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Understanding the Evolving Limits for Heavy Metals in Foods

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In the United States, lawsuits drive the development of new regulations, and more than 300 class action lawsuits were filed last year against food and beverage companies. Within the past 18 months, several lawsuits have targeted prominent food retailers due to a potential risk of high levels of heavy metals in retail brands of herbs and spices. Moreover, several leading U.S. manufacturers have faced lawsuits due to the potential presence of heavy metals such as arsenic, lead, and cadmium in baby and toddler foods. 

Heavy metals have received significant regulatory and media attention in recent years as a food safety issue. Due to rising public health concerns, authorities at the state and federal levels are under pressure to set limits for heavy metals in food.

Federal Actions

Responding to consumer concerns about toxic metals in baby foods, the Food and Drug Administration (FDA) unveiled an action plan in April 2021 that provided a blueprint for reducing arsenic, lead, cadmium, and mercury in foods intended for babies and young children.

The FDA’s Closer to Zero action plan outlines goals for evaluating the levels of heavy metals in food and setting action levels for certain elements in food intended for babies and young children (e.g., cereals, infant formula, pureed fruits, and vegetables). During the first year of the action plan, the agency developed draft action levels for lead in juice and announced progress toward developing interim levels for arsenic and cadmium.  The FDA intends to finalize the lead action levels by April 2024. During a recent webinar, the agency suggested it may propose interim reference levels for cadmium and arsenic in 2023 and propose action levels in late 2023 or early 2024.

In 2020, the FDA finalized an action level of 100 parts per billion (ppb) for infant rice cereal, the first federal limit finalized for arsenic in infant food.  In previous years, the agency set action levels for mercury in fish, mercury in wheat, lead in candy to be consumed by small children, and arsenic in bottled water. 2013 the FDA issued draft guidance containing a ten ppb action level for inorganic arsenic in apple juice. 

State officials and consumers have expressed frustration with the FDA’s approach to reducing heavy metals in baby foods. In June, a coalition of attorneys general from 22 states petitioned the federal government to expedite activities for reducing heavy metals in foods. The coalition urged the FDA to set new limits for heavy metals in baby foods immediately and to provide guidance for manufacturers to conduct finished product testing for heavy metals.

State Actions

Heavy metals in herbs and spices are a potential chemical hazard relevant to a broad range of food products.  However, no federal limits currently exist for heavy metals in spices. California’s Proposition 65 law requires companies to warn consumers about specific chemical hazards. New York was the first state to establish action levels for heavy metals in food, specifically herbs, and spices, which can trigger a product recall.

For several years, the New York State Department of Agriculture and Markets (NYSAGM) and the Department of Health (NYSDOH) coordinated efforts to monitor the food supply for the presence of toxic metals and the development of appropriate action levels. In 2016, the state introduced recall action levels for lead, including Class 1 (25 ppm) and Class II (1 ppm), which resulted in more than 150 product recalls in the state. Last year, the state introduced significantly lower action levels for heavy metals (lead, inorganic arsenic, and cadmium) in spices. It announced plans to begin enforcing the lower limits beginning in 2023. 

In April 2022, the American Spice Trade Association (ASTA) and other trade groups released a joint letter that suggested the New York limits for heavy metals “are not based on sound scientific analysis, nor real-world exposure,” and “will result in an effective ban of many popular spices in the state of New York.”

Monitoring the U.S. Food Chain

The FDA monitored heavy metals in the U.S. food supply for years as part of the agency’s Total Diet Study (TDS), a survey of nutrients and contaminants in foods collected from retailers nationwide. In July, the FDA released the latest TDS report containing data from testing 3,241 samples of 305 foods during fiscal years 2018 through 2020. Cadmium was reported in 61% of samples from the TDS survey, including 98% of vegetable samples and 28% of fruit samples. The foods with the highest mean concentrations of cadmium included sunflower seeds, spinach, potato chips, leaf lettuce, and French fries.  Lead and arsenic were detected in 15% and 43% of the food samples.  Despite the prevalence of cadmium in the food supply, arsenic was detected at higher levels in food samples and in 39% of all fruit samples. The highest concentrations of inorganic arsenic were reported for select foods, including crisped rice cereal, white rice, and baby foods such as dry rice cereal, puffed snacks, and multi-grain cereal.

Do You Know Your Limits?

From the FDA’s Closer to Zero activities to the New York State limits for heavy metals in spices, the industry should be prepared to meet the evolving regulatory limits for heavy metals in food and beverage products.

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