The draft of the proposal has been made by Energy and Commerce Ranking Member Frank Pallone (D-NJ) and Committee Member Rep. Leonard Lance (R-NJ), and aims to close up gaps in the regulations of cosmetics and personal care products that have drawn criticisms from consumer watchdogs.
Under current laws the FDA cannot force cosmetics manufacturers to register with the Agency, which means that specific information about products and ingredients that could help inform consumers does not have to be labelled.
Furthermore, and perhaps of more concern, it also means that there is no legal requirement to test products for safety before bringing them to market.
Making safety testing a stipulation
The proposed legislation would strengthen the FDA’s regulatory authority over cosmetics products, ensuring that safety testing is a stipulation as well as raising the bar on labeling requirements.
The proposal was announced at a news conference that included the two congressman and Miriam Lawrence, the mother of an 11-year-old girl who was featured in a New York Times article that highlighted the fact she lost all her hair after an adverse reaction to Wen Cleansing Conditioner.
A catalogue of similar problems related to the Guthy Renker-owned brand has resulted in a high profile lawsuit that has attracted a multitude of plaintiffs, all of whom claim to have suffered some degree of hair loss after using Wen hair care products, and is ongoing.
New York Times triggered alarm
The New York Times article, which appeared in the newspaper last month, highlighted the problem with the hair care product, and raised the question of whether or not the FDA should have more of a say on product safety.
"Millions of Americans assume the cosmetics they use each day are safe, however the reality is that cosmetics are one of the least regulated consumer products on the market today," Pallone said. "
"Eliana Lawrence's story demonstrates that FDA's lack of authority over cosmetic products puts consumers at risk. The bipartisan proposal Congressman Lance and I are putting forward today outlines a modern cosmetics regulatory framework that gives FDA the tools, information, and resources necessary to protect Americans from potentially dangerous cosmetics products."
What the proposal means
The Pallone-Lance proposal would strengthen FDA's authority to regulate cosmetics by:
- Giving FDA mandatory recall authority for potentially dangerous cosmetic products and access to cosmetic records during an inspection;
- Providing FDA with authority to collect data and information on cosmetic ingredients and requiring FDA review such ingredients to determine if they are safe for use in cosmetics;
- Requiring cosmetic manufacturers, processors, packers, and holders to register their facilities with FDA;
- Mandating that cosmetic manufacturers report all adverse events to FDA;
- Requiring warnings on cosmetic products that are not appropriate for the entire population;
- Ensuring that all cosmetic manufacturers comply with good manufacturing practices established by FDA; and,
- Providing FDA with $20.6 million annually in user fees to implement these new authorities.