On March 22, 2021, the Food and Drug Administration (FDA) announced that it sent two warning letters to "Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief." As with any FDA announcement on cannabidiol (CBD), our regulatory attorneys immediately began fielding calls from concerned stakeholders. Here are links to each letter, named for the unfortunate recipient:
The main concern over these letters are the fact that they focus on topical products containing hemp-derived CBD (Hemp-CBD). While it may be true that the FDA is starting to focus more on topical products, that does not mean that Hemp-CBD cosmetics are now in grave danger.
Since 2015, the FDA has been sending out warning letters related to hemp-derived CBD (“Hemp-CBD”) products. The FDA's position since the advent of the Hemp-CBD market, has been that because Hemp-CBD has been approved as a pharmaceutical drug, it cannot be marketed or sold as a dietary supplement or as an ingredient int food. This is because of the “Drug Exclusion Rule” which basically means that once a compound is approved for use in a drug, it cannot be added to other consumable goods. In addition, the FDA objects to the sale of Hemp-CBD as an over-the-counter drug. The FDA determines what a product is based on the "intended use." If a product is marketed for therapeutic use or is marketed with disease claims, then the FDA considers that product a drug.
While the FDA's position is that Hemp-CBD is not allowed in any ingestible product, the agency does not have the resources to go after every company selling ingestible Hemp-CBD. Instead, the FDA's enforcement approach has largely focused on products that are marketed using therapeutic and disease claims.
The most recent letters seem concerning because of the targeted claims made about topical products. This is likely because the prevailing wisdom is currently that CBD topicals are the safest path to market given the FDA's position on consumable Hemp-CBD. Unlike with food and dietary supplements, cosmetics are not subject to the Drug Exclusion Rule so the FDA does not outright object to the inclusion of Hemp-CBD in cosmetic products. The fact that CBD has been approved of as a prescription drug does not ban the use of CBD in cosmetics.
Remember that the FDA determines whether something is a drug based on its intended use. If you have a topical Hemp-CBD product that would otherwise be considered a cosmetic and you start claiming it treats pain then that Hemp-CBD product is a drug and not a cosmetic. In both warning letters, the companies targeted were pretty clearly marketing their topical Hemp-CBD products as pain treatments, making them easy for the FDA to categorize as a drug.
More To The Story
With so many Hemp-CBD products marketed for some therapeutic use, it appears that the FDA has focused its enforcement resources on egregious claims such as "CBD cures cancer" or "CBD can prevent COVID-19 transmission." The March 2021 letters do contain claims about Hemp-CBD and pain, but they are not nearly as egregious as other claims. Does this mean that the FDA has is now going after any and all claims made about CBD?
The answer is maybe. After all, it's not as if there is currently any legal haven for making even the most innocuous health and safety claims, so maybe the FDA is just fed up with any Hemp-CBD company that makes any health or wellness claim. While this is a definite possibility, the idea that the FDA is on a Hemp-CBD warpath based on these last warning letters seems misguided. Why? Because the FDA has gone after companies for selling Hemp-CBD products before, even in the absence of health and wellness claims.
The FDA has sent at least two warning letters where the FDA took issue with the mere presence of CBD in foods and dietary supplements. These letters were addressed to Herbal Healer Academy, Inc. and Alternative Laboratories in September 2019. In both letters, the FDA appears to have discovered Hemp-CBD product labels during an FDA inspection. In each case, the FDA focused on the fact that (I know I sound like a broken record) Hemp-CBD cannot lawfully be added to food or dietary supplements.
Much like the September 2019 letters, this most recent batch of warnings appear to follow an FDA inspection. One could extrapolate that once the FDA investigates a facility that is manufacturing Hemp-CBD they deviate from their main enforcement priority: preventing consumer misinformation. Usually, FDA warning letters are a result of over-the-top marketing but in some cases warning letters follow an inspection and in those cases the FDA will focus on any health and wellness claim even if those claims are relatively vanilla compared to some of the far-fetched things people say online about CBD.
CGMP Arrives on the Scene
The letters this week add new, interesting pieces to the FDA’s CBD puzzle. First, they highlight each company's lack of Current Good Manufacturing Practices (CGMP). The FDA's warning letters are based on claims made by a Hemp-CBD distributor, which they use as the basis for the warning letter. Because drugs are defined based on their intended use, the FDA can determine from marketing alone whether a company is selling unapproved Hemp-CBD drugs. But, this last round of letters was not based on the company's marketing alone. Instead, the FDA investigated the companies' facilities and found a hit list of CGMP issues. It's not as if other companies that receive warning letters have achieved CGMP compliance, it's just that the FDA does not usually "get in under the hood" to look at how each recipient of a warning letter is operating.
Inactive VS Active Ingredients
The second interesting piece about these letters is that they dispel the idea that drugs containing Hemp-CBD that claim that CBD is the "inactive ingredient" somehow makes those products compliant. The FDA rejects this "inactive ingredient" theory two-fold.
In both letters, the FDA determined that CBD was an "active ingredient" because CBD was a component of the drug "intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention or to affect the structure or function of the body." This means that although these Hemp-CBD companies claimed CBD was inactive ingredient, they marketed the products by claiming that CBD was, in fact, the component of the drug used for health benefits. The FDA purports that "CBD" was prominently displayed on the package, that each company marketed CBD for its medicinal benefits, and that the companies provided language in their marketing on CBD dosing.
The FDA goes onto state that even if CBD was, in fact, an inactive ingredient in the offending products, that is still a problem because the FDA tightly regulates all ingredients in a drug. Here is the FDA's break down of the inactive ingredient issue, pulled from the Honest Globe letter:
In particular, these products would not [. . .] conform with the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable. A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.
Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD, however, has known pharmacological activity with demonstrated risks. It is unknown whether the levels of CBD used in your [Hemp-CBD] products have pharmacological activity or pose any concern for safety events.
Overall, it seems like the FDA is finding new ways to say the same thing: that Hemp-CBD should not be sold in any form that is consumable and cannot be marketed in any way that suggests Hemp-CBD has any medical benefit. While these letters may add nuance to the FDA’s position on CGMP compliance and “inactive” ingredients, they do not constitute a deviation from the FDA’s Hemp-CBD policy. What do you think?
You can contact Daniel Shortt at email@example.com or 206-430-1336.