking about
Amazon.
Amazon continues to get betterand better.
Let's hope they're moving inmore, continue to move in more
compliant direction.
I believe they probably are,but Amazon, I think, has gotten
(23:15):
four warning letters over thepast 16 months or so.
So Amazon really is in thecrosshairs of FTA just because
they're so big and, according toGMP regulations, distributors
are responsible for thecompliance of the products they
distribute.
So I'm actually glad thatAmazon, who is a distributor
(23:36):
they're actually handling theproduct has been held
accountable for either thedisease claims or the compliance
of the products that they aredistributing, because according
to GMPs, all distributors arecompliant.
So I certainly feel like ifsmaller or medium-sized
distributors should comply withGMP distributor requirements
(23:58):
can't remember which subpart itis, then of course the biggest
one in the world, amazon shouldbe held accountable as well.
Tina Smith (24:05):
Yeah, so I'm just curious, based on that question,
you haven't heard about smallerindependent retailers receiving
these warning letters.
Asa Waldstein (24:16):
Yeah, so only if they're thank you for clarifying
that only if they're makingdisease claims, almost only if
they're making disease claims.
These might be smallerpractitioners.
These might be smallerindependent retailers.
These might even be farmer'smarket style cottage industries
(24:42):
that are selling their productsat farmer's markets.
They snap a picture of theirsign hey, our echinacea is great
for flu prevention.
Whatever it may be, they putthat online.
On that maybe I'm speakinghypotheticals on their instagram
or whatever it may be, thatinstagram links to a shopping
(25:02):
cart where customers can orderproducts.
That certainly, without a doubt, has attracted warning letters.
So there's a lot of thesesmaller retailers that, to be
honest, probably just don't knowany better.
I don't necessarily thinkthere's very much of any
malicious activity or deceptiveactivity.
They probably just don't knowany better.
(25:23):
Taking and copying if you goonto Google or AI or whatever it
may be and say what are thebenefits of echinacea, you're
going to get disease, disease,disease.
Taking and copying those overonto marketing doesn't
necessarily translate intocompliant copy.
Same thing with clinicalstudies, right?
So branded ingredients, otherclinical studies we go on PubMed
(25:45):
, I'll stay with echinaceastudies.
We go on PubMed, I'll stay withEchinacea.
There's lots of studies abouthelps with mitigation of flu
symptoms or whatever it may be,those don't necessarily
translate in compliant marketing, so a lot of these smaller
retailers don't know that.
I guess that's why we're havingthis discussion right to help
educate people about what iseducation and where education
(26:09):
crosses that line into marketing.
Amanda Ballard (26:12):
So what about customer testimonials?
So we recommend that to a lotof our clients to use their
customer testimonials in theirmarketing, just because it's you
know, it's they're saying it,not me, right?
So how does that in in theregulatory space?
Like you know, customer says oh, this helped me get rid of
whatever ailment that I'mdealing with.
(26:34):
How do we handle that?
Asa Waldstein (26:38):
It's a great question.
So testimonials that a companyadopts, post on social, puts in
a banner ad, curates in any way,interacts with, engages with,
those are considered pieces ofmarketing and therefore their
labeling.
So let's say there's atestimonial such as this product
(27:00):
worked great for my arthritis,a social wall or coming maybe an
Amazon review or testimonial orcoming in through a third-party
widget that's non-curated,non-compensated, on a website,
all right, the authority hasbeen pretty hands-off with that.
Now, if I as a company thenlike it or say thanks on social,
(27:25):
I've adopted that as mymarketing and therefore it's
labeling.
If I engage with a producttestimonial or review on my
website, then I've engaged withthe same thing with socials.
I've adopted it as my marketing.
If I take that and then put itin a banner ad I see this
(27:46):
mistake happening all the time.
Customer testimonials we'reexcited when we get testimonials
with companies.
We'll copy and paste them ontoInstagram or whatever it may be.
That's labeling and that'smarketing.
So anything we adopt asmarketing is again labeling.
I know I'm repeating myself,but it's important.
We must have substantiation forand we're responsible for that.
(28:08):
So we's kind of.
You know, we've we've kind ofunpacked this a little, a little
bit of where the gray area isand where the gray area crosses
that line into into marketing.
Tina Smith (28:22):
And I'm curious, you just use the word substantiated
.
