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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis

 

BACKGROUND:

FDA occasionally receives requests for microbiological cultures isolated from samples analyzed by FDA. Requests for other entities isolated, extracted, or produced by sample analysis, i.e., chemical isolates, extracts, filth debris, etc., may also be received, especially regarding consumer complaint samples.

The Federal Food, Drug, and Cosmetic Act, makes no provision for FDA to provide to requesters portions of end or intermediate products resulting from FDA sample analysis. Section 702(b) of the act provides that, upon request, a part of an official sample of a food, drug, or cosmetic will be provided for examination or analysis to any person named on the label, the owner of the sampled product, or his attorney or agent. This section of the act applies to portions of the sampled commodity. It does not apply to intermediate or end products resulting from sample analysis.

POLICY:

Portions of intermediate or end products resulting from FDA sample analyses will not be routinely provided to requesters from outside the agency, including consumers from whom samples have been collected as part of the complaint investigation.

Exceptions to this policy may be considered when the agency determines that providing portions of intermediate or end products to the requester would help resolve a serious public health matter or would benefit the public wellbeing. When a request appears to warrant such consideration, the request should be referred to the Office of Compliance within the appropriate center for review.

Issued: 3/23/88