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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 560.250 Imports - Importer can be Required to Reveal Identity of Ingredients September 1989

Final

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


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.