Updated on 9/7/23.
On December 29, 2022, the FDA enacted "The Modernization of Cosmetics Regulation Act (MOCRA)."
The critical of the legislation is to guarantee that manufacturers of cosmetic products provide reassurances regarding the safety of their products. At the same time, it can be difficult to understand and unravel the necessary steps for companies to guarantee compliance.
Then, how should Cosmetics Companies Prepare for MoCRA?
1. Embrace digital transformation to adopt a more modern approach.
Today, many cosmetics companies lack the digitalization of managing, packaging, and supplying their products. However, it is crucial and essential to digitize, standardize, and centralize data in order to navigate FDA regulations and comply with the elements of MOCRA.
2. Reconceptualize the role of quality in Adverse Event Reporting.
Cosmetics companies are required to retain Adverse Event Reporting data for a period of six years, and any submitted reports initiate mandatory notifications to the FDA. It becomes increasingly crucial for quality teams to diligently monitor consumer complaints, maintain comprehensive records, and accurately link each complaint to relevant product and packaging component data. It is essential to establish a controlled, digital feedback loop to share this information with regulatory, product development, and packaging teams, particularly when modifications to products are necessary.
3. Designate “Responsible Person”
The term "Responsible Person" refers to the manufacturer, packer, or distributor whose name is indicated on the label of a cosmetic product. By December 29, 2023, the Responsible Person is obligated to provide FDA with a comprehensive listing of each cosmetic product, along with its corresponding ingredients. Furthermore, the Responsible Person must update the product listing information on an annual basis. Also, the Responsible Person must report to the FDA any "serious adverse event" linked to the use of a cosmetic product that they have manufactured, packed, or distributed in the United States. It is the responsibility of the designated person to ensure and retain records that provide sufficient evidence to substantiate the safety of the cosmetic product.
4. Mark the importance of GMP requirements.
ISO 22716 is the standard that the FDA is leaning towards as a reference for now, but we have to recognize that the FDA is not bound to ISO standards. We can see this both from the medical device industry standards and pharmaceutical industry standards. What cosmetics manufacturers and companies be aware of is to understand what their products are in essence. Are the products more than a cosmetic product but is not quite clear whether it is an OTC product? How about the claims? Based on a number factor, it is best to build the GMP in the most conservative fashion possible. Another important note is that such GMP requirement is a relatively huge commitment for both cosmetics manufacturers and companies who were never enforced to do so in a way MoCRA is demanding now. So preparation in advance with experts is highly recommended.
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