Everybody Else Is Doing CBD, So Why Can’t We?Sep 27, 2019 Compliance
How many times has any parent heard the familiar lament, “Everybody else is doing it!” Usually, that feeble protest is met with a definitive response along the lines of “That doesn’t make it right.” And, usually, that’s the best answer – especially when it comes to CBD.
Anyone who attended this year’s Natural Products Expo West in Anaheim, California or Expo East in Baltimore, Maryland knows that CBD products seemed to be just about everywhere. Some exhibitors even claimed that their products were “fully compliant.” That is an interesting assertion given that the FDA has expressly stated that CBD cannot be used as an ingredient in foods or dietary supplements. With regard to food, any substance that is intended to be a component of a food is a food additive, making it subject to premarket approval by the FDA unless it is already generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use. CBD does not enjoy GRAS status. Similarly, the FDA has concluded that CBD products are excluded from the dietary supplement definition under the Food, Drug & Cosmetic Act (Act) because CBD is an active ingredient in an existing drug, Epidiolex, a prescription medication intended to treat seizures.
While certain states may have looser views as to whether CBD can be used in those products, they do not trump the Act or the FDA. In other words, nothing is actually prohibiting the FDA from taking enforcement actions against manufacturers or distributors of CBD-containing food and dietary supplement products.
But, wait! What about major retailers’ recent announcements that they would be carrying “topical” products in various states across the country? This product category includes creams, sprays, roll-ons, lotions, salves and soap. That doesn’t sound like a drug, food or dietary supplement. “Topicals” sounds like … uh … cosmetics! That must be okay, right? Well, let’s take a look at the overarching Act to see if that conclusion holds up.
The Act defines “cosmetics” as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance….” Act, sec. 201(i). Products generally deemed to be cosmetics include skin moisturizers, perfumes, lipsticks, shampoos, deodorants, and so on. On the surface, this seems to be the general category that “topicals” fall into. However, whether a product is a cosmetic or a drug under the law is determined by a product’s intended use.
The Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals….” Act, sec. 201(g)(1). Products such as prescription medicines or flu vaccines, for example, are clear examples of drugs.
Wait, what? Some products meet the definitions of both cosmetics and drugs? Yes. This happens when a product has more than one intended use.
So, how is a product’s intended use determined? As with most straightforward questions, the legal answer is “it depends.” The intended use can be indicated by the claims stated on the product labeling, in advertising, on the Internet, or in other marketing materials. The intended use can also be establishing by consumer perception of what it is used for and/or the product’s marketplace reputation. Additionally, if a product has a well-known therapeutic use, that can establish it as a drug (e.g., fluoride toothpaste).
An example provided by the FDA on its website to illustrate this point would be that of a shampoo. It is a cosmetic because it is intended to clean hair, but if it is also formulated to treat dandruff, it would also be considered a drug.
“Okay, but so what?” you are probably asking. Manufacturers just need to be careful about identifying their CBD products’ intended uses. Not so fast.
If a manufacturer is not careful about the claims made on its product’s label and associated labeling (such as a website), what the manufacturer intends its products to be used for might not hold up. Under the Act, drugs must generally either receive premarket approval by the FDA through a New Drug Application (NDA) process or conform to a monograph for a particular drug category. These monographs specify the conditions under which over-the-counter drug ingredients are generally recognized as safe and effective. CBD does not currently enjoy this classification.
“Well, what about the Farm Bill?” you ask. An overly broad reading of that legislation has not been endorsed by the FDA when it comes to CBD. In a December 2018 statement following the passage of the Farm Bill, the FDA expressly noted:
In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
And, we should talk about soap. The regulatory definition of “soap” is different from the way in which people commonly use the word. The regulated term “soap” only applies when:
- the bulk of the non-volatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
- the product is labeled, sold, and represented solely as soap. (21 CFR 701.20).
“Soap” products that meet this definition are regulated by the Consumer Product Safety Commission (CPSC). If a product intended to cleanse the human body does not meet all the criteria for soap, it is considered to be a cosmetic (and, if you are not careful, it might also be a drug). Which puts us back in line with the regulatory chutes and ladders process that I outline above.
The takeaway? While a major retailer may be willing to push the issue in an effort to meet consumer demand, it is important to remember that retailers have no law or rule making authority. Whether the FDA takes more concerted action to stop or otherwise question the sale of CBD products at retail stores remains to be seen. However, what cannot be reasonably disputed is that many of those products are not likely in compliance with the Act or FDA guidance at this time. Therefore, just because everyone else seems to be diving in head first, doesn’t mean that you should be.