In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products, we’ve got some updates and insights that might interest you, especially if you’re in the cosmetic business.
First, nearly 50 public comments were submitted to the FDA regarding this draft guidance by the September 5, 2023 deadline. These comments covered various aspects, from concerns about the burden estimates to suggestions for making the whole process smoother and more transparent.
Let’s break down some of the key takeaways:
1. Burden Estimates: The FDA noted the public’s feedback and increased its burden estimates for certain reporting activities related to product listings. However, they didn’t tweak the estimates for tasks such as updating product labels or reporting severe adverse events. So, some things remain unchanged.
2. Confidentiality: If you were concerned about the confidentiality of the data you’d be submitting, the FDA referred to existing regulations. They pointed out that privacy and protection of trade secrets and commercially confidential information are covered by the Privacy Act of 1974 and FDA regulations (21 CFR part 20).
3. Deadlines: Unfortunately, if you were hoping for an extension of the December 29, 2023, deadlines for product listing and facility registration, there won’t be one. The FDA emphasized that these deadlines are mandated by law, so they’re set in stone.
Here’s a new term for FEI: Facility Establishment Identifier. This nifty little number is generated by the FDA and is used to identify your firm. You’ll need it when you’re submitting product listings and facility registrations.
If you’re wondering whether your company already has an FEI, here’s how to find out:
- Request access to the FEI portal [link].
- You’ll get an email with a password for the portal.
- Log in and search for your company using its name and address.
- If you need help finding an FEI for your company, you can request one by emailing firstname.lastname@example.org. Just make sure you provide all the required information listed in the article.
Getting an FEI ensures your cosmetic business complies with the FDA’s regulations. So, if you still need one, we suggest getting on that pronto.
We hope this update helps you navigate the regulatory landscape more smoothly. If you have any more questions or need assistance, please reach out. Your compliance is essential, and we’re here to support your cosmetic business every step of the way.