Refresher on the Exclusionary Clauses

One of the most pressing FDA regulatory obstacles facing the CBD industry are the so-called “exclusionary clauses” of the Federal Food, Drug, and Cosmetic Act.  In essence, the exclusionary clauses prohibit the use of a substance in a food or dietary supplement if that substance has been the subject of substantial clinical investigations that have been made public, or approved by FDA as a new drug.  There are exceptions to the exclusionary clause; however, FDA takes the view it has not to date been provided with information sufficient to change their current position that CBD is prohibited from use in food and dietary supplements under the exclusionary clauses.

FDA’s interpretation of the exclusionary clauses as applied to CBD is a legal bar preventing FDA from recognizing or regulating CBD as a food or dietary supplement ingredient; however, these provisions have not prevented the CBD marketplace from flourishing. As a result, the CBD market forged ahead without FDA oversight as part of a premarket authorization review such as the method of manufacture, appropriate specifications, establishment of an acceptable daily intake (ADI), contaminants, labeling, and many other issues.  Many states have begun regulating CBD in foods and dietary supplements, but the state by state approach has led to a patchwork of requirements that is challenging for any company trying to market a product nationally.

Even if Congress passes legislation that removes CBD from the exclusionary clause or FDA establishes a regulatory framework for the lawful marketing of CBD as foods or dietary ingredients, it is expected that any such actions would be conditioned on satisfying FDA’s premarket requirements to use CBD in foods or dietary supplements.  The CBD industry does not have to wait for FDA to say more; there are lessons to learn from FDA’s regulation of foods, dietary supplements, cosmetics, new drugs – and yes, even tobacco products, that can help shape what CBD companies do now.

Food and Dietary Supplement Regulatory Hurdles Still Remain

For foods and dietary supplement uses of CBD, we know the type of data and information that FDA would expect to support the safety of new food and dietary ingredients.  The industry has great success in achieving favorable reviews of GRAS notifications and food additive petitions because the agency expectations on the type of safety data need to support the marketing of the food ingredient are well understood.    Companies interested in the CBD market should be working with food and dietary supplement regulatory counsel and consultants now to assess the underlying data and identify potential data gaps.  FDA has identified several potential safety concerns with CBD, including liver injury, drug interactions, and male reproductive toxicity.  A thoughtfully prepared dossier would address each of these issues and would identify whether additional studies would be warranted—and the type of studies that should be conducted—to address the agency’s concerns.¹ FDA also stated that it needs additional information about cumulative exposure, special populations (children, elderly, pregnant and lactating women, adolescents), as well as the effects of CBD on animals before allowing food or dietary supplement uses of CBD.

FDA’s statements suggest that CBD is unlikely to receive special treatment by the agency when being evaluated as a food or dietary supplement ingredient – the same type of data and information required for any other food or dietary ingredient is expected.  And FDA is not alone in raising potential concerns about CBD safety.  A coalition of consumer advocacy groups including Center for Science in the Public Interest (CSPI) recently sent a letter to Congress highlighting FDA’s concerns with CBD, and urging Congress to provide more authority for FDA oversight of CBD products, and that Congress should not shortcut FDA’s review of CBD safety.  Thus we can anticipate that consumer groups, in addition to FDA, will continue to press for the same premarket rules to be applied to CBD as any other food or dietary supplement ingredient.

Beyond satisfying the premarket requirements for foods and supplements, CBD companies should also work with counsel to identify the aspects of their production and marketing of current CBD products that do not fit within FDA’s regulatory framework for that product category.  Special attention should be paid to the claims that are being made about the product.  Foods and dietary ingredients can bear properly substantiated claims regarding the effect of the substance on the structure of function of the body.  Disease claims, however, must be avoided.  Addressing manufacturing and labeling practices that are at odds with FDA precedent now not only puts a company in the best possible position if FDA does greenlight a new regulatory pathway for CBD – it also gives the company credibility.

Next Steps

Accepting FDA regulation and oversight of a budding industry that has been subject to relatively little enforcement is difficult to navigate; just see how bumpy the first four years of FDA’s regulation of e-cigarettes has been for the industry.  It has been over a year since FDA’s public meeting on scientific data and information on cannabis-derived compounds, and yet a number of questions posed by the agency then remain on the table, and time to shape the agency’s view before a regulatory framework is developed could be running out.  Companies that want to be successful long-term in this space should take seriously the concerns raised by the agency and develop regulatory and safety dossiers addressing those concerns and supporting the lawful marketing of their products.

Authored by Martin Hahn and Samantha Dietle

1. FDA Consumer Update, What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-Derived Compounds, Including CBD, https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis.