BREAKING: FDA Issues Warning Letters to 8 Marketers of CBD Products

 In Hemp, National News

Similar to a year ago, when the Food & Drug Administration (FDA) issued warning letters to six companies, the FDA issued several warning letters to marketers of products with cannabidiol (CBD):

ABC Productions
Dose of Nature
Green Garden Gold
Michigan Herbal Remedies
Sana Te Oils

The letters are all fairly similar and criticize health claims made by the company as supplements. Unless the product was marketed before GW Pharma (NASDAQ: GWPH) published clinical trials, the companies can’t make health claims:
FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.


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