EDF Health

Did your kids have a hyper holiday? Why those vibrantly colored treats need a warning label

Terry Hyland, Communications Manager

Many parents have experienced that foreboding sense of what might come next as they watch their child indulge in a decadent treat at a holiday gathering or birthday party. All that sugar means things are about to get a little crazy, right?

While sugar has its own issues, perhaps the source of that burst of hyperactivity is another ingredient: the synthetic dyes that brighten many of our sweet treats, and many of the not-so-sweet ones too.

Last year, California government scientists at the Office of Environmental Health Hazard Assessment (OEHHA) released a report finding that commonly used synthetic food dyes can lead to hyperactivity and other neurobehavioral problems in children, with some reacting very strongly to relatively small amounts of colorants. Children’s exposure is also higher compared to adults.

That stands to reason. According to OEHHA, the most common food items associated with food dye exposures include icings, fruit-flavored and juice drinks, sodas, and breakfast cereals. And it is not only the more than 6 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) that may be particularly sensitive to synthetic dyes; kids without pre-existing behavioral disorders can also be affected. Read More »

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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.

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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

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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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.

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FDA reinstates ban on lead added to hair dyes

Tom Neltner, Chemicals Policy Director

On October 7, FDA announced that it is reinstating its ban on lead acetate as the active ingredient in hair dyes that hide grey hair when used regularly. In 1980, the agency approved the chemical for hair dyes. In response to a color additive petition from the Environmental Defense Fund and others, in October 2018, the agency revoked its approval. Combe Inc, the maker of Grecian Formula, objected and forced the FDA to suspend its decision. With this new action, the FDA reinstates its decision effective January 6, 2022 and gives companies one year to reformulate lead acetate out of their products.

Grecian Formula reportedly stopped using lead acetate shortly before the FDA acted in 2018. From our searches, Youthair is the remaining brand that uses the chemical.

We applaud the FDA’s affirmation of its 2018 decision where it determined these products are not safe. The agency soundly rejects Combe’s arguments that low levels of lead are safe and concludes that “we have determined that there is no known level of exposure to lead that does not produce adverse effects” in adults. These adverse effects include heart and kidney damage.

People should not be spreading lead on their head! It gets through the skin where it can hurt their body in myriad of ways. While we applaud the decision, we don’t see anything in the record that explains why FDA took almost three years to reaffirm the obvious and allow consumers to unknowingly continue using the unsafe product. Therefore, it is even harder to understand why FDA chose to give Youthair another year – until January 2023 – to remove the product from the shelves.

The FDA has known for more than forty years that the lead in these hair dyes is absorbed through the scalp, especially when used every day to hide grey hair, but previously thought there was a safe level. Other federal agencies acknowledged a decade ago there is no known safe amount of exposure to lead in adults or children. The FDA’s action in 2018, reaffirmed today, brings it in line with the scientific consensus.

Beyond lead acetate hair dyes, the FDA needs to do more to drive down consumer’s exposures from all sources of lead in food and cosmetics by tightening limits on this heavy metal in common ingredients. To protect kids and adults, it needs to translate its recognition that there is no known safe level of lead exposure by updating its outdated standards for food additives, bottled water, metal cans, and brass faucets as we demanded in a petition last year. The agency’s Closer to Zero Action Plan for children’s foods is critical but not sufficient to protect adults.

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Broken GRAS: Undermining the safety of dietary supplements and food

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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