The US Food and Drug Administration (FDA) is proposing to prevent two sunscreen ingredients from entering the US market unless the manufacturers can provide new data proving safety and effectiveness.
The agency published its proposal on February 25 in the Federal Register . The two ingredients — ecamsule and enzacamene — were among eight ingredients that the agency has been reviewing for years.
In early January, the FDA said that the other six were not 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 — Public Access to SunScreens (PASS) Coalition — expressed dismay at the agency's proposal.
"Today's action taken by the FDA 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," said 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," added Werner. "FDA's latest action is inconsistent with this approach."
Need More Data
Ecamsule has been approved for use in the US since 2006, but only at a specific concentration and only in a few products manufactured by L'Oreal.
L'Oreal 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 sufficient 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. The trials only looked at concentrations of 0.33% to 3.96%, and in the end did not support "human dermal safety of ecamsule at any concentration," according to the FDA.
The agency also said that the company needed to submit more animal data to determine potential effects from systemic exposure, and that it wanted carcinogenicity studies, in addition to other data.
L'Oreal also needs to prove effectiveness, said the FDA, which is requesting two such trials.
The FDA is also seeking more data on enzacamene, including on bioavailability, dermal safety, and toxicity. Some published studies have also indicated that the ingredient has the potential to be an endocrine disruptor, so the FDA has requested more data on hormonal changes.
In addition, the agency said that the manufacturer needed to conduct two, and possibly three, efficacy studies.
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.
Eventually, the agency will publish a final determination
