Proceed at Your Own Risk: The Farm Bill Does Not Authorize CBD in Food or Dietary SupplementsDec 21, 2018 Compliance
I have said it before, and I will say it again: no, you cannot use CBD as an ingredient in food or dietary supplements. While some have touted the recent passage of the Agriculture Improvement Act of 2018 (aka, the Farm Bill) and its relaxation of the controls on the production and marketing of hemp as an implicit sign that it is acceptable to use cannabidiol (CBD) in food and/or dietary supplements, those fortune tellers are wrong. Yesterday, the Food & Drug Administration released an updated guidance document regarding its current positions on cannabis and CBD, in particular.
The FDA has expressly stated that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the Food, Drug & Cosmetic Act (the Act). If a substance such as THC or CBD is an active ingredient in a product that has been approved as a drug or that has been authorized for investigation as a new drug, then products containing such substances are outside the definition of a dietary supplement. According to the FDA, “[t]here is an exception to sections 201(ff)(3)(B)(i) and (ii) if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.”
With regard to food, the FDA has also provided unequivocal guidance:
Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.
While there are exceptions to this rule when the drug has been previously marketed as a food before the drug was approved or clinical investigations involving the drug was initiated, like dietary supplements, the FDA has concluded that none of these exceptions apply for THC or CBD. Accordingly, the FDA has concluded that “it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.”
Given this clear guidance, I stand by my often provided advice to clients (and to those of you reading this blog): CBD cannot be used in food or dietary supplements, and if you do so, you proceed at your own risk. The Farm Bill does not serve as any legal basis for the use of CBD-derived hemp. In fact, the Farm Bill expressly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds. Until the FDA approves the use of CBD, I would also caution against any rationalizing of the use of CBD that comes from hemp as opposed to cannabis. As the FDA notes, it has seen no evidence to change its current thinking on CBD, but it will consider any evidence to the contrary by interested parties. Thus, if you want to use CBD, do your homework, develop your evidence, and then work with your legal counsel to present your findings to the FDA so as to obtain approval of including CBD in your product before you release it in commerce.