Personal Care Product Safety Act will intensify oversight of the FDA and stream-line compliance.
The bill’s drafters:
The bill addresses a range of issues including:
- registration of facilities
- registration of products
- mandatory recall authority – present, the FDA can “ask” a company to do a recall
- adverse and serious adverse event reporting – present, companies voluntarily report adverse incidents. Under this new Act, they would be required to report them within 15 business days. They must also report all nonserious events — like rashes — annually.
- ingredients – the FDA will now be required to study five different chemicals for safety every year. First up would include propylparaben, methylene glycol (a formaldehyde-releasing chemical) and lead acetate which is used in some men’s hair dye.
- good manufacturing practices
- user fees – manufacturers to cover the cost of all the new oversight
- required labeling ingredients – “not appropriate for children” and those that should be “professionally administered”, complete ingredient labeling online
The bill’s drafters seem to have drawn from existing provisions in the FDC Act applicable to nonprescription drugs, such as establishment and product registration requirements, and from certain provisions applicable to foods, such as the provision giving FDA mandatory recall authority.