BACKGROUND:

Components of coatings for fruits and vegetables may consist of food additives regulated under Part 172, where the condition of use permit this use; generally recognized as safe (GRAS) substances, most of which are listed under Parts 182 and 184; and substances that are prior-sanctioned for such use. It should be noted that some GRAS substances and many prior-sanctioned substances may not be listed in the CFR. If the status of a component cannot be determined, contact the Office of *Food Additive Safety* (HFS-200) for assistance.

Section 403(i)(2) of the act requires that the label of a food bear a statement of ingredients and, to the extent that compliance with the requirements is impracticable, requires the Secretary to establish exemptions. Accordingly, FDA has provided for an exemption from such labeling in 21 CFR 101.100(a)(2) as follows:

"A food having been received in bulk containers at a retail establishment, is displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter card, sign, or other appropriate device bearing prominently and conspicuously the information required to be stated on the label pursuant to section 403(i)(2) of the act."

Waxed fruits and vegetables are subject to the requirements of section 403(i)(2). When in package form, the label shall declare the fact that wax has been applied. When received in bulk by the retailer, it is the retailer's responsibility to display the food to prospective purchasers either with the labeling of the bulk container plainly in view or with a counter card bearing the required information.

POLICY:

Waxed fruits and vegetables are subject to the requirements of section 403(i)(2) of the act and 2l CFR l0l.l00(a)(2) of the regulations. Therefore, the absence of a proper declaration of ingredients by retail establishments on the sales bin or counters renders the food misbranded under section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act.

REGULATION ACTION GUIDANCE:

FDA encourages enforcement action by the states as the most efficient and manageable approach to achieving compliance with the requirement at the retail level.

*Material between asterisks is new or revised.*

Issued: 8/3/77
Reissued: 10/1/80
Revised: 2/1/89, 5/2005
Updated: 11/29/05