$32,500 for CBD Oil?

If we don’t change a key FDA policy, that’s how much you may be forced to pay if you want to purchase CBD oil. Action Alert!
For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company which holds drug market exclusivity requests FDA do so. Unless we change the rules, we may see a government-sponsored monopoly on CBD oil, and in the near future, additional monopolies on other cheap, safe, and effective supplements.
This is happening because of a back-channel that allows natural supplements to be turned into drugs by the FDA. It works like this: if a company is investigating a substance as a drug, FDA rules give the company market exclusivity on that substance—even if it is currently being sold as a supplement. There are two exceptions: if the supplement was “marketed in or as a dietary supplement” before 1994, or if a supplement company has filed a “new supplement” notification with the FDA before the company’s investigation began. (Recall, too, that the FDA has not completed the policies for submitting a “new supplement” notification, so supplement companies don’t even know how to comply!) Pyridoxamine, an important form of vitamin B6 was removed from the market by the FDA through this exact same mechanism.
This means that, at any time, GW Pharmaceuticals, the manufacturer of the CBD drug, can ask the FDA to remove cheap CBD oil supplements from the market, and the only option consumers will have is their new drug that costs $32,500 a year. This hasn’t happened yet, but we think GW is simply waiting for the market for CBD oil to grow—which it is. When it reaches a tipping point, then GW can ask the FDA to remove all the CBD supplements, and wait for the cash to roll in from consumers who don’t have any other choice.
This threat to affordable CBD oil shows how broken this system is. An opioid epidemic is ravaging our country, with drug overdose deaths surpassing car accident fatalities. People are addicted to and dying from FDA-approved drugs, yet the agency is poised to eliminate consumer access to a non-addictive, cheap, safe, and effective alternative in CBD oil—all so one drug company can charge tens of thousands of dollars for what currently costs a few dollars.
The Senate Farm Bill took one step to protect CBD oil by legalizing the growth of hemp (though it remains to be seen if the final bill will contain this language), but that alone will not preserve consumer access to this important medicine. ANH-USA is crafting legislation that will, among other things, protect CBD oil and other natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement. These rules should apply retroactively to protect CBD oil and other substances that have already (or are likely to be) removed before this legislation becomes law.
Until we close this loophole, we will see drug companies continue to turn our natural dietary supplements into drugs. News headlines are filled with Phase II or Phase III drug trials failing; Big Pharma is in search of a sure thing, and what could be better than supplements that have demonstrated health benefits? The FDA will not protect us—they’re in on it! More drugs mean more user fees—more money—for the agency, so don’t expect the FDA to defend your access to supplements.
Action Alert! Write to Congress and the FDA and tell them you support a legislative change that eliminates market exclusivity for INDs filed on substances that are currently sold in the market as dietary supplements. Please send your message immediately.

22 comments

  1. CBD oil only enhances what the body does naturally. It’s just that being natural, and freely given to the earth, it doesn’t create corporate profits.

  2. We have a chance so don’t be shy about pressuring your federal congress representatives and senators. More than half the states were brave enough to open the doors to this medical miracle and those people have their stars still in hand, plus there’s state income at risk for cbd oils… so hammer congress people to smash fda greedy drug lords’ planning

  3. You can make your own CBD oil if you go to CO, or WA or one of the other states where they legally sell MJ. Directions are online. I don’t want to give away too much information . . .

    1. I’m not an expert on this, but my understanding is that marijuana is bred and raised for high THC and industrial hemp is more likely to be bred and raised for high CBD.
      From a documentary I watched: Part of the way they force high THC is to isolate female plants from male plants so these sexually frustrated female plants will make much more THC. They do not do this for industrial hemp which that combined with genetics make it more likely to have low THC and high CBD which is what is preferable for making CBD oil.
      CBD oil is being used to help people with chronic pain, cancer, autism, and other illnesses for which conventional medicine is highly ineffective and likely to use toxic and addictive medications that are highly profitable.
      The founders of the real United States (not the fake modern one) would have been appalled by what is going on in almost every area of society, including healthcare.
      modern USA = Unrelenting Sickness for All, as that is so much more profitable for big corporations than a healthy population

      1. Just get some of whatever you can get ahold of and use it to make the oil. If you know it has high THC just use less of it. Most of the people I know use it transdermally, some use it sublingually if they know what they’re using and adjust the dose.

      2. Selective breeding has turned recreational marijuana and medical marijuana into two very different plants. Recreational marijuana, as you say, is bred for maximum THC. But medical marijuana is bred to maximize CBD.
        It also depends on what part of the plant you use. Hemp seeds do not contain THC. A lot of hemp oil is made from the seeds only, and is thus free of THC.

