Trends in Recent FDA Warning Letters for Cosmetic and Cosmetic-Adjacent Products

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics in nearly 85 years.  FDA is now enforcing MoCRA’s product listing and facility registration requirements (as of July 1, 2024) along with MoCRA’s adverse event reporting, safety substantiation, recall authority, and records access requirements.  But how is FDA actually effectuating its new enforcement powers regarding cosmetics?  Below we explore two significant emerging trends that shed light on this question.  These trends reveal that at present, FDA is most focused on regulating products that exist at the nexus of the definition of “drugs” and “cosmetic products.”  In other words, FDA continues to focus on companies and products already on its radar as part of its authority over drugs.

Whether FDA considers a product to be a drug or a cosmetic product is critical as the agency ramps up its enforcement of MoCRA.  Under MoCRA, a “cosmetic product” is defined broadly as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”  Products regulated by FDA as drugs or medical devices are exempt from MoCRA’s requirements, though FDA has separate regulatory requirements for medical devices and drugs.  Facilities that manufacture, distribute, or package cosmetic products that are not regulated as drugs or medical devices must comply with MoCRA.

First, we observed over the summer that FDA’s early efforts to enforce MoCRA appeared to focus on companies it was already inspecting pursuant to its authority over drugs. This trend continues.  FDA recently issued three warning letters to drug manufacturing facilities, noting that some products may be considered “cosmetics” regulated under MoCRA.

• On October 21, 2024, FDA issued a warning letter to a drug manufacturing facility in North Carolina for violations of Good Manufacturing Practices (GMPs) and adulterated rash and itch cream products. Based on a review of the product’s label, FDA determined these were unapproved new drug products and contained unlawful marketing materials.  FDA further advised the company that its facility may be subject to MoCRA requirements. 
• On October 17, 2024, FDA notified a Turkey-based drug manufacturer that inspectors observed numerous violations of current GMPs for a topical drug product, including failures to perform appropriate testing and failure to establish written procedures to assure product identity and quality. FDA’s letter observed that some of the drug company’s products appeared to be cosmetics such that the facility may be subject to MoCRA’s requirements.  FDA warned the company that the conditions causing the drug products to be adulterated may also cause its cosmetic products to be adulterated.  
• In September 2024, FDA issued a similar warning letter to another drug manufacturer, citing violations of GMPs for pharmaceuticals and warning that its drug products were adulterated and/or unapproved new drugs. The letter further noted that some of the company’s products may be regulated as cosmetics and thus subject to MoCRA.  

Second, FDA has been active recently regarding skin products consumers may consider to be cosmetics, but which FDA considers to be drugs. 

In July, FDA issued a warning to consumers not to purchase or use certain chemical peel skin products without appropriate professional supervision due to the risk of serious skin injuries, severe chemical burns, swelling, or infection.  The consumer warning indicated that these products contain glycolic acid, salicylic acid, lactic acid, and trichloroacetic acid (TCA) in concentrations that may be too high to be used safely at home.  FDA encouraged both consumers and health care professionals to report adverse events or issues with chemical peel products.

FDA published this warning following a series of warning letters to companies manufacturing, selling, and/or distributing chemical peel products.  These letters indicated that FDA considers these products to be “unapproved new drugs” per the Federal Food, Drug, and Cosmetic Act due to their intended “use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.”

In support of its determination that chemical peel products are “drugs” rather than “cosmetic” products, FDA researched and cited language from product labels, product webpages, and even companies’ social media pages.  Specifically, FDA found claims that the peels “clear acne,” “remove dead skin,” and “reduce scars and wrinkles” demonstrate they are intended to be used as drugs.  Notably, in connection with its recent October 21 warning letter regarding adulterated rash and itch cream products, summarized above, FDA performed a similar analysis and reached a similar result.  FDA determined that the rash and itch creams were drugs based on claims on the product labeling that the topical cream, among other things, “soothes inflamed, irritated, and itching skin”.  

Determining whether a product is a “cosmetic product” or a “drug” may be difficult in some instances, and FDA will make its own determination.  As FDA continues to develop its MoCRA enforcement strategy, companies that manufacture and distribute products that could be considered either a “cosmetic” or a “drug” should follow regulatory developments in both spaces.  We will continue to monitor and report on FDA’s guidance and enforcement actions on cosmetic and other personal care products.