What is the story with CBD dietary supplements? Are they legal for sale in my store?
There is no easy way to describe the current situation concerning cannabidiol (CBD). On the one hand, the U.S. Food and Drug Administration (FDA) has explicitly stated that it is not legal to sell in interstate commerce a food to which CBD has been added. On the other hand, CBD products seem to be marketed everywhere and for everything.
The situation with CBD, which is a naturally occurring constituent of some parts of the hemp plant, is basically analogous to that of lovastatin in red yeast rice, see: Pharmanex, Inc. v. Shalala, 221 F.3d 1151 (10th Cir. 2000); 2001 U.S. Dist. LEXIS 4598 (D. Utah Mar. 30, 2001) (district court opinion on remand). To summarize that decision, it was unquestioned that traditionally prepared red yeast rice had been marketed as a food for many years and that the ingredient contained a natural substance, mevinolin, which is chemically identical to the active ingredient, lovastatin, in the prescription drug, Mevacor. Such traditional red yeast rice, however, does not contain more than trace amounts of lovastatin, if any.
Concerning the presence of lovastatin, FDA and the courts have taken the position as stated in a recent warning letter:
“Section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)] specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505, unless the article was marketed as a dietary supplement or food before its approval as a new drug. FDA approved Mevacor as a new drug on August 31, 1987; neither lovastatin as a single ingredient, nor any red yeast rice product manufactured and promoted for lovastatin content, was marketed as a dietary supplement or as a food before that date.”
Warning Letter to IP-6 International Inc. April 23, 2014—www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm396822.htm.
In simpler terms, if an “article” (lovastatin or CBD) was approved as a new drug, certified as an antibiotic, or licensed as a biologic or authorized for investigation as any of those “for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public” prior to its having been marketed as a dietary supplement or as a food, then the article is prohibited from ever being marketed as a food or dietary supplement unless FDA, acting through the Secretary of Health and Human Services, issues a regulation, after notice and comment, finding that the article would be lawful under this Act. Or, even more simply, the marketing of the “article” as a food or dietary supplement must predate the public disclosure of “substantial” drug studies. Clearly, the statute was intended to provide some measure of exclusivity to companies that make the enormous investment required to bring a new drug to market and not having dietary supplement companies being able to market directly competing products.
FDA concluded, and the courts agreed, that lovastatin’s approval as a new drug in 1987 preceded its marketing as a food or dietary supplement and that a “lovastatin-enhanced” red yeast rice product could not be marketed as a dietary supplement. Companies can continue to market traditional red yeast rice as a dietary supplement but are prohibited from producing red yeast rice with enhanced amounts of lovastatin beyond what is naturally occurring or promoting the presence of lovastatin on the label or in any labeling. Conversely, because omega-3 fatty acids were marketed in dietary supplements before approval of the drug Lovaza, there is no issue with the continued marketing of these dietary supplements in the absence of “drug” claims.
As for CBD, FDA acknowledges that various hemp ingredients, including hemp seed oil, have been marketed as dietary supplements for an extended period and that some amount of naturally occurring CBD may be present in these products. FDA has found, however, that products formulated to increase the amount of the naturally occurring CBD or touted for their CBD content have not been marketed for any great length of time. In fact, FDA claims to have determined that the existence of substantial clinical investigations regarding CBD were made public prior to the marketing of CBD as an “article” of food in dietary supplements. In this instance FDA cites, two clinical investigations involving GW Pharmaceuticals’ investigations of Sativex and Epidiolex. (See Sativex Commences U.S. Phase II/III Clinical Trial in Cancer Pain [published Nov 26, 2007] and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome [published May 7, 2014]). It was a GW Pharma CBD drug that was approved by FDA on June 25, 2018. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611047.htm.
Again, in simple terms, FDA has concluded that there were publicly noticed substantial drug investigations on CBD (as early as 2007) by GW Pharma, prior to any company marketing CBD as a dietary supplement or food and, therefore, CBD cannot be marketed as a dietary supplement absent notice and comment rulemaking. FDA has announced this position in a “Public Health Focus” and in warning letters.
For example, in the Public Health Focus, “FDA and Marijuana: Questions and Answers” – “FDA has therefore 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. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.”
www.fda.gov/newsevents/publichealthfocus/ucm421168.htm; See also Natural Alchemist Warning Letter—www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm583205.htm; and Stanley Brothers Social Enterprises, LLC d/b/a CW Botanicals d/b/a CW Hemp Warning Letter—www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm583192.htm.
