FDA Delays Setting Limits on PFAS in Bottled Water

The agency relies on outdated research to explain why it's 'premature' to regulate the toxic chemicals

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The Food and Drug Administration is declining to set limits for potentially toxic chemicals in bottled water, despite pressure from consumer advocates and a major industry group—a decision the agency justifies in part by pointing to a now-outdated analysis that employed limited testing methods, a review of FDA documents by Consumer Reports shows.

The chemicals in question—a group of approximately 5,000 compounds known as PFAS (per- and polyfluoroalkyl substances) that are used for the manufacture of many products—are linked to an array of health problems, including learning delays in children and cancer.

The International Bottled Water Association, an industry group that represents bottlers including Danone and Nestlé, first called on the FDA to set limits for PFAS in a letter in early November 2019. The group told the FDA that it shouldn't wait on the Environmental Protection Agency, which is in the process of studying PFAS, to set standards for tap water.

More on Bottled Water

It also suggested that the FDA, which regulates bottled water, enact an enforceable limit of 5 parts per trillion (ppt) for one PFAS compound and 10 ppt for multiple PFAS. (For context, 1 ppt is the equivalent of one grain of sand in an Olympic-sized swimming pool, according to some estimates.)

But the agency responded by letter in December that it would be unnecessary—at least for now—to set a limit for PFAS chemicals in bottled water. “Establishing a [standard] for PFAS in bottled water at this time would not significantly enhance FDA's mission of public health protection,” said the letter, which was signed by Paul South, director of the FDA's division of plant products and beverages.

CR obtained a copy of the letter (PDF) through the Freedom of Information Act after the IBWA referenced it in a statement published last month following an investigation by CR, which tested 47 bottled waters and detected PFAS in most of the products.

A Limited Test

In addition to telling the IBWA that it would be “premature” for the agency to establish a limit for PFAS in bottled water, South pointed to a bottled water analysis the agency conducted in 2016, in which samples of 30 carbonated and non-carbonated brands from retailers in the Washington, D.C., area were tested for two PFAS compounds, PFOA and PFOS.

“None of the 30 samples had detectable levels of PFAS,” South said.

But the results of that analysis, published on the FDA’s website, show the agency used a testing method that had a detection limit of 4 ppt—meaning any level of PFAS below that would not register.

CR’s recent tests of bottled water used a method that can detect some PFAS at levels below 1 ppt. The results showed PFAS in 43 of the 47 bottled water products tested. That includes levels above 1 ppt—which some scientists and advocates endorse as a safe limit for total PFAS—and up to almost 10 ppt.

The IBWA, which says most of its members use a PFAS detection test that is sensitive to 1 ppt, believes it’s “incorrect” to claim that bottled water with PFAS levels at greater than 1 ppt pose a human health risk, according to Jill Culora, a spokesperson for the IBWA. The trade group says its members’ bottled water should have PFAS levels below 5 ppt for any single compound and 10 ppt for more than one.

Regardless of the testing sensitivity in the 2016 FDA analysis, the agency says on its website that the sample size is limited “and cannot be used to draw definitive conclusions.”

‘The FDA continues to believe that establishing a standard of quality for PFAS in bottled water at this time would not significantly enhance the FDA’s mission of public health protection.’

Monique Richards, Spokesperson, Food and Drug Administration

Nevertheless, South leaned on the findings to assert that a PFAS standard isn’t necessary for now.

The FDA’s position hasn’t changed since December, a spokesperson confirmed last week. “The FDA continues to believe that establishing a standard of quality for PFAS in bottled water at this time would not significantly enhance the FDA’s mission of public health protection,” FDA spokesperson Monique Richards said in an email.

James Rogers, PhD, director of food safety and research at CR, says that while the FDA generally waits to set water standards until the EPA acts, the agency has the authority to act on its own and should revisit its position.

“Much has changed since 2016, the last time the FDA determined the presence and levels of two PFAS chemicals in bottled water,” Rogers says. “The FDA can now test bottled water for 29 different PFAS chemicals with better sensitivity than in the previous study.”

The IBWA plans to keep pressing the issue with the agency. Culora, the IBWA spokesperson, says the organization is likely to schedule a routine meeting with the FDA in the coming months “and will again mention our position on PFAS at that time.”

What Happens Next

The FDA has indicated that it plans to wait for the EPA to enact legal limits for PFAS in tap water. But that could “take years, if it ever happens,” says David Andrews, senior scientist at the advocacy organization Environmental Working Group.

The EPA has previously said the process to set a limit is ongoing.

Andrews says it’s “ironic” that the bottled water industry has turned to federal regulators “in the hope of getting a stamp of approval for their product.” But he says it’s “prudent” of the IBWA to seek a standard covering a number of detectable PFAS in drinking water, not just the two best-studied compounds, PFOA and PFOS.

“This entire family of PFAS is a significant concern, and they should not be in tap water or bottled water,” he says.

For consumers, one way to reduce exposure to PFAS is to test your home water, filter your tap water, and choose bottled water carefully. (You could start by finding out what's really in your bottled water.)

You should also take care when choosing and using certain products—such as stain-resistant fabrics, microwave popcorn bags, and nonstick cooking pans—known to contain the compounds.

Head shot of Ryan Felton, a CR author of investigative reports and special projects

Ryan Felton

I'm an investigative journalist with an appetite to cover anything and everything. My job and goal is to dig into complicated issues that affect people's health, safety, and bottom line. I've covered everything from dangerous tires to subprime lending to corporate malfeasance. Got a tip? Drop me an email ( ryan.felton@consumer.org), or follow me on Twitter ( @ryanfelton) for my contact info on Signal.