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FDA details its new push on heavy metals in food

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant

In May 2017, the US Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) announced it had “established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.” FDA set a goal of limiting lead “to the greatest extent feasible.”

In April 2018, FDA released an interview with the Working Group’s chair, Conrad Choiniere, providing an update on its activities. An overarching point expressed by Choiniere during the interview is that “these metals [lead, arsenic, cadmium and mercury] can have effects on children’s neurological development.” This affirmation of scientific evidence is a welcome sign from the agency. FDA’s key statements are:

  • Initial scope: Children’s exposure to “metals like lead, arsenic, cadmium, and mercury in foods, cosmetics, and dietary supplements.”
  • Approach: “Looking at all the metals across all foods rather than one contaminant, one food at a time.”
  • Initial findings: “Even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”
  • Next steps:
    • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”
    • “Begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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New Study Says Lead – Even at Low Levels – is Associated with Risk of Premature Death

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

This week, a team of researchers led by Dr. Bruce Lanphear published an important new study on the deadly impact of lead exposure for adults. The researchers examined data on more than 14,000 adults and found that an increase of 1 to 6.7 micrograms of lead per deciliter of blood (µg/dL) was significantly associated with an increase in mortality of 37% for all-causes, 70% for cardiovascular, and 108% for ischemic heart disease. The findings remained significant even after they considered and accounted for other factors that could have explained this effect.

This research fills a gap identified by the National Toxicology Program in 2011 in our understanding of the risk of lead exposure at low levels in adults. And it goes further by providing a quantitative relationship crucial to better evaluating the potential economic benefits of various policy options.

The study also had startling estimates about how many people are hurt by lead exposure. The authors estimated that over 400,000 Americans every year die from lead related illnesses – ten times higher than previous assessments. That’s on par with deaths from smoking cigarettes.

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Posted in Emerging Science, EPA, Health Policy, Health Science, lead, Regulation / Also tagged , , | Read 1 Response

A path to leadership: Food packaging product stewardship considerations released

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

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Washington State takes action to eliminate use of PFAS in food packaging

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Around 1990, driven by a concern to keep heavy metals out of recycled products, many states adopted laws prohibiting the intentional addition of arsenic, cadmium, lead, and mercury to packaging and limited their total concentration to 100 parts per million. Manufacturers and suppliers of packaging and packaging components in these states were also both required to furnish a Certificate of Compliance to the packaging purchaser and provide a copy to the state and the public upon request. The Toxics in Packaging Clearinghouse currently reports that 19 states have adopted this type of legislation.

Out of concern about consumer’s health and contamination of compost, on February 28, 2018, Washington State extended its heavy metal packaging law in a groundbreaking way. The legislature passed HB-2658 banning the intentional use of “perfluoroalkyl and polyfluoroalkyl substances” (PFAS) in food packaging made from plant fibers, pending a determination by the Washington Department of Ecology that safer alternatives are available. The law defines PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”

The ban goes into effect in 2022 or two years after the Department makes the safer alternative determination, whichever is later.[1] If, after evaluating the chemical hazards, exposure, performance, cost, and availability of alternatives, the Department does not find safer alternatives by 2020, it must update its analysis annually. We anticipate that this approach will spur innovation among companies offering alternatives and provide a thoughtful and rigorous review of the options.

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FDA on Lead in Grape Juice: Too Late, and Way Too Little Improvement

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Update on May 12, 2018: Despite the concerns raised, the Codex Committee on Contaminants in Foods decided that lowering the limit for grape juice from 50 ppb to 40 ppb was sufficient.  The fill Commission will make a final decision at its July 2018 meeting.

On March 12, the Food and Drug Administration (FDA) will be leading the U.S. delegation in the Netherlands proposing that the Codex Alimentarius Commission adopt a maximum lead limit of 40 parts per billion (ppb) in grape juice. The current limit, set by Codex in the 1980s, is 50 ppb. While a small step in the right direction, FDA’s proposal falls woefully short of adequately protecting children from lead.

For context, the 40 ppb proposed Codex limit would be 2.6 times greater than the 15 ppb lead action level established for drinking water by the Environmental Protection Agency (EPA) in 1991 and 8 times FDA’s limit of 5 ppb for bottled water. In addition, a child drinking a single 8-ounce serving of juice with a lead concentration of 40 ppb will be exposed to 160% of FDA’s maximum daily intake level of 6 micrograms of lead per day. This level, set in 1993, should be much lower because it does not reflect scientific discoveries of the past 25 years showing harm to children at lower levels.

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We are what we eat: New paper outlines how the regulatory gaps in the US threaten our health

Sarah Vogel, Ph.D.is Vice-President for Health.

In a new paper published in PLoS Biology today, Maricel Maffini, Tom Neltner and I detail the regulatory gaps in how the US manages chemicals in food. We explore how failures in our current regulatory system put the public’s health at risk as exemplified in the case of perchlorate, a chemical allowed in food and a well-known endocrine disrupting compound. Perchlorate’s ability to disrupt normal functioning of the thyroid means that even low levels of exposure, especially in those with inadequate iodine intake, can adversely impact the developing brains of infants and children. It is not a chemical that should be in the food of pregnant women, infants and children. And yet it is, and the levels children consume have increased in recent years.

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Posted in FDA, Food, GRAS, Health Science, perchlorate, Public Health / Also tagged , , | Comments are closed