We would have to be able tosubstantiate the claim.
What does that entail?
Like what would you to be ableto substantiate the claim?
What does that entail?
Like what would you need tohave to substantiate a claim?
Asa Waldstein (28:33):
Got it.
Just need to make sure that wehave some firm clinical data to
back up whatever we're saying.
So if a customer's, we'll stayon testimonials.
As an example, let's say acustomer says, hey, this product
helped me sleep eight hoursthrough the night, we better
have some data to back up thatour product can actually do that
(28:55):
, that that is a reproducibleresult in, I'll just say, the
majority of the population.
Now to take substantiation alittle deeper, and I don't want
to scare anybody out there, butthe gold standard is placebo,
controlled, randomized, blindedclinical trials.
So that is a well-powered studyof dozens and dozens of
(29:19):
individuals that don't know whatthey're taking.
If they're taking a placebo oran active product and it's
reproducible, that is veryexpensive to do.
On dietary supplements, whichis why a lot and it just doesn't
make sense because we're notsupplements are not drugs in
many cases.
So that's why a lot ofcompanies depend on the data
(29:40):
that's available, either throughbranded ingredient or, you know
, for example, pubmed.
So if there is a study on athousand milligrams of vitamin C
I'm making up these numbers, sodon't quote me on that A
thousand milligrams of vitamin Ctaken as a capsule twice a day
for immune support.
Let's say there's awell-powered study on PubMed
about just vitamin C.
(30:01):
Now companies oftentimes willuse that to build out their
substantiation dossier.
That's just a fancy word forthe packet.
So if our product has athousand milligrams of vitamin C
it's the same study population,the same form, like the capsule
then that probably helps ussubstantiate a claim of immune
support.
So it's kind of finding thedata out there, making sure like
(30:25):
matches, like animal studiesdon't necessarily they're not,
they're not the best.
We want to find human clinicaltrials on ingredients that we
can then use to prove theirproducts work.
We have data to back it up.
We're not just, you know,looking into a crystal ball and
saying, hey, this product'sreally good.
Let me make up a bunch ofclaims about it.
Amanda Ballard (30:46):
Basically, I mean a bunch of claims about it.
Basically, I mean, what I'mhearing is that retailers need
to be super careful in whatthey're engaging with online,
even if you know someoneliterally just comments on
Instagram this is my favoriteproduct you sell in your store.
I'm sleeping better than I'veever slept in my life and you
(31:08):
hit that like button next to itLike you are claiming that as a
factual statement.
Asa Waldstein (31:15):
Yep, it's true.
It's true, and with thatexample, that might be a
calculated risk on the company'spart because there's not any
disease words, high risk diseasewords there.
If there was word insomniathere, ding, ding, ding, we've
really elevated the risk.
It's all about you have to betruthful, not misleading, but it
(31:36):
is oftentimes all about thatrisk.
So, as we're working withretailers or whomever brands,
agencies, influencers, whateverit may be, it's great to educate
about this, especially withonline engagement.
Here's the best practices.
Here's a training.
(31:56):
I do this a lot in my supplementadvisor group, my consulting
company.
Here's the training about bestpractices for online and social
media engagement.
Here's your parameters.
Here's your do's and don'ts.
Here's some examples.
So then we know Oftentimes thecompany employee who's engaging
(32:18):
with social media.
They may be so far away,removed from regulatory or
compliance they may not have anyidea.
The name of the game isengagement in essentially all
industries except supplements.
What works in tech appareldoesn't necessarily translate
over here.
So making sure this frontlineperson that's the front and last
(32:40):
barrier to potential issues,making sure they're trained,
creating a company culture ofcompliance is really important
and it doesn't have to becomplicated.
It can be a 10-minute talk thatyour social media managers sign
off on, and just making surethat they're aware of this and
that there are some written downprocedures, do's and don'ts, is
(33:03):
usually a pretty good start.
Tina Smith (33:07):
So do you have examples of some of the biggest
offenses?
I know we've talked a littlebit about some of these, but
just to help us clarify a littlebit, like these are big don'ts,
these have really had bigconsequences.
Asa Waldstein (33:22):
Disease claims Disease claims.
So we've talked about sleepingthrough the night that's a lower
risk.
We're the night that's lowerrisk.
