Over the last few weeks I have received several questions about the CBD Oil inside of th3 Kannaway products and if it’s legal to use and sell. It has taken a while to gather enough info from different sources to put this editorial together. Now anyone who is truly interested should have enough info and 3rd party datapoints to make an informed decision on if Kannaway is a company they can market for, or buy from.
FDA Regulation of Hempseed Oil
Many have asked if Hempseed Oil is safe and if the FDA has issued an opinion or approval of its use in the Kannaway products.
The FDA has a specific notice for Hempseed Oil GRAS Notice No. GRN 000035. You can review this information in full at: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm154140.htm
The FDA stated the following:
Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the FFDCA), a substance that is added to food is not subject to the requirement for premarket approval as a food additive if its safety is generally recognized, among qualified experts, through experience based on common use in food. Under 21 CFR 170.3(f), “common use in food” requires a substantial history of consumption for food use by a significant number of consumers. Thus, the fact that something may be used as a food does not, in itself, demonstrate that such use is safe, unless that use is sufficiently broad to demonstrate to qualified experts that the use in food demonstrates safety. Accordingly, we have evaluated your submission in the context of whether the uses that you describe demonstrate safety.
FDA has evaluated the information that you discuss in your GRAS notice as well as other data and information that are available to the agency. Your notice describes some use of hempseed oil within one foreign country but does not show that use was sufficiently widespread to demonstrate safety. Your notice also cites a reference that hempseed oil rarely was used for food; describes uses of the related substance, hemp seed; references an Executive Order that includes hemp and several other inedible products in its definition of food resources for the purposes of that Executive Order; and cites an electronic mail message of an FDA employee in response to a question from a consumer about whether hempseed oil has been approved by FDA. As Dr. Linda Kahl of the Office of Premarket Approval discussed with you by telephone on April 7, 2000 and June 9, 2000, it is our view that this information does not provide a sufficient basis for a determination that hempseed oil is GRAS, through experience based on common use in food, under the proposed conditions of use. Given that you based your GRAS determination on common use in food, we did not evaluate whether there would be a basis for GRAS status through scientific procedures.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval’s homepage on the Internet (at http://vm.cfsan.fda.gov/~lrd/foodadd.html).
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
So based on the above info, the FDA has not rendered an opinion period on Hempseed Oil! And in order for the FDA to render an opinion they would first have to evaluate the basis of GRAS through scientific procedures. Based on the fact the FDA has not offered an opinion, many legal minds believe that hempseed oil is a GRAS, based on the fact it has been in the food chain under the “prior market clause”.
Troy’s Thoughts: I personal tend to agree with the legal minds, since Hempseed Oil now commonly purchased from health food stores, as well as most grocery stores nationwide.
Now personally I think a more important question is whether or not a constituent of Hempseed Oil known as Cannabidiol (CBD) is listed as an illegal controlled substance on the DEA’s Schedule 1 list?
There are some who believe that the Kannaway products contain ingredients outlawed on the DEA Schedule 1 List. And in doing a quick review, I also thought there might be an issue. Here is what I have found!
1. Industrial Hemp or what we just call Hemp has been used in the USA since long before we became a country. However, back in 1937, there was a push to outlaw the Cannabis plant… All Cannabis plants. But for the most part industrial hemp did survive to a certain degree which is why we have seen hemp products on store shelves throughout the years.
2. The Hemp oil used in Kannaway products is gathered through a process called “Cold Press”. And the Hemp Oil used in the Kannaway products comes from the mature stalks of industrial hemp.
3. The laws governing industrial hemp can be found at 21 U.S.C. 802 (16) which states the following:
(16) The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.
Base on the above definition, many legal minds have concluded that NONE of the hemp oil or the CBDs found in the Kannaway products is banned by the DEA as a controlled substance on the DEA Schedule 1 List.
