Tag Archives: Dietary Supplement

FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD

On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions. As described in the … Continue Reading

FDA Announces Modernization of NDIN Electronic Submission System

FDA has announced that it is launching a new electronic submission system for New Dietary Ingredient Notifications (NDINs) on Friday, September 6.  The new system, the CFSAN Online Submission Module (COSM) is replacing the current FDA Unified Registration Listing System (FURLS).   NDINs are required to be submitted to FDA at least 75 days before marketing … Continue Reading

Bill Introduced to Protect State Cannabis Programs from Federal Interference

As previously reported on this blog, while the 2018 Farm Bill removed hemp from the Controlled Substances Act, its passage did not affect FDA’s authority to regulate cannabidiol (CBD) or other hemp products in FDA-regulated products. In December 2018, FDA released a statement clarifying that it is illegal to sell a food or dietary supplement that … Continue Reading
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