On May 24, 2021, Valisure petitioned the US Food and Drug Administration to recall certain sunscreen and after-sun care products after discovering Benzene in product samples during safety testing. Valisure LLC is an online pharmacy and laboratory that independently performs chemical analyses of medications to protect consumers. Sunscreen products contain pharmaceutical ingredients such as avobenzone, oxybenzone, octisalate, octinoxate, homosalate, octocrylene, and zinc oxideare. Therefore, the FDA considers these products drugs, and they are regulated by the US Food and Drug Administration (FDA).
According to the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services, the World Health Organization (WHO), and the International Agency for Research on Cancer (IAR), Benzene is a carcinogen to humans. The FDA currently lists Benzene as a dangerous, “Class 1 solvent” that “should not be used in the manufacture of excipients, drug products, and drug substances due to Benzene’s toxicity. However, if Benzene use is unavoidable in the manufacture of a drug product with a vital therapeutic value, then the level of Benzene should be restricted to no more than (2) two parts per million (PPM).
According to Valisure’s test results, many of the after-sun and sunscreen products it tested did not test positive for Benzene. This means suncare and after-sun products can be manufactured without causing Benzene contamination. Moreover, Valisure warns about the long history and widespread use of suncare products and that exposure to Benzene also currently constitutes a substantial risk to the public.
The FDCA dually regulates some suncare products as cosmetics, and the classifications “drug” and “cosmetic” are not mutually exclusive.
The National Institute for Occupational Safety and Health (“NIOSH”) advises workers who expect to be exposed to Benzene at concentrations of 0.1 ppm to wear protective equipment to avoid ingestion, skin absorption, or inhalation.
Valisure’s Petition stated that Benzene, a known human carcinogen in sun care products meant to help prevent skin cancer, makes the Benzene discovery particularly troubling. Especially since sunscreen and after-sun products are regularly used by children and adults and in large volumes.
Valisure’s testing of approximately 80 suncare products found multiple products contained Benzene and some of the products tested contained Benzene contamination above (2) two ppm. The FDA regulates after-sun care products as cosmetics under the FDCA, and the Fair Packaging and Labeling Act (FLPA).
Valisure is asking the FDA to recall the batches of sunscreen products it has identified as containing a known human carcinogen in accordance with Section 501 of the FDCA (21 USC § 351) and misbranded under Section 502 of the FDCA (21 USC § 352); and for the FDA to conduct investigations and examinations under Section 702 (a) of the FDCA (21 USC § 372(a)) concerning these suncare products, their manufacturing processes, and the manufacturer.
The Petition also requests that the Commissioner provide information to the public concerning the suncare products in accordance with Section 705(b) of the FDCA (21 USC § 375(b)). Valisure is also asking the FDA to revise the FDA’s sunscreen rule under 84 Federal Register 6,204, develop guidance documents for identifying Benzene in sunscreen products, and update the current FDA guidance concerning the acceptable concentration of Benzene in drug products, and expand its statement that “Benzene should not be used in the manufacture of drug substances” to clarify that there is no tolerable level of Benzene, and ascertain a reasonable limit of detection.
A list of Valisure’s test results and the products affected may be reviewed here.
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