FDA has also responded to two New Dietary Ingredient Notifications concerning CBD (Pureevolution Enterprise dated December 15, 2015 and HoneyColony dated April 5, 2017) stating, for the reason discussed above, that CBD Products are excluded from the definition of a dietary supplement.
If FDA has stated that it is a “prohibited act” to introduce into interstate commerce any “food” (which includes dietary supplements) to which CBD has been added, how are there so many products promoting CBD on the market? Nothing has been definitively stated by FDA, but it seems that the agency has, at least for now, decided to limit its enforcement focus to CBD products that make unsupported disease claims and not to the category generally.
In a June 25, 2018, public statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana, FDA Commissioner Scott Gottlieb, MD said that:
“The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.
“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.”
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611047.htm.
There was no explanation given as to why the Commissioner chose to limit his remarks to CBD products “with unproven medical claims,” instead of referring to the agency’s position discussed above that it was a prohibited act to introduce CBD products into interstate commerce generally. Perhaps, the agency is signaling its intent to permit enforcement discretion to allow CBD products that do not make unproven medical claims to remain on the market or its openness to consider notice and comment rulemaking to permit the marketing of CBD, but again, there is no express statement or guarantee that this is the agency’s position or how long such discretion, if it exists, may last.
In terms of classification of CBD products by the Drug Enforcement Administration (DEA), the agency issued an internal directive regarding the presence of cannabinoids in products and materials made from the cannabis plant on May 22, 2018. In the directive, DEA acknowledged that the U.S. Court of Appeals for the Ninth Circuit had enjoined the agency from enforcing certain regulations with respect to products made from parts of the hemp plant that are excluded from the definition of marijuana in the Controlled Substances Act (CSA). See Hemp Industries Ass’n v. DEA, 357 F.3d 1012 (9th Cir. 2004).
Pursuant to the Ninth Circuit decision, products and materials that are made from the cannabis plant that are outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products, if made from these parts of the plant, may be distributed without restriction under the CSA. DEA further stated that “the mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.”
Finally, any company marketing CBD products or any retailers carrying them in their stores must be concerned about the potential for state and local enforcement. It is possible that the future of CBD in dietary supplements and foods may be determined at the state level. There have been reports from retailers that some local officials have no idea whether CBD may legally be sold in their jurisdictions or whether it is prohibited because of its association with marijuana or even for some other reason. The State of Indiana passed legislation this spring (S.B. 52) that allows for the purchase, sale and possession of CBD oil, if it complies with certain labeling requirements and contains no more than 0.3 percent THC. Other states have taken steps that appear to prohibit CBD products.
Most recently, on July 6, 2018, the California Department of Health (CDH) announced that the only forms of industrial hemp products that will be allowed in the state are “seeds derived from industrial hemp and industrial hemp seed oil or hemp seed oil derived from industrial hemp.” www.cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/FoodSafetyProgram/HEMP/Web%20template%20for%20FSS%20Rounded%20-%20Final.pdf.
CDH further stated that any CBD products derived from cannabis or industrial hemp or any seed oil enhanced with CBD or other cannabinoids “will not be allowed in food.”
Wisconsin also appears to prohibit most CBD products. On May 4, 2018, Wisconsin Attorney General Schimel Issued a guidance to Wisconsin law enforcement on CBD oil and industrial hemp production stating that:
1. An individual may possess CBD only if he/she has a doctor’s certification under Section 961.32 of the Wisconsin Statutes;
2. Only a physician or pharmacy may sell CBD if they have an FDA investigational drug permit and approval from the Wisconsin Controlled Substances Board, under Sections 961.34 and 961.38 of the Wisconsin Statutes;
3. The Legislature has only chosen to allow this type of possession and distribution if the CBD does not have a psychoactive effect.
www.doj.state.wi.us/news-releases/ag-schimel-issues-guidance-wisconsin-law-enforcement-cbd-oil-and-industrial-hemp.
In two other examples, there are reports that Nebraska Attorney General Doug Peterson sent a memo in September 2017 to state law enforcement taking the position that CBD is a controlled substance and in South Dakota, the Governor signed legislation on March 17, 2017 (SB 59—https://sdlegislature.gov/Legislative_Session/Bills/Bill.aspx?Bill=95&Session=2017 ) that excluded cannabidiol from the definition of marijuana, but made it a Schedule IV controlled substances.
The bottom line is that while FDA has stated that CBD products cannot be legally marketed, the apparent exercise of enforcement discretion and various state actions have left the market in flux. Between the actions of the federal government and state and local governments, it is important that you obtain specific legal advice concerning any products that you may choose to market or to sell at retail. VR
Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.
