Marketing Marijuana as Medicine Under the Food, Drug, and Cosmetic Act
Last week, me and an attorney from our law firm’s Philadelphia office gave a presentation on marijuana marketing for this month’s Women Grow Philly Chapter meeting. In preparation for the presentation, I reviewed Pennsylvania’s regulations for the marketing and advertising of medical cannabis products, and was admittedly surprised to find that Pennsylvania’s regulations incorporate the federal Food, Drug, and Cosmetic Act (“FD&C Act”) standards for prescription drug advertising. More specifically, Pennsylvania regulations require medical marijuana growers, processors, and dispensaries to comply with the federal regulations governing prescription drug advertisements, contained under 21 CFR 202.1.
The only exception is for growers and processors marketing and advertising products directly to dispensaries, which doesn’t require adherence to federal law standards. Pennsylvania’s legal standard for medical cannabis advertising presents a rather significant, but often overlooked, issue for the existing medical cannabis market: How can and will the Food and Drug Administration (“FDA”) regulate medical cannabis in light of the FD&C Act?
The FD&C Act requires prescription drug manufacturers to obtain pre-market approval from the FDA prior to marketing and advertising drug products for purposes of curing or treating a specific disease or medical condition. If a product is not an FDA-approved prescription drug product but is promoted for use in the treatment of a specific disease or medical condition, the manufacturer is in violation of the FD&C Act provisions banning claims or statements that suggest a product is FDA-approved for treatment of a medical condition.
In the case of medical cannabis, manufacturers are prohibited from making claims or suggestions that cannabis is approved for the diagnosis, treatment, or cure of any disease or medical condition. It is for this reason that I generally recommend that clients refrain from suggesting that a product is capable of curing or treating a specific condition, as the Rohrabacher-Blumenauer Amendment does not prevent the FDA, which is part of the Department of Health and Human Services, from cracking down on the medical cannabis industry. In the event that you choose to advertise or market your cannabis product for treatment of a medical or health condition, you should, at the very least, include some sort of disclaimer language to mitigate the risk of an FDA enforcement action.
Notwithstanding the fact that the introduction of any product containing or derived from marijuana is illegal under federal law, the FD&C Act prohibits the marketing and sale of food products or dietary supplements that contain any “article” authorized for investigation as a new drug, antibiotic, or biologic, if there have been substantial clinical investigations that have been disclosed to the general public. Additionally, the FD&C Act prohibits the sale of dietary supplements or food products containing any active ingredient found in an FDA-approved drug product. According to the FDA, this ultimately prohibits the sale of dietary supplements containing THC and CBD, as the FDA has approved the prescription drug product, Marinol, which contains a synthetic form of THC, and FDA is currently reviewing clinical applications for CBD-containing prescription drug products.
In contrast to the FD&C Act marketing and advertising provisions, the prohibition on selling a product that contains an “article” found in a new drug application or active ingredient contained in a prescription drug is not related to the illegality of marijuana under federal law. Rather, the FD&C Act prohibits the sale of THC and CBD products because these “articles” are currently, or in the future will be, used to manufacture FDA-approved prescription drug products. Even in a post-federal legalization world, the FD&C Act theoretically bans the sale of CBD and THC products, which presents a significant concern for the existing medical cannabis community. If the FD&C Act bans the sale of THC and CBD-containing products outside of the FDA-approved prescription drug context, then the medical cannabis industry will hardly benefit in a post-legalization world.
With the current legal landscape of conflicting federal-state marijuana laws, state-specific marketing and advertising laws have largely reigned supreme, but only because FDA has exercised significant restraint in failing to launch a large-scale, widespread crackdown on the industry. However, as last October’s warning letters to four CBD manufacturers made clear, FDA is hardly reluctant to initiate enforcement actions in the event of suspected foul play. I have previously advised clients to refrain from using health claims to promote products to consumers, not only because of the underlying ethical implications of misleading desperate consumers, but also because of the potential for FDA enforcement action. As the United States moves closer and closer to federal legalization, FDA’s regulatory oversight will become increasingly important to the medical cannabis industry, so it is important to consider how the FDA will exercise oversight in a post-federal legalization world so you can begin protecting your cannabusiness now.