Letter of Guaranty for a Product's Intended Food-Contact Use

Determining the Regulatory Status of Components of a Food Contact Material Main Page

CFSAN/Office of Food Additive Safety
December 2007

Section 303 of the Federal Food, Drug, and Cosmetic Act

Section 303 of the Federal Food, Drug, and Cosmetic Act (the Act) provides penalties for persons who violate certain provisions of the Act. Section 303, paragraph (c) of the Act states that no person shall be subject to the penalties of subsection (a)(1) for having received, or proffered delivery of, adulterated or misbranded food additives if he has established a good faith guarantee from whom he received the articles. This paragraph was included in the 1958 amendments to the Federal Food, Drug and Cosmetic Act and remains the legal basis for the "letter of guaranty" supplied by many manufacturers to their clients. Title 21 CFR 7.12 Guaranty and Title 21 CFR 7.13 Suggested forms of guaranty, provide example language for such a letter of guarantee.

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