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Draft Guidance for Industry: Action Levels for Lead in Juice April 2022


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2019-D-5609

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

FDA is committed to reducing lead in food to the extent feasible. FDA’s Closer to Zero action plan is a science-based, iterative approach to decreasing toxic elements (such as lead) in foods over time, including by setting action levels. This guidance provides information to industry on the action levels for lead in juice.  The action levels for lead in juice in this document would, if finalized, replace the current level of 50 parts per billion (ppb) described in the Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance (Juice HACCP Guidance), First Edition (Ref. 1).  FDA considers the action levels described in this guidance to be achievable by industry (or you) when measures are taken to minimize the presence of lead. 

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidance means that something is suggested or recommended, but not required.

Download the Draft Guidance

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