In November 2019, the Food and Drug Administration (FDA) issued more than a dozen warning letters to companies whose websites or social media platforms claimed that various products, including those classified as cosmetic/beauty products, violated FDA regulations and the federal Food, Drug and Cosmetic Act. The alleged offenders run the gamut from CBD-enhanced retinol creams to healing oils and facial masks. The message to Green Rush product marketers is clear: The safety and efficacy of CBD in these products is evolving and unproven.
While the FDA is cognizant of the strong public interest in CBD products, it is also concerned that a misinformed consumer may take a nonchalant attitude toward these products to the detriment of their health. Given the limited available data about the safety and risks of CBD, the FDA’s recent actions clearly telegraph the message that CBD has not been fully evaluated and is not generally accepted as safe.
So, what’s a cannabis beauty product manufacturer to do? What can be included in a legally compliant marketing campaign is less obvious than what cannot. Examples of claims that raised the FDA red flag in the fall of 2019 include the following:
– Claims that CBD products “relieve” pain, inflammation, anxiety or seizures;
– Claims that CBD products are “beneficial” for those with certain medical conditions;
– Claims that CBD products have a “demonstrative” neurogenic effect;
– Claims that CBD products can “prevent” Alzheimer’s disease and diabetes; and
– An incorrect reference to the “fact” that government-funded research proves CBD’s efficacy in treating/preventing all of the above plus myriad diseases including alcoholism, multiple sclerosis and schizophrenia.
Each of the examples above run afoul of current regulations because they tout products that affect the structure or function of the body or claim to cure, mitigate, treat or prevent disease. The last example cited is especially egregious as there are no scientifically reliable studies proving such claims to date, much less any that are “government-funded.” These unproven and even blatantly false claims render the respective product as “misbranded,” which is generally defined as false, misleading or deceptive.
Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies that substantiate the claims are true. More general, making or exaggerating such claims, whether directly or indirectly, without rigorous scientific evidence sufficient to substantiate the claims, violates the Federal Trade Commission Act.
Many CBD products are also considered misbranded under the Food, Drug and Cosmetic Act, because the product labels and product information fail to include adequate directions for use. If a product is marketed to treat or cure a disease or body function, it is considered a drug by the FDA. Drugs in the United States must contain directions explaining how a consumer can use it safely for its intended purpose.
Until such time as the FDA and other agencies enact clarifying regulations, a cannabis beauty product marketing campaign is best structured around demonstrably objective facts, anecdotal claims attributed to real users and innocuous “puffery.” It is also important that product labels clearly state that any claims made have not been evaluated by the FDA and, depending on the use, an admonition to seek the advice of a physician prior to use.
Cannabis beauty product labels and marketing should also include the following information: percentage of CBD (this is required if the product can be considered both a cosmetic and a drug); supplemental/cosmetic ingredient list; net weight; manufacturer/distributor names; instructions on how to safely use the product for its suggested use; whether the CBD in the product is full-spectrum, broad-spectrum or isolate; and batch date/code.
Given the explosion of cannabis beauty products in the marketplace and the recent media focus on contaminants in certain THC/CBD products, especially those manufactured abroad, product manufacturers might also consider focusing on “Made in the USA” claims and verifiable testing that demonstrates purity of the CBD in their products, as well as any additional ingredients.
Staying abreast of state and federal enforcement actions, regulatory guidance and lawsuits relating to cannabis beauty product labeling is as important as staying abreast of new scientific research. Frequent evaluation and even modifications to marketing campaigns may be required given the fast-paced development in both the regulatory and scientific arenas.
Stephanie Spardone, a member of Foley & Mansfield’s national cannabis law team, has extensive experience defending product manufacturers, retailers and premises owners in product liability and personal injury litigation. She has also defended pharmaceutical manufacturers in catastrophic child-injury and death cases. She works closely with clients to successfully execute defense strategies that minimize liability and risk and can be reached at email@example.com.