EDF Health

Selected tag(s): FDA

Latest federal data on lead in food suggests progress made in 2016 was fleeting

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

The Food and Drug Administration’s (FDA) Total Diet Study (TDS) is an important source of data for both the agency and the public to estimate exposure, track trends, and set priorities for chemical contaminants in food. EDF analyzed TDS data for samples the agency collected from 2003-2013 in our 2017 report to reveal that lead in food was a hidden health threat. In follow-up blogs using TDS data from 2014-2016, we reported that overall trends for detectable rates of lead appeared to be on the decline, especially in 2016. In our analysis, we summarized that the trends were both good news and bad news for children because there were stubbornly high rates of detectable lead in baby food teething biscuits, arrowroot cookies, carrots, and sweet potatoes.

In this blog, we analyze the latest lead in food TDS data, released by FDA in August, and we take a new look at the trends. Overall, the 2017 data reversed the progress in 2016, largely driven by the percent of samples[1] with detectable lead in prepared meals nearly doubling from 19% to 39%. The good news is that fruit juices continued their dramatic and steady drop in samples with detectable lead, from 67% in 2016 to 11% in 2017. When we compared results for baby foods to similar samples of regular fruits and vegetables, the most notable finding was that baby carrots and peeled and boiled carrots had significantly lower detection rates than baby food carrot puree. Additionally, we were surprised to find that 83 of 84 samples of canned fruit had detectable levels of lead.

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Chemours asks FDA to suspend its approved uses of PFAS in food packaging

Tom Neltner, J.D.Chemicals Policy Director

Politico reported today that Chemours notified the Food and Drug Administration (FDA) that it had officially abandoned its three approved food packaging uses of per- and poly-fluorinated alkyl substances (PFAS) and asked the agency to withdraw its Food Contact Substance Notifications (FCNs) for those uses. We do not know with certainty what prompted Chemours to abandon its PFAS products for food packaging or whether they were ever used in the United States. Based on past experience, we anticipate that FDA will grant the request.

This action takes us one step closer to reducing people’s exposure to these chemicals linked to an array of health risks posed by PFAS at extremely low levels. Additionally, the action should serve as an incentive for other companies to do the same.

Chemours also has FCNs for six PFAS uses in repeat-use food contact articles like gaskets and seals. The company apparently has not asked the agency to abandon these uses. We suspect that the PFAS-treated gaskets may still be in service even if it has stopped treating new gaskets with the chemicals.

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Posted in FDA, Food, GRAS, Health Science, PFAS / Also tagged , , | Read 2 Responses

FDA must abandon its flawed assumptions when reviewing safety of approved PFAS uses in food

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

All the PFAS uses allowed by FDA that we reviewed had estimated exposures exceeding the most protective minimal risk level for PFOS proposed by the Centers for Disease Control and Prevention (CDC).

In its June 2019 release of a webpage dedicated to per- and poly-fluoroalkyl substances (PFAS) in food, FDA stated that it is “reviewing the limited authorized uses of PFAS in food contact applications.” As we mentioned in a previous blog, we were pleased to see FDA’s public position on PFAS but we highlighted three major concerns that could impact the ongoing safety review and questioned the conclusion that all is fine. In this blog, we discuss the implications of FDA’s statements on its review of 62 authorized PFAS uses in contact with food and make recommendations to the agency as it proceeds with this promising effort.

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Posted in FDA, Food, GRAS, Health Science, PFAS / Also tagged , , | Read 1 Response

FDA concluded PFAS in food are safe. Now it has to show how it reached that conclusion.

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

In June, the Food and Drug Administration (FDA) posted a webpage that serves as a helpful starting place to learn about the agency’s efforts and plans regarding per- and poly-fluoroalkyl substances (PFAS) in food. The webpage explains that FDA is “assessing food for PFAS through sampling” and is “reviewing the limited authorized uses of PFAS in food contact applications.” In a statement accompanying the webpage’s release, FDA’s acting and deputy commissioners assured the American people that the agency “does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.”

We were surprised by FDA’s statement that all is fine given the results the agency published and the evidence about the array of health risks posed by PFAS at extremely low levels. Although the information posted is useful, we found it confusing and vague in some important aspects. Therefore, we are taking the opportunity here to raise some issues concerning FDA’s statements and planned next steps on PFAS. Additionally, in another blog, we discuss the implications of FDA’s statements on its review of 62 authorized PFAS uses in contact with food and make recommendations to the agency as it proceeds with this promising effort.

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Posted in EPA, FDA, Food, Health Policy, PFAS / Also tagged , | Comments are closed

FDA finds surprisingly high levels of PFAS in certain foods – including chocolate cake

[Update: FDA has published a webpage on PFAS and released the data for the studies discussed in this blog].

