On April 20, 2015, the Personal Care Products Safety Act was introduced by Senators Dianne Feinstein and Susan Collins. This attempts to create a national standard for cosmetics and personal care products and comes as the regulatory approach in the U.S. involves both federal and state regulation. The Personal Care Products Council and The Independent Cosmetics Manufacturers and Distributers (ICMAD) and their member companies alongside members of Congress have been seeking reform of federal regulatory oversight for over five years. The changes made by this new Act would include an increase in FDA control over unsafe product ingredients. The FDA would have authority to prevent cosmetic products containing ingredients deemed to be unsafe from going on sale. A few of the main regulatory changes to the current framework are as follows:
- Manufacturers and processors will be required to register their facility with the FDA.
- If the registering entity has average gross annual sales of greater than $500,000 (for previous 3-year period), a user fee must be paid or registration will not be complete.
- The FDA can suspend a registered facility if there is reasonable belief products may cause serious health effects to humans.
- Mandatory annual review of at least 5 cosmetic ingredients that were not reviewed in the prior 3 years.
- The FDA will develop cGMP’s which will be mandatory, with large businesses compliant with GMPs after 180 days, and small businesses taking effect 2 years (after date of published final rule).
- Mandatory serious adverse event reports filed with FDA within 15 days after adverse event is received and a mandatory annual report summary of all adverse events.
ICMAD has weighed in on the bill and indicated that it “places too large a burden on small business, stifles innovation in the cosmetics and personal care industry, and does not provide appropriate and significant national uniformity,” but are hopeful some other form of federal cosmetic regulation will be enacted.
If you would like additional information on the new Act, or have any questions or concerns on what this means to you or your business, please feel free to contact Focal Point Research.