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originally posted by: reldra
originally posted by: dogstar23
a reply to: wisvol
Actual Factual Information
I had a quote from the above link I was going to include, but now my browser has gone stupid, but a quick review of that short article reveals the truth. It's a US News article from 3/11.
That US News article is from 3/2015. It is true that the article addresses products that are mislabeled- they are not supposed to say they cure anything and/or misstated the amount of CBD.
But the OP is right- when asked, the FDA will say that products containing CBD can't be sold as a dietary supplement and the why is connected to pharmaceutical company trials.
The FDA states that these products are in violation of the FD&C act, yet is less clear about if, when or how often they will enforce this. They do note that because it is in involved in drug trials, that is one of the main reasons it is against federal law to sell as dietary supplements.
originally posted by: Boadicea
Full title at link:
The FDA just outlawed CBDs and hemp oil extracts by claiming all plant molecules now belong exclusively to Big Pharma
Most ATSers are already aware of the many amazing healing properties of cannabis, and its cannabinoids, incluing CBDs. Many are also well aware of the healing properties of high CBD oils, legal and available in all 50 states. And many of us have expressed our fears and/or outrage at the role Big Pharma has played in keeping this natural medicine illegal and unavailable to the masses. I guess this is the next play in their dirty game.
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.
More specifically, not against CBDs, but against anyone and everyone not Big Pharma... how? Like this:
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."
Adulterated? Really??? Yup. Adulterated.
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.
So what exactly does the FDA say?
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.
However, Stuart Tomc, VP of Human Nutrition at CV Sciences (previously CannaVest), begs to differ:
“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.”
I take objection to the entire process and a bureaucracy which has prioritized profits over people, at the expense of our health... and our very lives. Medical research has proven that cannabis and its cannabinoids are absolutely vital to our bodies' immune system and our health. Cannabis is a weed. It grows like crazy in all kinds of conditions all over the world. Given half a chance, anyone could grow their own medicine and treat -- if not cure! -- a whole host of diseases and conditions all by their lonesome. Even better, regular supplements or use as a food or tea, could serve to nurture and maintain health, and avoiding many diseases/conditions altogether. Every effort should be made to increase both our knowledge of and access to this powerful medicine; not restrict us. No one has the right to deny us the life nurturing and life saving benefits provided by the fruits of the earth, much less criminalize our use -- not in the name of our "safety," and sure as hell not in the name of patents and profits.
UPDATE: This article has caused a tremendous amount of discussion and a lot of disinformation is flying around, so I'm adding these notes for clarification.
One thing I've learned is that the people who sell CBD oil don't even know there is more than one CBD molecule. Some have attacked me for using "cannabidiols" in a plural form, because they are ignorant of the full chemistry of CBD synthesis and molecular variants. Even wikipedia lists seven CBD molecular variations, each with its own name. They are named delta-5-cannabidiol, delta-4-cannabidiol, delta-3-cannabidiol, delta-3,7-cannabidiol, delta-2-cannabidiol, delta-1-cannabidiol and delta-6-cannabidiol. They share the same elements in their molecular composition, but they have variations in their double bonds, meaning they behave slightly differently when interacting with other molecules.
If there are seven of something, that makes it plural. Hence, the term "cannabidiols" is scientifically correct, and anyone who thinks there is only one cannabidiol doesn't have the full picture. Yes, it's true that only one of these is naturally occurring, but because cannabidiols have been successfully synthesized in various forms, we must look for all those forms, including synthesized forms. Why? Because hemp oil sellers might theoretically be adding synthetic CBD molecules to their hemp oil in order to achieve a CBD test result that shows a sufficiently high CBD concentration. Yet these CBDs might not be from hemp plants but rather could theoretically come from chemical laboratories. So when talking about CBDs, we have to consider more than one molecule.
Secondly, the FDA did outlaw (i.e. regulate into an illegal substance) CBDs as a dietary supplement. It's printed right on the FDA's own website: "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..." The FDA has also started sending aggressive warning letters to CBD product marketers.
Some of the people commenting on this article have said you can just sell CBDs as a "food" and not a dietary supplement. Clearly they are not FDA regulatory attorneys or they would not leap to such conclusions without doing their homework. While there may be a way to achieve this with sufficient legal consultation, the definition of a dietary supplement is not the selection of the marketing company; it is a definition that is forced upon them by the opinions of the FDA. You can't just take an alcohol extract of something, for example, and call it a "food." The FDA would reject such claims. Thus, if the FDA decides that any hemp oil containing CBD molecules is a "dietary supplement" and not a "food," then that's the designation that counts as far as FDA enforcement is concerned. And if someone is selling hemp oil (a food) that's spiked with CBDs (an extract), then how might the FDA rule on the category for that combined substance? It's difficult to say. But it's not as simple as just declaring your CBD oil is a "food."
There is no question that some smaller companies are right now selling hemp oil with CBD content, but this does not mean such sales are immune from FDA regulatory prosecution. The FDA tends to go after larger suppliers first, ignoring smaller suppliers due to its own limited resources. For this reason, smaller suppliers of CBD supplements or hemp oil products containing added CBDs may be able to continue selling such products for a very long time without facing regulatory action. Nevertheless, that regulatory risk is ever present and may be invoked at any time by the FDA to target that company and confiscate its products. Selective prosecution is one of the key regulatory weapons of all federal agencies. This is how they protect their pharma friends and punish the competition.
Finally, anyone who actually reads my article would instantly discover that my position is pro-CBD, pro hemp oil and strongly opposed to the FDA's regulatory oppression of natural hemp medicine. Yet somehow, this article is being misconstrued by certain people in the industry who somehow believe it is attacking the CBD industry. Apparently, some people have been smoking way too much WEED and have forgotten to READ. This, not surprisingly, is an extremely common problem across the entire marijuana industry, where scientific standards are virtually non-existent, and shockingly few people have any idea at all what they're actually selling. While there are a few exceptions and a few honest operators in the industry, a whole lot of the people selling CBD oils are actually selling counterfeit products containing no CBDs at all. My advice is to do your homework before purchasing any of these products, and make sure you're purchasing from a reputable supplier that can provide scientific analysis documentation for the exact production lot you're purchasing. Otherwise, you might end up buying nothing but really expensive canola oil with imaginary cannabidiols.
OK, so I went to the Internets to check this out - apparently, the horrifying premise of the Natural News article is, thankfully, false. The FDA is cracking down on companies selling CBD oil with labeling/guidance for use as a medical treatment (just as they do with any product which has not obtained FDA approval for such uses.) They are NOT outlawing CBD oil as a supplement sold without making specific medical claims. They're treating it the same as every other dietary supplement. So, I take back my initial outrage and replace it with relief and understanding. Looks like Natural News hoaxed me good there for a minute!
Stop voting democrat or republican, get those two loser parties out of DC..