In the last few weeks, two major drugstores publicly announced that they will start carrying products containing hemp-derived cannabidiol (“Hemp-CBD”). Both CVS and Walgreens announced that CBD topicals would be available in their stores, in a select number of states. Notably, both drug store chains limited products to non-ingestible topicals.
Dr. Scott Gottleib, the outgoing head of the FDA must have heard the news because on April 2 the FDA issued new guidelines on Hemp-CBD, updated its marijuana and hemp FAQs online, and sent a new round of warning letters to distributors of CBD products. Gottleib himself took to Twitter to chime in:
I was also concerned to hear recently that several national pharmacy chains and other major retailers have begun to sell or will soon begin to sell cannabidiol (CBD) products in several states.
— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019
The FDA has long held that Hemp-CBD cannot be added to food or dietary supplements because of the Drug Exclusion Rule. The FDA’s position is that the Food, Drug and Cosmetics Act (“FDCA”) and underlying FDA regulation do not allow articles approved as drugs to be used in food or dietary supplements unless they were marketed as such prior to public investigations into that drug. CBD has been investigated and approved of as a drug (Epidiolex) and that is the basis for the FDA’s determination. The FDA has also focused on prohibiting companies from making any type of health claims about Hemp-CBD as such claims cause the FDA to classify that product as a drug.
Prior to the April 2 guidance, the FDA had side-stepped the issue of Hemp-CBD in cosmetics, unless those products were deemed drugs based on the way they were marketed (e.g., “this CBD cream cures cancer”). That is no longer the case as the FDA has updated its cannabis FAQs to include this question: What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
Before looking closely at FDA’s answer there, it’s important to understand how the FDA defines cosmetics. Cosmetics are “articles intended to be rubbed poured, sprinkled or sprayed on . . . or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering appearance,” except for soap which is classified separately. 21 USC 321(i). Unlike food and drugs, cosmetics and ingredients in cosmetics are not subject to pre-market approval. For cosmetics, the FDA relies on consumer complaints to monitor the industry. There has been a push for years for Congress to change laws to give the FDA broader jurisdiction over cosmetics. That hasn’t happened yet.
Though cosmetics aren’t regulated as tightly as other products, the FDA still has regulatory authority over them and their ingredients. For example, color additives used in cosmetics are generally subject to premarket approval. Additionally, the presence of a harmful ingredient in a cosmetic causes the FDA to deem that cosmetic adulterated. The FDA has determined by regulation that some ingredients cannot be used in cosmetics. For example, if a product contains chloroform (other than in trace amounts) it is deemed adulterated. According to the FDA’s FAQs, CBD does not fall into this category:
Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients.
The story doesn’t end there though. In addition to ingredients that are prohibited by rule, cosmetics are adulterated if they contain “any poisonous or deleterious substance” which could harm users. The FDA’s FAQs take a look at this as it applies to cannabis:
Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.
In other words, just because an ingredient is not prohibited per se doesn’t mean it’s safe for its intended use.
Let’s also take a look at what makes a cosmetic “misbranded.” The FDA will deem a cosmetic misbranded if it is labeled in a false or misleading way, does not bear required labeling information, or is made or filled in a deceptive manner. This is true for all cosmetics, including those containing Hemp-CBD.
The bottom line is that all of these cosmetic regulations were in place before April 2. Companies selling Hemp-CBD cosmetics should have been aware of the regulatory environment before entering the industry. Are the FDA’s recent comments significant? Of course! It is important to carefully track whatever the FDA says and does with regards to Hemp-CBD. But it’s also important not to overreact. The FDA has not determined that the presence of Hemp-CBD makes a cosmetic adulterated or misbranded. That may change in the future, but I for one don’t think it will. The CBD-infused toothpaste is out of the tube and the FDA knows it.