FDA has been petitioned and has received inquiries from a number of firms concerning the labeling of a product which does not conform to the standard of identity for frozen raw breaded shrimp (21 CFR 161.175) in that it contains substantially less than 50 percent shrimp *material*.
The Supreme Court ruled in a related situation (62 cases *** Jam v. United States, 340 U.S. 593 (1951)) that a substandard jam-like food product could legally be sold as "imitation jam" and that a food labeled as an "imitation" of a standardized food could not be condemned pursuant to Section 4O3(g) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 343(g), on the theory that it purported to be or was represented as the standardized article.
FDA has no legal authority to prohibit the labeling, as an imitation, of a product which appears to be frozen raw breaded shrimp, but which fails to conform to the standard (21 CFR 161.175) by reason of a deficiency in shrimp content, or the presence of ingredients not authorized by the standard. FDA believes, however, that the article is more properly described as "imitation frozen raw breaded shrimp," since that is the article imitated.
FDA has suggested to the industry that the shrimp content of the article should be stated prominently in terms of the actual percent of shrimp in the product. A statement of percent qualified as "not less than may be misleading by representing or suggesting that more shrimp is present than is actually the case.
The policy contained herein *was* sent to state and local governments in the form of an informational memorandum to alert them of the potential for substitutions of the imitation for the standardized product in restaurants.
*Material between asterisks is new or revised.*
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.