In connection the Administration's Food Standards Program, instructions state, "For products incorporating natural substances as ingredients, such as jams, jellies, preserves, . . . it may be necessary to collect factory (authentic) samples of raw materials, used to make the finished product, to substantiate deviations from the established standard." These instructions raise questions about the status of import samples of jams, jellies, preserves and fruit butters found to deviate from the standards in 21 CFR 150, since usually authentic samples of raw materials used in making products outside the U.S. cannot be collected.
Section 801(a) of the Federal Food, Drug, and Cosmetic Act provides for samples to be taken when foods are being imported or offered for import in the U.S., and provides further that articles shall be refused admission, "If it appears from the examination of such samples or otherwise" that the article is adulterated or misbranded. In the case of Harry Sugarman v. Jack B. Forbradg, Fred E. Norman, (267 F. Supp. 817), the Court took note of the fact that import samples may be obtained by the Secretary of Health, Education and Welfare, and that "The Secretary is directed to refuse admission of such food - if it appears from examination of such samples or otherwise that . . . such article is adulterated . . ."
This applies equally to foods which upon examination appear to be misbranded. The Court, also, stated "In a like manner, it may be said that Congress has set up procedures with respect to imports which are strikingly different from procedures regulating products of domestic origin."
Whenever analysis of an import sample of jams, jellies, preserves or fruit butter indicates a significant deficiency of fruit based upon values previously established by the Food and Drug Administration for authentic packs of the fruit or fruits involved, the lot shall be detained, in spite of the fact that authentic samples of raw materials used in the lot are not available.
After detention, the importer may request a hearing. If he can demonstrate by acceptable evidence that the required amount of fruit ingredient actually was used, and that the finished fruit product only seemed to be deficient in fruit because the indices of the fruit used differ significantly from indices for United States fruit, then the shipment can be released.
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.