The U.S. Food & Drug Administration (FDA) has issued draft guidance to establish a new industry standard around safe levels of lead in juice products, as the agency aims to reduce children’s exposure to naturally-occurring toxic elements specifically found in ready-to-drink apple juice, among other juice and juice blends.
The draft recommends a lower level for lead in apple juice (10 parts per billion (ppb)) than other “single-strength” juices (20 ppb), including blends that contain apple juice. According to the press release, the agency recommends lower levels of lead in apple juice since it is the most common juice variety consumed by kids. The standard lead level for juice, regardless of variety, is 50 ppb, established by the FDA 2004.
Industry stakeholders, including brands, manufacturers and suppliers, have the opportunity to submit comments on the draft guidance now through June 28. After that period the agency will work to finalize the guidance. This guidance was spurred by the FDA’s Closer to Zero action plan, which was launched last April in response to a congressional report that found toxic levels of heavy metals, including arsenic, cadmium, mercury and lead, in products sold by over a dozen baby food brands.
“Exposure of our most vulnerable populations, especially children, to elevated levels of toxic elements from foods is unacceptable,” said Robert M. Califf, FDA Commissioner, in a press release. “This action to limit lead in juice represents an important step forward in advancing FDA’s Closer to Zero action plan, which we are confident will have a lasting public health impact on current and future generations.”
The FDA’s plan will take a broad look at foods commonly consumed by young children and infants and will continue to work toward its “Closer to Zero” goals by first establishing limits for arsenic and lead on a category-by-category basis through a four-stage process. According to the release, the agency will repeat this review process for cadmium and mercury over the following years.
The first stage of the Closer to Zero process includes a review of relevant scientific information to establish interim reference levels (IRLs). Next the agency presents recommended levels to the industry by issuing draft guidance. After a period for soliciting opens up industry feedback, and the FDA’s “science-based” “iterative” process, will be complete with the agency setting recommended limits per each heavy metal outlined in the plan.
Manufacturers are not required to comply with the finalized recommendations, but the FDA said it hopes the guidelines will encourage the industry to maintain lead levels below its recommendations. The agency also noted that it is nearly impossible to completely remove heavy metals from certain foods as they are typically found in soil used to grow most fruits and vegetables, however, the agency said it has not found any evidence indicating children are at an immediate risk due to the current level of metal found in food.
While the most recent draft guidance is still in its collaborative stage, the agency also announced it is close to finalizing recommendations for inorganic arsenic reference levels in juice, but did not give a timeline for that release. The finalized guidance is always subject to change, the agency said, despite the formal commenting period ending next month.
“In addition, our work in this important area of food safety will progress with advancements in science,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, in the release. “Action levels may be progressively lowered over time, as appropriate, to make continual improvements in reducing the levels of lead, arsenic, cadmium and mercury in foods eaten by babies and young children.”
The new guidance comes as momentum behind a cluster of baby food class action suits begins to wane. Over the course of this year, multiple lawsuits primarily brought by young parents alleging misleading health claims, have been dismissed including one against Sprout Organics just last month.
More products may also come into the fold as the FDA turns its attention to mercury and cadmium over the next few years. When the action plan was first announced, the agency said it was focused on establishing guidance for categories including but not limited to cereals, infant formula and pureed fruits and vegetables, and indicated it will continue to identify and establish standards to reduce young children’s exposure to heavy metals via food.