Episode 26

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:

• What piggybacking is and why it’s problematic

• The implications of the CarnoSyn® beta-alanine NDI success

• NAI’s push for stronger FDA enforcement

• How this issue reflects broader weaknesses in DSHEA enforcement