EDF Health

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

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 »

Posted in FDA, Food, GRAS / Comments are closed

Eight steps to strengthen FDA’s Closer to Zero plan to reduce toxic metals in children’s food

Tom Neltner, Senior Director, Safer Chemicals

EDF this week submitted comments to the Food and Drug Administration (FDA), applauding the agency’s recent activities related to its Closer to Zero Action Plan for reducing toxic elements in children’s food and outlining specific steps to strengthen the FDA’s action.

The agency’s November 18 public meeting on the action plan included excellent presentations by scientists as well as an extended public comment period and an opportunity to provide written follow-up comments. We also appreciate the December 1 colloquium focusing on the latest evidence showing the significant risks posed by arsenic to the development of children’s nervous and immune systems.

Our primary takeaways from these meetings are that:

  • There is an urgent need for FDA and industry to do more to reduce lead, arsenic, and cadmium levels in food that children eat, given the evidence that there are no safe levels of exposure;
  • FDA faces a challenge in effectively communicating to the public about the risks from even relatively low-level, short-term exposure to lead and arsenic;
  • Folic acid and iron play an important role in reducing – but not eliminating – the harm from these toxic elements; and
  • The U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) play a critical supporting role in the overall effort to protect children from these toxic elements.

The Closer to Zero plan is a step forward because it commits FDA to specific actions and general deadlines for the first time. In our comments, we identify eight areas for improvement with specific suggestions for each that we think the agency can and should adopt to strengthen its efforts. These are:

  • Reduce the maximum daily intake level / IRL for lead from 3 to 2 µg per day for children and from 12.5 to 9 µg per day for adults as the next step towards the Closer to Zero goal.
  • Reverse the flawed practice of evaluating lead content of each food in isolation and allowing those with high levels to remain in commerce. Instead, FDA should focus on comparing the product to other lot numbers or private brand to its competitors as recommended by 22 state attorneys general.
  • Release the Total Diet Study results for 2018-19 cycle and investigate outliers.
  • Define “as low as possible” based on best performing ingredients or products in a class.
  • Define “children’s food” to include foods commonly consumed by children younger than six years of age.
  • Be consistent on public health messaging and avoid phrases like “no immediate health hazard.”
  • Move up deadlines for arsenic and cadmium action levels.
  • Add milestone for compliance verification with action levels and preventive controls.

We look forward to continuing to work with FDA to ensure that levels of toxic metals in children’s food really do get closer to zero.

Posted in FDA, Food / Read 1 Response

Flint area residents raise the bar on raising environmental justice concerns

Ugbaad Ali, Community Environmental Health Tom Graff Fellow

We all deserve to live in a healthy and vibrant community, yet many residents of Flint, Michigan, are overburdened by a lifetime of toxic exposures and environmental injustice. Recently, a coalition of environmental justice groups and community organizers in Flint used their combined power to organize against the siting of a new hot mix asphalt facility.

The Stop Ajax Asphalt Coalition was formed to protect neighboring communities from further environmental harm. The Coalition, which includes residents from Flint and Genesee Township, St. Francis Prayer Center, C.A.U.T.I.O.N, Environmental Transformation Movement of Flint, Flint Rising, Greater Holy Temple Church, Michigan United, R. L. Jones Community Outreach Center Campus, and Mi JustUs, submitted extensive comments and generated hundreds of public comments to contest the state’s permitting of a hot mixed asphalt facility by Ajax Materials Corp. near homes, schools, and parks.

Historically air permit decisions have been made in isolation, ignoring the cumulative impact from surrounding exposure sources. After hearing from the Coalition, the regional office of the Environmental Protection Agency (EPA) – which serves Michigan and five other states – weighed in with a letter that recommended Michigan’s Department of Environment, Great Lakes and Energy (EGLE) “conduct a cumulative analysis of the projected emissions from all emission units at the proposed facility, fugitive emissions from the proposed facility, and emissions from nearby industrial facilities, to provide a more complete assessment of the ambient air impacts of the proposed facility on this community.” It concluded that “because of the environmental conditions already facing this community, and the potential for disproportionate impacts, the siting of this facility may raise civil rights concerns.”

The U.S Department of Housing and Urban Development’s (HUD) regional office also  raised serious civil rights concerns in a letter to EGLE, highlighting that the proposed location is near two HUD-assisted communities housing low-income families of color – and expressing concern that EGLE failed to engage HUD on a decision that could impact HUD-assisted residents.

“This isn’t a defeat for the citizens of Flint. We’re just getting started.” – Anthony Paciorek, Michigan United (ABC News)

Despite the public comments and federal agency letters, EGLE approved the air permit, but with tightened requirements. The Coalition remains concerned about the siting of the facility and is committed to challenging the state to require additional measures to protect their community. Read More »

Posted in Air Pollution, Civil rights, EPA, Flint / Tagged , | Read 2 Responses

Helping EPA identify and protect those at greater risk from chemicals undergoing TSCA risk evaluation

Jennifer McPartland, Ph.D., is a Senior Scientist, and Lariah Edwards, Ph.D., is an EDF-George Washington University Postdoctoral Fellow

EPA Administrator Michael Regan recently completed a five-day “journey to justice” tour, highlighting communities across three US states that have been adversely affected by decades of chemical and air pollution. EPA’s focus on protecting those whose health is at greater risk, including communities disproportionately burdened by harmful chemical exposures, must be a priority in its implementation of the Toxic Substances Control Act (TSCA).

This week, EDF submitted comments to EPA to support the agency’s review of nine widely used substances currently undergoing TSCA risk evaluation: 1,3-butadiene, formaldehyde, and seven ortho-phthalates (phthalates). Our comments identify key groups that are at greater risk from these chemicals because they are more susceptible to their effects or are disproportionately exposed from environmental releases. Importantly, while our comments involved a broad review of the public literature, they do not capture all groups potentially at greater risk to exposure from these substances—and we strongly urge EPA to comprehensively identify all such groups using its information authorities as needed. Read More »

Posted in EPA, TSCA Reform / Read 1 Response

EPA’s updated guidance highlights property management companies’ responsibilities under the Lead-Based Paint Rule

The Environmental Protection Agency (EPA) intends to withdraw two answers to frequently asked questions about the responsibilities of property management companies (PMCs) to comply with the agency’s Lead-Based Paint Renovation, Repair, and Painting Rule (RRP). EDF applauds the agency’s action, which is consistent with the intent of the rule. The agency’s Federal Register notice explaining the change also has important implications for improving compliance.

In comments submitted this week, EDF encouraged the EPA to further revise the guidance by replacing the withdrawn answers with the agency’s own detailed explanation to help PMCs – as well as residents, contractors, and landlords – better understand who is responsible for complying with the RRP rule.

Read More »

Posted in lead / Comments are closed

Breaking silence around Black women’s reproductive health: A conversation with Lilly Marcelin

Community activist Lilly Marcelin has dedicated her career to addressing racial and social inequities. In 2012, she founded and is now the Executive Director of the Boston-based organization, Resilient Sisterhood Project (RSP). The organization’s mission is to educate and empower women of African descent about common, but rarely discussed, diseases of the reproductive system that disproportionately affect them through workshops, trainings, empowerment circles, and community education and outreach programs. Ms. Marcelin ensures RSP’s work is done in partnership with – rather than on behalf of – Black women in order to address deeply rooted systemic racism.

I recently spoke with Lilly Marcelin to learn more about her advocacy around Black women’s reproductive health, including the importance of involving and centering Black women in this work. Read More »

Posted in Industry Influence, Markets and Retail, Uncategorized / Tagged , | Read 1 Response