Did the FDA ban CBD?

Be warned: the FDA is looking into CBD.

Be warned: the FDA is looking into CBD.

Cannabidiol, commonly known as CBD, is currently high on the FDA’s priority list. As many of my readers will know, the FDA sent out official Warning Letters on February 4, 2016 to several retailers of CBD products. All of the letters were similar and later published on the FDA’s website. Click here to read the letters. A question that I often get is whether the FDA has banned CBD.

Medical claims cannot be made about CBD products, nor can they be marketed as dietary supplements. The FDA (short for “Food and Drug Administration”) is responsible for protecting public health in the USA by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the food supply, cosmetics, and products that emit radiation. Click here to read the FDA’s official statement about its activities and mandate, called “What We Do.”  CBD has gotten the attention of the FDA for at least a few reasons. Primarily, the FDA is concerned about CBD suppliers making health claims. Additionally, and for reasons I’ll discuss below, the FDA contends that CBD cannot be marketed as a dietary supplement. Finally, the FDA has concerns about how much, if any, CBD is in any given batch of product being marketed and sold as CBD.

The thrust of the February Warning Letters was that the claims made by the CBD retailers established that “that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“the FDA Act”) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Despite enormous evidence that CBD offers a wide range of health benefits, this warning was pretty non-controversial. You cannot market a substance as treating any specific disease or symptom without FDA approval. As much as many of us think the FDA is overly-influenced by large pharmaceutical companies who are driven more by the profit motive than the desire to help treat disease and alleviate suffering, the fact is that we are better off having oversight as to what types of health claims can be made about particular products. The FDA does an imperfect job (at best) at this task, but the job itself is useful and beneficial to society. I’d like to see CBD approved to treat specific diseases; however, until that time comes it cannot and should not be marketed as a treatment for any specific disease or ailment.

Additionally, in the Warning Letters the FDA claimed that the retailers were illegally marketing their products as “dietary supplements” because CBD products are excluded from the definition of dietary supplement under section 201(ff)(3)(B)(ii) of the FDA Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. This is more controversial. The FDA asserted that if an article, 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. The FDA contends that substantial clinical investigations have been made public by virtue of GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. The problem, and hence the controversy, is that there are credible claims that CBD was being used as a dietary supplement prior to the initiation of the clinical investigations, claims which if true would make them “grandfathered” in and allowable as dietary supplements. The FDA’s position is currently firm on the matter. If you have specific information about CBD being used as a dietary supplement prior to the GW Pharmaceutical trials, I encourage you to contact the FDA. It may be that CBD is ultimately accepted as a dietary supplement by the FDA. Until such time, it would be irresponsible of me to recommend that anyone market their CBD products as such.

The FDA has not banned CBD. Based on the current state of the law, CBD products do not violate the FDA Act so long as they do not make medical claims and/or are marketed as dietary supplements. And, of course, products that are marketed as CBD but which contain little to no CBD may be violating any number of laws. Fortunately, there is a growing number of quality-driven CBD companies, many of whom I represent, who voluntarily obtain lab testing and willingly publish the results. This is a good practice because self-regulation and a focus on quality will help the growing hemp, cannabis, and CBD industry thrive.

I am a business lawyer who provides legal representation to CBD businesses, laboratories, and other legitimate businesses in the cannabis and hemp industries. If you have questions about hemp law, CBD law, or cannabis law please do not hesitate to contact me. I’d love to hear from you. Thank you for reading my blog.

Posted June 14, 2016.

7 thoughts on “Did the FDA ban CBD?

  1. Jeff Potts

    Mr Kight, I’m a fan of your blog. I love your eloquent and informative approach to these topics. Lots if good info, easily digested and clearly relevant. Thank you very much, for you’re invaluable, powerfully informative, legal opinion.

    Although you may have far more belief in the justification for the FDA’s existence, than I, (I think they’re essentially a tool for capitalist fascists, they have less concern for public safety than they do for corporate profiteering, and have long since out lived their original protective value to our society. I’d say, it could be argued, rather than protecting us, they’ve, in fact, endangered our lives, numerous times, often in the guise of protection, which I would consider criminal behavior and justification for their abolishment: by authorizing many legal, and highly addictive, chemicals, while banning others – usually botanicals that cannot be patented – that are some cases far superior than their synthetic, legal analogues), I do wholeheartedly agree that the quality control issue is a serious issue. The ability to self regulate our industry, with some formal rules created, should be allowed room to mature. I feel that a dynamic system of self governance is a far superior means of establishing said rules than any corrupt, authoritarian, institutional agency such as the FDA.

