Why companies should pay attention to FDA’s new push on heavy metals in food

This blog was co-authored with Maricel Maffini, Ph.D., Independent Consultant, and Michelle Harvey, Senior Consultant at the Environmental Defense Fund.

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 include:

  • 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      • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”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.”

    A week later, CFSAN Director Susan Mayne released a statement on arsenic in rice, in response to a Government Accountability Office report on FDA’s efforts to protect children, especially infants. She committed to:

    • Updating FDA’s 2016 risk assessment for arsenic in rice products if there is any new and evolving science that would impact its conclusions; and
    • Finalizing the guidance establishing an action level for inorganic arsenic in infant rice cereal by the end of 2018.

    EDF is pleased to see FDA focusing on the cumulative effect of these four heavy metals on children’s brain development and reiterating its commitment to reduce exposures to the greatest extent possible. From our analysis of recent test results from FDA’s Total Diet Study and of a common ingredient such as carrageenan, we think there are significant opportunities for progress.

    This is also good news for food manufacturers and retailers seeking to address customer concerns about heavy metals. One of the food industry’s current key challenges is the inability to consistently point their sourcing managers or suppliers to FDA standards or even meaningful guidance on heavy metal contamination in food. For many foods, each company has to decide on its own what’s “good enough.” Credible, authoritative action levels provide consistent sideboards for decision making, and protecting customer health.

    For companies who have used the lack of health protective standards to take a more lax approach to heavy metal contaminant management, this should be a wake-up call. FDA’s recognition that small amounts of heavy metals can still add up to problematic exposures undercuts one frequently heard argument, that a little doesn’t matter. As FDA begins reevaluating lead levels previously set for different foods, current science dictates that action levels must be set very low.

    To support companies stepping up to tackle the challenge of heavy metal in foods, to motivate those hiding behind inadequate guidance, health-protective FDA guidance is crucial.


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