Jane Vergnes, Ph. D., Quoted in Bloomberg BNA Daily Environment Report Article “FDA Says More Data Needed to Determine If Six Chemicals Safe for Use in Sunscreens”
Comments made by Jane S. Vergnes, Ph.D., were featured in a Bloomberg BNA Daily Environment Report article covering the initial determination by the U.S. Food and Drug Administration that additional data are needed to establish that six chemicals submitted for inclusion as active ingredients in the over-the-counter sunscreen monograph using the Time and Extent Application processes are generally recognized as safe and effective.
The decisions show the bar to get new active ingredients into sunscreens remains high in the U.S., Jane Vergnes, a toxicologist working with Bergeson & Campbell P.C., told Bloomberg BNA Jan. 9. The agency’s decision that none of the six chemicals could be designated ‘‘generally recognized as safe and effective,’’ or GRASE, is likely to disappoint companies that hoped the law’s passage would speed the approval of chemicals that already have long been used in other countries as active ingredients in sunscreens, Vergnes said.
The agency’s decisions will not be a surprise to the BASF Corp., L’Oreal USA Products Inc. or other companies that had requested the agency’s approval to use the chemicals in sunscreens, Vergnes said. In preparation for the Sunscreen Innovation Act, the FDA already had sent the companies letters providing its initial decisions and the test data it would need to determine whether the chemicals were safe, she said. The initial determinations and data requests are, however, likely to be of interest to the broader audience of specialty chemical manufacturers that make or use active ingredients for sunscreens, Vergnes said. The requested information makes clear the types of data the agency expects to receive, she said. Making those expectations clear and easy to find— through a single Federal Register notice that listed the individual dockets where materials related to each decision can be found—can help manufacturers and the public, Vergnes said. Active ingredient manufacturers and their customers will know ahead of time what FDA’s expectations are, she said.
The public and interest groups that increasingly have voiced concerns about the safety of sunscreens also will see the extent of data the FDA is requiring companies to provide, Vergnes said. The FDA’s requirements go beyond expectations in some other countries, she said. The reason is that active ingredients in sunscreens are considered over-thecounter nonprescription drugs in the U.S., whereas some other countries consider them cosmetic ingredients, Vergnes said. Knowing FDA’s expectations combined with the process and deadlines the Sunscreen Innovation Act established for the agency to decide whether a chemical is GRASE may eventually speed the agency’s approval, according to Dr. Vergnes.