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

As reported by the Associated Press today, at a conference last week in Helsinki, Finland, the U.S. Food and Drug Administration (FDA) presented the results of three studies it conducted of 16 per- and poly-fluoroalkyl substances (PFAS) in various foods. A friend who attended the conference sent us photos of the poster. The results for samples of meat and chocolate cake purchased by the agency in October 2017 as part of its ongoing Total Diet Study (TDS) jumped out at us as surprisingly high and worth further investigation:

  • 17,640 parts per trillion (ppt) of perfluoro-n-pentanoic acid (PFPeA) in chocolate cake with icing. These levels suggest that the cake was contaminated from the intentional use of the chemical to greaseproof paper that contacted the cake rather than from an environmental source. We cannot find any evidence that FDA ever reviewed the safety of PFPeA as a food contact substance – meaning the manufacturer may have secretly designated it as Generally Recognized as Safe (GRAS). We also found little evidence – good or bad – of the health risks posed by this PFAS. We have reached out to FDA to learn more, but as of this blog posting the agency has not yet responded. This chemical was also found in chocolate milk at 154 ppt.
  • Nearly half (10 of 21) meat samples had quantifiable levels of perfluoroctanesulfonate (PFOS) with concentrations ranging from 134 ppt in a frankfurter to 865 ppt in tilapia. Unlike the chemical in chocolate cake, PFOS has been extensively studied because of widespread environmental contamination, especially around the facilities in Alabama and Minnesota where it was previously produced. It is associated with increased cholesterol, thyroid disease, testicular cancer, and decreased birth weight. While comparisons are complicated, the PFOS levels found in some of these meats were far greater than the 70 ppt health advisory set by the Environmental Protection Agency (EPA) for drinking water in May 2016. Two years later, the Centers for Disease Control and Prevention (CDC) proposed limits that are almost 7 times more protective than EPA’s, partly because more recent studies indicate the chemical may undermine the effectiveness of vaccines. Production of PFOS in the United States reportedly ended in 2002, though it is still made overseas and may have been imported paper. In 2016, FDA removed its approval to greaseproof paper with PFOS.

FDA’s poster also showed testing results from food produced around two PFAS contaminated areas. FDA found most of the 16 PFAS at varying levels measured in produce sold in farmer’s markets downstream of a PFAS production facility in the Eastern U.S. – presumably Chemours’ plant in North Carolina. The highest produce sample had 1,200 ppt and was purchased within 10 miles downstream of the production plant and short-chain PFAS were prevalent.

The other contaminated area was a dairy farm near an air force base in New Mexico. FDA found many of the 16 PFAS in the water and silage used to feed the cows but PFOS was the most prevalent among a few PFAS measured in the milk with levels higher than 5000 ppt. The agency also detected several PFAS in cheese produced by the farm in lower amounts than the milk. Many of the PFAS are likely from aqueous film forming foam (AFFF) used to fight fire and conduct firefighting training at the Air Force base.

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Posted in FDA, Food, GRAS, PFAS, Public Health / Also tagged , , | Read 2 Responses

Too much cadmium and lead in kids’ food according to estimates by FDA

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

The Food and Drug Administration (FDA) released a study in April estimating young children’s exposure to lead and cadmium from their diets and identifying food groups that are a significant source of these heavy metals. The study used data from the agency’s Total Diet Study (TDS) program for 2014 to 2016 and the Center for Disease Control and Prevention’s (CDC) What We Eat in America (WWEIA) Survey for 2009 to 2014.[1]

The study is a reminder of how pervasive heavy metals are in children’s diets and that, while the levels are relatively low, the cumulative exposure is significant. Based on FDA’s analysis (Table 1 below), we estimate that about 2.2 million children exceeded the agency’s maximum daily intake (MDI) for lead at a given time. The results for cadmium are new and worrisome, with estimated daily intake (EDI) levels that are 3 to 4 times greater than lead. And while FDA has not yet set an MDI limit for cadmium, the average young child exceeds most of the relevant daily exposure limits set by other agencies. Clearly, cadmium warrants greater attention, but note that the evidence of neurotoxicity is still emerging.

Table 1: Young children’s estimated dietary intake (EDI) of lead and cadmium based on FDA’s TDS results for years 2014 to 2016 (based on hybrid method)

Age GroupLead Mean EDI Lead 90th Percentile EDICadmium Mean EDICadmium 90th Percentile EDI
LimitsFDA’s MDI is 3.0No MDL set by FDA. Intake exceeded most limits set by other agencies
1-6 years1.8 µg/day2.9 µg/day6.8 µg/day11.0 µg/day
1-3 years1.7 µg/day2.6 µg/day5.8 µg/day9.7 µg/day
4-6 years2.0 µg/day3.1 µg/day7.8 µg/day12.1 µg/day

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Posted in FDA, Food, lead / Also tagged , , | Comments are closed