Medical aesthetic products. US cosmetics regulatory update signed into law

THE WHAT? President Biden has signed the Consolidated Appropriations Act 2023 into law, according to a report published by the National Law Review. The legislation includes the Modernization of Cosmetics Regulation Act (MOCRA) of 2022, amending Chapter IV of the Federal Food, Drug and Cosmetic Act.

THE DETAILS MOCRA imposes new requirements on facilities and ‘responsible persons’ that are engaged in the manufacture and distribution of cosmetics in the United States. Facilities must be registered with the FDA, with the registration renewed every two years, bringing the regulation of beauty manufacturers up to code with the food industry. In addition, responsible persons will need to submit cosmetic product listings to the agency.

The regulation also ushers in new reporting requirements for ‘serious adverse events’. The FDA has also been directed to bring in labelling requirements and thresholds for fragrance allergens, rules governing testing for the presence of asbestos in talc and report on the use of PFAS in cosmetics.

THE WHY? Product listings will allow the FDA to monitor the industry more effectively and track products in the event of a safety issue. With several safety scandals prompting both lawsuits and recalls in the last five years, many would argue this legislation is long overdue.

Medical aesthetic products refer to a category of products used in the field of medical aesthetics, which combines medical practices with cosmetic procedures to improve the appearance of individuals. These products are typically used under the supervision of trained medical professionals such as dermatologists, plastic surgeons, or specialized nurses. They are distinct from over-the-counter cosmetics in that they often contain higher concentrations of active ingredients or require medical expertise for their application.

Examples of medical aesthetic products include:

• Dermal Fillers: Injectable substances used to restore volume, fill wrinkles, and enhance facial contours. These may include hyaluronic acid fillers like Juvederm or collagen-stimulating fillers like Sculptra.

• Botulinum Toxin (Botox): Injectable neurotoxins used to temporarily paralyze facial muscles, reducing the appearance of wrinkles and fine lines caused by facial expressions.

• Chemical Peels: Solutions containing chemical exfoliants like glycolic acid, salicylic acid, or trichloroacetic acid, used to improve skin texture, treat acne scars, and reduce hyperpigmentation.

• Laser and Light Devices: Equipment used for various skin treatments, including hair removal, skin resurfacing, tattoo removal, and treatment of vascular and pigmented lesions.

• Prescription Skincare Products: Formulations containing active ingredients such as retinoids (e.g., tretinoin), hydroquinone, or prescription-strength antioxidants, designed to address specific dermatological concerns under medical supervision.

• Microneedling Devices: Devices that create tiny punctures in the skin to stimulate collagen production and improve skin texture and elasticity.

• Cosmeceuticals: High-quality skincare products that bridge the gap between cosmetics and pharmaceuticals, often containing biologically active ingredients with proven efficacy.