That’s when he has to let them know that studying an ingredient as a drug may preclude it from being lawfully included in a food or product labeled as a “dietary supplement” under the Food, Drug, and Cosmetics Act (the “Act”).
However, Durkin said companies shouldn’t necessarily avoid doing it altogether. “What they should do is make sure they do things in the right order. There are two separate provisions of the ACT Sections 301(ll) and 201(ff)(3B), that taken together, work to exclude from being added to food or from the definition of a dietary supplement, an article that was either an approved drug or studied in certain ways to be an approved drug before it was introduced in the commerce as a food or a dietary supplement. So it's not that interested folks out there shouldn't explore the monetization opportunities of an ingredient, they just need to be careful that they do it in a way that doesn't exclude all the possibilities of that monetization.”
The two sections of the Act have come to be known in the industry as creating a “race to market” between those interested in investigating an article as a drug and others interested in marketing the same article as a food, including food labeled as dietary supplements.
Durkin said the FDA is relying on these sections of the Act in its current determination that CBD is a violative ingredient.
“It's almost as though the use of the Epidiolex IND to exclude CBD from being a food or dietary supplement may have gained a little more little more traction than it should have and I think it might be being relied on now to exclude other naturally derived extracts that contains CBD from being included in a food or a dietary supplement. That seems like it might be an overly broad application of the statute by the agency,” observed Durkin.
To hear more about the ‘race to market’, and how CBD and NAC, another ingredient that has had similar issues, come into play, listen to the NutraCast. You can also subscribe on iTunes, Spotify , Stitcher and Google Podcasts.
NutraCast is a podcast that focuses on insights from inside the nutrition industry. It is a production by NutraIngredients-USA. Music by Kevin Macleod.