FDA — 10 ppb Inorganic Arsenic Action Level for Apple Juice

In June 2023 the US Food and Drug Administration finalized an action level of 10 parts per billion inorganic arsenic in single-strength apple juice, including apple cider, intended for human consumption (FDA CFSAN 2023). The final guidance completes an approach the agency first proposed in a July 2013 draft (docket FDA-2012-D-0322) and replaces the earlier, non-cancer 23 ppb “level of concern” that FDA had used since a 2008 hazard assessment (FDA CFSAN 2023). Apple juice is singled out because it is consumed disproportionately by infants and young children, for whom inorganic arsenic is a developmental as well as a carcinogenic hazard (FDA CFSAN 2023).

Scope

The action level applies to single-strength (ready-to-drink) apple juice and apple cider as consumed. Apple-containing juice blends are not automatically in scope; FDA notes that applicability to blends requires case-by-case review (FDA CFSAN 2023). The level is expressed for inorganic arsenic specifically, not total arsenic, so speciation is integral to a compliance determination.

Exact limit and units

Enforcement posture

The 10 ppb figure is an action level, not a binding maximum: it is the concentration at or above which FDA may regard apple juice as adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act and consider enforcement (FDA CFSAN 2023). FDA set the value on the basis of achievability under current good manufacturing practices together with a quantitative risk assessment spanning both cancer (lung and bladder) and non-cancer (neurodevelopmental) endpoints; the agency’s FY2011 speciated survey found 100 percent of sampled apple juice already at or below 10 ppb inorganic arsenic, so the level codifies achievable practice rather than requiring new controls for most producers (FDA CFSAN 2023).

How tested

Compliance turns on measured inorganic arsenic, which requires arsenic speciation rather than a total-arsenic screen. FDA’s cited surveillance used inductively coupled plasma mass spectrometry with chromatographic speciation to separate inorganic arsenic from the less-toxic organic forms (FDA CFSAN 2023). Because total arsenic overstates the regulated fraction, a total-arsenic result above 10 ppb does not by itself establish an exceedance.

How it compares

This is FDA’s second matrix-specific inorganic-arsenic action level for a food eaten heavily by young children, alongside the 100 ppb level for infant rice cereal; the far lower apple-juice figure reflects the beverage’s lower baseline occurrence and its as-consumed basis. It sits within the FDA’s broader effort to reduce toxic-element exposure in foods for babies and young children, which also includes the lead action levels published under Closer to Zero, though the apple-juice arsenic work originates in the separate 2013 draft guidance rather than in that initiative. The value bears on the apple juice evidence page and the wider arsenic profile.

History of changes

• 2008 — FDA hazard assessment establishes a 23 ppb inorganic-arsenic “level of concern” for apple juice, based on short-term, non-cancer endpoints.
• July 2013 — FDA issues draft guidance proposing a 10 ppb inorganic-arsenic action level (docket FDA-2012-D-0322).
• June 2023 — FDA finalizes the 10 ppb action level; the 2008 level of concern is superseded.

References

Works cited in this page’s text, in first-appearance order. This is not the full corpus for this page; it is only what the prose above draws on. The complete set of sources is listed under Sources below. Each title links to its source record, which carries the ingest receipt, the extracted values, and the file hash of the document it was built from.

1. Action Level for Inorganic Arsenic in Apple Juice: Guidance for IndustryFDA CFSAN · U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition · 2023 · www.fda.govGuidance

Sources

• FDA CFSAN 2023 — U.S. Food and Drug Administration, June 2023. Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry. Government guidance, A-tier.

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