Enter the Regulators: The FDA Issues A Statement About Hemp and CBD
As anyone in the cannabis industry is aware, the 2018 Farm Bill (Farm Bill) was signed into law yesterday. As I mentioned in this post, this is monumental. Under the Farm Bill, hemp and all of its parts, including cannabinoids such as CBD, are lawful and are explicitly removed from the Controlled Substances Act (CSA). There are a number of issues that the Farm Bill raises. Arguably, the most important is the Food and Drug Administration’s (FDA) stance towards hemp and CBD. The Farm Bill makes clear that it does not “affect or modify” the Food, Drug & Cosmetic Act (FD&CA) or the FDA’s authority.
Shortly after the Farm Bill was signed, FDA Commissioner Scott Gottlieb, M.D., issued a “Statement… on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds” (Statement). Although not binding law, the Statement provides some important insights into the FDA’s current view and the direction it may take with respect to hemp and CBD.
In short, the Statement did not contain much new information. The FDA acknowledged “the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD).” It also clarified that the FDA “treat[s] products containing cannabis or cannabis-derived compounds as [it does] any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
The Statement reiterated a position that the FDA has taken for several years, namely, that manufacturers of hemp and CBD products cannot make disease claims. The FDA stated that it is “concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce.” It further stated: “We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”
While none of the above are new, the Statement serves as an important reminder that products containing cannabis-derived compounds should not be marketed as having therapeutic benefit, and certainly not as being able to prevent or cure a disease. The FDA has previously taken action against manufacturers who do so. We can expect this to continue.
Although not new, the FDA also made a point to reassert the position it took several years ago on a non-binding FAQ page, that it is “unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements.” To be clear, this is the FDA’s position on the law based on its interpretation. The FDA has not attempted to enforce this position and it has not been tested by any courts. As I argue in this post, legal precedent exists which may ultimately make distinction between products which are enriched with CBD isolate and products which contain hemp extract, including naturally occurring CBD. (This raises a host of other questions, most notably, what constitutes “naturally occurring CBD” in an era when cannabis compounds can be isolated and reconfigured into various consumer-ready formulations. That issue is for another post.)
However, and despite the fact that this is a legal position, rather than decided law, it gives rise to an important consideration for manufacturers of products containing CBD, particularly CBD isolate. Namely, should manufacturers continue enriching products with CBD? According to the FDA, the answer is clearly, “no”. Time will tell whether or not the FDA will attempt to enforce its position. It has spent the last two years holding this position without enforcing it while the industry grew. We do not currently know whether the Statement is a warning shot in advance of enforcement or a simple reiteration of a position it does not intend to enforce.
In a new development announced in the Statement, the FDA signaled its willingness to review and update its positions on hemp and CBD. First, the FDA announced that it “has completed [its] evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe.” Of course, this should have been done years ago. But, it is a good sign that the FDA is moving in a positive direction on hemp.
Second, the FDA stated that it “recognize[s] the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.” To that end, the FDA announced that it intends to hold a “meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers.” This is a helpful sign. The FDA recently recommended that Epidiolex, an approved drug containing CBD derived from marijuana, be removed from the CSA. Additionally, the World Health Organization (WHO) has issued two reports in the past year which find that CBD is safe, non-toxic, non-addictive, non-psychoactive, and has significant potential as a health aid. In this context it is possible that the FDA will conclude that CBD may be added to foods, at least in certain circumstances. I will update my blog to provide notice of the meeting once a date is announced and encourage you to make your voice heard.
All in all, the Statement can best be viewed as the FDA reminding the public that the Farm Bill does not displace its authority to regulate hemp and its derivatives that are intended to be consumed. While the DEA’s role in cannabis continues to diminish (it will play no role in hemp), the FDA’s role continues to expand. The Statement did not provide a lot of new information; however, it is a helpful insight into the FDA’s thinking.
We represent a large number of companies in various sectors of the hemp and CBD industry. If you have questions about your company’s hemp and CBD products you can reach us by clicking here.
December 21, 2018
Rod Kight is an attorney who represents lawful cannabis businesses. He speaks at cannabis conferences across the country, drafts and presents cannabis legislation to foreign governments, is regularly quoted on cannabis matters in the media, and maintains the Kight on Cannabis legal blog, where he discusses legal issues affecting the cannabis industry. You can contact him here.