Import Alert 99-21

"Detention Without Physical Examination and Surveillance Of Food Products Containing Sulfites"

The revision of this Import Alert dated 4/27/11 updates the charge code for detention and includes information regarding removal from DWPE. Changes are bracketed by asterisks (***).

There is a continuing problem of undeclared sulfites in a wide variety of imported foods. This has been primarily a misbranding situation which can be corrected by relabeling to alert sensitive individuals to the presence of sulfites. It has been reported in scientific literature that 10 mg of sulfites ingested at one sitting could pose a life threatening hazard to a sulfite sensitive individual.

Districts may detain, without physical sampling and analysis, the specified products from the firms identified in the Red List for this alert.

Districts should continue coverage of imported foods suspected of containing undeclared sulfites. Undeclared sulfites are frequently found in dried fruits, canned fruits and vegetables (mushrooms, vegetables containing potatoes, fresh and frozen cut fruits and vegetables, shrimp, lobster, and baked goods. This is not an all inclusive list. Detention is appropriate when sulfites are not declared and analysis shows the presence of sulfites at levels greater than 10 ppm. A single violation is sufficient reason to recommend a firm/product for Detention Without Physical Examination.

The level of undeclared sulfite in a food should be determined using Sulfurous Acid (Total) in Food Modified Monier-Williams Method Final Action" in "Official Methods of Analysis of the Association of Official Analytical Chemists," 14th. ed. (1984), sections 20.123 - 20.125.

An appropriate alternate method may be used to determine residual amounts of undeclared sulfite if the method is documented by a validation study to provide adequate precision and accuracy for the specific analysis. Equivalency to the official method must be demonstrated in the submission of analytical data.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-5992.

*** In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov ***

Various (see attachment)

*** The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption [Misbranded, 403(a)(1)], and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient [Misbranded, 403(i)(2)]; ***

*** OASIS charge code SULFITELBL ***

RECOMMENDING
OFFICE:
*** Center for Food Safety and Applied Nutrition
Division of Import Operations and Policy ***