Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or Dietary Supplements

We are often approached by clients interested in conducting studies relating to an article that qualifies as a dietary substance or ingredient. Some of these clients are interested in studies intended to provide insight into a consumer’s experience with an ingredient that is already being sold in commerce. These clients also may be interested in substantiating claims they currently make for products that include the ingredient or for making new claims. Other times, clients are just beginning the process of introducing an ingredient to the market and are looking for guidance concerning the early stages of product development, including any studies they might require. More often than not, these clients – those with a new and unique ingredient – are also curious about the prospects of studying an ingredient as both an ingredient in food and drugs. Some clients have already started studies and, in an effort to be economical and efficient and to get a product to market as quickly have possible, have done so in a way that investigates the ingredient for both food and drug use at the same time. However, these clients are sometimes surprised to learn that studying an ingredient as a drug may have already precluded it from being lawfully included in a food or product labeled as a “dietary supplement” under the Food, Drug, and Cosmetics Act (the “Act”). Two separate sections of the Act works to prohibit the use of a substance in a food, including dietary supplements, if certain circumstances are met.

Exclusionary Clauses

Sections 301(ll) and 201(ff)(3) of the Act prohibit food (including animal feed) and dietary supplements, respectively, from containing any article that:

• is approved under 21 U.S.C. § 355 (section 505 of the Act); or

• has been authorized for investigation as a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.1

There are two exceptions to 301(ll) and 201(ff)(3):

• if article was marketed in food or dietary supplement before the drug was approved or before the substantial clinical investigations involving the drug had been instituted; or

• the Secretary, at the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the Act.

These 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. These sections of the Act are intended to preserve the financial incentives to conduct research on new drugs. The FDA is relying on these sections of the Act to determine that cannabidiol (CBD) is a violative ingredient when added to food or contained in a product labeled as a dietary supplement. Most recently, FDA relied on Section 201(ff)(3) to inform a distributor of dietary supplements that one of their Ingredients, NAC, an ingredient that, by some accounts, has been marketed in dietary supplements for decades, is excluded from being an ingredient in dietary supplements. For the purpose of Sections 301(ll) and 201(ff)(3), as indicated in the current version of FDA’s draft guidance on New Dietary Ingredient Notifications, the agency has interpreted:

• the word “article” to mean either the entire product or a component of the product;

• the term “active moiety” to follow the definition under 21 C.F.R. § 316.3(b)(2); and

• the term “authorized for investigation” to mean that the article is the subject of an IND that has gone into effect as described in 21 C.F.R. § 312.4.4

AGG Observations

• The agency’s current interpretation of sections 301(ll) and 201(ff) is likely based on precedents that are no longer determinative:

Determining an article’s “active moiety” and evaluating its regulatory status relative to sections 301(ll) and 210(ff)(3) is ingredient specific and, oftentimes, is relatively complicated:

• FDA’s interpretation of the term “authorized for investigation” may be flawed in that INDs are not authorized by FDA;

• The determination of whether an IND exists for a particular article or its active moiety can be difficult, if not impossible, as the general public doesn’t have access to required information; and

• Companies should carefully consider the exclusion issue when designing and conducting studies on ingredients or products that may be considered drugs and dietary supplements.

For more information, please contact Bob Durkin.

 

[1] See 21 U.S.C. § 331(ll)(2) (applying to foods) and 21 U.S.C. § 321(ff)(3)(b) (applying to dietary supplements).

[2] See: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

[3] See: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purple-biosciences-llc-593772-07232020

[4] See: https://www.fda.gov/media/99538/download