We're talking about insomniahigher risk.
We've talked about supports aninflammatory response after
exercise lower risk.
We're talking about chronicinflammation higher risk.
Joint support lower risk.
(33:44):
Arthritis higher risk.
Cardiovascular support maybelower risk.
Prevents heart attack higherrisk.
So you would kind of I likethis example structure function
to disease claims.
Disease claims really are theeasiest way to get in trouble
Now, because everything's anextension of label.
(34:06):
This is somewhat nuanced, sohashtag is considered marketing.
So let's say, we have acompliant post and we add
hashtag flu prevention, we'vetaken a perhaps compliant post
and made it non-compliant.
The same thing with claimstatements in a video text
overlay that type of thing.
(34:27):
So disease claims really arethe key.
Another thing that's not talkedabout very often but it's
important is making sure that wedon't compare our products to
drugs or saying our products arebetter than drugs.
Natural health fanatic, butsaying our herbal dietary
(34:54):
supplement works as good orbetter than drugs is a great way
to attract FDA attention.
We're just not allowed to sayit and the higher the
ramifications of someone nottaking their drug, the higher
risk it is.
So let's say we're talkingabout ibuprofen, maybe that's
not super high risk, but ifwe're talking about an SSRI,
some depression med, someonegoes off their depression med or
(35:17):
their statins or whatever maybethis can create a serious
health crisis.
So saying, hey, you knowproducts or opioid withdrawal is
another huge one that agenciesare paying a big, huge attention
to, or a lot of attention to,rather, so hey, this product
(35:37):
helps you get off opioids orthis product helps you not be on
your depression beds anymore,that would really tip the scale
into warning letter category.
So we've talked about FDA, ofcourse, but another thing that I
wanted to make everyone awareof is with plaintiff attorneys.
So there are a lot of statementsthat FDA and in some ways, ftc
don't pay that much attention tothat plaintiff attorneys really
do.
No artificial flavors, noartificial colors, all natural
(36:03):
made in the USA, although FTCreally does focus on that as
well.
These type of statements arelow-hanging fruit for plaintiff
attorneys.
So I can't tell you the numberof calls I get from clients and
prospective clients and justcolleagues in the industry
saying, hey, I was making anall-natural ingredients claim,
but I have citric acid in myproduct and I got a demand
(36:25):
letter for between $20,000 to$50,000.
What do I do?
You're making an all-naturalclaim, but you're using an
ingredient that's notall-natural.
Basically, settle up is kind ofhow it works, and the plaintiff
attorneys are really smart andthey understand that.
So being careful, not just onlyfrom a prevent warning letter
(36:46):
point of view, but preventingthese lawsuits, is also really
essential.
Amanda Ballard (36:50):
So what would you do in a situation because
this happens a lot, especiallywith TikTok being as influential
as it is you know customerswill come in.
Something starts trending, likeBerberine is nature's ozempic,
that was pretty recent.
Or I think for a while, gabba'snature's Adderall, or I think
(37:11):
for a while, gaba's Nature'sAdderall.
What do you do in thosesituations?
Because you're not saying thatas the retailer, customers are
coming in but it's a problem,and you're like, well, I know I
can't say that, but they'resaying it.
Should I make any sort ofstatement on this to say like,
hey, we can't say that, but someway to address a situation like
(37:33):
that in a compliant manner?
Asa Waldstein (37:36):
Customers that are non-compensated, meaning not
free samples, they're not paid.
Influencers or ambassadors canessentially say whatever the
heck they want.
And so if that's on TikTok, hey, I tried this new Burberry
product.
I lost all these pounds.
Nature's is epic Hashtag nomore obesity.
Ok, now if I as a companyengage with that, again back to
(38:00):
the liking and engaging.
I've adopted that in mymarketing.
Oftentimes it'll be brandambassadors, people that have
received free product,influencers, saying these types
of statements, and if the brandcan't say it, then the
influencer or ambassador can'tsay it as well, shouldn't be
able to say it, and so there'sno kind of loophole there other
(38:23):
than to state that if a customeris not receiving free product,
they're just passionate.
They can say essentiallywhatever the heck they want
about the product if the brand'snot paying them, compensating
them or engaging with theircontent.
Amanda Ballard (38:39):
So would that be something we'd have to be
cautious of?
