"Invite-Only" Compliance Is Over: Is Your Cosmetic Company Ready?

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 The "handshake" era of cosmetic compliance is officially over. Under new authorities in Sections 605, 610, and 704, the FDA has moved from simple observation to an aggressive "access and copy" mandate. In this episode, Darshan Kulkarni breaks down the "SAHCOD" threat and explains why your internal communications, medical assessments, and even cross-contamination logs are now fair game for federal investigators. If you handle raw materials or shared manufacturing equipment, your entire catalog could be at risk of a forensic audit. Learn where the FDA's power ends—and where your defense begins. 

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Episode Transcript

Darshan (00:00):
Compliance just lost its invitation-only status for
cosmetics.
Under the new establishedauthorities of Section 605, 610,
and 704 of the Food, Drugs, andCosmetics Act, FT has just moved
past simple observation to anaggressive access and copy
mandate.
Section 605 focuses on mandatoryadverse event reporting.

(00:24):
610, now that's where the realgame changer is.
It grants the FT authority todemand records the moment they
have a reasonable belief that aproduct or ingredient presents a
threat of serious adverse healthconsequences or death.
You might see calledS-A-H-C-O-D.

(00:44):
This is an expansion of theinvestigational and inspectional
authority that places yourinternal files directly in the
hands of federal investigators.
Just because there's a guidancedoesn't mean that it's binding.
So be careful of that.
Having said that, adverse eventlogs are now no longer just
annual reviews.
The FDA now expects that acomprehensive history for every

(01:05):
single health-related eventassociated with your products is
being kept.
You must have a responsibleperson, and this person must
maintain records for a minimumof six years after creation.
Now, certain businesses mayqualify for a three-year window,
but that is unique.
This archive must include notjust the final report, but every

(01:29):
scrap of communication with theclaimant and your internal
medical assessments used todetermine if this event was
serious.
Now, you want to be careful.
But this means that if one ofyour products has a contaminated
raw material that can trigger aforensic audit of your entire

(01:52):
catalog, you must be trackingthat information.
So if you share manufacturingequipment, you use common
suppliers for containers orclosures or even process
products in close proximitywhere cross-contamination is
possible, those records are nowfair game.
The FDA is looking for systemicprocess deficiencies like

(02:13):
failure in sterilization or pHadjustment that can turn a
localized issue into amulti-brand disaster.
Enjoying our content?
Refusing access to mandatedrecords is still a prohibited

(02:34):
act, but there are limits toSection 610 authority.
For example, it generallyexcludes your secret recipes,
financial data, and pricingstructures.
Failure to comply can result incivil actions, criminal
prosecution, or effectively banyour products from entering the

(02:57):
US state andor entering UScommerce.
Now, if you have questions aboutthis and how it applies to you,
reach out to me at the KilkaniLaw Firm.
I'd be happy to help guide youthrough this.
Call, click, or email.