EDF Health

Broken GRAS: Undermining the safety of dietary supplements and food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 27, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administration’s (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDA’s decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

  1. Bypass mandatory new dietary supplement ingredient (NDI) notice requirements; and
  2. Expand their market from dietary supplements into conventional food.

We have long-challenged FDA’s interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agency’s flawed approach to GRAS also undermines the safety of dietary supplements. Read More »

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Beyond paper, part 2: PFAS intentionally used to make plastic food packaging

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 12, 2021

Tom Neltner, Chemicals Policy Director; Maricel Maffini, consultant; and Tom Bruton with Green Science Policy Institute

Since 2002, FDA has authorized the use of four types of per- and polyfluorinated alkyl substances (PFAS) to make plastic food packaging, one as recently as 2016. The PFAS are allowed in plastic at levels up to 2000 parts per million (ppm); although lower than those used to greaseproof paper, these levels still contaminate food. The PFAS are added to facilitate the production of articles such as bottles and wraps. They reportedly improve polymer extrusion, reduce build-up on the injection mold, and improve surface roughness among other technical effects.

EDF submitted a Freedom of Information Act (FOIA) request for seven food contact substance notices (FCNs) that FDA has authorized. From FDA’s response[1], we learned that these PFAS can contaminate food in contact with the packaging. In one case the overall amount of the PFAS in the diet would be as high as 41 ppb (see pages 31-32 of FOIA response) – much more than is tolerated for some PFAS in drinking water.

These plastic processing aids, along with fluorinated polyethylene, are the latest additions to a growing list of sources of ‘forever chemicals’ in the diet. They join environmental contamination and greaseproofed paper and cardboard as sources that food companies must consider in order to keep PFAS out of their products and respond to consumer demand for safer food. Given the evidence, FDA needs to move forward pursuant to our June 2021 citizens petition to evaluate the safety of PFAS taking into account the cumulative effect of these chemicals in the diet from many sources.

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FDA’s short-sighted approach to building trust in the safety of cell-cultured meat and seafood products

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 17, 2021

Tom Neltner, J.D., is Chemicals Policy Director

Consumer trust that products are safe to eat is essential to acceptance of any innovative food product.

One of the most innovative food products expected to enter U.S. markets in coming years is cell-cultured meat and seafood. Producing these products by culturing cells in tanks and forming them into foods that look and taste like their conventionally produced counterparts is a technological achievement. Proponents enthusiastically tout these products as climate-friendly alternatives that provide real hope to meet the world’s growing demand for animal protein in a sustainable way that also minimizes animal welfare concerns.

Consumer trust that products are safe to eat is essential to acceptance of any innovative food product. That trust is built through a rigorous, transparent, and independent scientific review to ensure safety. Without that, questions linger that undermine widespread consumer adoption.

Unfortunately, we have serious concerns that the process the Food and Drug Administration (FDA) may be planning to use to review the safety of cell-cultured meat and seafood is inadequate and will undermine consumer trust. From our perspective, the manufacturing process for cell-cultured meat and seafood is a significant departure from current practice and warrants careful scrutiny. FDA guidance is clear that, for these types of changes, the appropriate review options are a food additive petitions or the voluntary Generally Recognized as Safe (GRAS) notification process. We strongly recommend FDA rely on these existing options existing options rather than create a new approach.

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House Oversight Committee draws renewed attention to heavy metals in baby food and calls for FDA to act

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 11, 2021

Tom Neltner, J.D. is the Chemicals Policy Director.

Last week, the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy released an important report summarizing baby food testing data submitted by four companies (Beech-Nut, Gerber, Happy Family, and Earth’s Best), finding that “baby foods are tainted with dangerous levels of arsenic, lead, cadmium and mercury.” These heavy metals are widely recognized as harming children’s brain development.

The report found that three of the four companies (all but Gerber) used ingredients that had exceeded limits set in their internal standards. Additionally, the committee cited “grave concerns” that three other companies (Walmart, Plum, and Sprout) did not provide their internal standards and testing results in response to the legitimate request by the House Committee. Their lack of transparency undermines credibility and trust.

Due to the alarming nature of these findings about a food marketed as safe and healthy for infants and toddlers, the report garnered significant attention and has prompted calls for the Food and Drug Administration (FDA) and food manufacturers to do more on this issue.

Importantly, the report provides new insights into industry decision-making processes, highlights the need for greater oversight, and adds urgency to EDF’s ongoing efforts to reduce heavy metals in food.

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Getting lead out of brass and bronze food equipment

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 12, 2021

Tom Neltner, J.D. is the Chemicals Policy Director.

Many people may not be aware that lead is still added to brass and bronze used to make drinking water faucets and food equipment like coffee brewers and more. This is problematic because lead can leach into the water and beverages from the equipment – putting consumers at risk. As part of EDF’s efforts to reduce exposure to lead from all sources, we have advocated to stop this use of the heavy metal.

Last June, our three-year effort yielded results when the committee responsible for the national consensus standard for plumbing devices, known as NSF/ANSI/CAN 61, made its lead leaching standard five times more protective for endpoint devices – from 5 to 1 parts per billion. Endpoint devices are faucets, drinking water fountains and other devices installed within the last one liter of water distribution systems in a building. For all other plumbing devices, lead is limited to the amount added to the device’s material, 2500 parts per million (ppm) [1], and leaching limit does not apply.

This fall, we turned our attention to lead leaching into drinking water from food equipment such as ice machines, coffee brewers, teapots, and water heaters. We have submitted petitions to NSF International and to the Food and Drug Administration (FDA) asking them to prohibit use of lead in brass and bronze commonly used in these devices.

For food equipment, we leveraged the more protective safety standards for food contact substances in the Food Additives Amendment of 1958. These standards require that additives not be used unless there is a reasonable certainty of no harm from their intended use after taking into account related substances in the diet. It also prohibits use of carcinogens. Lead is unsafe under both these restrictions because it is a carcinogen and no safe threshold has been found for lead in the blood to prevent neurologic development harm in children and heart disease in adults.

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It’s time to eliminate lead from tin coating and solder on metal food cans

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 11, 2021

Tom Neltner, J.D. is the Chemicals Policy Director.

In October 2019, we reported finding canned foods had a surprising number of samples with lead based on the Food and Drug Administration’s testing results. Almost half of the 242 samples had detectable lead, including a staggering 98% of 70 canned fruit samples.

We suspect that the high lead detection rates are a result of lead in the tin – either added to make an alloy or as a contaminant – used to coat the steel or join steel pieces together in the cans. This lead can then leach from the coating or solder into the food. Light-colored fruits and fruit juices would be more likely to have lead contamination based on a report indicating they are commonly packaged in tin-coated steel cans without a synthetic coating on the inside isolating the food from the tin. The lead detections in the other canned products in FDA’s study could have resulted from flawed synthetic coatings.

In December 2020, EDF and ten health, consumer, and environmental groups[1] petitioned FDA to ban the use of lead in food contact materials such as tin. We also included that FDA should presume that lead was intentionally used when levels in food contact materials are at or above 100 parts per million (ppm) and provided an option for the agency to specifically authorize the use only if:

  • The part of the food contact article that contains added lead does not contact food under intended conditions of use; or
  • No lead migrates into food from the food contact article under intended conditions of use.

Our petition demonstrates that, because lead is a carcinogen that is unsafe at any level in the blood, its use in tin coatings and solder for food cans should be expressly prohibited. The agency posted the petition for public comment and must make a decision how to proceed by June 2021. There is no deadline for comments, but it is best to submit them by April 1 so they can influence the agency’s decision.

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