New legislation titled the Personal Care Product Safety Act is intended to replace the 83 year old law that currently governs this category of regulated product. The bill, introduced by Senators Feinstein and Collins in mid-June 2021, will help improve safety for consumers and strengthen the FDAs authority.
The FDA will provide companies with guidance on limitations and warnings needed when certain ingredients are incorporated in a product. Other powers brought forth by this bill includes authority over recall. If a company refuses to conduct a recall, the FDA will have the authority to issue recalls on any product that is likely to cause significant harm.
Other highlights :
- Registration with the FDA, disclosure of ingredients and attest to safety records
- Must report adverse events within 15 days and annual reporting of all reported adverse health events
- banning of products that intentionally contain the harmful chemical PFAS (perfluoroalkyl or polyfluoroalkyl substances).
- Issuing regulations that will outline GMP for personal care products
- Flexibility for small businesses
- Website only business models will be required to provide full labeling including ingredients and warnings
- Authority to seize counterfeit products and seek civil penalties for any violations
- State safety laws in effect prior to the date of enactment will remain in effect
- To collect user fees from manufacturers to help fund oversight activities
- This bill is being supported by many companies and associations
For more information on this article and to understand how this may affect your business’ day-to-day activities and future pipeline planning, please contact us