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.
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.*
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.