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This guidance provides information to manufacturers on the action level of 10 parts per billion (ppb) or 10 micrograms/kilogram (µg/kg) for inorganic arsenic in apple juice that is intended to help protect public health by reducing exposure to inorganic arsenic and that is achievable by industry with the use of current good manufacturing practices. This guidance presents the background and rationale for FDA’s action level.
Consistent with 21 CFR 109.6(d), this action level reflects the level of inorganic arsenic at which FDA may regard apple juice as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(1)). We intend to consider this action level, in addition to other factors, such as our confidence in a measured analytical value, when considering whether to bring enforcement action in a particular case.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0322.
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