FDA Testing Finds Bottled Water Samples Do Not Exceed EPA Limits for PFAS in Drinking Water

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The U.S. Food and Drug Administration (FDA) has shared results from a sampling and testing assignment of bottled waters for per- and polyfluoroalkyl substances (PFAS), in which no samples were found to have levels of “forever chemicals” that would exceed maximum contaminant levels (MCLs) for public drinking water recently set by the U.S. Environmental Protection Agency (EPA).
Between 2023 and 2024, FDA sampled 197 domestic and imported bottled waters of purified, artesian, spring, and mineral varieties. The samples were tested for 18 different types of PFAS. A total of ten samples contained detectable levels of the chemicals, eight of which tested positive for between one and four different types of PFAS, and were either bottled or spring water samples. The other two samples were imported artisan waters, which contained one or two types of PFAS.
Of the PFAS detected, four were present at levels below EPA MCLs, and two do not have MCLs established by EPA. In April 2024, EPA set MCLs for five PFAS known to occur individually and as mixtures in drinking water: PFOA, PFOS, PFNA, PFHxS, and HFPO-DA (also known as GenX Chemicals). EPA also set a limit for mixtures of any two or more of four PFAS: PFNA, PFHxS, PFBS, and GenX chemicals.
Under section 410 of the Federal Food, Drug, and Cosmetic Act, when EPA sets MCLs for public drinking water as part of the National Primary Drinking Water Regulations (NPDWRs), FDA is required to establish a standard of quality regulation for the same contaminants in bottled water, or to determine that such a regulation is not necessary to protect public health because the contaminant is not present in bottled water. If FDA does not establish a regulation or determine that such a regulation is not necessary, then the levels set by the relevant NPDWR would be considered the applicable regulation for bottled water. FDA can take enforcement action against bottled water that presents a safety concern even if there is no standard of quality for a contaminant.
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