The U.S. Food & Drug Administration (FDA) runs a voluntary program for the registration of cosmetic formulations in the United States. It is from this database that I periodically report the Frequency of Use of Preservatives (the next update will be later this year). Companies voluntar– ily report their formulations to the FDA using Form 2512a, and also report discontinuations using Form 2514. My last report on preservatives, based on the statistics of February 2001, was comprised of 16,687 registered formulations. The present article reports on organic UV filters and is based on the data as of May 2003 where 17,907 formulations where listed. The Voluntary Registration Program There are four major reasons why companies should participate in the voluntary registration program.
• Active self-regulation;
• Valuable data;
• International participation; and
• Ingredient frequency-of-use statistics.
Each of these points will be discussed now in more detail. Active self-regulation: Cosmetic suppliers and manu– facturers need to show the government that they can selfregulate. Part of doing so is to actively and continuously participate in the program. Some people, including con– gressmen, regulators and consumer groups, believe that cosmetics should be pre-approved by the FDA before they are allowed on the market (similar to drugs). They feel that participation in the program should be mandatory, which could be the fi rst step down the “slippery slope” process of pre-market approval of cosmetics.