FDA adopts decade-old draft guidance for arsenic in apple juice

It’s been 10 years in the making, but the FDA has announced final guidance on the levels of arsenic in apple juice, seen as crucial for children’s safety.

The new guidance sets the level at 10 parts per billion (ppb), the same as the agency’s draft guidance issued in 2013. In its final guidance document the Food and Drug Administration says it is possible to further reduce public exposure to inorganic arsenic from apple juice in general, and specifically from apple juice that currently may contain inorganic arsenic at levels above 10 ppb.

The action June 1 by the Food and Drug Administration is too little as far as the consumer safety group Consumer Reports is concerned.

“Today’s announcement by FDA will have minimal impact on public health because the action level should be lower than 10 ppb based on current science. Plus, they waited until a vast majority of the industry was already meeting this level, so this announcement is virtually irrelevant,” said Brian Ronholm, director of food policy for Consumer Reports.

“Nonetheless, it is encouraging that the FDA has recently undertaken a renewed focus on addressing food chemicals and heavy metals. Hopefully, the FDA will continue to focus on these issues and monitor and take action if they find troubling levels of inorganic arsenic in apple juice.” 

As if it knew that its action would be criticized, the FDA’s announcement included what could be considered a disclaimer.

“The FDA’s testing results reflect a trend in reductions in the amount of inorganic arsenic in apple juice on the market, with an increasing percentage of samples testing below 3 ppb and 5 ppb. However, since the release of the draft guidance (in 2013), we have identified some apple juice samples with inorganic arsenic levels above 10 ppb. Therefore, we are finalizing an action level of 10 ppb because we consider this level achievable with the use of good manufacturing practices,” according to the agency’s announcement.

Guidance documents from the FDA do not carry the weight of law, a fact readily admitted by the agency. Its announcement says that the “non-binding” limit for arsenic in apple juice will “help encourage” manufacturers to reduce levels of inorganic arsenic in apple juice.

The FDA says guidance documents do not establish legally enforceable responsibilities but instead describe the agency’s current thinking on a topic and “should be viewed only as recommendations.” The use of the word “should” in FDA guidances means that something is suggested or recommended, but not required.

Inorganic arsenic in apple juice is considered a key component in food safety for children. The FDA says apple juice is a greater potential source of dietary inorganic arsenic exposure for children than for adults, because children’s dietary patterns are often less varied than those of adults, and they consume more apple juice relative to their body weight than do adults.

Scientific studies have shown that inorganic arsenic can impact the development of children, and lead to a host of problems including damage to the brain and nervous system, which can cause learning and behavioral problems.

“A report by the National Research Council (NRC) also listed adverse pregnancy outcomes and neurodevelopmental toxicity as adverse health effects of concern for exposure to inorganic arsenic,” according to the FDA’s final guidance document.

“The Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives, which includes participation by FDA scientists, concluded that food can be a major contributor to inorganic arsenic exposure, and the European Food Safety Authority concluded that dietary exposure to inorganic arsenic should be reduced.”

Consumer Reports has repeatedly urged the FDA to set lower levels for inorganic arsenic in foods, especially baby foods, and to lower the action level to 3 ppb for arsenic in apple juice. 

In 2018, Consumer Reports tested 45 popular fruit juices sold across the country — including apple, grape, pear, and fruit blends — and found elevated levels of cadmium, inorganic arsenic, and/or lead in 21 of them. The consumer organization’s tests showed that it is possible for manufacturers to sharply reduce inorganic arsenic in their juices.

“Setting limits for inorganic arsenic in foods, especially foods consumed by children, is vital to help reduce exposure and better protect public health. While Consumer Reports (CR) supports an action level to offer regulators a necessary enforcement and accountability tool and a key benchmark for apple juice manufacturers, CR research shows the FDA’s final action level is not in the best interest of consumers,” the group said in a statement following the FDA’s announcement.

The FDA says it is possible for manufacturers of apple juice to reduce the levels of arsenic in apple juice by sourcing apples from orchards that have less ground contamination and less use of certain pesticides. Among other action, the agency also cautions manufacturers to test water sources for inorganic arsenic. 

“. . . recent research by FDA shows that the use of some filtering aids to remove sediments in juice can contribute to elevated arsenic levels. Changing or treating filtering aids may reduce the levels of arsenic in filtered juices,” according to the final guidance.

Looking at an averaging technique for data collected through the Total Diet Study (TDS), the FDA says the data had a mean of 2.7 ppb total arsenic with a standard deviation of 2.0 ppb total arsenic and ranged in concentration from 0 to 10 ppb total arsenic. The FDA did not use that data. 

“Because the compositing provides an ‘average’ result, and our achievability assessment is based on percentiles of arsenic concentrations in individual samples, we did not use the TDS data in the achievability assessment or other assessments in Section IV (of the final document),” according to the FDA.

In its conclusion of the final guidance, the FDA says it will take the following actions sampling and enforcement approach to arsenic in apple juice. 

• We intend to initially analyze apple juice samples for total arsenic. 
• We intend to speciate samples containing more than 10 μg/kg or 10 ppb total arsenic to determine inorganic arsenic levels. 
• We intend to consider the action level of 10 μg/kg or 10 ppb inorganic arsenic as an important source of information for determining whether apple juice is adulterated within the meaning of section 402(a)(1) of the FD&C Act (21 U.S.C. 342(a)(1)). 

“FDA considers on a case-by-case basis whether a food that contains a contaminant is adulterated. When considering whether to bring an enforcement action in a particular case, we will consider whether the inorganic arsenic causes apple juice to be adulterated under section 402(a)(1) of the FD&C Act,” the final guidance says.