The Safe Cosmetics Act of 2011 was introduced in June 2011. This bill is similar to legislation introduced in the previous session of the United States Congress. There are some changes from the previous legislation, however, the focus of the proposed bill remains unchanged, and the bullet points below provide the highlights:
1. The new legislation empowers the FDA to do things it already can do such as seizing unlawful and unsafe products, issuing injunctions and seeking significant fines and damages for violations plus criminal prosecution if needed.
2. The legislation creates a rigorous regulatory scheme that imposes an impossible zero risk of harm standard for testing all personal care product ingredients.
3. The legislation requires extensive cosmetic ingredient safety reviews by FDA based on massive amounts of safety information required to be submitted annually by ALL cosmetic manufacturers. These kinds of tests are not currently required when these same ingredients are used in products like medicine sold over the counter without a prescription (OTCs), like aspirin or cough medicine, and dietary supplements, all of which are ingested.
4. The legislation will cause the cost of manufacturing and distributing cosmetics in the United States to dramatically increase, resulting in the overall cost of the products to increase and possible job losses in our struggling economy.
5. The legislation requires manufacturers and packers to register their facilities, report their annual gross sales, and submit detailed product information on ingredient safety, including inadvertent ingredients present in parts per billion concentration levels as well as components of select ingredients. Manufacturers and packers with gross receipts in excess of $10 million would have to pay fees to help support the FDA’s enhanced regulatory obligations.
6. The legislation states companies who are manufacturers or packers with gross receipts of $2 million or less would be exempt from paying registration fees and filing registration statements, but would still have to be in compliance with labeling and extensive safety testing—an impossible standard and burden for small business.
7. The legislation requires that all ingredients be declared, including not just intentionally added ingredients but processing aids and inadvertent ingredients, even if present in parts per billion. This will create incredible testing burdens and make ingredient declarations encyclopedic in presentation.
We will continue this discussion as activity on the bill is made available.
Personal Care Truth was given permission to re-post this news, which can be found here.