On January 13th, 2020, Representative Collin Peterson (D-MN), with co-sponsors Rep. Thomas Massie (R-KY), Rep. James Comer (R-KY), and Rep. Chellie Pingree (D-ME), filed a bill that offers a reasonably pragmatic solution to address the current conundrum surrounding hemp-derived cannabidiol, otherwise known as CBD. The bill would amend the Federal Food Drug and Cosmetic Act by inserting: “other than hemp-derived cannabidiol or hemp-derived cannabidiol containing substances” after the phrase ‘an article’ found in the definition of a dietary supplement, referred to as the “exclusion clause,” or the “race-to-market clause,” that is currently preventing CBD from being a legal ingredient in products marketed as dietary supplements. This narrowly-crafted legislative amendment would simply pull CBD out of the exclusionary clauses, while requiring CBD-containing products to still adhere to all other aspects of the Act. The result would be that CBD remains an unlawful ingredient in conventional food because the prohibited act that prevents CBD from being legally marketed in conventional foods, would remain intact. In addition, firms that want to market CBD and CBD-containing dietary supplements would still need to follow the new dietary ingredient (NDI) notification statutory requirements.
Limiting the legal path for CBD-containing products to the dietary supplements path while maintaining the statutory requirement for CBD and CBD-containing products to adhere to the NDI notification process would not only promote the submissions of notifications related to CBD, it would also accomplish at least two other things:
- it would allow stakeholders that have invested time and money in conducting preclinical studies on CBD the opportunity to profit from those efforts without making their private data public, and
- it would afford the Food and Drug Administration (FDA) an opportunity to see data and information it might not otherwise have access to.
As positive a development as this may appear, it seems less than equitable to approach the current situation in a way that would only benefit stakeholders marketing CBD-containing products. There are certainly other dietary ingredients that are, or will be, caught up in the exclusionary clause that should have an opportunity to be considered for the same treatment as CBD (Pyridoxamine, for one, comes to mind). It is neither equitable nor practical to expect separate acts of Congress in order to address each ingredient that is, or winds up, excluded as CBD currently is.
A course of action that could have broader application, and one I recommended late last year (A Practical Guide to Bringing a Dietary Supplement to Market), would be for FDA to recommend that the Secretary of Health and Human Services exercise their authority under the exclusionary clause to issue a regulation finding that CBD is a legal ingredient under the Act. If this regulation could be narrowly crafted to only remove CBD from the exclusionary clause, as Rep. Peterson’s bill does, it would accomplish all the bill could, but also offer something more: a pathway to address other dietary ingredients precluded from being in dietary supplements the same way CBD currently is. If FDA were to approach this exercise with an eye towards making it a systematic, reproducible activity that it could repeat as needed, it might open the exclusionary clause in a way that is more equitable to stakeholders with interests in bringing new and innovative NDIs to market.