1-800 CONTACTS, Inc. (CTAC) Message Board

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Non-Tech : 1-800 CONTACTS, Inc. (CTAC)

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To: FiberOptic who wrote (1)	6/19/2000 3:02:00 PM
From: Sir Auric Goldfinger	of 25

Gee I wonder what the FDA would do if this happened?: "It is possible that the FDA will consider certain of the contact lenses we sell to be misbranded. The FDA also regulates the labeling of medical devices. The contact lenses that we sell are prescription devices, and therefore contain the statement required by FDA regulations: "Caution: Federal law restricts this device to sale by or on the order of a (physician or other licensed practitioner)." However, because of the difficulty we have encountered in obtaining the cooperation of eye care practitioners, we sometimes sell lenses based solely on the prescription information provided by the customer without a written prescription or other order by the customer's eye care practitioner. Although the FDA has not objected to the sale of contact lenses without a written prescription or other order directly from the customer's eye care practitioner, it is possible that the FDA will consider contact lenses that are sold in such a fashion to be misbranded. The sale of misbranded devices is unlawful under the Federal Food, Drug, and Cosmetic Act, and can result in a warning letter, seizure, injunction, civil penalties, or prosecution."

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