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Selected tag(s): FDA

FDA’s updated results for PFAS in food suggest progress but raise questions about its method

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

The Food and Drug Administration (FDA) recently released revised lab results from testing for 16 PFAS in food. Initial results of the testing were announced last June and gained wide attention because the levels of PFAS in certain foods were quite high. Surprisingly, the revised lab results show significantly fewer detections and, in the case of ground turkey and tilapia, concentrations of PFOS that are almost nine times lower than the values initially reported in June. In addition to the revised lab results, the agency also released a validated method for analyzing food for the substances and updated its PFAS webpage.

We were glad to see FDA’s ongoing work on PFAS and have already heard from commercial laboratories who are considering using the validated method as a potential new service to offer their customers. In analyzing the documentation that FDA provided,[1] we have concerns about the agency’s criteria to determine whether a sample had detectable levels of a PFAS. It appears unnecessarily restrictive and effectively underestimates the public’s exposure to PFAS. We are planning to meet with the agency to better understand their rationale for the criteria selection and its implications.

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Think PFAS in food packaging are safe simply because FDA accepted their use? Think again.

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

PFAS manufacturers’ claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.

Per- and poly-fluorinated alkyl substances (PFAS)—recently dubbed “forever chemicals”—have received a large amount of national attention, mostly due to contamination of drinking water affecting millions of Americans. Since June 2019, when the U.S. Food and Drug Administration (FDA) released its testing results from three studies, questions have arisen about food as a source of PFAS exposure. The main routes by which PFAS enter the food supply are environmental contamination—such as from nearby chemical manufacturing facilities, airports or Department of Defense operations—and from food packaging and processing equipment.

With greater attention on PFAS in food, we’ve noticed several misleading PFAS manufacturers’ talking points asserting that FDA review and acceptance is required for any PFAS to be used in contact with food, and that, due to this review, PFAS that go through this process are safe. However, their claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.

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

Time for a safer food supply: The legal challenge to FDA’s GRAS Rule

Tom Neltner, J.D.Chemicals Policy Director, Environmental Defense Fund

This blog initially was published as a guest column in Chemical Watch on September 9, 2019. After publication, FDA filed its reply brief to the plaintiff’s August 23, 2019 brief. The briefings are complete and the case awaits a decision by the judge.

Litigation is a time-consuming and often inefficient means to fix a broken regulatory system. However, when there is a fundamental disagreement about a regulatory agency’s responsibilities under the law, it is an essential option. Such is the case with the “Generally Recognized as Safe” (GRAS) exemption from the requirement for pre-market approval of food additives in the Federal Food, Drug, and Cosmetic Act (FFDCA). The Food and Drug Administration (FDA) interprets this exemption as allowing companies to determine whether a substance’s use is GRAS in secret without any notice to the agency.

Next year, I anticipate a federal district court will make a final decision on a lawsuit[1] challenging the FDA’s 2016 GRAS Rule that formalized the agency’s broad interpretation of the exemption and its narrow interpretation of its responsibilities under the FFDCA to “protect the public health by ensuring that . . . foods are safe, wholesome, sanitary, and properly labeled . . . .” (21 U.S.C. §393(b)). It would come a decade after the U.S. Government Accountability Office (GAO), the independent, nonpartisan agency that works for Congress, concluded that “FDA’s oversight process does not ensure the safety of all new GRAS determinations.” The GRAS Rule does little to address the shortcomings described by GAO.

Environmental Defense Fund (EDF), represented by Earthjustice, and the Center for Food Safety (CFS) are the plaintiffs in the lawsuit asking the court to declare the GRAS Rule unlawful and vacate the rule. On August 23, we filed with the court our response to the agency’s brief on both parties’ motions for summary judgment. FDA is expected to file a reply in September. Based on these briefs, the court may order oral arguments before making a decision.

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Posted in FDA, Food, GRAS, Health Policy, Public Health, Regulation / Also tagged , | Comments are closed

Without a food safety overhaul for additives, the innovative food craze could spiral out of control

Tom Neltner, J.D.Chemicals Policy Director

At an FDA-sponsored conference, EDF proposed a new path forward to ensure innovative food ingredients are safe by overhauling how food additives are regulated today.

Every day brings reports of new ingredients that food innovators around the world have developed to meet consumer demands for a healthier and more sustainable food supply. The innovations range from new ways to extract useful additives from existing sources such as algae to bioengineering to make novel ingredients like sweeteners or proteins that can be grown in a tank instead of on a farm.

At EDF, we encourage innovation that helps communities and the environment thrive, especially in the face of the threats posed by climate change. However, an innovator’s bold claims, especially those involving food safety, must be closely scrutinized before the additive hits the marketplace. Given the potential for harm to consumers, we cannot simply take a company’s assertion of safety at face value – there must be transparency and the Food and Drug Administration (FDA) must provide an independent review.

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EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

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

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

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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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