Why is the FDA not doing more to protect consumers from harmful carcinogens? Congresswoman Rosa DeLauro shares that she believes the FDA feels like they are in partnership with industry instead of being a regulatory association. She shares that the FDA does not have mandatory recall authority for beauty products. What Consumers Can Do Avoid Benzene Products FDA STATEMNT: BENZENE On-the-Record: Patient safety is the FDA’s top priority. The FDA continues to monitor the issue of benzene in drugs and other products and proactively works with companies, when appropriate, to request that products be recalled, and to encourage retailers to remove products from store shelves and online marketplaces when quality issues arise. Certain hand sanitizers and aerosol drug products have been voluntarily recalled due to benzene contamination. Several cosmetic products were similarly voluntarily recalled because of elevated benzene levels. In addition, the FDA alerted manufacturers to the risk of benzene contamination in certain drugs and asked these particular manufacturers to test their drugs and not release any with benzene levels higher than 2 parts per million. The FDA continually gains new information that allows us to identify and address emerging risks. When the agency becomes aware of new drug or cosmetic product risks to consumers, we make every effort to analyze, understand the issues, and provide our best recommendation to the public as quickly and accurately as possible. On Background: The FDA does not have the authority to issue mandatory recalls for most drug substances or cosmetics, including certain drugs and cosmetics which were recently recalled due to benzene contamination. Under the Federal Food, Drug, and Cosmetic Act, a recall is a voluntary action taken by a company to remove a defective drug product from the market. Voluntary drug and cosmetic recalls may be conducted on a company’s own initiative or by FDA request. The FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall. If a company does not issue public notification of a recall, the FDA may do so if the agency determines it is necessary to protect patients. Manufacturers should not use benzene in the manufacture of drugs unless its use is unavoidable to produce a drug product with a significant therapeutic advance. The agency continues to remind manufacturers, distributors, repackagers and importers that they are responsible for the quality of their products and that, under current good manufacturing practice requirements, manufacturers are required to test their ingredients to ensure they meet specifications and are free from harmful contamination.