Many food additive regulations require that the label or labeling of an additive or a premix containing the additive bear adequate directions for use. Because many additives have multiple uses, it may be impractical to include complete directions on the label.
The labeling requirements for food additives with multiple uses may be met by listing complete directions in a brochure or leaflet and labeling bulk drums as follows:
"Caution: This substance should only be used in or on foods (or food packaging) in accordance with the regulations issued under the Federal Food, Drug, and Cosmetic Act. Specific details furnished in "________" (Insert name of brochure)."
The brochures must be provided to each food customer with each shipment of product.
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.