05/06/2016 / By fdanews
MAJOR CORRECTIONS: I’m issuing a huge correction / clarification to this story after speaking with people in the hemp industry. They’ve pointed out that my article, although posted with the best intentions to help keep CBDs legal and readily available, was freaking out CBD retailers who thought some sort of new law had been passed outlawing CBDs.
In no way did I intend to disrupt CBD retailers with that article! My only goal was to sound the alarm of how to FDA is attempting to destroy this entire industry, and help create a backlash that would keep natural medicine legal in America.
The FDA is trying to destroy the CBD industry with regulatory assaults, but the industry is pushing back (and the weight of the evidence and the science is on the side of the hemp industry). Nevertheless, the FDA is a formidable opponent and they can wage all sorts of regulatory assaults against natural substances they wish to regulate out of existence.
So I’ve decided to post a serious correction / clarification to this story to make sure nobody misreads what I’m asserting here, and I apologize for any misconstruing of my intention in posting this, which was to ALERT people to the regulatory assaults of the FDA that are trying to destroy the hemp extract industry. As a food scientist and natural medicine activist, I am 100% pro hemp, pro CBDs and pro plant medicine.
Essentially, my use of the term “outlawed” in the title of my original article was misconstrued. By “outlawed,” I meant the FDA essentially writes its own “regulatory laws” and has posted a clear statement on its own website which states that CBDs cannot be sold as a dietary supplement. This is a regulatory attack on hemp extracts, but it is not technically a law that was passed by Congress. I regret my choice of the word “outlawed”, and I will be more careful in my choice of words when covering this issue in the future. In the article below, I have replaced any reference to “outlawing” with the more accurate terminology of “regulating out of compliance” or similar language.
But make no mistake: Cannabidiol is on the target radar of the FDA, and they are waging a campaign of regulatory intimidation to try to destroy the marketplace. If they get their way, they will EFFECTIVELY outlaw CBDs via regulatory assaults. Their goal is the same: destroy the CBD marketplace.
My hope is that they fail in their efforts, of course.
Hemp oil extracts containing CBDs (cannibidiols) are such a threat to the pharmaceutical industry that the FDA is now invoking totally insane justifications for outlawing them.
UPDATE: This article has caused a tremendous amount of discussion and a lot of disinformation is flying around, so I’m adding these notes for clarification.
One thing I’ve learned is that the people who sell CBD oil don’t even know there is more than one CBD molecule. Some have attacked me for using “cannabidiols” in a plural form, because they are ignorant of the full chemistry of CBD synthesis and molecular variants. Even wikipedia lists seven CBD molecular variations, each with its own name. They are named delta-5-cannabidiol, delta-4-cannabidiol, delta-3-cannabidiol, delta-3,7-cannabidiol, delta-2-cannabidiol, delta-1-cannabidiol and delta-6-cannabidiol. They share the same elements in their molecular composition, but they have variations in their double bonds, meaning they behave slightly differently when interacting with other molecules.
Secondly, the FDA did attempt to “regulate into non-compliance” CBDs as a dietary supplement. It’s printed right on the FDA’s own website: “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…” The FDA has also started sending aggressive warning letters to CBD product marketers.
However, the industry is rightly pushing back against this unjustified regulatory classification by the FDA. In fact, the industry needs to push back even harder, or else the FDA will steamroll everyone…
Some of the people commenting on this article have said you can just sell CBDs as a “food” and not a dietary supplement. UPDATE: Efforts are under way to GRAS list cannabidiol with the FDA, but CBD is not currently GRAS listed, meaning it cannot be sold as a food without attracting regulatory scrutiny from the FDA. I spoke with a highly competent regulatory attorney who confirmed all this.
There is no question that some smaller companies are right now selling hemp oil with CBD content, but this does not mean such sales are immune from FDA regulatory prosecution (and intimidation attempts). The FDA tends to go after larger suppliers first, ignoring smaller suppliers due to its own limited resources. For this reason, smaller suppliers of CBD supplements or hemp oil products containing added CBDs may be able to continue selling such products for a very long time without facing regulatory action. Nevertheless, that regulatory risk is ever present and may be invoked at any time by the FDA to target that company and confiscate its products. Selective prosecution is one of the key regulatory weapons of all federal agencies. This is how they protect their pharma friends and punish the competition. This is why the hemp industry needs to push back HARD against the FDA!
CBDs are non-psychoactive compounds found naturally in hemp plants. They work so well as powerful natural medicine that people everywhere are realizing CBDs work better than pharmaceuticals for treating epilepsy, seizures, neurological disorders and other serious health conditions (including HIV infections).
So the FDA has just launched a massive regulatory assault against CBDs by invoking the most insane logic you’ve ever heard. Here’s how it goes:
1) CBDs work so well that drug companies are now investigating them to be approved by the FDA as medicines.
2) Because CBDs are being investigated by drug companies, the FDA has granted CBDs status as being “investigated as a new drug.” In the FDA’s own language from their website, “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.”
3) Because CBDs work so well and have been authorized for drug investigations, the FDA is now attempting to regulate them out of existence as dietary supplements. Per the FDA’s own website: “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.”
