The FDA has recently established new regulatory requirements for cosmetic products in the United States through MoCRA. At the same time, the FDA wanted to avoid excessive burden on small businesses and, therefore, set some exemptions.
For this purpose, a small business is defined as a company whose average annual gross sales of cosmetic products in the United States for the previous 3-year period are less than $1,000,000, adjusted for inflation.
Exemptions to MoCRA for small businesses
Small businesses are exempt from the following MoCRA requirements:
- Product listing
- Facility registration
- Good Manufacturing Practices (GMP) compliance
Nevertheless, small businesses can list their products and their facilities on a voluntary basis. It helps communications with the FDA and it shows high commitment to compliance.
Furthermore, small businesses must keep the records of adverse events for three years, instead of six years as normally required.
On top of this, MoCRA provides that the exemptions are not applicable to companies that produce or sell particularly high-risk products. These products are the following:
- Cosmetic products that regularly come into contact with mucus membrane of the eye;
- Injected cosmetic products;
- Cosmetic products for internal use;
- Cosmetic products intended to alter the appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions.
Hence, if your company falls within the definition of a small business but produces or sells any of the above products, the exemptions do not apply to you. Moreover, if a small business manufactures or sells a wide range of products, including one the falls under one of the categories listed above, it will have to list all its products with the FDA.
FDA Questions and Answers
The FDA replies to some of the most frequent questions on small businesses in its final guidance on cosmetic product listing and facility registration. In the same document, the FDA provides some examples of products regularly in contact with the mucus membrane of the eye and products intended to alter appearance for more than 24 hours.
In the final guidance, the FDA clarifies that small businesses do not have to provide any documents to confirm they fall under the definition.
Do you need help to comply with MoCRA? Obelis, with 35 years of international regulatory experience, is the ideal partner to support you in the compliance journey. Contact us today to discover our US services dedicated to manufacturers, brand owners, and producers of cosmetic products.
Francesca Santacatterina
Regulatory Intelligence and Innovation Department
30.04.2024
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