For the first time in eight decades, a significant piece of legislation was introduced to modernize the regulatory oversight of the cosmetic products industry by the FDA. This landmark legislation, known as the Modernization of Cosmetics Regulation Act (MOCRA), was officially signed into law on December 29, 2022. It marks the first substantial set of amendments related to cosmetics in the Food, Drug, and Cosmetic Act (FDCA) since it was enacted in 1938.
MOCRA establishes a comprehensive regulatory framework which introduces new FDA registration and listing requirements, labeling rules, enforcement authority, and good manufacturing practices requirements, among other regulatory obligations for cosmetic manufacturers. While some small businesses are exempt from some of the requirements of MOCRA such as facility registration, they are not exempt from mandatory allergen reporting, adverse event reporting, and labelling requirements. Small businesses, for the purposes of MOCRA, are defined by an average gross annual sales figure amounting to less than $1 million, which will encompass much of the indie perfume world.
With these upcoming changes, we’ll be seeing a significant enhancement of transparency throughout the entire supply chain and among perfumers. The evolving landscape seeks to address a longstanding concern where the term "fragrance" has historically encompassed a myriad of ingredients without specifying allergens. These fragrance allergens usually only affect a very small percentage of people and they are found in both natural and synthetic materials. These are materials you may be familiar with like Eugenol (think cinnamon, cloves, bay leaf) and Evernia prunastri (Oakmoss) which some people are sensitive to as well as other naturals and synthetics used in fragrance. These materials are already restricted by IFRA (the International Fragrance Association) and those of us who abide by IFRA already compose within those limits. To learn more about allergens, you can read a page that I have written about them at this link.
Every perfumer and cosmetics maker that you buy from, large and small, is now required to adhere to MOCRA compliance, which will result in a likely surge of label modifications across the indie perfume and cosmetics landscape in 2024. Although some brands already disclose potential allergens on labels, it was not mandatory before.
This development is noteworthy, especially when considering the historically unregulated landscape of indie perfumes which on sites like Etsy can sometimes operate like the Wild West. In the previously unregulated space of indie perfumery, where practices such as mixing mystery stock oils and labeling it as "perfume" have been way too prevalent in recent years, I feel like mandating greater transparency is a positive step forward for indie and niche perfume as a whole. Individuals engaging in the blending of unidentified oils and those lacking familiarity with their materials may encounter challenges in meeting the necessary requirements to legally operate, which I feel is an overall good thing for the art of perfumery.
The FDA is expected to release a notice of proposed rule-making within the next few months that defines the specific materials that will be classified as allergens under MOCRA. The allergens will most likely mirror those defined by IFRA and the EU, so that’s how we have been preparing our labels, with the expectation that we will make any further amendments once the list is updated or additional amendments are added. Overall, I feel that the enactment of MOCRA not only addresses legal compliance but also represents an unparalleled opportunity for perfumers to enhance transparency and heighten awareness about the perfumery process and its ingredients.
-KA