EDF Health

EDF and others take FDA to court to demand action on carcinogenic flavors petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 17, 2018

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

FDA’s priority must be resolving safety concerns with
existing chemicals over approval of new ones.

On May 2, EDF and other consumer health advocates filed a lawsuit to force the Food and Drug Administration (FDA) to make a final decision on our food additive petition, which asked the agency to reverse its approvals of seven carcinogenic synthetic flavors. Earthjustice is representing EDF in this petition for a writ of mandamus to the court of appeals. We did not take this action lightly. However, with the statutory deadline for a decision passing more than 20 months ago, we saw little chance that FDA would act without court oversight.

Our food additive petition narrowly focused on one specific issue where the law and science were clear, and laid out our review of both the scientific literature and the law concluding that the seven chemicals were no longer safe. FDA formally accepted the petition for filing – essentially confirming it was complete – which triggered a 180-day deadline under the statute to make a final decision. That deadline passed in August 2016 without a decision by FDA.

Read More »

Also posted in Food, Health policy, Public health, Regulation / Tagged , , | Authors: / Comments are closed

FDA details its new push on heavy metals in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 25, 2018

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.”

Read More »

Also posted in Food, Lead, Public health / Tagged , , , , | Comments are closed

Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2018

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

[pullquote]

Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

[/pullquote]

In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

Read More »

Also posted in Food, Health policy, International, Regulation / Tagged , , , , , , , , | Comments are closed

A path to leadership: Food packaging product stewardship considerations released

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 13, 2018

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.

Read More »

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

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 8, 2018

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.

Read More »

Also posted in Food, Health policy, Health science, PFAS, Public health / Tagged , , , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 5, 2018

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.

Read More »

Also posted in Food, Health policy, Health science, Lead, Public health / Tagged , , , , , , , | Comments are closed