    Furthermore, there’s a growing perspective among many, (mostly) independent scientists, that the nature of the endocannabinoid system, and it’s relationship with cannabinoids, may, in fact, justify an entirely different category for the cannabinoids. Cannabis has apparently evolved with humans over millennia, to such an extent that our optimum health potential may be reliant upon them. To break it down Barney style, cannabinoids are not supplements, at all. Instead, they are considered by some scientists to be, “essential nutrients.” Under this classification, I do believe the FDA has zero authority to regulate these compounds. Question is, how do we secure that classification of, “essential nutrient,” to our precious cannabis plant, the cannabinoids and any other compounds that all function synergistically to produce the most powerful essential nutrient known to man, with over 700+ medical applications known to date?

    Sorry, I know, It’s pedantic and mediocre to make such bold, opinionated statements with no evidence to back it up. But, that’s what my good pal, Google, is for, So…go see for yourselves. This response is already too long.

    Thanks again, Mr Kight. You’re a local treasure.

    JK Potts

    Reply
    1. Rod Kight Post author

      Thanks for your kind and thoughtful comments. I have read quite a bit about cannabinoids being more in the nature of “essential nutrients” than “medicines” and, from what I’ve learned, tend to agree with that position. I am no apologist for the FDA and, in fact, believe as you do that its policies and failings have caused a great deal of harm. As a lawyer, my philosophical leanings tend toward working to improve a flawed system rather than abandoning the system altogether. I do believe that the FDA’s essential functions and missions, at least as the pertain to proper labeling and making product claims based on verifiable science, are valid and useful to society. It just needs an overhaul. Thanks for reading the blog and for commenting.

      Reply
    1. Rod Kight Post author

      This is semi-good. Certainly, almost any move towards legalization and away from Schedule I should be seen as positive. This will help with banking, tax issues, research, and access. However, Schedule II may help consolidate the cannabis industry in the hands of a few large corporate conglomerates, rather than as the small-business model which has emerged in CO, WA, and OR. (I think that the small-business model is much better.) Also, you won’t likely be able to get a prescription for the plant/flower, but rather a prescription for a pill or “edible” style medication. And, based on the article below, if Hillary Clinton becomes President then we’re probably stuck with Schedule II since it’s the most helpful classification for her friends in Big Pharma. Ideally, it would be completely unscheduled, or at least move further up the ladder to schedule 3 or 4. Here’s the article: https://www.denverpost.com/2016/06/17/how-the-dea-should-classify-marijuana/

      Reply
  2. dic renet

    After much research and meditation on the subject; i believe billary clinton is setting up to win the presidency. i’ll just leave the Cannabis information i feel is pertinent. bernie sanders camp (Delegates) have already won 81-80 the inclusion of Federal Cannabis legalization. i believe billary, OF course, will include Cannabis FREE for Veterans with PTSD and possibly pain management as well. Thus, setting up Medicinal Cannabis for the general population at large (More importantly, setting in place a system for insurance to pay for Cannabis as a Pharmaceutical Drug). No one SHOULD read into my characters placed side by side, other than what is has been typed out. DE scheduling Cannabis is the ONLY thing that makes sense. Although, i am sure the dea and the powers that be, will do everything in their power to ensure that this does NOT occur. On another note, Solar Energy (Storage) for the win

    Reply
  3. Christopher Robideaux

    Hi Mr. Knight,

    I wanted to share with you an email I just today sent to Mr. Trey Gowdy, who has been busy rooting out corruption in DC, regarding the DEA’s unthinkable declaration of CBD as a Schedule 1 drug. As you can read, I pointed Mr. Gowdy to your site for more information about CBD:

    Hello Mr. Gowdy,

    Firstly, I would like to say THANK YOU for all your hard work on Capitol Hill rooting out corruption. We the People greatly appreciate your efforts, and are behind you 1,000%.

