Furthermore, many of the body sprays Valisure tested contain highly volatile propellants such as butane, propane and others, which could potentially evaporate and disperse benzene rapidly in the air.Īssuming a 5 gram application of a contaminated aerosol fully evaporates and dissipates into a one cubic meter volume (approximately 35.3 cubic feet), the most contaminated body spray Valisure analyzed could potentially raise the air concentration of benzene to 28 ppb, or approximately 69 times the EPA-estimated threshold for increased cancer risk. Although the EPA calculated concentration of 0.4 ppb in air does not directly apply to the level of contamination inside an aerosol product, which is not likely inhaled in its entirety, it does provide rational guidance for calculations of potential exposure for such products as body sprays that may regularly be used indoors and in enclosed spaces. N-Nitrosamines like “NDMA” have been detected by Valisure in drug products and this was followed by broad recalls of ranitidine (Zantac), metforminand other drugs. The EPA has estimated that lifetime exposure to benzene at 0.4 parts per billion (“ppb”), or 0.0004 ppm, will increase the risk of developing cancer in humans at the same 1 in 100,000 exposed persons rate as FDA uses to set regulatory limits on other trace impurities like N-nitrosamines. Valisure’s FDA Citizen Petition: Valisure’s FDA Citizen Petition on Body Spray(all attachments and other resources linked below)Ĭ has published a review a for its members of the Valisure data suggesting products to avoid and which might be safest with regard to the benzene results. It is important to note that not all body spray products contain benzene and that uncontaminated products are available and can continue to be used without the potential risk from benzene.
Valisure is asking for a recall of the contaminated batches and requesting the FDA better define limits for benzene contamination in drug and cosmetic products. 54% of samples tested by Valisure contained detectable benzene and some batches contained up to nine times the conditionally restricted FDA concentration limit of 2 parts per million (ppm).
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The National Institute for Occupational Safety and Health (NIOSH) defines benzene as a carcinogen and lists “inhalation, skin absorption, ingestion, skin and/or eye contact” as exposure routes.
Centers for Disease Control and Prevention, the Environmental Protection Agency (EPA), the World Health Organization, and other regulatory agencies. Benzene is known to cause cancer in humans according to the U.S. NEW HAVEN, CT – NOVEM– Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as cosmetics. VALISURE DETECTS HIGH LEVELS OF KNOWN HUMAN CARCINOGEN BENZENE IN SEVERAL BODY SPRAY PRODUCTS AND REQUESTS FDA ACTIONSĥ9 antiperspirant and deodorant body spray products contained benzene, an industrial chemical known to cause leukemia and other potentially serious health risks
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