        1. Hemp is completely different from the MJ used by people to get high. We used to call it Kansas ditch weed and you would literally get a headache if you tried to smoke it. It was grown to make rope, not dope.

          1. “Hemp” is currently being used as a generic term for cannabis of all varieties. It sounds less scary than “cannabis” or “marijuana”. A lot of companies are now marketing various sorts of non-psychoactive edible oils derived from cannabis plants, and they are using the term “hemp oil” for legal and marketing reasons. Some of them have recently taken to using the term “full-spectrum hemp oil”.
            But you’re right about hemp grown for fiber. It was grown in my home county for rope during WW1, and it is still said to grow wild. Those who have smoked it say it’ll get you sick before it gets you high.

    2. You don’t need MJ to make good CBD oil.
      Most high quality CBD is made from Hemp therefore eliminating the THC factor and making the oil legal to buy everywhere…Certain Hemp strains are bred to be high in CBD, terpenes, CBN etc. all in the CBD oil
      Just make certain it is a high quality brand CBD.

  4. Maybe the comments to Congress should include shutting down the FDA entirely?
    Some points to support that the agency is at best completely incompetent and more likely also thoroughly corrupt and should therefore be abolished:
    1) It took two decades to write draft guidance for supplement companies to submit information on new ingredients as called for in the DSHEA of 1994.
    2) They take many years to do anything about drugs that are killing tens of thousands (or more) people even when used as intended. Drugs like Bextra, Vioxx, Trasylol, and Premarin are among them.
    3) FDA even covered up the problem with mercury contamination in high fructose corn syrup, apparently to protect the corporations poisoning the food supply. The agency is incapable of protecting public health because it does not care about the public, only about corporations.
    4) FDA approves the use of thimerosal containing medications (such as vaccines), even though thimerosal is toxic and the only safety study for it is a 1931 Eli Lilly study in which all the severely ill study participants died (yes, they all died) and therefore it was said to be SAFE.
    5) FDA approves dangerous Pharma drugs that cause disease, violence, and deaths such as statins and SSRI antidepressants. Then they do nothing meaningful to encourage safer prescribing of these drugs such as to point out the more appropriate first line use of other much safer and less expensive options such as omega-3 fish oils and active form B vitamins that often (probably almost always) work better than the drugs.
    6) There is a pattern of revolving door jobs with the head of the FDA company from Pharma companies and after leaving government going back to Pharma company. Thus industry effectively runs the FDA.
    Obviously the FDA doesn’t care about the typical American being healthy. They care about corporate profits first and foremost.
    The agency has obviously become just a fascist scheme to suppress competition and pump up profits for Pharma and other huge companies.
    It shows time and again that it refuses to do its basic task of protecting public health in both drugs and food.
    Bottom line is the FDA harms the health of the American people while costing lots of taxpayer money to run.
    SHUT DOWN THE FDA !
    Maybe it is time for a whitehouse.gov petition about shutting down the FDA because of its abusiveness and incompetence?
    Perhaps it can be replaced with an agency that does no regulation but only monitoring and reporting to the public and states for them to take action as they see fit. The replacement would do nothing but test both widely used food and drugs for dangerous contaminants along with random sampling of the rest and then issue reports on findings and alerts when something obviously very dangerous (e.g. excessive lead in baby food) is found.
    It seems like that sort of agency might be less subject to abuse because it cannot take anything off the market or be used to enforce monopolies.

    1. Even if we the people can never get the FDuh actually SHUT DOWN, we could/should at least ask our reps on the hill to ponder why in the world this agency is in charge of both drugs and food?? We need to make it so they do not wield that much power.
      I feel that way because the FDuh and the USDuh are always in the process of trying to eliminate our healthiest foods, by some referred to as superfoods, such as raw milk. I grew up drinking raw milk but between the FDuh and the State laws, it is impossible for small dairy operators to continue to supply raw milk (cow or goat) around here. TPTB have harassed these providers right into the ground. The State Dairy and Egg Board is finishing what the FDA starts in that regard.
      Either get rid of the FDA or at least reign in their power. IMO they do a lousy job of regulating the safety of drugs, too, so why are they the arbiters?

