Is 2020 the year FDA will finally make CBD a legal ingredient in dietary supplements and food? No one (but FDA) knows. And this is where we find ourselves yet again at the start of 2020 when it comes to hemp cannabidiol (CBD), today’s biggest ingredient disruptor: with many questions and few answers.
But first: What a year it’s been for CBD. Since President Trump signed the 2018 Farm Bill into law in December 2018, legalizing industrial hemp as an agricultural crop—with hemp defined as cannabis containing less than 0.3% tetrahydrocannabinol (THC) content—and removing it from Schedule I of the Controlled Substances Act, the CBD products market has exploded. Today, CBD is infused in everything from hair gel and toothpicks to personal lubricant, hand sanitizers, and even bed sheets.1
Despite being sold on shelves and online, CBD dietary supplements and food are still not legal according to FDA. For dietary supplements, FDA’s primary reasoning for why CBD can’t be a legal dietary supplement ingredient is that before CBD was ever sold as a dietary supplement, it was first publicly researched as an investigational new drug (IND) by GW Pharmaceuticals. This means that, under the Federal Food, Drug, and Cosmetic Act’s “IND exclusion clause,” CBD is ineligible to meet the definition of a dietary supplement under the Act’s Section 201(ff)(3)(B)(i) and 201(ff)(3)(B)(ii).
Last year saw many try to get FDA to forge a legal pathway for CBD products. Last October, dietary supplement and natural product associations—the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), and the United Natural Products Alliance (UNPA)—sent a joint letter asking Congress to create legislation to create a waiver for CBD under the definition of a dietary supplement (FD&C Act Section 201(ff)(3)) that would specifically authorize legal use of CBD in supplements. The Natural Products Association (NPA), meanwhile, was involved in pushing forth an amendment to a House spending bill last June that would have had FDA perform a Health Hazard Evaluation of CBD and ultimately set a safe usage level for consumers. The amendment language, which made it through the House bill, was unfortunately ultimately excluded in the version of the spending bill passed by the Senate.
Federal and state lawmakers, as well as state attorneys general, have also asked FDA to provide either more oversight over CBD, set a safe usage level, or to at least adopt a policy of enforcement discretion for CBD products. Notably, last September, Senate Majority Leader Mitch McConnell (R-KY) added report language to the 2020 spending bill to require FDA movement on CBD. The ultimate 2020 spending bill that President Trump signed last December requires that FDA, within 60 days, update Congress on its progress in developing a policy for enforcement discretion for CBD, and within 180 days, evaluate the market to determine the scope of CBD products that are mislabeled or making illegal claims.
But enforcement discretion does not make CBD legal in supplements; it merely means that FDA will exert discretion in how it enforces against CBD companies. And so the supplements industry is still seeking a true legal pathway forward for CBD.
The two potential pathways most commonly discussed are: 1) to somehow create a regulatory exception for CBD in Section 201(ff)(3) of the FD&C Act that would include CBD within the legal definition of a dietary supplement, or 2) to see the Secretary of the U.S. Department of Health and Human Services promulgate a new regulation for CBD specifically declaring CBD as both a legal dietary supplement and/or food ingredient.
This January, a newly proposed bill opted for the first pathway (carving out an exemption for CBD in the FD&C Act’s definition of a dietary supplement). Proposed by House Agriculture Committee Chairman Collin Peterson (D-MN), the bill would essentially ensure that the IND exclusion clause in Section 201(ff)(3)(B)(i) and 201(ff)(3)(B)(ii) does not pertain to CBD. For instance, under the text stating that a dietary supplement is not “an article authorized for investigation as a new drug…,” Representative Peterson’s bill would add the phrase “other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance.”
Whether this bill will pass is anyone’s guess. “What makes it really hard to say is [that] we are kicking off an election year,” says attorney Kevin Bell, partner, Arnall Golden Gregory LLP (AGG; Washington, DC). “If anything is going to get done with it, it would need to move faster than in a non-election year. At some point, you’re going to reach the middle of the year, and legislators—that’s not going to be what the focus is going to be on in an election year because you don’t know what’s going to change, not only from the general election, but also how that might affect committees and things like that.”
