It looks like you're using an Ad Blocker.
Please white-list or disable AboveTopSecret.com in your ad-blocking tool.
Some features of ATS will be disabled while you continue to use an ad-blocker.
CBDs are non-psychoactive compounds found naturally in hemp plants. They work so well as powerful natural medicine that people everywhere are realizing CBDs work better than pharmaceuticals for treating epilepsy, seizures, neurological disorders and other serious health conditions (including HIV infections). So the FDA has just launched a massive regulatory assault against CBDs by invoking the most insane logic you've ever heard.
1) CBDs work so well that drug companies are now investigating them to be approved by the FDA as medicines.
2) Because CBDs are being investigated by drug companies, the FDA has granted CBDs status as being "investigated as a new drug."
3) Because CBDs work so well and have been authorized for drug investigations, the FDA now OUTLAWS them being sold as dietary supplements.
4) Now the FDA has begun sending warning letters to CBD makers, claiming they are in violation of FDA regulations because they are selling "adulterated products."
In other words, the FDA just handed Big Pharma an absolute monopoly over CBDs (hemp oil extract) by ridiculously claiming such natural products are "adulterated" with molecules (CBDs) that the FDA says might one day become a drug.
12. Can products that contain cannabidiol be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) 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 as 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 cannabidiol. For more information on this provision, including an explanation of the phrase "marketed as," see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
FDA is not aware of any evidence that would call into question its current conclusion that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act.
“FDA routinely sends out warning letters for drug claims, however this issue originated from an FDA Q and A online post about marijuana, not dietary supplements. Notwithstanding the FDA’s Q&A posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, thereby rendering the IND preclusion inapplicable.”
who can do anything about it? what are we going to do about it? something NEEDS to be done about it.
originally posted by: dogstar23
a reply to: Boadicea
My God...this is HUGE, telling, and QUITE disturbing! My guess is the Big Pharma investigations and trials will take decades, and end up with no positive findings for medicinal use.
Though, I don't think they'll get away with this one. It's at the point where they'll have to be kicking down doors across the nation to rip out plants people are using to make their own medicine.
Land of the Free indeed.