    As for the subject of this email, as you may be aware, having had these clowns in your firing line already, the DEA has now unilaterally declared CBD — cannabidiol — a potent cannabis extract with no psychotropic effects that is healing millions of people, including children of seizure disorders and symptoms of Autism — to be a Schedule 1 “drug”. It has been legalized for years now, and many proprietors and retailers sell it legally both online and off. The FDA’s warnings about CBD have been found by independent scientific study to be baseless. This move by the DEA appears to be a brutal, warrantless crackdown on users/patrons of a substance they simply wish to control (likely on behalf of lobbying pharmaceutical companies who are losing profits due to this amazing herbal healer). Whatever the reasoning, it is completely absurd, outrageous, and downright un-American. This product is legal in many states — as is cannabis itself now, as it is in Oregon, Washington, and CA. It is mostly derived from the hemp cannabis plant, and hemp is completely legal everywhere, as you may know. Can you picture gangs of armed-to-the-teeth DEA agents kicking in the doors of peaceable, non-combatant families trying to heal their children’s (and their own) illnesses, and others who are simply using a plant extract to try to heal their bodies? This Draconian, inhumane move by this abusive agency simply cannot stand. I plead with you to do what you and the House Committee on Oversight can to reign in this obvious and blatant abuse of power by an alphabet agency accustomed now to having underage teen sex parties, policing and jailing people for profit for non-violent drug “crimes,” and who knows what other mendacity, chicanery, and criminality. It is likely that the pharmaceutical industry is behind this unlawful action. The DEA needs to be sent a strong message that you are not corporate lackeys or bagmen — you are answerable only to the American people and Congress, and having this product be a Schedule 1 drug is NOT the will of the People, nor is it founded in the law at all.

    If you are not familiar with the CBD healing plant extract that’s giving families, children, and people everywhere hope for healing, here is a good website to check out: http://www.leafscience.com/2014/02/23/5-must-know-facts-cannabidiol-cbd/.

    I thank you once again for your efforts against evil and corruption in our government agencies. You are a true American hero, and we are all cheering for you, Jason Chaffetz, et al. who are making history and bringing about amazing changes in our nation’s capital.

    Sincerely,

    Christopher Robideaux
    Author/Researcher

    Reply
  4. Shannon

    So cbd and thc being illegal/banned/prohibited is wrong, I think (for the most part) capitalism is a good thing.

    Prohibition worked well didn’t it? And yet alcohol does much more damage to people / families
    Or why won’t you ban alcohol or tobacco? The chemicals really help your heart, liver and lungs.

    But just think of how many companies that would be seriously hurt/go out of business beyond big pharma, if you could (more easily without fear) grow your own medicine, clothes, fuel, plastics, paper… Maybe we should keep it illegal to save the trees… Oh wait it takes much longer (and more damage to the earth/people) to replace our trees than a weed that grows easily in many places. Yea this makes much sense.. NOT!
    Wait these are these big companies “too big to fail”… Yea that worked out good.

    Or just maybe those that abuse it are jumping out of windows, damaging their souls, killing people with axes… Hey parents tell your kids, this is a dangerous product!

    There is people who abuse every product known to humans… Should we ban excessive food, soda, sugar, pain pills use? No, pills ban would hurt pharma… Smh

    Indoctrination is one of the worst things govts and the greedy can do to people.
    It is naive to think they are doing this to protect us.

    And wait in our founding fathers days was it untrue that farmers were taxed if they didn’t grow hemp?…or am I indoctrinated?

    Psst To politicians: here is some money to keep things illegal we dont like or would hurt our bottom line.
    From lobbyists / big business.

    Hemp, marijuana, cbd, thc whatever it is should not be your choice (without the majority of peoples input) to decide its illegality (or whatever you want to call it).
    I say if half (or more) of the states which we have decided to allow this product then the feds/any govt department needs to GTFO… Doesn’t that say its what the people want?
    We the people tell the government what to do, NOT the other way around! YOU WORK FOR US.

    Kight may be on our side but the govt and big business is not.

    Yes keep narcotics, and other hard drugs controlled.

    The plant may need to be regulated by the states not the feds.

    ATTEN: politicians we are watching those who listen (and don’t) to the people…If you want to remain in power, START WORKING FOR US!
    or is money more important to you?
    I’m not a partisan but look what happened to the Democrats in 2016 elections… BTW I didn’t vote for Trump.

    Signed
    TBI, epilepsy and many other disabilities patient that lives in a state of indoctrination and wrong control.

    Reply

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