Cosmetics are something of a bright spot when it comes to federal cannabis regulation. Unfortunately, however, there is quite a bit of misunderstanding when it comes to the federal legal framework for cannabis cosmetics. Following up on question that was asked during a recent webinar, here are the basics of which cannabis brands should be aware.
First, the distinction between hemp and marijuana applies to cosmetics. If a cosmetic’s THC content exceeds 0.3%, it is considered marijuana and is a controlled substance under federal law.
Second, provided its THC level does not exceed 0.3%, there is no prohibition on the use of cannabis as a cosmetics ingredient. According to FDA, “certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients.”
This available legal space sets cosmetics apart from other products, such as foods. Under the drug exclusion rule, foods to which CBD or THC has been added cannot be legally sold or marketed in the United States (even if the THC does not exceed the 0.3% threshold).
Third, while the presence of cannabis as an ingredient does not by itself render a cosmetic unlawful, brands must comply with other regulations. For one, even though cannabis is not a prohibited ingredient, brands must ensure that their products do not contain any of the ingredients that are prohibited. In addition:
“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. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual.”
Finally, depending on its intended use, a cosmetic can also be considered a drug, as defined in the Federal Food, Drug, and Cosmetic Act. Drugs are intended to “affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease.”
Depending on a cosmetic’s nature, the line between being considered a drug or not is a fine one. It is however a line of great legal import. A CBD cosmetic may be lawful under federal law, provided it meets all of the legal requirements for cosmetics. On the other hand, a CBD drug is certainly unlawful.