The FDA assaults CBD extracts, attempts to regulate out of existence.

Remy

Administrator
Make sure you catch this part at the end:

"The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration."

Wonder what it'll cost once Big Pharma is done with it?

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. Here's how it goes:

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." In the FDA's own language from their website, "FDA considers a substance to be 'authorized for investigation as a new drug' if it is the subject of an Investigational New Drug application (IND) that has gone into effect."

3) Because CBDs work so well and have been authorized for drug investigations, the FDA now OUTLAWS them being sold as dietary supplements. Per the FDA's own website: "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."

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 with what, exactly? CBDs, of course! "The debate over hemp CBD’s legal status continues after FDA sent eight warning letters to manufacturers of CBD dietary supplement and food products earlier this month," reports Nutritional Outlook. "The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration."

Learn more: http://www.naturalnews.com/053369_CBD_hemp_oil_extract_FDA_regulations.html#ixzz43TcHEBCp
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Make sure you catch this part at the end:

"The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration."

Wonder what it'll cost once Big Pharma is done with it?
One part of me says that drug companies producing products based on CBD's is a good thing. The other part says what about all the people for whom CBD products are working and who are getting them at a good price?
 

Remy

Administrator
One part of me says that drug companies producing products based on CBD's is a good thing. The other part says what about all the people for whom CBD products are working and who are getting them at a good price?
Listen to the other part. :)
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Listen to the other part. :)
;) ;) ;)

I told Corinne about CBD's and their possible antiviral properties. It was old news to her - she had tried them with no effect but then she pointed me to an FDA study which found no CBD at all in some products. She didn't know if she got any CBD in the substance she tried.

http://www.cortjohnson.org/forums/r...oid-fda-comes-down-hard-on-cbd-producers.322/

That's why I was thinking the FDA move to call CBD a new drug might produce some standardization that could be helpful in the long run....
 
Last edited:

Remy

Administrator
That's why I was thinking the FDA move to call CBD a new drug might produce some standardization that could be helpful in the long run....
The FDA could allow CBD to be sold as a drug and a supplement...like Niaspan and Lovaza. Let people choose which they feel is more reliable.

On the one hand, more stringent regulations on pain meds. On the other, taking away viable alternatives like CBD. I despair of our government sometimes.

This is all about the money.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
The FDA could allow CBD to be sold as a drug and a supplement...like Niaspan and Lovaza. Let people choose which they feel is more reliable.

On the one hand, more stringent regulations on pain meds. On the other, taking away viable alternatives like CBD. I despair of our government sometimes.

This is all about the money.
That sounds good. The CBD industry could self-regulate itself - if it's not doing that already - establish standards of excellence - create standardized testing procedures - set up an independent agent to test the products; then you could probably have faith..
 

Remy

Administrator
Hiya @GGG!

Particularly galling is this, "But politicians and media are making CBD oil into the good kind of cannabis while arguing that THC is the bad kind of cannabis. While that is not how any of this works, that is the case that is subtly being made.

As that happens, two forces will likely come into play. One, in order to push the market away from small sellers and harvesters of CBD oil, states and the feds will likely create a regulatory climate that is so difficult to manage, they will, through cronyism force CBD oil into the hands of a few, which in turn limits supply and forces the price to rise considerably.

Two, big pharmaceutical companies will being putting out a “safe”, “legitimate” form of CBD oil. That is already starting to happen."

UGH.
 

LisaR

Member
I think this article is completely overblown and alarmist. I can find no evidence anywhere else that THE FDA JUST OUTLAWED CBDs and HEMP OIL!!! as this article claims. The FDA did send out a batch of warning letters last February and again this February to companies selling CBD oil. The warnings related to products which were found to not contain the levels of CBD they claimed to contain, or problems related to their marketing and labelling, because they claimed their products cured or treated diseases. The latest round of warning letters went out last month and gave the companies 15 days to correct the violations. I'm sure some of you have ordered CBD since that time. It has not been outlawed. In fact, I don't think that the fact that CBD is excluded from being sold as a dietary supplement is anything new or anything that just happened, as this article implies. Issues of whether CBD is a drug or a supplement, whether it's legal to sell in all states or only states with medical marijuana laws, and the conflict that exists between MMJ being legal in some states but still illegal federally, are all issues that are complicated and still have to be worked out and only time will tell. But no one has outlawed CBD, as that article claims, as far as I can tell.
 

