FDA just outlawed CBDs and hemp oil extracts

[JRace]

So the FDA has outlawed CBD for use as a dietary supplement
or is there other 'outlawing' happening as well?

 

[bombadil.360]

So the FDA has outlawed CBD for use as a dietary supplement
or is there other 'outlawing' happening as well?

No, it outlawed advertisement and labelling as a dietary supplement. Period. No buts or ifs.

Can't believe this sort of thread grossly misinforming people stays up...

 

[Weird]

So the FDA has outlawed CBD for use as a dietary supplement
or is there other 'outlawing' happening as well?

Apparently you didn't read the FDA guidelines verbatim or understand the criteria for classification.

The only FDA regulations that CBD could fall under is either drug or dietary. It is non psychoactive, non toxic and it could have multiple purposes both medicinal and dietary, in fact they are not always mutually exclusive. Vitamin C would be a good example.

Further add to the irony that it is recognized on a state level (just like legalization) and not on the federal level.

9. What is FDA’s reaction to states that are allowing marijuana to be sold for medical uses without the FDA’s approval?
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of marijuana and its derivatives or are considering doing so. In particular, we know that a number of states are interested in allowing access to cannabinoid oil, or cannabidiol, in an attempt to treat childhood epilepsy. It is important to conduct medical research into the safety and effectiveness of marijuana products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of marijuana and its derivatives to provide information on Federal and scientific standards.

By not allowing it to be classified as a dietary supplement it will have to go through the FDA drug regulation process which will immediately put anyone but big pharma with big pockets a chance to grow CBD rich plants and sell the extracts.

Did you read the response from CannaVest I posted earlier? What do you have to say about the bolded?

[FONT=Arial, Helvetica, sans-serif]Earlier today, the Food & Drug Administration (FDA) posted 8 warning letters issued to marketers of products containing cannabidiol (CBD). Two of the companies receiving the letters were criticized for claims they made about products manufactured by CV Sciences, formerly CannaVest (OTC: CANV). Stuart Tomc, Vice President Of Human Nutrition, responded to the news, saying “CV Sciences did not receive a warning letter from the FDA and never has.” The company strongly condemns distributors of its products making health claims. “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,” said Tomc. [/FONT]

CBD should be a closed market that only big pharma can cater to? It is the most dangerous and difficult to process cannabinoid?

is the process that scientific? No

This feels like preemptive patent protection and extension to me.

Goodbye Jack Herer Hello Martin Shkreli

 

[EastCoast710]

I been saying it for a while now.. its a WAR ON THE MINDS OF THE WORLD.. first get people on all these meds. then take them away.. get them addicted to all these illegal drugs.. then take them away.. watch wat happens lol.. talk about walking dead.. well when everyone has no meds.. we will have a lot of crazy people on the streets !

 

[_tessarecting]

We already do.

 

[Weird]

No, it outlawed advertisement and labelling as a dietary supplement. Period. No buts or ifs.

Can't believe this sort of thread grossly misinforming people stays up...

The only thing gross is your trolling, I can be sold either as a drug, a dietary product or labeled not for ingestion.

One classification allows for it to be sold as dietary and the other a drug.

Which one is CBD to you? and if you think it requires a drug classification what is your reasoning?

You won't answer cause your not really here for any reason than than express your passive aggressive nature.

Man up and stop being juvenile.

 

[stoned-trout]

I got my crossbow ready......yeehaw

 

[JRace]

By not allowing it to be classified as a dietary supplement it will have to go through the FDA drug regulation process which will immediately put anyone but big pharma with big pockets a chance to grow CBD rich plants and sell the extracts.

It has not been banned nor has it been outlawed.
You are inferring a lot.

I see no post by cannavest, so I assume you mean this:

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,” said Tomc.

Again, CBD has not been banned nor has it been outlawed by the FDA.

 

[Weird]

It has not been banned nor has it been outlawed.
You are inferring a lot.

[FONT=Arial, Helvetica, sans-serif]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

[/FONT]

I see no post by cannavest, so I assume you mean

Well it is in the post you quoted.

[FONT=Arial, Helvetica, sans-serif][FONT=Arial, Helvetica, sans-serif]Earlier today, the Food & Drug Administration (FDA) posted 8 warning letters issued to marketers of products containing cannabidiol (CBD). Two of the companies receiving the letters were criticized for claims they made about products manufactured by CV Sciences, formerly CannaVest (OTC: CANV). Stuart Tomc, Vice President Of Human Nutrition, responded to the news, saying “CV Sciences did not receive a warning letter from the FDA and never has.” The company strongly condemns distributors of its products making health claims. “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,” said Tomc.[/FONT][/FONT]

 

[Weird]

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm#dietarysuppl

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. Interested parties may present the agency with any evidence that they think has bearing on this issue.

