The Food and Drug Administration (“FDA”) recently issued guidelines to minimize benzene exposure in the consumer market. Specifically, the guidelines are directed at drug manufacturers and the way they test products. The new guidelines suggest what tests manufacturers should perform when creating products containing benzene. Further, the guidance suggests that the United States Pharmacopia (“USP”) currently permits unacceptably high levels of benzene in some products. As a result, currently acceptable levels need to be lowered.
What is Benzene?
Benzene is a known human carcinogen. The toxic chemical is known to decrease the formation of blood cells. This causes serious injuries such as leukemia, lymphoma, and other blood disorders. Exposure to benzene can occur by inhalation, orally, and through the skin. There is no safe level of exposure to benzene.
What products contain Benzene?
Products like dyes, detergents, and plastics contain benzene. Also, common personal care products like detergents, antiperspirants, sunscreen, and hand sanitizer contain benzene. Benzene is not added to the products themselves. But, it is in propellant that sprays the products out of cans.
Are products with benzene recalled?
Several products are recalled due to benzene contamination. For example, certain hand sanitizers and aerosol products were recalled due to benzene contamination. Additionally, certain types of sunscreen were recalled due to benzene contamination.
Recently, Insight Pharmaceuticals issued a recall of its Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene. The company confirmed that benzene is not an ingredient in the products. However, a third-party lab found that a low level of benzene came from the propellant that sprays the product out of the can.
What do the FDA’s guidelines suggest?
The FDA recommends that drug manufacturers using benzene switch to alternative ingredients. Additionally, the FDA recommend that manufacturers conduct risk assessments to ensure the products conform to safety and quality specifications.
What do the FDA’s guidelines to USP suggest?
The new guidelines suggest that USP standards allow unacceptably elevated levels of benzene in some products. Consequently, the FDA has asked UPS to remove these standards. Further, the FDA acknowledges that benzene is sometimes a necessary ingredient. Nevertheless, benzene levels need to be limited. In response to the guidelines, USP issued a notice of their intent to revise permissible benzene levels.
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