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Expert Analysis

FDA Policy On Wellness Products Is Healthy For Industry

Law360, New York (January 27, 2015, 1:28 PM EST) -- On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance[1] concerning the classification and regulation of general wellness products. The draft guidance is the FDA's latest attempt to provide some regulatory clarity in the wake of the explosion in popularity of wearable wellness devices and general fitness products. The draft guidance, which slightly loosens the FDA's hold on general wellness products, comports with the agency's current policy of refocusing its resources on high-risk products and away from products that present a low risk to the end-user....

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