So, like I mean, a customercould put out a story on their
Instagram and say, hey, I gotthis berberine at this store and
I've lost all this weight.
It's like Nature's Ozempic andthey tag the local health food
store that they, like you, haveno control over that.
Do you potentially get introuble for something like that?
Asa Waldstein (39:04):
I don't know if I would remove the tag or not.
It's probably best to removethe tag, but I'm not.
I will say I'm not aware of anyenforcement for just leaving
the tag on there and notengaging.
And so, as a business owner,that'd be a decision, a risk
reward decision.
I would, you know they would,they would have to make.
(39:25):
But again, I don't, I don'tthink that that would be
superbly risky.
You know, brands love thesetrue believer, passionate folks
that just get out there and singfrom the rooftops.
It can be an interesting wayfor customers to talk about
products in a way that brandscan't or shouldn't.
(39:47):
Brands can't or shouldn't.
But that being said, if thebrand is manipulating that in
any way, then that crosses thatline, that ethical and
regulatory line.
Tina Smith (39:59):
Yes, that's interesting.
So what if you do have a brandinfluencer?
You're paying someone.
You've given them guidelineslike please don't make the
following claims, but say youknow these other things about it
.
You're welcome to say that, butstay away from this.
And they do it anyway.
Then what do you do?
Do you ask them to take it down?
Like, how do you react?
Asa Waldstein (40:18):
Influencer contracts are essential because
they kind of handle.
They should lay out a fewthings Parameters of what the
influencer or ambassador can andcan't say and ramifications for
what happens.
So brands can't just say, hey,here's a contract, you sign it
(40:39):
and go nuts.
There should be some type ofreview that the brand does.
I review 50 posts from 10% ofour influencers once a quarter,
whatever it may be.
So the brand should have thatas part of their internal
documents.
That's really important.
Then, on the influencercontract, it should lay out what
the ramifications are.
What's the stick there?
(41:00):
So if influencers are makingserious disease claims or
anything out of line, thecompany does have the right to,
I'm sure, ask them to take downthe post.
If there are repeat issues,then the termination of contract
happens.
(41:20):
That's pretty common.
I know that brands are hesitantfor really high value
influencers to do that, butlet's hope it never comes to
that.
I've worked with giganticcompanies on their influencer
outreach and training programand I'm just making this up.
It may be after two offenses.
The influencer needs toparticipate in a complimentary
(41:45):
influencer best practicetraining program, of which I've
done several of those, so theyunderstand how to talk about the
products in their own authenticbrand voice without crossing
the line.
Another part of that influencercontract that I want to make
sure I didn't forget isdisclosing material connection.
Most of the enforcement withinfluencers is not related to
(42:06):
disease claims, yet it's relatedto not disclosing material
connection.
That would be, if there's animage that would be hashtag, ad
or sponsored or brand ambassador, whatever it may be above the
fold, not buried.
Disclosing material connectionis really important.
So we'd want to make sure thatthat's part of the influencer
contract.
(42:26):
Now, with the new FTC guidelineson disclosure, now with the new
FTA FTC, rather, guidelines ondisclosure, if an influencer is
making a statement or a benefitstatement out loud, verbally,
then the disclosure should alsobe verbally.
It's kind of bananas, I don'tnecessarily.
I mean, I understand it, butit's also difficult.
So let's say there's a story,an influencer, says hey, I took
(42:49):
this product.
Thanks so much.
You know it's helping my jointsbe better.
Hey, I took this product,thanks so much, it's helping my
joints be better and I'msleeping through the night.
Is it really fair to ask themto then say thanks to brand ABC
for being my sponsor here?
Is it fair to ask them to saythat in a 30 second video?
I don't know, but that's whatthe rules are.
However, the endorsement ismade, then the disclosure should
(43:12):
be made in the same way.
So I know I went a littlesidetracked, but I want to make
sure I didn't miss thatimportant point about influencer
disclosures as well.
Tina Smith (43:21):
No, that's awesome.
I mean, obviously we're sort ofnitpicking, going down rabbit
trails a little bit, but this iswhat you do every day and it's
really nice to have an expert tobe able to ask these questions.
So I'm curious what is ApexCompliance?
Because I feel like a lot ofour retailers and manufacturers
might be interested in thatservice.
