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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 560.250 Imports - Importer can be Required to Reveal Identity of Ingredients

 

BACKGROUND:

Section 801(a) *of the Federal Food, Drug, and Cosmetic Act* provides that if it appears from the examination of a sample or otherwise that an article is adulterated or misbranded, such article shall be refused admission. In the case of Harry Sugerman v. Jack B. Forbragd, Fred E. Norman, Food and Drug Officers, the United States District Court for the Northern District of California held that "the mere appearance of adulteration is enough to compel refusal to admit. There is no requirement that the food actually be adulterated or that the Secretary find, as a fact, that the food is adulterated." (267 F.Supp. 8l7).

POLICY:

Whenever an article appears, from examination of a sample or otherwise, to contain a non-permitted food additive or otherwise illegal ingredient(s), it is incumbent on the importer to supply information concerning the complete composition of the article, including the identity of each ingredient. Otherwise, the article may be refused entry.

*Material between asterisks is new or revised.*

Issued: 9/15/76
Revised: 10/1/80, 7/19/89