Now in digging a little more I did find a case from 1971 where a chemist at the Unitied States Customs Lab, testified as follows:
Concerning the relationship between marihuana and hashish, Sydney L. Waldour, chemist at the United States Customs Laboratory, testified as follows:
Ordinary marihuana is the flowering top of the Indian hemp plant, of the female Indian hemp plant, which contains the active resin known as tetrahydrocarbinol. The hashish is a concentrated form of this commonly known as the resin portion and it is much more active than the regular marihuana. * * * Several methods of manufacture are possible. One method of manufacture would be to pick the flowering tops from the Indian hemp plant and roll them on leather blankets so as to squeeze the resin out. This could be scraped off of the leather blanket with a dull knife and compressed into cakes, which is a common form that hashish enters the country * * * according to the research done by one of our chemists in our New Orleans laboratory, it takes about 625 pounds of marihuana to manufacture one pound of hashish. * * * It would have to be very good marihuana, very high resin content * * * any marihuana grown within the confines of the United States has a resin content so low as to not be attractive to the persons using it. * * * To our knowledge hashish has never been manufactured in the United States.
Now although, the above might seem like a rabbit trail, as I was researching to figure out if the Cannabildiols (CBDs) inside the Kannaway products are illegal, I realized that the above chemist was very clear where and what Marihuana is, and what industrial hemp is not!
Troy’s Thought: Kannaway products contain Hemp Oil gathered through a Cold Press process from the mature stalks of the Cannabis plants. The Hemp Oil is NOT gathered from the “flowering top of the Indian Hemp Plant.”
But does the above really clarify if the Hemp oil, specifically the Cannabidoil found inside the Kannaway products legal to use and sell? Not really, but here is some additional research I found.
1. Cannabidiol doesn’t seem to be listed on the Controlled Substances Act (CSA).
Where the confusion seems to rest is in the fact that the Controlled Substance Act, doesn’t include the Cannibadiol gathered from the mature stalks of the Cannibus plant aka Hemp Plant. Yet, the DEA Schedule 1 seems to list it in combination with DEA Code 7360.
So, I kept digging trying to figure this out on my own before going to Kannaway directly to get any paraphilia (Marketing collateral) they might have on hand.
Troy’s Thoughts: From what I have gathered if when testing for controlled substance 7360 (Marihuana), that traces of 7273 (Cannabidoil) could be present also. However, in studying the DEA Schedule 1 list, 7273 (CBD) doesn’t appear as an individual line item, as does all the other banned controlled substances. Legal minds, who have rendered opinions, seem to conclude that DEA Code 7273 Cannabidoils is NOT a banned substance when gathered from the mature stalks of the hemp plant.
But, this brought up a new question for me… Could Hemp Oil be listed inside the definition of Marijuana inside the Control Substance Act? And for those of you who are thinking “Doesn’t he know how to spell Marijuana/Marihuana I have found it listed inside official documents spelled both ways.
As I listed above nowhere inside the CSA (http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html) is hempseed oil, hemp oil, or anything close to it listed as part of the marijuana/marihuana legal definition.
Troy’s Thoughts: I’ve concluded that if CBD is a natural occurrence from harvesting Hemp Oil using a cold press from the mature stalks of an industrial hemp plant, then it’s not illegal to use or sell it. But… Just like all opinions, there is bound to be those who will totally disagree. 🙂 I figure as the Industrial Hemp Industry matures we will see more clarity come from all current and future regulations.
I almost forgot… I promised in the video above to share the amounts of CBD in each of the Kannaway products (at least as of this editorial.)
Serum (2 oz bottle) 35 mg
Moisturizer (1.75 oz bottle) 25 mg
Toner (4 oz bottle) 25 mg
Cleanser (4 oz bottle) 10 mg
Exfoliant (4 oz bottle) 10 mg
Salve (1.3 oz jar) 50 mg
Capsules 4 mg per capsule (60 caps per jar)
Soak (16 oz bottle)
10 mg HempVap 30mg per atomizer
Kannakick 5mg per chew