EDF Health

Our experience with FDA’s food chemical program reinforces alarming findings from Politico investigation

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, consultant

A powerful investigative article by Politico’s Helena Bottemiller Evich revealed significant structural and leadership problems at the Food and Drug Administration’s (FDA) food program. The article articulated what has been implicitly understood by the food safety community. It led to demands from Congress for Commissioner Robert Califf to take aggressive action and even prompted calls for a new agency focused solely on food safety.

“Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems. There’s a long running joke among officials: The “F” in FDA is silent.”

– Helena Bottemiller Evich

from Politico article

In response, FDA leadership has pointed to Congress for failing to adequately fund the program and touted examples of where the agency has taken action on food safety.

Yesterday, 30 groups representing food industry leaders, and consumer groups, including EDF, joined in a call for Califf to unify the FDA’s food program under a deputy commissioner for foods with direct line authority over all food-related programs.

We have been advocating for FDA to improve the safety of chemicals added to our food for more than a decade, often working with FDA officials to push for regulatory reforms. From that narrow but deep perspective on food safety, everything we have seen reinforces the shortcomings highlighted in the Politico article. Read More »

Also posted in FDA, Food, Health Science / Tagged , | Comments are closed

FDA has new funding to start modernizing how it assesses food chemical risks

Joanna Slaney, Sr. Director, Federal Affairs; and Tom Neltner, Senior Director, Safer Chemicals Initiative

For the first time in recent memory Congress approved funds for FDA specifically to address food safety from potentially dangerous chemicals that may present health hazards. Now it’s time for the agency to get to work.

Congress appropriated $7 million for “Emerging Chemical and Toxicology Issues” and $11 million for “Maternal and Infant Health and Nutrition” for the current fiscal year. While these numbers are below the agency requests of $19.7 million and $18 million respectively, the funds can help FDA meet its stated goals to bring on new staff and to:

  • “Enhance and update its approach to chemicals—both those directly added as food ingredients and those that come into the food supply through food contact and environmental contamination” and
  • Address issues of concern that include lead, cadmium, and arsenic in children’s food.

Read More »

Also posted in FDA, Food, Public Health / Tagged , | Comments are closed

Broken GRAS: A scary maze of questions a corn oil producer couldn’t answer

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

This blog is the fourth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food, how the process works in practice, and why it is broken. Companies voluntarily submit these notices seeking a “no questions” letter from FDA that makes it easier to market the chemical to food companies.

In our latest blog we address a chemical called “COZ corn oil” developed by the Iowa-based company, Corn Oil ONE. We obtained documents from FDA revealing that the agency twice raised significant concerns about the safety of COZ corn oil with the company, which withdrew its notification without addressing the agency’s questions. As with the other examples in the series, FDA did not make its concerns public or take steps to block the chemical’s use in food.  Read More »

Also posted in FDA, Food / Tagged , | Comments are closed

The new FDA Commissioner has a full plate; here are three steps he can take to keep focused on food safety too

Tom Neltner, Senior Director, Safer Chemicals.

The U.S. Senate today voted to return Robert Califf to the role of FDA Commissioner, bringing needed leadership to an agency that plays a vital role in protecting public health. 

While Dr. Califf faces historic challenges in the form of the COVID-19 pandemic and the opioid epidemic, he also has a tremendous opportunity to elevate the agency’s important role in protecting the public from unsafe chemicals in food. 

We put together a list of three things Dr. Califf and the FDA have the authority to do right now to keep problematic chemicals out of our food:  Read More »

Also posted in FDA, Food, lead, Public Health / Tagged , , , , , , | Comments are closed

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

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.

____

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 »

Also posted in FDA, Food / Tagged | Read 1 Response

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).

____

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 »

Also posted in FDA, Food / Comments are closed