13. How did the FDA determine that cannabidiol products are excluded from the dietary supplement definition?
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 an article (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.
The existence of substantial clinical investigations regarding cannabidiol has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). 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. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

14. Will FDA take enforcement action regarding cannabidiol products that are marketed as dietary supplements?
A. When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

 

[bombadil.360]

The only thing gross is your trolling, I can be sold either as a drug, a dietary product or labeled not for ingestion.

One classification allows for it to be sold as dietary and the other a drug.

Which one is CBD to you? and if you think it requires a drug classification what is your reasoning?

You won't answer cause your not really here for any reason than than express your passive aggressive nature.

Man up and stop being juvenile.

LOL!

you seriously think that all the copy and paste you have done supports the claims you have made, specially in the very misleading thread's title?

they don't.

the fda has not banned CBDs nor hemp oil extracts. it has simply outlawed these products from being sold as Dietary Supplements.

if you can't understand the difference, which is huge, there's nothing we can do to help you. read carefully again what you yourself have quoted from the fda, and hopefully a little light bulb will turn on and you'll get it.

 

[Tynehead Tom]

Naturalnews.com should be the first sign for anyone this is bogus.

Read the warning letters the FDA sent out. The companies sent letters were claiming to sell a medicinal product containing CBD that when tested had no CBD present. The FDA basically said, hey quit the shit you lying assholes. Standard regulatory stuff. If the FDA didn't do this people would complain they aren't doing their jobs. Weird.

All that being said, there is certainly potential for the gov't to classify CBD such that it becomes either prescribed medicine or a tightly controlled OTC like sudafed. I'm not discounting that possibility, but that doesn't mean the current story is true.

so it is a coincidence that as of yesterday Canada Border Services has started seizing CBD oils shipping from the United States, destined for Canadian medical patients. Was all over the news this evening up here in canukistan.

 

[Weird]

LOL!

you seriously think that all the copy and paste you have done supports the claims you have made, specially in the very misleading thread's title?

they don't.

the fda has not banned CBDs nor hemp oil extracts. it has simply outlawed these products from being sold as Dietary Supplements.

if you can't understand the difference, which is huge, there's nothing we can do to help you. read carefully again what you yourself have quoted from the fda, and hopefully a little light bulb will turn on and you'll get it.

So instead of a dietary aid you feel it should be classified as a scheduled 1 drug, unless you feel people labeling it not for consumption is "kosher".

Good to know you think life saving benign cannabinoids should be restricted to big pharma for extraction, preparation and delivery to patients.

I guess all those with cancer who wanted to use a known dietary aid to help them should be ass out because the government wants to regulate CBDs like they do opiates, because CBDs are that fucking dangerous right?

You know I love when people have such a nut for me they argue against the virtues of a plant they pretend to be about, because it shows their real intellectual integrity

\\

 

[Weird]

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm118079.htm

How Vitamins are Regulated

Vitamin products are regulated by FDA as "Dietary Supplements." The law defines dietary supplements, in part, as products taken by mouth that contain a "dietary ingredient" intended to supplement the diet.

Listed in the "dietary ingredient" category are not only vitamins, but minerals, botanicals products, amino acids, and substances such as enzymes, microbial probiotics, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms. The Dietary Supplement Health and Education Act of 1994 requires that all such products be labeled as dietary supplements.

In June 2007, FDA established dietary supplement "current Good Manufacturing Practice" (cGMP) regulations requiring that manufacturers evaluate their products through testing identity, purity, strength, and composition.

 

[CosmicGiggle]

I guess all those with cancer who wanted to use a known dietary aid to help them should be ass out because the government wants to regulate CBDs like they do opiates, because CBDs are that fucking dangerous right?\\

...not dangerous, just effective and potentially lucrative.!

If there's money to be made, it must be controlled by the Gov.
..... or the Blackmarket!

 

[Weird]

Article from leafy.com

https://www.leafly.com/news/headlin...use-us-patents-to-shape-the-future-of-medical

That wariness has its roots in the 1990s (more on that below), but it continues to this day. And for good reason. GW Pharma is quickly becoming the world leader in FDA-approved cannabis medicine while American companies are effectively shut out of the game by their own government. Here’s the kicker: While two federal agencies (the Justice Department and the Department of Health and Human Services) actively prevent Americans from developing cannabis medicine, another agency (the U.S. Patent and Trademark Office) is helping GW Pharma lock up the intellectual property rights to a broad swath of cannabis-derived medicines and techniques.

