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Unleaded Juice: FDA needs to start with public health—not market impact

Tom Neltner, Senior Director, Safer Chemicals 

This is the fifth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and its implications for the agency’s Closer To Zero program. 

FDA’s approach to setting draft action levels for lead in juice is based on two ill-conceived presumptions:

  • Action levels should not impact more than 5% of the market. Unfortunately, FDA does not appear to consider market trends or whether the products were made using best practices shown to reduce contamination.
  • Action levels should help ensure 90% of young children have a dietary intake of lead that is below FDA’s Interim Reference Level, the maximum daily intake from food. Unfortunately, this effectively ignores the top 10% or 2.4 million of the most-exposed young children.[1]

To its credit, the agency has shown it is willing to go beyond the 5% impact for three types of juices (grape at 12%, pomegranate at 6%, and prune at 6%),[2] and it has proposed the most protective lead-in-juice standards in the world. However, for a heavy metal like lead where relatively short-term exposures can result in long-term harm to young children’s developing brains, the current approach has serious weaknesses.

We think the agency should evaluate alternatives that impact more than 5% of the market and protect more than 90% of children. And when FDA evaluates impacts, it should assess the socioeconomic benefits of the alternatives. For substances like lead (and arsenic), these societal benefits can be quantified using established methods. In a previous blog, we showed that reducing young children’s overall dietary intake of lead by just 6% would yield $1 billion a year in benefits. The agency should compare these benefits to the investments that industry would need to make to achieve these action levels using best practices.

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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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New EPA model enables comparison of various sources of childhood exposure to lead

Tom Neltner, J.D.is Chemicals Policy Director and Dr. Ananya Roy is Health Scientist

This week, Environmental Health Perspectives published an important article by scientists at the Environmental Protection Agency (EPA) that sheds important light on the various sources of children’s lead exposure. Led by Valerie Zaltarian, the article shares an innovative multimedia model to quantify and compare relative contributions of lead from air, soil/dust, water and food to children’s blood lead level. The model couples existing SHEDS and IEUBK models to predict blood lead levels using information on concentrations of lead in different sources, intake and gut absorption. The predicted blood lead levels compared well with observed levels in the National Health and Nutrition Evaluation Survey population. Given the variety of independent sources of lead exposure, the model provides a critical tool that public health professionals can use to set priorities and evaluate the impact of various potential standards for all children and not just those with the greatest exposure.

This peer-reviewed article builds on a draft report EPA released in January 2017 evaluating different approaches to setting a health-based benchmark for lead in drinking water. The report has provided a wealth of insight into a complicated topic. Earlier this year, we used it to show that formula-fed infants get most of their lead exposure from water and toddlers from food, while the main source of lead for the highest exposed children is soil and dust. In our February blog, we provided our assessment of a health-based benchmark for lead in drinking water and explained how public health professionals could use it to evaluate homes. The information was also critical to identifying lead in food as an overlooked, but meaningful, source of children’s exposure to lead.

The new article reaffirms the analysis in the January 2017 EPA report and highlights that evaluating source contribution to blood lead in isolation versus aggregating across all sources can lead to very different answers and priorities. A health-based benchmark for lead in drinking water could vary from 0 to 46 ppb depending on age and whether all other sources of lead are considered. For example, a health-based benchmark for infants (birth to six months old) would be 4 ppb or 13 ppb depending on whether or not you consider all sources of exposure.

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Posted in Drinking Water, Emerging Science, EPA, Food, Health Policy, lead, Uncategorized / Also tagged , , , , , , , | Comments are closed

Podcast: You Make Me Sick! Plasticizers, fast food, and your urine

From the shores of the Puget Sound to the inside of your colon, EDF Health’s You Make Me Sick podcast has been bringing you the latest in environmental health science. In today’s episode, we’re excited to showcase the work of Dr. Ami Zota of the George Washington University Milken Institute School of Public Health.

We sat down with Dr. Zota to discuss her recent study where she looked at how certain chemicals associated with plastics show up in people’s urine after they eat fast food.

 

Want more? Subscribe to us on iTunes or Google Play, or check out our SoundCloud to listen via desktop!

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When it comes to lead, formula-fed infants get most from water and toddlers from food, but for highest exposed children the main source of lead is soil and dust

Tom Neltner, J.D.is Chemicals Policy Director

On January 19, the Environmental Protection Agency (EPA) released a major new draft report proposing three different approaches to setting health-based benchmarks for lead in drinking water. We applauded EPA’s action and explored the implications for drinking water in a previous blog. One of the agency’s approaches provides useful, and surprising, insights into where the lead that undermines the health of our children comes from. Knowing the sources enables regulators and stakeholders to set science-based priorities to reduce exposures and the estimated $50 billion that lead costs society each year.

The EPA draft report is available for public comments until March 6, 2017, and it is undergoing external peer-review by experts in the field in support of the agency’s planned revisions to its Lead and Copper Rule (LCR) for drinking water. Following this public peer-review process, EPA expects to evaluate and determine what specific role or roles a health-based value may play in the revised LCR. With the understanding that some of the content may change, here are my takeaways from the draft:

  • For the 20% of most exposed infants and toddlers, dust/soil is the largest source of lead. Since we know that 21% of U.S. homes (24 out of 114 million) have lead-based paint hazards, this should not be surprising.
  • For most infants, lead in water and soil/dust have similar contributions to blood lead levels, with food as a smaller source. If the infant is formula-fed, water dominates.
  • For 2/3 of toddlers, food appears to provide the majority of their exposure to lead. This result was a surprise for me. EPA used data from the Food and Drug Administration’s (FDA) Total Diet Study collected from 2007 to 2013 coupled with food consumption data from the National Health and Nutrition Examination Survey collected from 2005 to 2011. In August 2016, FDA reported on levels of lead (and cadmium in food) commonly eaten by infants and toddlers based on a data set that is different from its Total Diet Study. FDA concluded that these levels, “on average, are relatively low and are not likely to cause a human health concern.”
  • For all children, air pollution appears to be a minor source of lead exposure. We think it is most likely because exposure is localized around small airports and industrial sources.

For a visual look at the data, we extracted two charts from the draft EPA report (page 81) that show the relative contribution of the four sources of lead for infants (0-6 month-olds) and toddlers (1 to <2 year-olds) considered by the agency. The charts represent national exposure distributions and not specific geographical areas or age of housing.

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Posted in Drinking Water, Emerging Science, EPA, FDA, Food, Health Policy, lead / Also tagged , , , , , | Comments are closed