FDA Still Hasn't Pushed for Recall of Bottled Water Import With Excessive Arsenic

Consumer Reports told the FDA of high levels more than two weeks ago. The FDA flagged Peñafiel in 2015 for elevated levels.

Penafiel water Lacey Browne

Update: On June 21, Keurig Dr Pepper withdrew its Peñafiel bottled water for sale in the U.S., citing high arsenic levels.

The Food and Drug Administration has known for more than two weeks that Keurig Dr Pepper might be selling bottled water that contains excessive arsenic in the U.S. On Friday, the agency—which regulates bottled water in the U.S.—said it did not have immediate plans to request a recall.

After Consumer Reports revealed last month that a bottled water brand owned by Keurig Dr Pepper had excessive levels of arsenic, the company decided to conduct its own testing and then announced it would stop production of the product for two weeks to improve its filtration system at a Mexico plant.

The company said it tested samples of the bottled water, Peñafiel Mineral Spring Water, that were "for sale within the U.S. market." The result? An average of 17 parts per billion of arsenic. The federal limit in bottled water is 10 ppb.

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CR thinks the bottles should be recalled. But Keurig Dr Pepper says it doesn't plan to issue a recall, and claims the U.S. Food and Drug Administration (FDA), which regulates bottled water in the U.S., supports that decision. Records show that the agency has pushed for a recall of bottled water in the past for similar reasons and that Peñafiel already was on an FDA import alert since 2015.

Import alerts are designed to “prevent potentially violative products from being distributed in the United States,” according to the agency.

For more than two weeks, CR repeatedly has asked the FDA about the company's assertion that it agrees Peñafiel water doesn't need to be recalled, and the agency has only said that it was investigating the issue.

On Friday evening, the FDA said in a prepared statement that Peñafiel's inclusion on the import alert was "based on testing conducted in 2015 that confirmed high levels of arsenic in mineral water manufactured" at one facility in Mexico owned by the company.

"Since this action was based on product manufactured over four years ago, FDA does not believe there is any product available to recall," the Friday evening statement says.

But CR provided FDA with results on April 11 from a spot test of Peñafiel that showed three samples tested on average 18.1 ppb of arsenic. The agency's statement Friday also said that it doesn't have enough information about our tests.

The FDA has not asked Consumer Reports for more information about our testing.

"FDA is aware of recent reports highlighting elevated levels of arsenic in bottled water from manufacturers in Mexico," the FDA statement says. "Lacking more detailed information about the testing that was the basis for this report, FDA will look to analyze products similar to those mentioned in the report to determine if any product contains elevated levels of arsenic and, if warranted, take action, such as requesting a recall, to remove the product from U.S. commerce."

A Keurig Dr Pepper spokesperson didn't immediately respond to a request for comment on the FDA's statement Friday evening. Earlier, a company spokesperson told CR that production of Peñafiel would resume this week, and said the company would, as soon as possible, provide an updated bottled water quality report that details contaminant levels.

"This is absurd," said William Wallace, manager of home and products policy for Consumer Reports. "Consumers need the FDA to take action, not plead ignorance more than two weeks after CR's investigation came out. If the water is not safe enough for Peñafiel to produce without changes at its plant, then it's not safe enough to be on store shelves or in homes. We continue to demand an immediate recall."

CR contends that the federal limit for arsenic in bottled water should be revised down from 10 ppb to 3 ppb, a level we found several brands to be at or above in our earlier investigation of aresnic in bottled water published on April 18. That list included Oregon-based EartH₂O. After CR's story ran, an EartH₂O rep contacted us with new test results that showed the arsenic level in its bottled spring water had fallen from 3 ppb to 2 ppb, within the CR-recommended safety limit.

A History of Arsenic

Back in 2008, regulators in New Jersey tested a sample of Peñafiel that had been brought to the state by a local Mexican food importer, R.R. Importaciones.

Tests conducted by the the state's health department, which oversees bottled water in New Jersey, found the Peñafiel sample had 22 parts per billion of arsenic, above the federal standard of 10 ppb. The importer, R.R. Importaciones, agreed to voluntarily destroy the product and to cease importing and distributing Peñafiel, according to a state report and a health department spokesperson.

But a year later, New Jersey inspectors found that R.R. Importaciones was still importing Peñafiel. Follow up tests of the new samples revealed arsenic levels of 17.3 ppb, a spokesperson for the health department says. Again, in 2013, New Jersey dinged R.R. Importaciones for importing Peñafiel, which tests of samples collected that year revealed 21.1 ppb of arsenic, according to a state report and the spokesperson. And again, R.R. Importaciones agreed to destroy the product.

"We kept a tight surveillance on them, stopping in from time to time unannounced," said Nicole Kirgan, the department spokesperson. "This firm has been subject to numerous enforcement actions–penalties, voluntary destructions, and embargoes."

This time, however, the FDA got involved. Consumer Reports learned that, in response to the 2013 tests, the FDA sent an inspector to R.R. Importaciones and spoke with the company's president. The inspector, according to records obtained under the Freedom of Information Act, asked for records to trace the product back to the manufacturer, but the company president said he "does not have any documentation and that he does not keep and/or store those documents."

Despite those concerns, the report notes that the inspector did not collect any “physical or documentary samples.”

Keurig Dr Pepper says the company wasn't importing Peñafiel into the U.S. during the time frame of the New Jersey testing.

"Therefore, the product referenced in those reports was imported into the U.S. illegally, and it was labeled and formulated for sale in Mexico only," Katie Gilroy, director of corporate communications for Keurig Dr Pepper, said earlier. "As we were not the importer of this product, we were not made aware by any authorities of the testing."

The FDA doesn't appear to have taken further action against Peñafiel, until nearly two years later, when routine testing of imported products conducted by the agency found the bottled water still had levels of arsenic in excess of the federal limit.

In response, the FDA added Peñafiel water to the import alert. The tests results, obtained through FOIA, showed the FDA found Peñafiel had 13.1 ppb of arsenic.

Keurig Dr Pepper says it was never notified of the import alert, and, when it looked into the situation, found it didn't apply to the product itself, only to a warehouse it owns. (A FDA spokesperson, in a statement earlier this month, says the manufacturer listed on an import alert would've been notified of their inclusion on the list.)

The product continued to make its way into the states. When CR decided in March to commission a spot test of Peñafiel and other bottled water brands previously flagged by regulators for excessive arsenic, we were able to purchase it on Amazon and at a Walmart in New Jersey.

The tests found levels of arsenic consistent with previous tests done by the FDA and New Jersey. All three samples registered arsenic levels above the 10 ppb limit, at an average of 18.1 ppb.

That's higher than the amount of arsenic that Starkey Water, a bottled water brand owned by Whole Foods, had in late 2016 and 2017, when it recalled more than 2,300 cases for excessive arsenic.

Records obtained by CR show that, in December of 2016, the FDA was notified of tests conducted by Florida's bottled water regulator revealing that Starkey had roughly 12 ppb of arsenic, above the federal safety threshold.

The FDA told Starkey about the tests, indicated that the findings could warrant a recall, and asked how the company planned to respond, according to FDA records on the recall (PDF). A day later, Starkey agreed to the recall.

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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.