Remy

Administrator
I think this article is completely overblown and alarmist. I can find no evidence anywhere else that THE FDA JUST OUTLAWED CBDs and HEMP OIL!!! as this article claims. The FDA did send out a batch of warning letters last February and again this February to companies selling CBD oil. The warnings related to products which were found to not contain the levels of CBD they claimed to contain, or problems related to their marketing and labelling, because they claimed their products cured or treated diseases. The latest round of warning letters went out last month and gave the companies 15 days to correct the violations. I'm sure some of you have ordered CBD since that time. It has not been outlawed. In fact, I don't think that the fact that CBD is excluded from being sold as a dietary supplement is anything new or anything that just happened, as this article implies. Issues of whether CBD is a drug or a supplement, whether it's legal to sell in all states or only states with medical marijuana laws, and the conflict that exists between MMJ being legal in some states but still illegal federally, are all issues that are complicated and still have to be worked out and only time will tell. But no one has outlawed CBD, as that article claims, as far as I can tell.
The latest round of warning letters from Feb 2016 also apparently contained reference to the fact that the FDA has excluded CBD as a dietary supplement as well as the marketing/labeling violations. That's a new wrinkle that should concern everyone that uses it.

Now they have to show that CBD was sold prior to 1994 in order to be granted an exception.

Can you still buy CBD products today? Yes. Will that change at any moment? Almost certainly yes.

The article may be a bit alarmist, I agree, but the threat is very, very real in my opinion.


“Based on the available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the [Food, Drug, and Cosmetic Act],” says the statement from FDA, published in an online Q&A about the agency’s treatment of marijuana. The reasoning? Companies have already filed investigative new drug (IND) applications to make CBD a drug ingredient, such as those submitted by GW Pharmaceuticals for its Sativex and Epidiolex products.

FDA’s statement continues, “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.”
- See more at: http://www.nutritionaloutlook.com/regulatory/finding-home-hemp#sthash.1EIp1oPr.dpuf
 
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LisaR

Member
The latest round of warning letters from Feb 2016 also apparently contained reference to the fact that the FDA has excluded CBD as a dietary supplement as well as the marketing/labeling violations. That's a new wrinkle that should concern everyone that uses it.

Now they have to show that CBD was sold prior to 1994 in order to be granted an exception.

Can you still buy CBD products today? Yes. Will that change at any moment? Almost certainly yes.

The article may be a bit alarmist, I agree, but the threat is very, very real in my opinion.

My point is that the FDA excluding CBD as a dietary supplement is not new. It happened almost a year ago -- as opposed to that article that makes it sound like something just happened which "OUTLAWED CBDs and HEMP OIL!!" Obviously, that 2015 ruling did NOT outlaw CBD -- it's continued to be sold since then. Is it in danger? Maybe. Should we be worried? Possibly. But this has been and continues to be a gray area with much to be worked out, none of which is going to happen overnight. And the New Drug application by GW Pharmaceuticals was just filed in 2014, so I think they only have to show that CBD was marketed as a supplement before that, from what I understand. Articles from May 2015 on this: http://www.nutraingredients-usa.com/Regulation/FDA-says-no-to-CBD-in-supplements and http://www.nutraingredients-usa.com...overturned-after-more-info-comes-in-exec-says
 

Remy

Administrator
My point is that the FDA excluding CBD as a dietary supplement is not new. It happened almost a year ago -- as opposed to that article that makes it sound like something just happened which "OUTLAWED CBDs and HEMP OIL!!" Obviously, that 2015 ruling did NOT outlaw CBD -- it's continued to be sold since then. Is it in danger? Maybe. Should we be worried? Possibly. But this has been and continues to be a gray area with much to be worked out, none of which is going to happen overnight. And the New Drug application by GW Pharmaceuticals was just filed in 2014, so I think they only have to show that CBD was marketed as a supplement before that, from what I understand. Articles from May 2015 on this: http://www.nutraingredients-usa.com/Regulation/FDA-says-no-to-CBD-in-supplements and http://www.nutraingredients-usa.com...overturned-after-more-info-comes-in-exec-says
The crackdown is new though as is the language in the warning letters as of last month.

This is where I got that about 1994.

Anyway, I still think that if you want CBD you should probably try it now. And contact your lawmakers to let them know where you stand on the issue.

