Currently, U.S. law does not require cosmetic products and their ingredients, other than color additives, to have FDA pre-market review before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.
Remember that a cosmetic cannot claim to actually “reduce wrinkles”, as an example, but instead can only claim to “reduce the appearance of wrinkles”; any product that claims to reduce wrinkles will be regulated by FDA as a drug, biologic, or device, depending on the specific product.
The two main laws that apply to the regulation of cosmetics are the Federal Food, Drug, and Cosmetic Act (Title 21 of United States Code) and the Fair Packaging and Labeling Act (Title 15, Chapter 39 of United States Code).
The EU already implemented a regulation in 2009 (1223/2009) which covers cosmetic products. As part of that regulation, they used ISO standard 22716:2007 – Cosmetics – Good Manufacturing Practices as the basis for regulating cosmetics manufacturers selling in EU Member States.
FDA is looking to similarly revise its regulation of cosmetics by creating and implementing good manufacturing practice regulations for cosmetic products. As part of this process, FDA will be holding a public meeting regarding Good Manufacturing Practices for Cosmetic Products on 01-June-2023. In this meeting, they’ll be seeking feedback from cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts.
So, what are they looking for?
- Are there any national or international standards related to manufacturing practices for cosmetic products, like ISO 22716:2007, that could be used and to what extent could they be used?
- Are there specific items in these standards that could be perceived as burdensome or is there a less burdensome alternative that would still protect the public health and ensure that cosmetic products are not adulterated.?
- How could these standards be flexible to be effective for different sizes and scopes of businesses engaged in the manufacture of cosmetic products and the risks to public health posed by cosmetic products?
- To what extent are manufacturers of cosmetic products already following a national or international standard for good manufacturing practices?
- For manufacturers that are not currently following such a national or international standard, what would it cost for them to implement good manufacturing practices consistent with such a standard?
- If (when) good manufacturing practices regulations for cosmetics are implemented, what would be considered and appropriate amount of time for a manufacturer to come into compliance with these regulations?
As a manufacturer, implementing a new anything is difficult, let alone new requirements for how products are supposed to be manufactured to ensure public safety. This is the chance to make your voice heard.
Registration is required for this event https://fda.zoomgov.com/webinar/register/WN_mkmMSjv5Rt6Ir6BqczCq0w
FDA has provided the following deadlines:
- May 18th, 2023 (6 pm eastern daylight time): Deadline to register if you wish to speak at the meeting. Each public comment will be limited to approximately 3 minutes, depending on the number of public comments.
- May 22, 2023: Deadline to submit all presentation materials, in pdf format, to MoCRAGMPMeeting@fda.hhs.gov, for persons selected to speak at the meeting. We ask that all presentation materials also be submitted to Docket No. FDA-2023-N-1466 by June 1, 2023.
- June 1, 2023: Deadline to register to attend the listening session; registration may be performed at any time before or during the listening session.