Hemp In Food Update - GHC

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Newsletter 20 September 2017
Hello Visitor,

Thank you for all those who attended and/or followed up on the Emergency Hemp Meeting on July 20th, 2016. Things are not progressing in a positive direction for the Hemp Industry here in Colorado regarding the use of hemp in food and CBD. 

Staying up to date on the facts and what is changing is one of the most important things we can all do right now.

*Please Note: GHC will host another meeting in the next 60 days or less regarding these critical industry issues. Please plan on participating in person or via live-stream.

What is FACT now:

1.CBD is now considered an adulterated ingredient (ie. in food & anything for human consumption or use), as well as any other plant matter from Industrial Hemp other than non viable seed products. Obviously this is very serious issue for at least 90% of the hemp industry.

2. CBD is only approved for food use if it comes from non viable seed products


With harvest around the corner this has now become an even bigger concern. Please see more info below on where we are at and what we can do.
 

New Revised Wholesale/Manufacture License with the wrong legal terminology!?!

Overnight, with zero notice or input from Industry as promised by CDPHE, changes were made to the State Wholesale/Manufacture license

The application from CDPHE now asks if applicants are using "Cannabis" or "Hemp". Not only were these changes unexpected but now legally inaccurate. The word cannabis here in Colorado incorporates both Hemp and Marijuana with out separation. There has already been bad law here in Colorado such as in Denver which used the word "Cannabis" for regulating or banning marijuana but because the word "cannabis" is used and not marijuana specifically. The CDA has been addressing Denver's use of the word Cannabis since it has effected hemp as well.

This may seem minor to some people but the fact that a state agency has already disabled a large portion of the Hemp Industry virtually overnight with new positions and continue to do so on hemp in food including CBD, is not acceptable and has caused even more confusion and distrust.

Please CLICK HERE to see new form

NEW LINK for new update (2nd) - https://www.colorado.gov/pacific/sites/default/files/DEHS_MfgFd_RegApp_FY2017_v2.pdf

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Cottage Food Option to Consider for your business

pictureIt is now, no longer possible to get a Wholesale/Manufacture License anymore with CDPHE unless you are storing, producing and or manufacturing non viable hemp seed products.

There is a possible alternative existing legal option you can consider for your business until this all get resolved in legislative session next year.

The Cottage Foods Act is a option you many want to consider for your business depending on your current or expected production levels. Max earnings from one product is 10k per year.  For example, if you make a hemp brownie with walnuts you can make 10K max under the Cottage food act, but you can also made a hemp brownie with peanuts and make 10K max from that one product.

More info can be found on the Cottage Food Act from the link below but in general this would still allow you to legal sell your hemp food product not made from non viable hemp seed

https://www.colorado.gov/pacific/sites/default/files/Reg_DEHS_CottageFoodsAct_Brochure.pdf

 

There has been a new update made by FDA about CBD

There has been a new update made by FDA about CBD - which is believed to be even more concerning for the Industrial Hemp farmer, producer and distributor. IF you are involved in any way in hemp and or CBD from domestic or imported sources YOU MUST READ this update.

It has been understood by the Hemp Industry that certain claims can not be made due to GW Pharms use of FEDs patent on CBD, but this update seems to now includes food and anything human consumable with CBD to be prohibited also.



"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. 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.

There is an exception to section 201(ff)(3)(B)(ii) 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. "

(GHC COMMENTS: this seem to be a totally new position as it is a well known fact that CWeb and Dixie are exceptions already.)


"13. Is it legal, in interstate commerce, to sell a food to which cannabidiol has been added?

A. No. Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before any substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for cannabidiol. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which cannabidiol has been added. FDA is not aware of any evidence that would call into question this conclusion. Interested parties may present the agency with any evidence that they think has bearing on this issue.

14. In making the two previous determinations, why did FDA conclude that substantial clinical investigations have been authorized for and/or instituted about cannabidiol, and that the existence of such investigations has been made public?

A. 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 [disclaimer icon] and [disclaimer icon] GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome).

15. Will FDA take enforcement action regarding cannabidiol products that are marketed as dietary supplements? What about foods to which cannabidiol has been added?

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."

CLICK HERE to read full updated doc

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