Am I making a “cosmetic product”?
If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which determines whether MoCRA pertains to your product at all.
Under MoCRA, a “cosmetic product” is defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” 21 U.S.C. § 364(2). As indigestible as this definition may be, it turns on what constitutes a “cosmetic,” a term defined under the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301, et seq., “the Act”). The Act defines a “cosmetic” as:
(1) article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
(2) article intended for use as a component of any such articles;
except that such term shall not include soap.
21 U.S.C. § 321(i).
While “soap” is excluded from the definition of a “cosmetic,” the U.S. Food and Drug Administration defines this term narrowly as an “article that meet[s] the following conditions:
(1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and
(2) The product is labeled, sold, and represented only as soap.”
21 C.F.R. § 701.20(a).
Products regulated as drugs and medical devices are also exempt from MoCRA. This includes over-the-counter products (“OTC”) with a cosmetic intended use that contain drug active ingredients, such as sunscreens, and other OTC products like dandruff shampoo or anti-fungal creams. The definition of a drug in the Act, which is very similar to the definition of a device, includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and  articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1). While these products are exempt from most parts of MoCRA, the provisions related to fragrance allergen disclosures and labeling of cosmetic products for professional use may still apply. More on those requirements in our later posts.
It is important to keep the definition of a “cosmetic product” under MoCRA and the definition of a “cosmetic” under the Act in mind when assessing whether MoCRA applies at all. MoCRA’s departure from the Act’s definition of a “cosmetic” seems to indicate that the new regulation is applicable to any product found in the Health & Beauty section of a grocery store, from make-up to lotions to shampoos to nail polish. The fact that MoCRA does not rely solely on the Act’s definition of a “cosmetic,” and, instead, ventures into the concept of a “cosmetic product” creates opportunity for interpretation and, likely, litigation in years to come. If there are any questions over whether a product meets MoCRA’s definition, your counsel can provide guidance.
I am a manufacturer, packer, importer, or distributor of a cosmetic. Now what?
Assuming your product qualifies as a cosmetic product and is not exempt as a soap, an OTC, or a medical device, there are a series of steps you will have to take to ensure compliance with MoCRA’s new requirements. And there is no better way to ensure compliance than to designate a person or an entity responsible for it. In fact, MoCRA requires you to do just that by December 29, 2023.
Pursuant to MoCRA, cosmetic labels must include a “responsible person” designation. A “responsible person” is a manufacturer, packer, or distributor whose name, U.S. address, telephone number, and electronic information appear on the label and who will serve as the point of contact with the FDA.
What is the “responsible person” actually responsible for? A whole slew of compliance actions, including, but not limited to the following: registering the products and submitting product listings to the FDA, registering product “facilities” with the FDA, receiving, responding to, investigating, and, when necessary, reporting adverse events to the FDA, maintaining a cosmetovigilance dossier, maintaining safety substantiation records, managing FDA’s audits, and organizing market recalls. Some of these requirements are akin to the responsibilities imposed on drug manufacturers. For example, the meaning of cosmetovigilance is the collection, evaluation, and monitoring of spontaneous reports of undesirable effects observed with the use of cosmetic products under normal or predictable conditions. This is similar to the concept of pharmacovigilance employed in the drug industry.
Manufacturers, packers, importers, and distributors of cosmetics should take the time now to review contracts across the supply chain of their products and negotiate the proper allocation and cost of taking on the “responsible person” designation. Some of the above-referenced responsibilities, like the requirement to list product and facilities with the FDA, must be met by December 29, 2023. To facilitate the execution of the duties of a “responsible person,” you may want to take an inventory of your products, assemble information necessary to complete product and facility listings, evaluate your existing adverse event reporting policies and procedures, and put in place or update a comprehensive cosmetovigilance process. If you are not sure where to begin, do not hesitate to reach out to our team for further guidance, and stay tuned for additional MoCRA posts on our blog.