Julia Gustafson, vice president of government relations for CRN, said FDA has openly discussed for several years that rapid product development on what some might term the fringes of the dietary supplement industry has put the Agency in a bind. If a product looks like a supplement, but does not fully meet the definition in some respects, such as including ingredients that don’t easily fit into the ‘drug or dietary ingredient’ dichotomy, does FDA have authority over that product?
FDA raised issue in comments on hemp bill
Gustafson said the idea of a change to the regulatory definition of a dietary ingredient has been floated informally, and was addressed in a more formal fashion in its Technical Assistance Comments on HR 8179 in 2020, which addressed the status of hemp/CBD products. At the end of those comments, Gustafson said FDA included comments about the broader definitional issue within the supplement industry.
“It was only three lines, and it included no proposed legislative text,” Gustafson said.
As matters stand, the definition of dietary supplement in DSHEA goes like this:
A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described [above]…
Item E in the above list is where what many in the industry have characterized as ‘the loophole’ comes in. It apparently can be stretched in some product formulators’ minds to mean almost anything. It’s an open question whether a stimulant ingredient that was marketed decades ago as over the counter nasal decongestant fits that bill. And for some of these ingredients, assertions of botanical origin have been advanced as a way to lay claim to Old Dietary Ingredient status. That is, for those companies in this category that bother with such regulatory niceties at all.
“It’s clear that FDA is not comfortable with the regulatory authority that the FD&C Act provides them,” Gustafson said.
New language in the works
Gustafson said this issue has been raised on a number of occasions by critics of the industry, including Dr. Pieter Cohen. She said CRN was contacted about the issue by the office a federal lawmaker. Gustafson said CRN is working with the staff of the lawmaker, who she declined to name at this time, to craft a final version of a proposed change to the definition. She said CRN is hopeful the final revisions to the proposed change will be agreed on soon and can be made public.
“If a product is branded or marketed as a dietary supplement, then it should be held to account as if it was a dietary supplement,” Gustafson said.
“CRN and our members want to get rogue and illegal products out of the supplement market as they jeopardize public health and hurt consumer confidence in the responsible industry,” she added.
Gustafson said the prospects of making this change, from a legislative perspective, are better than they’ve been in recent years.
“I do feel the time is right for Congress to act on some of the pressing issues with the Agency. This past year we took our feet off the gas and let them deal with the COVID-19 crisis, and rightfully so,” she said.