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Noncompliance with “Nonbinding” Guidance Could Lead to Enforcement Action

Continuing its Closer to Zero quest, the FDA’s new draft guidance on lead in foods for babies and young children sets reduced action levels for which the food will be considered adulterated. A key aspect of this guidance is FDA’s statement that while it, like all guidance, is considered not binding, the agency “would consider the guidance action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.”

So what does the new Action Levels for Lead in Food Intended for Babies and Young Children draft guidance require?

Covering all processed foods intended for babies and young children less than two years old, the new guidance related action levels are intended to help ensure dietary exposure does not exceed FDA’s Interim Reference Level of 2.2 ug/day. Differing action levels are set for differing foods to account for variances in consumption levels, the ease with which the risks can be controlled, and the amounts of lead taken up from the environment:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings and single-ingredient meats. 
  • 20 ppb for root vegetables (single ingredient).
  • 20 ppb for dry cereals.

In the draft guidance, FDA states that it considers the action levels to be achievable “when measures are taken to minimize the presence of lead.” While FDA also expects that industry will strive for continual reductions over time, the agency will continue to assess whether action levels should be lowered even further, based on evolving science on health impacts and mitigation techniques, and input from industry on achievability. To accomplish this, FDA will:

  • Monitor industry’s progress in reducing the levels of lead, while ensuring that manufacturers are implementing preventive controls to reduce or eliminate lead in their products.
  • Continue to evaluate scientific advances in reducing the levels of lead in foods and the role nutrition plays in reducing the health impact of lead exposure.
  • Assess comments from its previous public meeting, response to this guidance (submitted by March 27), and other information and data to determine if further adjustments are needed.

While acknowledging that it is not possible to remove lead entirely from the food supply, the FDA expects that the recommended action levels will cause manufacturers to implement agricultural and processing measures to lower lead levels, reducing the potential harmful effects. In its Constituent Update, the agency also affirmed that the presence of a contaminant does not mean the food is unsafe to eat, and that the guidance action levels are not intended to direct consumers in making food choices, as children should be fed a varied and nutrient-dense diet across and within the main food groups.

TAG’s Take.

As we noted in the opening paragraph, FDA stated that, despite the fact that all guidance by its very nature, is nonbinding, the agency would take into consideration an establishment’s compliance with the “action levels” stated in the guidance “when considering whether to bring enforcement action in a particular case.” That all but says that the recommendations are requirements and is a fair warning to the industry that the detected levels of lead in foods for babies or young children should be taken as seriously as a regulation. In fact, the guidance states, “Consistent with 21 CFR 109.6(d), these action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

This is of particular significance when it is further considered that FDA states it “is committed to assessing if action levels should be lowered even further.” For a variety of reasons, not the least of which is consumer pressure, the agency is staunchly focused on reducing heavy metals in foods, particularly foods intended for babies and young children. And the industry may as well get on board now with the “nonbinding” action levels, as these are likely to get lowered ever further as science’s ability to detect contaminants gets ever lower as well.  We anticipate that we will see similar “guidance documents” emerge in the future related to arsenic and cadmium.  Whether the FDA does anything different regarding mercury remains to be seen.


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