Apple juice and tap water now share the same arsenic number, but the rules behind that number are very different. In its June 1, 2023 final guidance, FDA set an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. That matches the 10 ppb FDA allows in bottled water and EPA allows in public drinking water. Unlike those two limits, the juice figure is not legally binding for FDA or industry.
FDA describes the 10 ppb figure as the level at which it “may regard apple juice as adulterated” within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. The key word is “may.” FDA says it will weigh the action level alongside other factors, such as its confidence in a measured analytical value, when deciding whether to take enforcement action. Its guidance documents “do not establish legally enforceable responsibilities”. Instead, they describe the agency’s current thinking.
How FDA chose the number matters too. The agency says the level is meant to protect public health by reducing exposure, and that it is achievable by industry with current good manufacturing practices. ATSDR explains the difference this way: regulations can be enforced by law, while recommendations cannot.
FDA says the guidance supports its goal of reducing exposure to environmental contaminants from foods commonly eaten by babies and young children. ATSDR explains why children matter here. Because children eat and drink a less varied diet than adults, contaminated juice can be a significant source of exposure.
Arsenic can get into juice in more than one way. FDA notes it can enter food during processing, including when filtering aids used on juices contain arsenic. The guidance also names the water manufacturers use to dilute concentrate into ready-to-drink juice as a possible source. It says producers may be able to lower levels by buying apples or concentrate with lower or no detectable inorganic arsenic. Old orchard practices are part of the background as well. Inorganic arsenic compounds were once used mainly as pesticides on cotton fields and in orchards, and can no longer be used in agriculture.
The science behind the number has shifted. FDA’s guidance says the 2013 risk assessment focused on cancer, but a growing body of research suggests a link to harm to brain development in infants and children.
| Item | Arsenic level | Instrument | Legally binding? |
|---|---|---|---|
| Public drinking water | 10 ppb | EPA Maximum Contaminant Level | Yes |
| Bottled water | 10 ppb | FDA quality standard | Yes |
| Apple juice | 10 ppb | FDA guidance action level | No |
The water limit has a long history. In January 2001, EPA lowered the drinking-water limit from 50 to 10 ppb, and the 10 ppb limit applied as of January 2006. The juice figure came more than a decade after that and uses the same number. But it rests on guidance, which describes FDA’s current thinking rather than enforceable law.
| Date | Event | Impact |
|---|---|---|
| December 2011 | Apple juice arsenic test results posted | Public testing data |
| December 2012 | Peer review of risk assessment | Outside scientific review |
| 2013 | Draft 10 ppb guidance issued | Level proposed |
| July 1, 2013 | Quantitative risk assessment published | Cancer-focused basis |
| August 2020 | Infant rice cereal guidance | Parallel action for babies |
| June 1, 2023 | Final apple juice guidance | 10 ppb finalized |
The figure barely changed between the draft and the final version. FDA described the 2023 document as identifying the 10 ppb action level first issued in draft in 2013. In the same announcement, FDA said that because lower arsenic levels better protect health, it expects to revisit this action level under its “Closer to Zero” action plan.
That is a stated plan, not a new limit. Any lower figure is speculation until FDA publishes it.
FDA’s advice for families relies less on the action level and more on how much juice young children drink. Citing USDA’s Dietary Guidelines for Americans, FDA’s consumer guidance says:
FDA also recommends eating a variety of age-appropriate healthy foods. It says this helps children get important nutrients and may reduce exposure to contaminants from any single food. For lead as well as arsenic in juice, FDA has a separate page called What You Can Do to Limit Exposure to Arsenic and Lead from Juices.
Water is the other half of the picture. FDA and CDC both identify contaminated drinking water as the most common source of high inorganic arsenic. If your home uses a private well, FDA advises testing it in spring or early summer to make sure arsenic stays at or below 10 ppb. If it tests higher, ATSDR says to consider another water source for drinking and cooking. FDA hasn’t issued guidance on mixing juice at home. Still, the guidance names dilution water as a source of arsenic in factory-made juice.
The 10 ppb action level gives FDA grounds to act against apple juice it considers contaminated. For parents, the federal advice doesn’t depend on that number: no juice before age one, a varied diet, and a tested well if your water comes from one.