In other words: Epidiolex, the company’s epilepsy drug now moving through the FDA approval process, is only the beginning.

On its web page, GW Pharma lists a number of other pharmaceuticals in the development pipeline. Those drugs treat everything from glioma (a form of brain cancer) to diabetes and schizophrenia.

But the company is also, unbeknownst to many, applying for and receiving patents that cover substances and techniques already widely used in the cannabis world.

The company’s latest patent (No. 9,205,063), granted last December, covers the prevention and treatment of neural degeneration with a pharmaceutical formulation of cannabis obtained by running the plant through a common carbon dioxide (CO2) extraction method. The patent lists all the usual active components of cannabis: THC, CBD, terpenes, sterols, triglycerides, alkanes, flavonoids, etc.

Let us legalize so a single, big pharma firm can proprietorship over nature.

 

[bombadil.360]

So instead of a dietary aid you feel it should be classified as a scheduled 1 drug, unless you feel people labeling it not for consumption is "kosher".

Good to know you think life saving benign cannabinoids should be restricted to big pharma for extraction, preparation and delivery to patients.

I guess all those with cancer who wanted to use a known dietary aid to help them should be ass out because the government wants to regulate CBDs like they do opiates, because CBDs are that fucking dangerous right?

You know I love when people have such a nut for me they argue against the virtues of a plant they pretend to be about, because it shows their real intellectual integrity

\\

Actually, quite the opposite, fact is, the FDA in this case is working to protect sick people from snake-oils sold as containing CBD when in fact these so-called extracts contain none or not even enough to be active.

"FDA issued several warning letters to firms that market unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases. Some of these firms claim that their products contain cannabidiol (CBD). FDA has tested those products and, in some of them, did not detect any CBD." 2015.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm

"In February 2016, FDA issued eight warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). FDA had previously issued six such letters in February 2015. FDA has tested these products, and many were found to not contain the levels of CBD they claimed to contain."
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm

But whatever, you can insist in that your mis-readings of the very thing you are quoting is what is actually being said...

none of the so called medicinal extracts for which these warnings were made, contain the necessary amounts of CBD for them to be considered medicinal at all, some contain none at all; if that is not unethical, I don't know what is... if you think fooling sick people like that is ok, well, whatever, I don't care what you think really.

 

[Weird]

Actually, quite the opposite, fact is, the FDA in this case is working to protect sick people from snake-oils sold as containing CBD when in fact these so-called extracts contain none or not even enough to be active.

"FDA issued several warning letters to firms that market unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases. Some of these firms claim that their products contain cannabidiol (CBD). FDA has tested those products and, in some of them, did not detect any CBD." 2015.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm

"In February 2016, FDA issued eight warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). FDA had previously issued six such letters in February 2015. FDA has tested these products, and many were found to not contain the levels of CBD they claimed to contain."
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm

But whatever, you can insist in that your mis-readings of the very thing you are quoting is what is actually being said...

none of the so called medicinal extracts for which these warnings were made, contain the necessary amounts of CBD for them to be considered medicinal at all, some contain none at all; if that is not unethical, I don't know what is... if you think fooling sick people like that is ok, well, whatever, I don't care what you think really.

Your arguing the basis of their actions a year ago which has bearing on anything I have posted and like your typical squirmy self you don't answer any questions directly.

Dude if you want me so bad why not ask me out on date it would be a lot less awkward than your piss poor trolling.

 

[bombadil.360]

Your arguing the basis of their actions a year ago which has bearing on anything I have posted and like your typical squirmy self you don't answer any questions directly.

Dude if you want me so bad why not ask me out on date it would be a lot less awkward than your piss poor trolling.

Lets try this again, pay attention this time:

"In February 2016, FDA issued eight warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). FDA had previously issued six such letters in February 2015. FDA has tested these products, and many were found to not contain the levels of CBD they claimed to contain."

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm

the lessons are over on this though; you are on your own now.

over and out!

 

[mexcurandero420]

Obama’s New Appointee To Head The FDA Is A Big Pharma Mega-Lobbyist

http://www.mintpressnews.com/obamas-new-appointee-to-head-the-fda-is-a-big-pharma-mega-lobbyist/210458/

Keep on growing