IA #85-03, 9/12/94 SUBJECT : INTENSIFIED COVERAGE OF NOVELTY CONDOMS TYPE OF ALERT: Intensified Coverage PRODUCT : Novelty Products Which Appear to be Condoms (Condom-like Products) PRODUCT CODE : 85HIS HARMONIZED CODE : 4014.10.00-00-4 PROBLEM : Novelty products which appear to be condoms are being confused with medical device condoms. In order to be considered as an unregulated novelty product, a condom-like product must have been rendered incapable of functioning as a condom, and must not have any medical claims in its labeling or promotional materials. A product which is usable as a condom is a medical device and must comply with all applicable requirements (see the February 23, 1994, letter from the Director, Office of Compliance, CDRH). PAC FOR COLLECTION : 82008 COUNTRY : All MANUFACTURER/ SHIPPER : All CHARGE : NOTE: A product which appears to be intended for use as a condom, see 21 CFR 884.5300 (or 5310) a "closely fitting membrane" which "completely covers the penis", and which has not been rendered unusable is a medical device regardless of humorous packaging, labeling, and/or disclaimers. For such a device which is not listed, and/or which does not have an approved premarket approval application (PMA) or substantial equivalency order, (510(k)), charge: 1. Failure to list: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that the article was not included in a list required by Sections 510(i)(j) and 502(o) and 21 CFR 807.40 of the Food, Drug, & Cosmetic Act [Misbranding, 502(o)]." 2. Failure to obtain approval of a premarket approval application or a substantial equivalency order: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a post amendments device for which it appears that a premarket application has not been approved and a substantial equivalency order (510(k)) has not been granted. [Adulteration, 501(f)(1) and Misbranding, 502(o)]." 3. Some condoms may be considered as "novelties" because of humorous or novel packaging, but actually are in compliance with the applicable listing and premarket notification requirements. If the novelty manufacturer has not altered the condom or its primary package labeling, these devices may be acceptable provided that they are distributed with the same, or substantially similar, instructions for use that were submitted in the 510(k) for the device. If the devices lack instructions for use, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that its labeling appears to fail to bear adequate directions for its intended use [Misbranding, 502(f)(1)]." RECOMMENDING OFFICE : CDRH, Office of Compliance, Division of Enforcement II, HFZ-300 REASON FOR ALERT : In recent years, there has been an increase in the popularity of novelty products which appear to be intended for use as condoms. Increased emphasis has been placed upon the importance of using condoms to serve as a barrier to sexually transmitted diseases, (STD) including AIDS. Consumers may assume that these novelty products will provide the degree of protection expected of a condom, even though the products have not met the testing requirements for legitimate condoms. The use of such products, with no assurance as to their safety and quality, can pose a danger to health. Based on these concerns, a decision was made to clarify the FDA's policy regarding "novelty condoms" which can function similarly to condoms. In a letter dated February 23, 1994, CDRH informed manufacturers, distributors, and importers of functional novelty condom-like products that, "These products by form and function meet the definition of a condom as defined in 21 CFR 884.5300 and must, therefore, comply with all requirements for condoms including leak testing, compliance with Good Manufacturing Practices regulations, manufacturer registration, product listing, and pre-market notification and clearance." Because individuals and firms distributing these products may not be registered, they may not have received the February 23 letter. We believe that many foreign manufacturers are also unaware of the modified policy and continue to ship misbranded and adulterated "novelty condoms" to the U.S. INSTRUCTIONS : Inspect shipments of novelty products which appear to be condoms to determine whether the products can function as a condom. 1. If the product has been rendered unusable, e.g. by removing the closed end, by sealing the rolled condom so that it cannot be unrolled, by embedding the condom in plastic etc., then the product is truly an unregulated novelty product. If no medical claims are present in the labeling, the shipment may be released without further investigation. 2. If the product can function as a condom, then use standard procedures to check CDRH's databases for product listings and 510(k)'s. Also, check to confirm that the importer has registered and listed. a. If the products do not have the required listings and premarket notifications, detain the shipment. b. Some importers may not be aware of the registration requirements. If the importer has not registered, the shipment should not be released to that importer until the required forms have been filed. c. If products are listed and have 510(k)'s, and the importer is registered, then examine the labeling. Products with inadequate labeling (such as lack of adequate directions for use) should be detained. d. If the products have the required listings and premarket notifications, and if the importer has registered, and a review of the labeling finds it to be adequate, then such products should be treated as normal imported condoms, (i.e. the shipment should be subjected to the routine FDA water leak test applied to imported condoms under IA 85-02). Subsequent to passing this test, the shipment may be released. CONTACTS: Questions regarding whether a specific product meets the functional definition of a condom should be directed to Byron Tart, PAPS, OC, CDRH, (301) 594-4639. Questions regarding whether a listing or a 510(k) exists for a specific product, regarding medical claims, or regarding required labeling can be directed to John Farnham, DOEII, OC, CDRH, (301) 594-4616. FOI : No purging is required. KEYWORDS : Condoms, Novelty Condoms PREPARED BY : Rosa K. Forehand, DIOP (301)443-6553