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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 500.300 "Approved by FDA" - Use of Phrase Objectionable in Marketing or Labeling of a Food Additive

 

BACKGROUND:

A firm that had *a regulated* food additive intended for coating paper used as a food wrap wanted to use the phrase "Approved by FDA" in connection with promoting the sale of the chemical to firms making food wrapping materials.

POLICY:

FDA objects strongly to the phrase "Approved by FDA" in connection with the marketing or labeling of a product which has been processed through the food additives regulations.

There is no objection to a firm providing information that it *is selling a regulated* food additive in response to an inquiry received from a customer or other interested party, nor is there any objection to it's issuing guarantees that shipments of the chemical are in *compliance with* of the food additive provisions of the Federal Food, Drug, and Cosmetic Act.

*Material between asterisks is new or revised.*

Issued: 9/23/76
Revised: 10/1/80
Reissued: 6/27/88
Revised: 8/96