What you can and can’t say today about your cannabis consumable product starts with something that happened over 80 years ago. In 1938, the United States Congress passed the Federal Food, Drug and Cosmetic Act (FD&C Act). It gave authority to the US Food and Drug Administration to oversee the safety of food, drugs, medical devices, and cosmetics.
At a federal level, cannabis — or marijuana — remains an illegal Schedule I drug because of the psychoactive effects of delta-9 tetrahydrocannabinol (THC) and its high potential for abuse. On the other hand, the 2018 Farm Bill allows for the sale of products derived from hemp as long as the THC concentration is not more than 0.3 percent on a dry weight basis. But that’s not all. The FDA continues to add to the scope of its regulation of cannabis and cannabis-derived products.
Thanks to startups, we’ve been bombarded with the concept of disruption. Some would say the old ways were rigid and wrong, and traditional thinking deserves to be disrupted. Think as you like, but federal laws regulate what you can say and claim about your new way of thinking when it comes to cannabis products — especially those that are eaten, drunk, or otherwise consumed.
Failure to follow the FDA rules about how you can describe what your cannabis product is or does is illegal. Acting this way is irresponsible and has a negative impact on the industry as a whole — and on your business.
The FDA has not been draconian. It has been transparent and public in its observation that there’s a significant and growing public interest in cannabis products — CBD in particular. The organization is working as fast as possible to find answers to unanswered questions about the safety, science, and quality of cannabinoids.
Until then, the FDA has specific regulations regarding claims made about CBD and cannabis consumables.
The most recognizable prohibition is making any claim that a cannabis consumable can cure, prevent, diagnose, or treat a serious disease. If you make this claim, you are identifying your product as a drug. Unless the FDA has given you approval to market this drug, that would be breaking the law. You can’t get around it by calling your product something else, either, like a dietary supplement. If it acts as a drug, then it will be classified as a drug and subject to a long set of testing and approval processes.
A dietary supplement, under the FD&C Act, also may not make such claims. The FDA is clear about this. According to the most recent version of the FAQ the FDA provides on regulation of cannabis and cannabis-derived products, the organization states that “HC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)].”
The FAQ goes on to say, “Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.”
Cannabis consumables cannot be sold as dietary supplements because CBD and THC are active ingredients in FDA-approved drugs, such as Dronabinol and Epidiolex.
Inappropriate classifications and claims will also put you on the radar screen of the Federal Trade Commission. This organization has truth-in-advertising laws that, among other things, require your product descriptions and marketing to be backed by legitimate research. Above all, any claim made by the manufacturer of a cannabis product must not mislead consumers.
Any statement you make about your product must be authorized first by the FDA, and this organization has made it clear that it has only just begun to undertake the steps necessary to approve such claims. Adding to the challenge is that THC is an illegal Schedule I drug, so research requires approval by the United States Drug Enforcement Administration (DEA).
If you haven’t already, acquaint yourself with the FDA’s structure/function claims. These are claims that describe the role of a dietary ingredient intended to affect normal structure or function of the human body. A structure/function claim makes no assertion that it can diagnose, cure, treat or prevent disease (which would require FDA approval).
Your cannabis consumable can restore, lower, maintain, promote, raise, regulate, stimulate, or support a human body function that relates to a non-disease condition. For example, the FDA cites "fiber maintains bowel regularity" and "antioxidants maintain cell integrity" as OK statements to make in its explanation of what structure/function claims may include
The FDA is a regulatory organization charged with upholding the law. You’ll stay on the right side of that law by using the correct language to describe and market your cannabis consumables.
That’s the tip of the iceberg of things you need to know to market cannabis effectively and legally. To learn more, visit the cannabis marketing from Content Bacon.