Children Still at Risk With FDA’s Arsenic Limit for Apple Juice

The FDA’s finalized limit on inorganic arsenic in apple juice is too high and marks a missed opportunity to force industry to more diligently work to lower early childhood exposure to the toxic heavy metal, food safety advocates say.

The agency on June 1 officially set the action level for inorganic arsenic in apple juice at 10 parts per billion. The limit, which the Food and Drug Administration will use to determine whether to take enforcement action against juice makers, is part of the agency’s “Closer to Zero” action plan aimed at reducing exposure to toxic heavy metals among babies and young children as much as possible.

The move also comes five months after Bloomberg Law published findings from its investigation into heavy metals in baby foods.

The FDA first proposed the 10 ppb inorganic arsenic limit in apple juice nearly a decade ago. More recent testing shows the majority of juices now have inorganic arsenic levels well below this limit.

The choice not to propose a lower action level based on more up-to-date testing means the industry won’t be pressured to choose apple orchards or other sources with lower inorganic arsenic levels, advocates say. They also argue that the FDA’s move hinders public trust in the agency’s ability to fulfill its mission to make sure that the food reaching consumers is safe.

“Instead of acting like a public health agency, it’s acting like an industry feasibility agency,” Brian Ronholm, director of food policy for Consumer Reports, said in an interview.

“That’s not reassuring to consumers, especially parents,” he added. “It’s especially frustrating when you know that there are instances where the industry certainly has the capability to meet much lower standards, much lower action levels in their products.”

Many Hit 5 ppb Standard

Inorganic arsenic in apple juices can often be a result of factors like previous agricultural use of arsenic-based pesticides on land currently used for apple orchards, naturally high levels of arsenic in soil or water, and byproducts from industrial activities, the FDA said in its guidance. Consumption of inorganic arsenic has been tied to cancer, diabetes, and other conditions in humans, and a growing body of research has found links to early childhood exposure and developmental problems.

A 2019 review of 14 studies on inorganic arsenic published in Chemical Research in Toxicology found consistent evidence demonstrating a link between early exposure to the heavy metal and an autism spectrum disorder diagnosis.

The FDA’s final guidance aims to encourage apple juice manufacturers to implement practices that will result in lower inorganic arsenic levels, an FDA official said in an email. The official also references FDA’s own testing results showing a trend in reductions of inorganic arsenic in recent years. Of the samples collected by FDA from fiscal 2013 to 2022, 78% met a 5 ppb standard—an increase from 54% in fiscal 2011.

But because there are still some apple juice samples with inorganic arsenic level above 10 ppb, the FDA decided upon 10 ppb as the most achievable for industry, according the FDA official.

“This guidance is meaningless when it could have been a meaningful step in lowering the levels of arsenic and its impact on the developing brain,” said Charlotte Brody, national director of Healthy Babies Bright Futures. The organization focuses on promoting awareness of children’s exposure to toxic substances.

‘Bad Message’

Finalizing the action level is an “important” step, as it’s a clear sign to industry that FDA will use this as the standard when overseeing manufacturing, said Tom Neltner, the Environmental Defense Fund’s senior director for safer chemicals.

But the fact that the action level hasn’t changed from what was proposed 10 years ago is a sign that the FDA isn’t “serious about continuous improvement,” Neltner said.

“That tells companies that these numbers are set, and they’re not going to be reduced in the realistic future. And that’s a bad message to go out for something like arsenic,” Neltner added.

And groups like Consumer Reports and HBBF have done their own testing and analysis supporting an action level much lower than 10 ppb. Testing conducted by Consumer Reports in 2018 of 45 popular fruit juices sold in the US found that all but one had inorganic arsenic levels below the FDA’s 10 ppb limit, with 58% below the advocacy group’s 3 ppb recommendation.

HBBF also issued a 2022 report that Brody says showed many juices could meet an inorganic arsenic limit as low as 4 ppb.

“How does FDA believe we are getting “Closer to Zero” when they set limits that are already the status quo?” Brody said.

The FDA official noted that the 10 ppb action level is the same amount that the US Environmental Protection Agency allows for public drinking water. The agency does plan to continue evaluating the latest evidence on dietary exposure to inorganic arsenic to determine whether the limit should be changed in the future, the official added.

Monitoring, Transparency

The FDA’s continued monitoring of inorganic arsenic levels and what industry is doing to lower concentrations in their products is critical to reaching the lowest exposure possible among young people, advocates say.

The FDA’s work aimed at addressing heavy metals in baby foods comes at a time of organizational changes on the food side of the agency. The FDA is currently in the “final stages” of the interview process to fill the new role of deputy commissioner for human foods, Julie Tierney, the FDA’s chief of staff, said Monday in a webinar organized by the Alliance for a Stronger FDA. She said the FDA hopes to fill this role, as well as a chief officer for critical foods, by the end of the summer.

Whoever is hired will be responsible for overseeing the entirety of the human foods program, and will report directly to the commissioner. The official will also have the responsibility of bringing in a new director of the FDA’s Center for Food Safety and Applied Nutrition following Susan Mayne’s retirement May 31.

“You need to have that person in place who’s going to try to start fixing the problems that resulted in the reorg the first time,” Neltner said, referring to criticism of the FDA’s response last year to reports of contamination at an infant formula manufacturing site.

And on the issue of apple juice, the FDA also still needs to finalize its action level for lead. The FDA’s recent update of its website that removed goal dates for finalizing the inorganic arsenic level and other planned Closer to Zero actions actions also hurts the public’s ability to keep track of the agency’s progress, advocates say.

“It’s nice that they finalized this and are paying attention to it. It will be even better if they’re able to maintain this focus and hold industry accountable,” Ronholm said.