April 2015

New bill would increase FDA regulation of personal care ingredients

Rawlings
A new bipartisan bill co-sponsored by Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME), the “Personal Care Products Safety Act”, would amend the Federal Food, Drug and Cosmetic Act of 1938 to give the U.S. Food and Drug Adminsitration (FDA) greater oversight of ingredients used in personal care products, allowing it to determine safe levels of ingredients such as potential allergens and giving it the power to order and enforce product recalls.
As it stands now, manufacturers of cosmetics and personal care products are not legally required to report negative side effects experienced by consumers who use their products, and the FDA can only ask manufacturers to conduct voluntary recalls. If the bill passes, companies would be required to disclose reactions to their products resulting in death, disfigurement or hospitalization within 15 business days.
The FDA would also study five different chemicals each year for safety. The first five would include propylparaben, methylene glycol, lead acetate, diazolidinyl urea and quaternium-15. Manufacturers of cosmetics and personal care products would be required to register annually with the FDA and submit ingredient statements, although FDA approval of new products would not necessarily be required before they hit the market. Another provision would require manufacturers to post ingredients and product warnings online for products sold over the internet.
ucm218078The bill was introduced as the result of discussions with industry stakeholders, according to Sen. Feinstein, including the Personal Care Products Council (PCPC), Johnson & Johnson, Procter & Gamble, Unilever, Estee Lauder, L’Oréal and Revlon.
“There were things that we liked more than others,” said John Hurson, PCPC Executive VP of Government Affairs. “But it is a compromise, and that’s a first.”
Others in the industry disagreed. In a statement, the Independent Cosmetic Manufacturers and Distributors (ICMAD) announced its opposition to the bill, claiming it would place an undue burden on small businesses.
“ICMAD has a long track record of working with federal regulators to promote product safety, honor the best science in our industry, and advance small businesses that innovate and provide jobs,” said ICMAD CEO Pam Busiek. “We admire Senator Feinstein’s sincere efforts toward these goals and we welcome her partnership. However, the approach taken in this legislation is in conflict with these goals.”
ICMAD said it would continue to collaborate with its sister organizations—including the Personal Care Products Council—to “modernize” FDA regulations.
The bill’s mixed support reflects a changing landscape in the cosmetics and personal care industries, with more pressure on manufacturers to address concerns about ingredients. Efforts over the years to pass similar legislation have repeatedly failed, according to The New York Times.
“We do feel it’s very important that the FDA’s authority in this space bring peace of mind to consumers and at the same time reflect modern science and advancements,” said Darrel Jodrey, Executive Director of Federal Affairs for Johnson & Johnson.
States would retain authority to enforce existing personal care product regulations, such as California’s Safe Cosmetics Act.
S. 1014, “A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics”, was referred to the Senate Health, Education, Labor & Pensions committee on Monday, April 20.
Read the full text of the proposed bill here.