Action level for inorganic arsenic in apple juice: guidance for industry

Action level for inorganic arsenic in apple juice: guidance for industry

Collection:
Health Policy and Services Research
Contributor(s):
Center for Food Safety and Applied Nutrition (U.S.), issuing body.
Publication:
College Park, MD : Center for Food Safety and Applied Nutrition, June 2023
Language(s):
English
Format:
Text
Subject(s):
Arsenic
Food Safety
Food Supply
Government Regulation
United States
Genre(s):
Guideline
Technical Report
Abstract:
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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (13 pages))
NLM Unique ID:
9918662584106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662584106676