Asa Waldstein (43:42):
Thank you.
Apex Compliance is my softwareas a service compliance program,
and what it does is it helpsfind and replace risky marketing
phrases on websites, videos orcontent before publishing, and
this really grew out of a needfor my own consulting practice.
So Supplement Advisor Group, myconsulting company, I was asked
(44:03):
to do website compliancereviews.
Hey, look at my website, tellme what's wrong, tell me what I
need to do.
Hey, look at my website, tellme what's wrong, tell me what I
need to do.
I went looking.
I've got a list of top top 50or 75 words that are trigger
words, disease words, insomnia.
We've talked about a lot ofthem cancer, alzheimer's, that
type of thing.
I went looking for a productthat would actually find, a
(44:25):
computer product that wouldactually search these websites
for these risky words and giveme a report.
Guess what?
There was none out there and soI invented it.
I had some programmers build mea program.
This was a kind of entry-levelproduct that worked well for my
own consulting company.
I type in the words, I cansearch the website.
It gives me a report.
(44:45):
I customize that, I give thatto the client.
Greatly reduces their onlinemarketing risk.
And then all my colleaguesstarted asking me for this, tina
.
They started to say, hey, can Ilicense it, can I buy this
product?
And that's when Apex Compliancewas born.
So I launched about nine and ahalf or 10 months ago or so.
(45:05):
So very new startup.
And again it's a subscriptionsoftware.
You can upload your videos,your podcasts, your content
before publishing blogs, socialposts.
It'll scan for risky words,give it a risk rating, suggest
low-risk alternatives.
There's AI powered.
I've trained the Apex AI oncompliance principles, wording,
letter trends, lawsuit trends,that type of thing.
(45:27):
And then a really new excitingfeature that we're launching
soon is with being able to scanfull YouTube channels.
So right now we can do YouTubevideos one by one.
Pretty soon, like in the nextweek or two or three, we'll be
able to put in a YouTube channeland I'll scan those top 250
videos on the YouTube I'm really, really excited about too.
(45:47):
So Apex is great for companiesthat are coming into the US that
might not understand thenuances of the regulatory
structure here, kind of forpeace of mind, and it's also
great for established brands,retailers, to make sure that
their online marketing iscompliant.
It's not going to come back andit should not come back and
bite them old blogs, ingredientstatements, whatever it may be.
(46:10):
But it's also really valuablefor streamlining that content
review process.
Before I post a blog, anysocial post run it through the
Apex engine and it should flagmany risky words.
So it cuts down on that backand forth between marketing to
regulatory, marketing toregulatory.
(46:31):
Hey come on, I've told youmarketing 10 times, we shouldn't
say this.
It cuts down that and saves alot of time, and so it's really
exciting.
I'm happy to announce that Apexhas been invited to VitaFoods
Geneva next month.
So it's VitaFoods Europe andGeneva biggest supplement trade
show in Europe, I believe and sowe are actually a top six
(46:52):
finalist in the new technologysolution category.
So little old Apex Complianceme.
You know I get to go pitch onbehalf of the small company
we're going up I should say thatin quotes because it's all fun
and games against five reallylarge companies for this startup
award.
So I get to be on stage inGeneva in just a few weeks, so
(47:15):
I'm excited to share that withyou today.
Amanda Ballard (47:18):
That's so awesome.
I can't help but just be justin awe of that whole program
just existing.
I think it's very, very neededespecially in the world that we
live in that's so digitalmarketing driven to be able to
be in compliance and just knowwhat we can say and what we
(47:40):
can't say and how to limit ourrisk.
I love that.
So thank you for that servicethat you're providing.
I think that's fantastic.
Asa Waldstein (47:48):
Thank you, and I did want to add that we just
launched an Amazon prohibitedword list so it helps scan for a
lot of the trigger words thatAmazon may.
That may lead to delistingingredients and more resources,
that type of thing, and it iscompletely customizable so
companies can add all naturalmade in the USA, whatever it may
be, and then use that use thatto that to search their content,
(48:12):
which is, you know, I made itfor the dietary supplement
industry but several industriesare using it law firms, that
type of thing as well.
Tina Smith (48:22):
Amazing.
Okay, so two things arounddisclaimers what disclaimer or
type of disclaimer do you thinkshould be on every retailers or
natural products manufacturerswebsite?
