EDF Health

FDA and industry continue to ignore cumulative effects of chemicals in the diet

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

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FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases

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

Update: FDA published the citizen petition upon receipt on 9/23, and is requesting public comment.

More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.

We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.

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New study links PFAS exposure and body weight regulation

Ryan O’Connell is a High Meadows Fellow

Perfluoroalkyl and polyfluoroalkyl substances (PFAS), sometimes referred to by the broader term “PFCs” (perfluorinated chemicals), are a large class of chemicals used to make products water- or grease-resistant. They can be found in everything from nonstick cookware and clothing to food packaging and adhesives. While PFAS have useful commercial and industrial applications, these chemicals also persist in the environment and in people, and a number of them have been shown to be very toxic.

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Posted in EPA, FDA, Health Policy, Health Science / Comments are closed

Making “safer” accessible to all

Lindsay McCormick is a Research Analyst.

I find purchasing shampoo and other common personal care products to be a surprisingly stressful experience – I pace the aisles at the drugstore for a good 10-15 minutes, read every product ingredient list, contemplate the legitimacy of claims like “paraben-free” or “no artificial colors or fragrances,” and weigh the impact on my wallet. In the end, I usually choose a moderately priced product with some sort of ingredient safety claim brightly printed on the front label, and hope the extra $2 I spent will actually reduce my exposure to hazardous chemicals.

Many consumers are hungry for information and solutions that help reduce their exposure to toxic chemicals.  As more research links exposures to common ingredients in personal care products and health impacts – like certain parabens to reduced fertility; certain phthalates to asthma, reproductive disorders, and neurological effects; and triclosan to obesity – many consumers want to feel empowered to take action. That’s why the results of a recent intervention study are so intriguing: researchers found that exposures to certain chemicals fell in a population of low-income Latina girls after using personal care products labeled as being free of such chemicals for three days.

The implications of this study raise several interesting questions that I’ll explore in this post. Specifically, are personal shopping choices an effective way to avoid chemical exposures?  And, is this strategy equally available to everyone in our society?   Read More »

Posted in Emerging Science, FDA, Health Policy, Health Science, Markets and Retail / Tagged , , | Comments are closed

Evidence mounts on BPA’s adverse effects on human health

Lindsay McCormick is a Research Analyst.

Bisphenol A (BPA) is a high production volume chemical that is used to make polycarbonate plastics and epoxy resins.  It is commonly found in food and beverage packaging, such as plastic bottles and the lining of food cans, as well as thermal paper receipts (see our previous blog).  BPA is widely-recognized as an endocrine-disrupting chemical, meaning that it can alter the normal functioning of the body’s hormonal system.  Hundreds of studies have been published associating BPA exposure with health effects, ranging from cancer to obesity to attention-deficit hyperactivity disorder.  Data from the Center for Disease and Control (CDC) show that nearly all people tested have BPA in their bodies.

Despite a plethora of data, numerous calls for action (for example, see here, here and here), and comprehensive regulation in France, it does not seem that national regulation of BPA in food packaging in the U.S. will be happening any time soon.  The official position of the U.S. Food and Drug Administration (FDA) is that, while BPA exhibits endocrine-disrupting properties at high doses, it is safe at the current levels occurring in food.  Although the FDA banned the use of BPA-based materials in baby bottles, sippy cups, and infant formula packaging in 2012, FDA said it based this action on changes in the market, rather than safety concerns.

In the fall of 2014, FDA completed a four-year review of the literature, including more than 300 scientific studies, and concluded that the information does not “prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.”

The European Food Safety Authority (EFSA) recently followed suit with their announcement that BPA does not pose a health risk to consumers, including children, at current exposure levels.  (This is in contrast to the action of several EU member states, which have banned BPA in food contact materials for children under 3 years of age over the past few years.)

Meanwhile, scientists continue to churn out studies linking low-level BPA exposure to a variety of health effects.  In this post, we discuss several new studies.   Read More »

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New bill puts BPA back in the spotlight

Sarah Vogel, Ph.D., is Director of EDF’s Health Program.

The hotly debated chemical BPA is back in the policy spotlight. This week Senator Edward Markey (D-Mass) joined Representatives Lois Capps (D-CA) and Grace Meng (D-NY) to announce the Ban Poisonous Additives (BPA) Act.  The bill would ban the use of BPA or bisphenol A from food packaging and mandates extensive consideration of the hazardous properties of any BPA alternative, so as to avoid substituting chemicals that may pose just as many health risks (as increasingly it appears to be with the case of the common BPA replacement, BPS).

Low dose exposure to BPA has been associated with a wide range of health effects including behavioral problems, prostate, breast and liver cancer as well as obesity.  A study released just last week demonstrated how low dose exposure to BPA during fetal development can alter gene expression in the mammary gland of female rats, resulting in abnormal development of the breast and increased susceptibility to breast cancer later in life.   Read More »

Posted in Health Policy, Health Science, Regulation / Tagged | Read 1 Response