Any guesses as to how this plays out for the smaller labs out there? I know with a new drug that the pharma companies pay millions for clinical trials. Reading this article it sounds as if any product (for consumption) that has any added CBD will require a clinical trial.
FDA Cannabis CBD/THC FAQ: FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) | FDA
12. Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), or 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 sections 201(ff)(3)(B)(i) and (ii) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.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 conclusions that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.
13. Is it legal, in interstate commerce, to sell a food to which THC or CBD 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 substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or 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 the drug was approved or before the 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 THC or CBD. 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 THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.
As a non lawyer it sounds like a death blow? But it has remained unenforced for 2+ years.
Certainly feels like doom for a small operation.
If all the small operations want to survive, they can petition the FDA, their state and federal legislatures, their departments of agriculture, and their departments of health. This is the time to get creative! Make alliances, raise funds, buy lobbyists!
The FDA’s stance has always been that CBD can’t be added to food. Green roads got a Cease and Desist for this a year ago. They have also always had the stance that you can’t make any claims regarding what CBD can do for someone unless it’s approved through them. This is mostly nothing new.
The regulations that come out of this could make things crazy but who knows. Hopefully they just regulate it as a supplement.
The entire market certainly is on unstable ground. Things can change via the FDA very quickly.
My take is that as long as you don’t make claims you’re ok in oil. But the real kicker is adding it to food or drink even without claims. Because it has been tested in the past by the FDA you have to get approval. This means coke will have the money to apply but the little guys won’t.
sounds about right
Like that means we all could do it that easy correct?
I feel like it might be a little more regulated than that. As in you can’t make it in your kitchen at home but I think this is somewhat legit.
No. Well…sure you can, but the FDA, and the government, will see you as selling a “Rx tainted supplement” (The FDA Found Hundreds of Supplement Brands Tainted with Rx Drugs. Most Weren't Recalled. | Live Science)
THC from hemp is now not schedule I, but is now schedule III. CBD w/ less that 0.1% THC from hemp is schedule V. Both are approved drugs by the FDA, and there for not allowed to be food supplements. It is cut and dry now after the farm bill, no more wink and nodding.
I, and a few others, see two paths for hemp cannabinoids. None of which the average CBD slanger really wants to hear.
keep it interstate only, and abide by your states Hemp/CBD laws. This is a state by state patchwork of laws and regulations. More than likely it means folding back into the existing MMJ/cannabis programs in each state. No possibility of interstate commerce, and most in-state MMJ programs have very large barriers to entry at this point. Teaming up with a state MMJ biz might be a path forward.
There MAY be a path for hemp derived cannabinoids through NDI’s. (New Dietary Ingredient) application. An argument could be made that a relatively precise blend of cannabinoids in low concentrations in food could be considered i) safe ii) different enough as a medication in total (think entourage effect) to not be classified as a CBD extract w/ less that 0.1% THC. This, if it could get passed (and the is a really big IF for a lot of reasons), would allow hemp (and all cannabinoids really, provided they meet the formulation submitted in the NDI) to be added to food/supplements and shipped interstate and exported/imported. These NDI’s take 1-2 years to complete, usually require animal and sometime human safety data. Also, showing a history of human use helps. And, no you can’t keep selling while you wait for the FDA to rule. If you are caught wholesaling CBD, CBD formulations, or retailing any of it, I think they fine you, pull the application, or both.
Other than these options one could just say FTW and keep the website up and shipping CBD capsules and vape pens until you get a take down letter from the FDA. May never happen, or it could happen tomorrow. FDA has been pretty lax on the CBD industry to date, but I think they have been waiting for the farm bill so the water was less muddy to start real enforcement.
It’s not a great time to be selling CBD…
Every time we try to do something they try to fuck us.
you are incorrect here big time. The FDA has yet to put out their stance on CBD in generally. The only thing that has been reclassified is GW’s product that they have a patent on. Outside of that Schedule V has yet to apply to anything but that product.
It seems the FDA will end up regulated the market other than GW as a supplement but who knows. We won’t know until they figure it out which probably won’t be for months.
um from Dec 20, 2018, pretty sure they have their stance set out. It could not be anymore clear.
"In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act. "
" Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug."
and the ray of hope…
“In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&;C Act are met, including those required for food additives or new dietary ingredients.”
the last sentence to me is basically saying, if you can prove to us in a NDI this stuff is safe for consumption as a food ingredient, we might carve out a hole for you.
That is literally the same as it’s been since day 1 of the CBD industry nothing has changed yet.
Oh, I agree FDA has said pretty much the same thing all along, but I suspect real enforcement is right around the corner for one reason. Up until now they (FDA) could say about CBD, “It’s DEA’s issue, they are selling a schedule I drug.” Now it is clearly the FDA’s issue, as it’s no longer schedule I. It maybe another set of letter at first, but I bet they start targeting producers and not just retailers next.
Plus they can now say, if you are sick and need CBD ask your doctor, we have a licensed drug right here. They did the same thing to AIDS and cancer patients in the 80’s with Marinol and smoked cannabis. Need THC, we have it right here…
The real interesting moment will happen when a large scale producer (there are only 20 or so in the US) gets a cease and desist and decides not to stop and take it to court.
2019 is going to be real interesting.