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NOVELTY CONDOM MANUFACTURERS MUST REVISE LABELS

This article was originally published in The Gray Sheet

Executive Summary

NOVELTY CONDOM MANUFACTURERS MUST REVISE LABELS to clearly state that the products are for "novelty use only," FDA says in warning letters to eight manufacturers of condom-like products. Unless the labeling is clarified, the agency states, the products will be considered medical devices requiring 510(k) clearance. FDA notes that labeling and packaging should be changed so that consumers are "able to clearly distinguish between condoms intended to be used as medical devices and those products sold only as" novelties. FDA issued warning letters in late September to: Gasworks, Forum Novelties, Licks International, MLF Enterprises, Global Protection Corporation, and Barnett International, The Rubber Plant Company and Hollywood Creations. One of the companies has responded to the letter and says it will submit a 510(k) for its products, according to FDA staffers. FDA plans to send a followup letter "in the near future" to all manufacturers of condom-like products reminding them of labeling and packaging requirements for novelty condoms, according to agency staffers. FDA first sent a letter to manufacturers in February 1989 detailing the agency's policy ("The Gray Sheet" Feb. 27, 1989, p. 11). FDA notes in the warning letters that the 1989 letter stated that labeling of "condom-like products" must indicate that the products are for "novelty only" and are "not intended to prevent pregnancy or the transmission of STDS." Otherwise, the products would be "regulated as a medical device" and "held to the applicable requirements for condoms." In several of the warning letters, the agency points out that the manufacturers" products do not have the statements "novelty only" or "not intended for the prevention of pregnancy or transmission of STDS" on their labeling. Additionally, in some cases, 11 nothing in the external packaging of the condom, nor the immediate packaging for the condom, nor the appearance of the condom itself leads one to think this product is other than a condom used as a medical device."
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