Under DSHEA, the law would allow CBD to be sold as a dietary supplement ingredient—based on grandfathered status and without NDI notification—so long as a company could prove that CBD was sold on the market as a dietary supplement ingredient prior to 1994.

Similarly, FDA’s May statement actually does leave some room for the possibility of CBD supplements—if the industry can show CBD supplements were on the market before GW Pharmaceuticals began its investigation into CBD for drugs.

“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,” says FDA in the same marijuana Q&A. Although the statement goes on to say FDA is not currently aware of any such evidence for CBD, it also invites interested parties to submit any information that might call into question that conclusion.

FDA has not specified the exact date when the drug ingredient process began, but it was likely between 2006 and 2008, says CannaVest’s Boucher. Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), says it is AHPA’s understanding that the earliest IND for CBD was filed in November 2007, the time when GW Pharmaceuticals announced a clinical trial of a drug containing CBD.

CannaVest is confident there is enough evidence to show CBD was marketed as a supplement ingredient first.

“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,” says Stuart Tomc, vice president of human nutrition, CannaVest.

Tomc also questions the “substantial” nature of the drug investigations on CBD that did exist at the time—namely, stating that those investigations that were publicized were not substantial, were limited in number, and were preliminary in nature, “thereby rendering the IND preclusion inapplicable,” he says.

But even if there is proof that CBD-containing supplements were on the market prior to what FDA would consider the critical date in drug development, FDA might still dismiss the idea of an exception to the drug application because CBD did not have regulatory approval for supplements.

“I suppose FDA could come back, or the pharmaceutical company could come back and say, ‘Yes, but you were selling [CBD in supplements] illegally. You didn’t have regulatory status’,” says John R. Endres, ND, chief science officer for GRAS and NDI consultant AIBMR Life Sciences Inc. (Puyallup, WA).

- See more at: http://www.nutritionaloutlook.com/regulatory/finding-home-hemp#sthash.1EIp1oPr.u3PUMXnx.dpuf
 

LisaR

Member
The crackdown is new though as is the language in the warning letters as of last month.

This is where I got that about 1994.

Anyway, I still think that if you want CBD you should probably try it now. And contact your lawmakers to let them know where you stand on the issue.
I see where you got the 1994. But then elsewhere in the article, it says "it is AHPA’s understanding that the earliest IND for CBD was filed in November 2007, the time when GW Pharmaceuticals announced a clinical trial of a drug containing CBD." So there's a lot of confusion around this, which is why I don't think anything is going to happen overnight. The exclusion of CBD as a supplement happened almost a year ago, and the Truth in Media article that GGG posted is from 2014, which goes to my point. Lots of gray areas for the lawyers to keep fighting out. But in the meantime, I might just go ahead and stockpile my CBD! :cool:
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Hiya @GGG!

Particularly galling is this, "But politicians and media are making CBD oil into the good kind of cannabis while arguing that THC is the bad kind of cannabis. While that is not how any of this works, that is the case that is subtly being made.

As that happens, two forces will likely come into play. One, in order to push the market away from small sellers and harvesters of CBD oil, states and the feds will likely create a regulatory climate that is so difficult to manage, they will, through cronyism force CBD oil into the hands of a few, which in turn limits supply and forces the price to rise considerably.

Two, big pharmaceutical companies will being putting out a “safe”, “legitimate” form of CBD oil. That is already starting to happen."

UGH.
I think "subtle" is a kind way of putting it...
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
My point is that the FDA excluding CBD as a dietary supplement is not new. It happened almost a year ago -- as opposed to that article that makes it sound like something just happened which "OUTLAWED CBDs and HEMP OIL!!" Obviously, that 2015 ruling did NOT outlaw CBD -- it's continued to be sold since then. Is it in danger? Maybe. Should we be worried? Possibly. But this has been and continues to be a gray area with much to be worked out, none of which is going to happen overnight. And the New Drug application by GW Pharmaceuticals was just filed in 2014, so I think they only have to show that CBD was marketed as a supplement before that, from what I understand. Articles from May 2015 on this: http://www.nutraingredients-usa.com/Regulation/FDA-says-no-to-CBD-in-supplements and http://www.nutraingredients-usa.com...overturned-after-more-info-comes-in-exec-says
Thanks for update!
 

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