While some welcome the Peterson bill, the regulatory route it takes—having Congress dictate a narrow exemption for CBD supplements in the IND exclusion clause—isn’t necessary most optimal, some say.
“We would have preferred to see FDA do this on its own using that discretion that’s under 21 U.S.C. § 321(ff)(3),” says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC). (Editor’s note: 21 U.S.C. § 321(ff)(3) is the same provision, but codified, as the FD&C Act’s 201(ff)(3) provision.) “That would have been the preferred way to market because then FDA would have more say in what the exclusion looks like. But given what we’re seeing out of FDA, which seems to be inaction, and the larger environment around it—all the things that are happening in the face of FDA’s inaction—we think this is a good alternative.”
“I think [the Peterson bill] is interesting, but it’s a little drastic,” says Robert Durkin, of counsel, Arnall Golden Gregory LLP (AGG; Washington, DC). Durkin is the former deputy director for FDA’s Office of Dietary Supplement Programs. “The agency could help the Secretary do basically the same thing if the Secretary were to promulgate a regulation…I think a better option would be for the Secretary to promulgate a regulation.”
Why? “Well, what [a new regulation] does is it establishes a precedent and a paradigm for the agency to do this in the future if it has to,” Durkin says. “They wouldn’t have to wait for a legislative fix. And, it’s really likely that CBD is not the only dietary ingredient to be affected like this. It’s a solution that can be used in the future.”
It’s also important to note that, by only amending the definition of a dietary supplement, Rep. Peterson’s bill would still not create a legal pathway for CBD in food, leaving a now quickly growing segment of the CBD market still illegal. “Food would still be in the same trap,” Durkin says. But, say some, leaving CBD out of food might just be FDA’s preference. “They’d much rather have this in dietary supplements than conventional food,” he adds.
“I think FDA has some real concerns about [CBD in food] that make it different than supplements,” says Mister. “Because supplements are, by definition, supposed to be pills, powders, concentrated liquids, capsules, things like that. By their very nature, they’re not allowed to be presented as a food substitute. And so the very act of taking a supplement becomes very intentional.”
He continues: “The problem they have with food is they’re concerned about the cumulative effects of CBD if it’s in everything—you know, you get up in the morning and you have a CBD-infused coffee, and then you have a CBD-laced bottle of water on your way to work, and then you have a CBD-infused brownie. Pretty soon, without realizing it, you’re starting to get an awful lot of CBD into your system. That’s, I think, what’s problematic about food. It’s very hard to do this in a way with food that you alert people to the potential dangers of overconsumption, and it’s also hard to warn vulnerable populations away from it. If you don’t want pregnant women using CBD, are they going to think about that when they’re at the grocery store and they pick up cookies or coffee that has CBD in it? Whereas with a supplement, you can label that supplement in such a way that cautions people: Do not use this product if you’re pregnant or nursing.”
It’s further important to note that if a bill like Rep. Peterson’s passes and makes CBD a legal dietary ingredient, CBD would be subject to all of the regulations and enforcement that all other legal dietary ingredients face—for instance, adhering to the new dietary ingredient (NDI) process and safety data requirements, the current good manufacturing practices (cGMPs) law, as well as labeling compliance.
“Oh, absolutely,” says Mister. “And I think that’s something that some people don’t understand, because they think that somehow it’s exempting CBD from all of the regulatory framework, and that could not be more wrong. What it does is it simply says it meets the definition of a dietary ingredient, but before anybody can bring anything to market, it would still require that you meet all of the requirements for a dietary supplement…So it’s not like a CBD supplement is going to get a free pass under this legislation, but what it does is it says, ‘This is the swim lane for CBD.’”
- Dimengo N. “The 12 Weirdest CBD Products.” GreenEntrepreneur. Published November 1, 2019. Accessed at: www.greenentrepreneur.com/slideshow/341602
- Smith T. “Herbal supplement sales in US increase by 9.4% in 2018.” HerbalGram, no. 123 (2019). Accessed at: http://cms.herbalgram.org/herbalgram/issue123/files/HG123-HMR.pdf