FDA CFSAN 2023 — Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry
FDA’s June 2023 final guidance establishes an action level of 10 µg/kg (10 ppb) for inorganic arsenic in apple juice intended for human consumption, including apple cider. This finalises the approach presented in the July 2013 draft guidance (docket FDA-2012-D-0322) and represents a binding enforcement reference under 21 CFR 109.6(d): apple juice with iAs at or above this level may be regarded as adulterated under 21 U.S.C. 342(a)(1). The action level was set on the basis of achievability with current good manufacturing practices and a risk assessment that considered both cancer (carcinogenic) and non-cancer (neurodevelopmental) endpoints.
Key numbers
Action level: 10 µg/kg (10 ppb) iAs in single-strength apple juice (and apple cider) Regulatory basis: 21 CFR 109.6(d); adulteration provision 21 U.S.C. 342(a)(1)
FDA surveillance data cited in the guidance:
- FY2011 retail sample survey (n=94): mean iAs 4.4 ppb, SD 2.4 ppb, range 0–9.8 ppb; 90 of 94 samples had total As ≤10 ppb; all 94 had iAs <10 ppb; 51 samples had iAs <5 ppb
- FY2013–2022 TEP data (n=160 single-strength apple juice samples): mean total As 4.6 ppb, SD 6.6 ppb, range 0–44 ppb
The guidance notes that FDA “occasionally find apple juice samples with inorganic arsenic levels above 10 ppb” in surveillance, justifying the action level as a risk reduction measure beyond the typical market distribution.
Codex status: No Codex ML for iAs in apple juice at time of publication.
Methods (brief)
Guidance document summarising FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food (TEP) program surveillance data from FY2005–2022. FDA’s speciation methods applied to retail and imported apple juice samples. Risk assessment includes both 2013 cancer risk assessment (NRC Ref. 5) and growing body of neurodevelopmental evidence (Refs. 5, 7).
Limitations
The guidance is non-binding as to the precise enforcement decision (FDA considers additional factors including analytical confidence); it does not establish a legally enforceable tolerance. Codex has not established a parallel ML, leaving the US standard isolated internationally. Total arsenic data from the TEP program are noted as the primary surveillance tool, with iAs speciation applied secondarily.
Implications
- Certification: This is the operative US regulatory limit for apple juice and apple cider for iAs. Action level = 10 ppb iAs. Any HMT&C product standard touching apple juice or apple juice concentrate must not set a higher limit than 10 ppb iAs.
- Courses: Key regulatory document for the US iAs-in-juice standard. Demonstrates FDA’s use of achievability as a co-criterion alongside risk in action-level setting.
- App: Apple juice as an ingredient carries a 10 ppb iAs regulatory ceiling in the US. Baseline FDA surveillance shows market mean ~4.4 ppb, suggesting most commercial apple juice is well below the action level.