In this episode on the Orange Pill Podcast, we tackle a long-standing regulatory loophole: piggybacking on NDI submissions. While companies like Natural Alternatives International (NAI) invest in proper safety and regulatory filings, like their recent successful NDI notification for CarnoSyn® beta-alanine, authored by the regulatory team at KGK Science, others sidestep the process entirely.
The FDA’s lack of enforcement has allowed un-notified, and in many cases counterfeit or imported ingredients, to remain on the market, undermining consumer safety and disincentivizing compliance.
We break down:
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What piggybacking is and why it’s problematic
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The implications of the CarnoSyn® beta-alanine NDI success
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NAI’s push for stronger FDA enforcement
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How this issue reflects broader weaknesses in DSHEA enforcement
A must-listen for industry professionals, regulatory stakeholders, and anyone invested in the future of dietary supplement safety.
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