COMPLIANCE POLICY GUIDE (CPG)
CPG Sec 515.350 Candy - Mixed with Trinkets and Sold in Vending Machines October 1980
For many years confectionery and nuts have been intermingled with various types of trinkets and dispensed from vending machines. The FDA has consistently viewed this practice with apprehension because of possible injury to children if they bite down on or swallow such trinkets.
A seizure was instituted against a lot of gum and candy intermingled with trinkets. It was alleged that the mingling of trinkets with candy resulted in adulteration in violation of Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act which provides that food shall be deemed adulterated "if it bears or contains any poisonous or deleterious substance which may render it injurious to health". The seizure was contested. The U.S. District Court upheld the seizure, but on July 24, 1951 the 4th Circuit Court of Appeals reversed this decision, holding that the trinkets were not contained within the gum or candy. (Cavalier Vending Corporation v. United States, 190 F. 2nd 386 (4th Cir. 1951) (reversing United States v. A Quantity of Candy Containing Trinkets, et al., 95 F. Supp. 490 (E.D. Va 1951).)"
In 1964, HEW and FDA initiated legislation intended to clearly outlaw the practice of vending confectionery mingled with trinkets through an amendment to Section 402(d) of the Act. Section 402(d)(1) was amended to provide that confectionery shall be deemed to be adulterated if it has partially or completely imbedded therein any non-nutritive object.
Considering the amendment, both the House and Senate Reports mentioned the Cavalier case, and both mentioned that FDA had asked for legislation to put a stop to the intermingling of trinkets with candy unless the trinkets were wrapped in cellophane or otherwise separated from the candy. Both the House and Senate said that such legislation should not be allowed, because the vending machine operators had one of the lowest liability insurance rates in the food industry, indicating a low incidence of injuries.
The FDA is still apprehensive about possible injuries resulting from vending trinkets intermingled with confectionery. FDA recommends that the trinkets be physically separated from candy or gum by some form of wrapping as a safety precaution.
However, because of the decision of appellate court in Cavalier Vending Corp. v. U.S., and the legislative history of P.L. 89-477, amending Section 402(d)(1), the Administration is not in a position to take regulatory action because of the intermingling of trinkets with confectionery, so long as the trinkets are not completely or partially imbedded in candy or gum.
typo corrected at cite, line 2; para 2, background: tc 11/27/2002
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.