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)). FDA is to consider this action level, in addition to other factors, such as its confidence in a measured analytical value, when considering whether to bring enforcement action in a particular case.
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