March 2, 2015 — The FDA is proposing to prevent two sunscreen ingredients from entering the U.S. market unless the companies using them in certain products can prove they’re safe and effective.
The agency published its proposal in the Federal Register. The ingredients, ecamsule and enzacamene, were among eight total that the agency has been reviewing for years. Both ingredients protect the skin from ultraviolet rays.
In early January, the FDA said the other six weren’t safe or effective. Ecamsule and enzacamene are the last two in the backlog that it was required to address as part of the Sunscreen Innovation Act, which was signed into law in December.
The organization that was most active in getting that law passed, the Public Access to SunScreens (PASS) Coalition, expressed dismay at the agency’s proposal.
The FDA’s action “regarding ecamsule and enzacamene means that Americans will not have access to innovative products that have been used safely all over the world — in some cases for more than a decade,” says Michael Werner, policy advisor to the PASS Coalition, in a statement.
“Last fall, the U.S. surgeon general issued a call to action on skin cancer urging the federal government to work with the private sector and take necessary steps to respond to this public health crisis,” he says. “FDA’s latest action is inconsistent with this approach.”
Ecamsule has been approved for use in the U.S. since 2006, but only at a specific concentration and only in a few products manufactured by L’Oreal. The company got approval for those products through a new drug application process. The FDA’s latest proposal applies to a different process in which L’Oreal is seeking a blanket approval for ecamsule at various concentrations and in various formulations.
Enzacamene has been under review at the agency since 2002. The application was submitted by a division of the German pharmaceutical company Merck KGaA.
According to the FDA, neither of the companies had enough data to prove that the ingredients were safe or effective.
L’Oreal, which is a member of the PASS Coalition, was seeking to market various products with concentrations of up to 10% ecamsule. Tests only looked at concentrations of 0.33% to 3.96%, and in the end did not support “safety of ecamsule at any concentration” on human skin, according to the FDA.
The agency also said that the company needed to submit more animal data to determine potential effects from exposure, and that it wanted studies on whether or not the ingredient is a carcinogen (cancer-causing).
L’Oreal also needs to prove effectiveness, says the FDA, which is requesting two such trials.
The agency is also seeking more data on enzacamene. Some published studies have indicated that the ingredient has the potential to interfere with the body’s endocrine system (which makes and releases important hormones), so the FDA has requested more data on hormonal changes.
Also, the agency says Merck KGaA needs to do two, and possibly three, studies on the ingredient’s effectiveness.
The FDA proposal is open for public comment until April 13. Manufacturers will also have a chance to meet with the FDA and submit more data. The agency will publish a final verdict later.