Tag Archives: Gail H. Javitt

FDA Commissioner Gottlieb Says Agency Will Not Tolerate Deceptive Marketing of CBD Products; Issues Warning Letters

On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products.  Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal and state level.  In a December 2018 press release issued on the heels of the Farm Bill’s passage, FDA forecast its intention to step up enforcement against CBD products, and earlier this year state and local governments initiated seizures of CBD products from store shelves.  For manufacturers, retailers, and consumers, the takeaway from these recent statements and actions is that it remains unlawful under the Federal Food Drug and Cosmetic (FD&C) Act to market conventional foods or dietary supplements containing CBD.

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FDA Issues Final Regulations Easing the Path for Direct-to-Consumer Genetic Testing

New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC), without a health-care provider intermediary.

The first rule exempts “autosomal recessive carrier screening gene mutation detection systems” that are offered DTC from FDA premarket review.  FDA first proposed this exemption in 2015, on the same date as the agency issued a final order classifying these types of tests as Class II medical devices, in response to a request from 23andMe.  The 2015 final rule specified the conditions under which all companies could offer autosomal recessive carrier tests directly to the public.  By finalizing the exemption, FDA is permitting companies to offer these tests DTC without the need for prior FDA review.  These companies will still be subject to general requirements applicable to all medical device manufacturers, as well as to the “special controls” specified by FDA for these types of tests in the final rule.

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