Latest Hemp Rules and Regulations Post-Farm Bill - Get Your 3-Minute Update
Many people are under the false impression that CBD supplements can be lawfully marketed with the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”). That is not correct.
On December 20, 2018, FDA Commissioner Scott Gottlieb, M.D. issued a press release to make their position clear. In the release, he said, “it's 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.” The given reason for this was that 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.
The wording of Commissioner Gottlieb's statement is interesting. Specifically, it indicated that “added CBD” could not be introduced into foods or dietary supplements. This suggests that CBD isolate cannot part of a dietary supplement. But what about a plant, such as hemp, that contains naturally-occurring phytocannabinoids—including CBD? The fact is, there are many plants, besides hemp, that contain phytocannabinoids. These include, but are not limited to:
Basil, cinnamon, black pepper, cloves, oregano, and rosemary;[i]
Theobroma cacao (from which chocolate is derived), Camellia sinensis (green and black tea), grapes, Brassica spp. (e.g. broccoli, cabbage, etc.), Apiaceae family (e.g. carrot, parsley),[iv] Helichrysum spp. (the sunflower family of plants), Amorpha spp. (the pea family of plants).[v]
Clearly, these plants are lawful to sell in dietary supplements and/or as foods, despite the fact that they all contain naturally-occurring phytocannabinoids.
Updates from the Recent FDA Meetings
In any case, after the departure of Commissioner Gottlieb, FDA Acting Commissioner Ned Sharpless kicked off the agency's historic first-ever meeting with natural product industry trade organizations (on May 6th, 2019), and subsequent public hearing on CBD (on May 31st, 2019. These meeting took place because Congress instructed the FDA to develop a clear path for the legalization of CBD as a dietary supplement.
The purpose of these meetings was not to establish the aforementioned path, but rather to identify issues associated with the development of the path. During the May 6th meeting concern was expressed about synthetic CBD and other synthetic cannabinoids. It was stated that quality issues also had to be resolved (due to many players in the space with substandard products) and that an appropriate daily intake of CBD needed to be established.
With 109 speakers, the May 31st meeting covered a great deal more ground, including suggested maximum serving sizes, and the recognition that CBD is here to stay. Some concern about potential CBD liver toxicity was also expressed based upon research by GW Pharmaceuticals (the company with the one FDA approved CBD drug), but that research was associated with the use of CBD in children at extremely high doses—much higher that levels currently offered with the overwhelming majority of dietary supplements.
Click the image below to hear my 4 key takeaways from the FDA's public hearing on CBD.
Next Steps for CBD Regulation and Legislation
These meetings have provided a backdrop for the FDA and for industry on how to proceed in the development of a legalization pathway for CBD supplements. Meanwhile, CBD sales continue to be brisk, and CBD continues to grow in popularityâ€”despite the fact that its legal status as a dietary supplement is not established. In fact, many companiesâ€”including several large, mainstream supplement companies—currently sell CBD products.
For a better understanding of what to do if you are interested in offering one or more CBD products as part of your current supplement line, see our article, “Winning the CBD game – Do's and don'ts for CBD supplement manufacturing”.
[i] Fidyt K, Fiedorowicz A, Strządała L, Szumny A. β-caryophyllene and β-caryophyllene oxide-natural compounds of anticancer and analgesic properties. Cancer Med. 2016 Oct;5(10):3007-3017
[ii] Gertsch J, Pertwee RG, Di Marzo V. Phytocannabinoids beyond the Cannabis plant - do they exist? Br J Pharmacol. 2010 Jun;160(3):523-9.
[iii] Hanuš LO, Meyer SM, Muñoz E, Taglialatela-Scafati O, Appendino G. Phytocannabinoids: a unified critical inventory. Nat Prod Rep. 2016 Nov 23;33(12):1357-1392.
[iv] Gertsch J, Pertwee RG, Di Marzo V. Phytocannabinoids beyond the Cannabis plant - do they exist? Br J Pharmacol. 2010 Jun;160(3):523-9.
[v] Hanuš LO, Meyer SM, Muñoz E, Taglialatela-Scafati O, Appendino G. Phytocannabinoids: a unified critical inventory. Nat Prod Rep. 2016 Nov 23;33(12):1357-1392.