EDF Health

Broken GRAS: It’s time for FDA to wake up and protect consumers from dubious ingredients

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 5, 2022

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

This blog is the third in our Broken GRAS series where we explore how the Food and Drug Administration’s Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food works in practice and why it is broken.

In this blog, we examine another voluntary GRAS notice submitted to the FDA, this one for Venetron, an extract of Apocynum venetum leaves. It is marketed for sleep improvement and anti-stress and used as a dietary supplement and food ingredient. Documents obtained through a Freedom of Information Act (FOIA) request reveal that FDA scientists raised safety concerns about Venetron. Under the broken GRAS system, however, the company that manufactures the ingredient was able to withdraw its notification and continue to market the chemical as GRAS, despite the questions raised by the agency.

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Japanese company Tokiwa Phytochemical (Tokiwa) voluntarily notified the Food and Drug Administration (FDA) in August 2014 that it had determined its extract of Apocynum venetum leaves was Generally Recognized as Safe (GRAS). The extract, called Venetron, would be an “ingredient in food” at levels up to 100 mg per day, the company said in the notice (GRN 530). Tokiwa indicated that Venetron could be incorporated into “health food product[s], such as tablet[s] or capsule[s],” but did not identify specific foods to which the substance might be added.

In support of its GRAS determination, the company presented results of preclinical and clinical investigations that examined the safety of the extract in mice and healthy adult male volunteers. They also reported data on the effectiveness of Venetron to treat individuals with mild depression. It convened a panel of three experts ‒ Drs. Veronika Butterweck (Univ. of Applied Sciences and Arts, Northwestern Switzerland), Sansei Nishibe (Health Sciences Univ. of Hokkaido), and Kuo-Hsiung Lee (Univ. North Carolina at Chapel Hill) ‒ to review the studies, as well as a “history of human intake” of Rafuma [another name for A. venetum] leaf extract and its use as a dietary supplement in Japan and as a drug in China to treat insomnia, kidney disease, hypertension and heart palpitations.

Tokiwa said the panel “unanimously concluded that VENETRON™, when used in foods in general at levels providing a daily total intake of 100mg/person/day, is safe,” and that the GRAS determination was based on “scientific procedures supported by a history of safe use.” Read More »

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Broken GRAS: Scientists’ safety concerns are hampered by FDA’s inactions on food chemicals

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 21, 2021

Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director

A federal district court this fall ruled that the Food and Drug Administration (FDA) has the authority to allow food companies to make Generally Recognized as Safe (GRAS) safety determinations for novel chemicals added to food without notifying the agency. The decision followed a lawsuit by EDF and others, in which we challenged this practice. The court agreed, in part, with FDA that an uptick in companies voluntarily choosing to send notices to the agency since the 2016 rule went in effect was a sign that the program was working.  We disagree with the court’s conclusion but opted not to appeal.

This blog is the second in our Broken GRAS series where we explore how the voluntary notification system works in practice and why it is broken. The first dealt with a synthetic chemical called apoaequorin and marketed as Prevagen, a chemical found in jellyfish and used in protein shakes. The company claims the substance helps memory, but FDA has repeatedly raised serious questions about its safety. Despite the agency’s concerns the company continues to sell the product as GRAS. 

In this blog, we examine another voluntary GRAS notice, this one for GABA, a neurotransmitter naturally produced in the brain and known to slow down certain nervous system activities. It is marketed as a food ingredient despite FDA’s serious concerns with the notice that prompted the company to withdraw it. The agency does not make such information publicly available. We were able to learn of FDA’s concerns through a Freedom of Information Act (FOIA).

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Companies have the option to voluntarily notify FDA when they determine that a use of a new chemical or a new use of an existing chemical is Generally Recognized as Safe, or GRAS. When they do notify FDA, agency scientists then review the data and supporting information and can ask additional questions. In most of the cases, FDA agrees with the company’s determination and publishes a “no questions” letter. In roughly 20% of cases, however, companies ask the agency to stop the process after receiving the scientists’ questions. FDA then stops its review and announces a “cease to evaluate” status in the GRAS notification inventory, and that’s the end of it. There is no public record of as to why the company withdrew the notice. In some cases, a brief summary is included in the agency’s response to the cease to evaluate letter published in its website. The company is free to market and sell the substance if it still believes the chemical’s use is GRAS.

This happened with gamma aminobutyric acid (GABA). As you will see, the GABA case is a prime example of the 1) importance of FDA’s scientific review of safety data, and 2) profound implications for health risks when the agency takes no action in response to safety concerns raised by its own experts. A product with the safety concerns we describe below warrants closer examination, regardless of its current market share. Where serious health effects are found, it is important for FDA to act quickly before a specialty product like this one becomes more popular, and its health risks amplified. Read More »

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

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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Chemicals in food continue to be a top food safety concern among consumers

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 16, 2021

Chemicals in food continue to be a top food safety concern among consumers

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The latest annual food industry survey demonstrates that U.S. consumers continue to have significant concerns about chemicals in food. Specifically, the survey from the International Food Information Council (IFIC) found:

  • 29% of consumers rated chemicals in food as their top food safety concern, more than any other issue, including foodborne illness from bacteria. Everyone rated chemicals in food among the top three concerns. Chemicals in food has been the top concern every year since 2017, tying risk from COVID-19 from food last year. It has been a significant concern back to the first IFIC Food and Health Survey in 2009.
  • 69% of consumers did not realize that the U.S. government is responsible for reviewing the safety of low-calorie sweeteners, which are among the most well-known food additives.
  • 54% of consumers reported it is important that ingredients do not have “chemical-sounding names” including 26% that rate it “very important.” Their opinion is primarily based on food safety and healthfulness concerns.

Our takeaway is that consumers continue to be concerned about chemicals in food, partly because they are not confident that the federal government is actually ensuring additives are safe. Therefore, they do their best to try and protect their health and safety by avoiding ingredients that sound like chemicals – the only way they see to control the perceived risk. In reaction to consumer concerns, food companies have undertaken “clean label” programs that either remove these ingredients (which can be helpful) or use names that do not sound like chemicals (which obscure the fact and can be misleading).

A better approach is to actually ensure the chemicals in food are safe and healthy rather than leaving consumers to judge products based on the sound of the ingredient names. Actual safety is the outcome that Congress intended when it adopted the Food Additives Amendment of 1958. Instead, the Food and Drug Administration (FDA), the agency with both the responsibility and the authority for food safety, allows companies to decide in secret that additives are safe, fails to consider the cumulative health effect of chemicals in the diet, and lacks any systematic reassessment of past decisions even when new evidence shows potential harm.

FDA needs to step up and address these shortcomings to make our food safe and restore consumer confidence. This involves not only improving its approach to addressing ingredient safety but also their approach towards contaminants that enter our food from the environment, from the packaging, or from food processing.

Read More »

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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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