BRIDGE BEAUTY COMPLIANCE

Its finally here! The beauty industry overhaul we all knew was coming. The legislation is full of information and I have boiled it down to 7 main points for this discussion, but do not panic! Not everything has to be done all at once, the bill does give the FDA some time to generate regulation and guidance. Which, in turn, gives you time to think through what changes need to be made and tasks that need to be completed.

So, what’s involved in complying? Nothing out of the ordinary if you are familiar with the pharmaceutical regulations or EU compliance. Some of these things have been coming for a long time, we just did not know exactly when. Let’s go through this and I will explain the key points.

ADVERSE EVENT REPORTING: New to the cosmetic industry, however it is not that different from the pharmaceutical reporting. You have to report serious adverse events within 15 days of knowing about it and you have to keep records of each adverse event report for 6 years. If you receive further medical information for a specific event that was reportable, you have one year to get that information in. Further, an authorized person is allowed to access your reports and request your composition to fragrances or flavors if they deem the adverse event may have come from there.

CURRENT GOOD MANUFACTURING PRACTICES (cGMP): The FDA has two years from December 29, 2022, to write the cGMP regulations as a draft. They will then ask for comments from the industry, then publish a final rule in the third year. They state that the regulation must be consistent with national and international standards. I am thinking it is going to be very similar to the international standard ISO 22716 GMP for cosmetics to which the FDA already provides a guidance. Compliance is mandatory, and noncompliance results in adulterated product.

FACILITY REGISTRATION: Cosmetic facilities both domestic and foreign are required to register with the FDA. If you are a foreign facility, you must have a US agent. I am sure you are asking, well who qualifies as a facility? A facility includes manufacturers and fillers. Which also includes packaging and repackaging if there is tangible product being filled in the container. I say this because there is an exemption for labelers, relabeling, packaging, repackaging, holding, and/or distributing cosmetics products. Also excludes research or evaluation facilities including facilities that test from production. Existing facilities have 1 year to register, and new facilities have 60 days to register from when they start manufacturing cosmetic products or 60 days after the deadline of existing facilities. Lastly, you must renew your registration biennially.

PRODUCT LISTING: These are the main points to product listing: The Responsible person is required to list all their products (Responsible person: is the person or entity whose name appears on the label). These are the items that need to be on the listing:  Place of manufacture, the cosmetic category, product ingredients, and product listing number. Products that are identical except for color, fragrance or flavor, or quantity of contents may be listed under a single listing. All products must be listed no later than one year after the enactment (deadline December 29, 2023). New products marketed after the enactment must be listed within 120 days.  The list must be updated annually.

LABELING: Cosmetic product labels must have a domestic address, domestic phone number OR (the “or” is key) electronic contact information. Electronic contact information includes a website however you must be able to receive adverse event reports through it. Fragrance allergens must be listed, I am going to assume it will be similar to the EU but we will find out in 18 months from the date of enactment, and then there will be a comment period after that. Then Act states that the file rule must be issued no later than 180 days after the comment period closes. Professional use only products also must comply and they shall bear a label that contains a statement that product is administered or used only by a licensed professional AND is in conformity with the requirements of the Secretary for cosmetics labeling under this Act and section 4(a) of the Fair Packaging and Labeling Act.

RECORDS: This allows an officer or employee designated by the Secretary to request access to records to determine if a cosmetic product is adulterated and presents a thread of serious adverse health consequences or death to humans. It can include reports to adverse events, Fragrance or flavor information if they think the event is connected to the allergens, and substantiation data for safety of the product and its ingredients.

MANDETORY RECALL: IF the FDA deeps that a product is adulterated or misbranded and the use or exposure to the cosmetic product will cause serious adverse health consequences or death, the responsible person will have the opportunity to voluntarily cease distribution and recall the product. If the responsible person refuses, then the Secretary can order the responsible person to immediately cease distribution.

To sum up, this looks like a lot of information, but in reality it is not overly complicated and there is time to complete all of the tasks that are being required. Just don’t leave them to the last minute. The FDA moves slowly so I would not expect a regulation or guidance on any of this for another couple of months. I will keep an eye out and give updates when they arise.

If you would like to read the Modernization of Cosmetic Regulations Act of 2022 you can find it in the HR2617 Consolidated Appropriations Act and it is under division FF – health and human services, Title III – Food and Drug Administration, Subtitle E – Cosmetics.