      1. I agree USDA is a fascist corporate profit building agency, also. Shut it down, too.
        You could get some small dairy goats, such as Nigerian Dwarf goats, to have your own raw milk supply. They are great for landscaping maintenance and eat a lot of the typical plant debris generated by a household, such as plant trimmings and citrus peels, that chickens cannot eat.
        Oh, get some backyard chickens, too. Chickens eat almost anything coming out of the kitchen and when given access to bugs and grass and other greens they make much better eggs than you are likely to find at the grocery store.
        Government knows this, which is why some governments are keen on shutting down the ability to have small animals and gardening at people’s home. These psychopaths believe government must force the masses to buy toxic low nutrient processed foods so they can be forced to buy sickness-promoting monopoly drugs so they beg for universal healthcare insurance and enrich and empower Big Pharma and Big Government to even more effectively rob them blind into slavery and ultimately a grave they may crave to escape the miserable mess.

        1. My town does not allow for backyard critters of any kind. I can buy local goat milk. The people who produce it were also selling raw cow milk for a while, but the state hassled them until they gave it up, so now I just use goat milk. I like it, my DH does not. I use it to make my easy homemade ice milk. Goat milk works just as well as cows milk for that, but I do miss the cow milk for some other reasons.
          We buy pastured eggs from a local producer, however, her chickens are quite fussy and sometimes she has eggs coming out her ears and other times weeks will go by and she has none. It’s very unpredictable. I would love to have my own chickens but the only way that would happen is if we moved outside the city limits and the chances of that happening anytime soon are somewhere between slim and none.

    2. Excellent comment! The FDA is the US agency in charge of the UN Nazi created Codex Alimentarius; a nutrient-deficient slow starvation diet that mandates irradiation of all foods, homogenization of all dairy products, mandatory addition of toxic food additives, and includes a ban on all natural products and on vitamin and mineral supplements that supply minimum dietary requirements of their ingredients.
      The FDA has a negative impact on the health of US citizens.
      IMO the current attack on Alex Jones’ nutritional products (which is probably warranted) is a veiled attack on nutritional supplements in general, in the context of Codex Alimentarius, and that Jones has been targeted as a means of labeling nutritional supplements a right-wing ‘conspiracy’ scam.

      1. You should assume this is a complete setup and Alex Jones is controlled opposition. They will use him as the scapegoat to effectively ban health supplements. Big pharma has been drooling over that possibility for years, it’s a “hole in their net” of complete pharma taxation.

  5. That’s a very lofty goal considering the existence of the black market for it. Consumers will just go back to that black market.

  7. 1) the US courts “including the supreme court” have all consistently ruled that the government has NO DUTY TO PROTECT YOU “google that phrase, no duty to protect you, to confirm that what I am saying is correct.
    2) there is zero authority in the constitution for the FDA to exist, nor for it to write laws or make them up to suit the pharmaceutical industry!
    So no constitutional authority to exist or make up laws, and no duty to protect anyone.
    We are being DEFRAUDED by a private for profit corporation known as the FDA, masquerading as a legitimate government agency!
    To further buttress my argument with fact,. the FDA is a PRIVATE FOR PROFIT CORPORATION
    Here is the fda, THEY TELL US IN WRITING THEY ARE A PRIVATE COMPANY! https://www.manta.com/c/mb4bds8/us-food-and-drug-administration‘
    The entirety of what we’ve been fraudulently lead to believe is legitimate government, is nothing more than PRIVATE BUSINESSES!
    EVERY SINGLE ALLEGED GOVERNMENT AGENCY YOU CAN THINK OF, IS LISTED AS A PRIVATE BUSINESS! ALL OF THEM!
    WE HAVE NO GOVERNMENT! ‘
    US SENATE https://www.manta.com/c/mm4qj5k/senate-united-states
    SUPREME COURT https://www.manta.com/c/mmg5dx2/us-supreme-court
    CONGRESS https://www.manta.com/c/mmny8xd/congress
    FBI https://www.manta.com/c/mtkd5gt/fbi
    DOJ https://www.manta.com/c/mhynk5t/us-department-of-justice
    US ARMY https://www.manta.com/c/mmcyb9v/us-army
    AIR FORCE https://www.manta.com/c/mm28tw1/united-states-department-of-the-air-force
    IRS https://www.manta.com/c/mr53k2q/internal-revenue-service
    ALL OF IT IS FRAUD! YOU’VE BEEN LIED TO, YOUR ENTIRE LIVES, BY THE VERY PEOPLE PERPETRATING THE FRAUD!
    There is no authority for our FAKE government to do any of this AND THEY KNOW IT! THEY ARE ALL IN ON THE FRAUD!

  9. You do realize that Congress has told FDA that they MUST create a regulatory pathway for CBD to be sold on the open market, right?

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