FDA just outlawed CBDs and hemp oil extracts

[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 For more information on this provision, including an explanation of the phrase "marketed as," see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.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.

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

https://www.newcannabisventures.com/breaking-fda-cbd-warning-letters/

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
• HealthyHempOil.com
• Michigan Herbal Remedies
• MorgueJuice.com
• PainBomb
• 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.

Note that this is a very broad attack on the CBD-from-hemp industry and includes products from CannaVest (OTC: CANV) as well as other companies like Endoca and Bluebird Botanicals.

CV Sciences Responds to Cannabidiol FDA Warnings

https://www.newcannabisventures.com...to-fda-warnings-issued-to-8-marketers-of-cbd/

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.

http://www.naturalnews.com/053369_CBD_hemp_oil_extract_FDA_regulations.html

The FDA just outlawed CBDs and hemp oil extracts by claiming all plant molecules now belong exclusively to Big Pharma


interestingly enough Rob Clarke has been supporting and urging people submit genes for identification so this wouldn't happen.

Seems like it simply will give pharmaceuticals companies like GW pharma exclusive access to life saving cannabinoids.

 

[stoned-trout]

bite me assholes....yeehaw...I have foreseen the future and it aint looking good...

 

[rasputin]

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.

 

[JRace]

Scare-titles, no supporting facts, and he is trying to sell his book by the end of it!

Not only that but he looks like the guys you said you don't trust in the other thread (people who look like you....)

 

[FireIn.TheSky]

The natural news guy is a douche he is also anti weed.
Half the shit he says isn't even true.

 

[Weird]

FDA verbiage

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

 

[Weird]

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.

The correlating information on the FDA's website seemed to run parallel to his claims.

I never read just news article but the source information that it references and then ancillary research for differing perspectives.

 

[Weird]

https://www.newcannabisventures.com/breaking-fda-cbd-warning-letters/

https://www.newcannabisventures.com...to-fda-warnings-issued-to-8-marketers-of-cbd/

unlike last year these warnings are based on dietary supplement qualification, for which they claim there is none

 

[CosmicGiggle]

Bummer, I can see where this is going, I don't even want to know!

 

[Weird]

cannabidiol is not dangerous or toxic and offers health benefits when consumed so regulation beyond extract purity and unsubstantiated claims such as effectiveness against specific diseases is not reasonable.

 

[trichrider]

will BHO or the CLEAR have residual levels of cbd?
probably.
then the fda can (using this angle) ban all cannabinoid preparations containing same.

sly bastards.

 

[Weird]

Apparently the natural news source is causing a distraction.

The additional links provide a bit more clarity and less sensationalism.

 

[JRace]

Where do you see the backup to this:

FDA just outlawed CBDs and hemp oil extracts

 

[Zaner-CC]

In reality, the FDA only made it illegal to sell CBD oils when labeled as a "dietary supplement." When CBD is derived from the marijuana plant, a schedule 1 substance, the DEA has full jurisdiction over the research and distribution of any product... http://www.dea.gov/divisions/hq/2015/hq122315.shtml

The DEA doesn't however have jurisdiction over CBD products derived from the hemp plant after HIA v. DEA... http://caselaw.findlaw.com/us-9th-circuit/1253723.html

So through my research you are perfectly capable of buying CBD infused products as long the CBD is derived from hemp, comes from an overseas source, and the seller of the product doesn't use the anecdotal research to market the products as a "dietary supplement."

I use a damn good oil for my vape pen everyday and I can say my experience almost directly correlates with the anecdotal evidence out there.

 

[Weird]

Where do you see the backup to this:

from my first post, its from the FDAs website

[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 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. [/FONT]

 

[Weird]

In reality, the FDA only made it illegal to sell CBD oils when labeled as a "dietary supplement." When CBD is derived from the marijuana plant, a schedule 1 substance, the DEA has full jurisdiction over the research and distribution of any product... http://www.dea.gov/divisions/hq/2015/hq122315.shtml

The DEA doesn't however have jurisdiction over CBD products derived from the hemp plant after HIA v. DEA... http://caselaw.findlaw.com/us-9th-circuit/1253723.html

So through my research you are perfectly capable of buying CBD infused products as long the CBD is derived from hemp, comes from an overseas source, and the seller of the product doesn't use the anecdotal research to market the products as a "dietary supplement."

I use a damn good oil for my vape pen everyday and I can say my experience almost directly correlates with the anecdotal evidence out there.

Dietary classification is the only way Cannabidiol can be brought to market and it is the same exact cannabinoid found in hemp, so why the differentiation based on source?

Not to mention that at least two of the sources that received letters where using hemp based CBDs.

CBD does not have known toxicity or detriment, I don't understand the effort to regulate it.

There are so many dietary supplements out there that are dangerous and under regulated that I wonder if the FDA is being driven by complaints from the corporate and not the private sector.

Many times the FDA investigates companies after consumer complaints, was this the instance here?

 

[FoothillFarming]

Does this mean cannabis breeders should stop listing CBD?

 

[fungzyme]

I guess if you market it as a 'bath salt' or as 'room odorizer' you'd be okay.../sarc

 

[_tessarecting]

Does this mean cannabis breeders should stop listing CBD?

No.

 

[Betterhaff]

Many times the FDA investigates companies after consumer complaints, was this the instance here?

Naw, it’s the government and their bosses. They’ve got the whole thing tied up (CBD & THC) with legaleeze and legislation let alone the numerous departments and agencies involved.