And second, what disclaimer dowe need to make about this being
legal advice on this podcastepisode.
Asa Waldstein (48:44):
Thank you for that.
So this is informationalpurposes only, does not
constitute any legal orregulatory advice.
We're just having an opendiscussion.
It's not specific to anyindividual's company.
So if you want referrals forlawyers or consultants, please
contact me and I'm happy to sendyou in the right direction.
Amanda Ballard (49:03):
That's my disclaimer.
Asa Waldstein (49:05):
The other disclaimer is where we talked
about the FDA to Shea disclaimerthese statements are not
intended to treat your diagnosedpreventive disease, so on and
so forth.
That's a good idea to have onwebsites to I'm using a lot of
air quotes here comply with thatdishe regulation that the
(49:25):
disclaimer must be on everylabel panel where the claim is
made.
It's a good idea, but I don'tknow how much it protects you.
For example, it doesn't allowus to say whatever we want.
We can't put a hey, this isinformational purposes only, not
approved by the FDA, and thensay turmeric's great for.
(49:46):
Alzheimer's if we sell turmeric,so it's not a get out of jail
free card.
They have to match.
So other than that, on websites, I don't know whatever makes
sense for your own, of course,terms and conditions.
Privacy policy, americans forDisability Act compliance is
(50:07):
really important.
A lot of small retailers andcompanies practitioners,
continue to get sued for theirwebsites not being ADA or
Americans for Disability Actcompliance and making sure that
your website is ADA compliant isreally essential to help avoid
some of these pesky lawsuits.
Amanda Ballard (50:24):
Well, I just really appreciate your time with
us today, asa, if people wantto get in touch with you or
learn more about Apex Complianceor your consulting business,
how can they get in touch withyou?
Asa Waldstein (50:36):
Sure.
Thank you for that.
Amanda Ballard (50:38):
I am really active on.
Asa Waldstein (50:39):
LinkedIn.
As some of you may know, Iwrite my weekly post-warning
letter Wednesday, which I postto it.
So connecting on LinkedIn is agreat way to find out what I'm
up to.
That's my name, Asa Waldstein,on LinkedIn, same as on Twitter
X, or you can visitasawaldsteincom.
That's my website and fromthere you should be able to
direct it to the Warning LetterWednesday, my consulting
(51:01):
services.
And then just to throw one moreURL at you
apexcomplianceprogramcom is ourstandalone website.
That's apexcomplianceprogramcom, for Apex Compliance.
But really connecting onLinkedIn, I'd love to chat with
any of the listeners here.
Through the Asa Waldsteinwebsite, you can set up a free
(51:21):
initial consult.
I don't care how big or smallyou are.
I'm happy to donate 15 minutesof my time to help point you in
the right direction, provide anyresources I can as well.
Tina Smith (51:33):
That's so generous of you.
Thank you so much.
I know that our listeners willappreciate that, and what I
imagine, though, is that we willalso get a lot of follow-up
questions from this, so what I'mhoping is that we can invite
you back once we have a fulllist of questions to ask you
again.
Asa Waldstein (51:48):
Yes, without a doubt.
You know my day in the life isI'm asked very, very, very, very
difficult questions, so evenvery large brands that when they
have hard ones, they send themover to me and so it's great.
It helps my, helps my brain,you know, work well.
So hard questions, easyquestions.
I look forward to theopportunity coming back on the
(52:10):
show and chatting with you aboutthis Awesome.
Thanks so much for your time,asa.
I look forward to theopportunity coming back on the
show and chatting with you aboutthis Awesome Thanks so much for
your time, Asa.
Amanda Ballard (52:15):
Have a good rest of your day.
Thank you so much.
Asa Waldstein (52:17):
Thanks so much.
Have a great day.
Amanda Ballard (52:20):
Thanks so much for listening to the Natural
Products Marketer Podcast.
We hope you found this episodeto be super helpful.
Make sure you check out theshow notes for any of those
valuable resources that wementioned on today's episode.
Tina Smith (52:30):
And, before you go, we would love for you to give us
a review.
Follow, like and subscribe onApple Podcasts, Spotify, YouTube
or wherever you're listeningtoday, and make sure you join us
for our next episode, where wegive you more marketing tips so
that you can reach more peopleand change more lives.
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