FDA recently issued untitled letters to three companies regarding certain direct-to-consumer ("DTC") genetic tests marketed without premarket clearance. FDA asserts that the companies' tests meet the definition of a "medical device" under Section 201(h) of the federal Food, Drug, and Cosmetic Act ("FDCA") but that the products have not obtained requisite clearance numbers from the Agency. According to FDA, the products are intended: "to predict how patients will respond to more than 120 of the most commonly prescribed medications" (DNA4Life); "to test for DNA genetic markers linked to thrombophia, deep-vein thrombosis, cardiovascular disease and stroke" (DNA-CardioCheck); or "to identify individuals with genetic predisposition for increased risk to diabetes and heart attack, Osteoarthritis Associated Conditions, and obesity-related genotype for weight loss" (Interleukin Genetics). Although less significant than warning letters, these notices demonstrate the Agency's continued enforcement focus in the area of DTC genetic testing. Each letter instructs the company to identify the clearance numbers for its tests or otherwise explain the basis for not obtaining premarket clearance.
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