4) Now the FDA has begun sending warning letters to CBD makers, claiming they are in violation of FDA regulations because they are selling “adulterated products.” Adulterated with what, exactly? CBDs, of course! “The debate over hemp CBD’s legal status continues after FDA sent eight warning letters to manufacturers of CBD dietary supplement and food products earlier this month,” reports Nutritional Outlook. “The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration.”
In other words, the FDA just handed Big Pharma an absolute monopoly over CBDs (hemp oil extract) by ridiculously claiming such natural products are “adulterated” with molecules (CBDs) that the FDA says might one day become a drug.
“Drugs,” according to the FDA, are substances that are proven to treat, prevent or cure a disease, and thus the FDA’s own logic admits that CBDs must be able to treat, prevent or cure diseases, otherwise they would be useless as “drugs”.
But when a dietary supplement company makes the same claim, they are hit with aggressive warning letters from the FDA, threatening to shut them down, confiscate their products and seek criminal prosecution of the company executives.
Do you see how this twisted, corrupt regulatory tactic can allow the FDA to instantly criminalize any dietary supplement, vitamin, herb or plant extract?
Vitamin D, for example, could be outlawed by the FDA announcing that it has granted “Investigational New Drug application (IND)” status to any drug company studying vitamin D.
Using this same corrupt, mafia-style tactic, the FDA could essentially “outlaw” resveratrol or even vitamin C, denying Americans the right to access safe, affordable, natural substances that are routinely found in nature.
If humanity is ever to achieve medical freedom, we must end the FDA’s outrageous medical monopolization of plant molecules such as CBDs. By allowing this corrupt, criminally-run regulatory agency to criminalize every molecule found in nature, our nation’s lawmakers condemn us all to life in what can only be called medical totalitarianism under FDA tyranny.
Any time a healing substances is found in nature, the FDA can simply assert that such molecules are now in the process of being studied as drugs and are therefore illegal to sell as dietary supplements even though they were developed by Mother Nature, not drug companies.
This FDA tactic is nothing more than the FDA proclaiming intellectual monopolies over all molecules of interest found in nature. It is Monsanto-like in its arrogance and wickedness, and it deprives the People of their right to access medicinal plants and healing substances that have existed in nature for countless thousands of years long before the FDA ever came into existence (1906).
If we do not stop this FDA, we are all doomed to living under a totalitarian regulatory regime that will systematically criminalize every healing molecule found in nature, from the curcuminoids in turmeric root to green tea catechins and even phycocyanins found in spirulina.
That this federal agency has now resorted to such tactics of medical totalitarianism and outright tyranny is proof that we need to strip the FDA of regulatory powers over natural dietary supplements and limit its domain to pharmaceutical drugs only.
Coincidentally, a Presidential election is upon us that threatens to shake up the entire establishment if the right person wins. “Establishment” candidates on both sides of the aisle would simply continue the FDA war on natural molecules that’s now under way, but there is one candidate who has openly threatened to challenge the authority of federal regulators like the EPA and FDA.
The FDA has now declared war on CBDs and hemp oil extracts. Its first targets are those companies who have inaccurate label claims or are committing outright fraud in claiming CBD concentrations that don’t even exist in their products.
On this point, I must agree that inaccurate label claims deserve regulatory enforcement. The CBD industry is heavily populated with fraudulent sellers whose products often contain no CBDs at all. (Make sure you buy from reputable sources that conduct real science to validate product composition.)
“The FDA has turned its back on the cannabis industry, claiming that CBD products cannot be sold as dietary supplements,” reports Canna Business. “Companies affected by the latest crackdown include Cali Stores, Dose of Nature, Green Garden Gold, Healthy Hemp Oil, Michigan Herbal Remedies, Morgue Juice, Pain Bomb and Sana Te Premium Oils. According to the FDA’s analysis, all products contained different amounts of 9-THC, THCa, CBDa, CBN and CBD than they had claimed.”
The second target of the FDA is companies that made disease treatment claims that their CBD products might treat epilepsy, cancer or other conditions. The FDA, of course, routinely attacks any dietary supplement maker that tells the truth about the medicinal benefits of their products. According to the FDA, there is no such thing as any food, nutrient, herb or natural molecule that has any ability whatsoever to treat, prevent or cure any disease. This position is, of course, patently absurd and stands in total violation of nutritional science, but it is the “big lie” the FDA must maintain in order to keep putting dietary supplement companies out of business.
Once the FDA finishes destroying all the companies with inaccurate labels and disease marketing claims, it will target all the honest suppliers of CBDs who are selling genuine, honest products that contain accurate CBD labels. This is the real goal of the FDA: to threaten, intimidate and destroy the entire CBD industry and thereby protect the medical monopolies of drug companies that can’t wait to cash in on these amazing molecules that really do treat disease (otherwise, Big Pharma would have no interest in them).
And so the great medical monopoly racket marches on, with the FDA giving a big “F-YOU” to the American people while handing lucrative medical monopolies to its greed-driven friends in the pharmaceutical industry. Meanwhile, the American people are denied healing medicine that works at a fraction of the cost of overpriced pharmaceuticals.
Entrepreneurial companies that offer such hemp oil extracts containing CBDs — natural medicines that could help reduce human suffering while lowering health care costs nationwide — are threatened by the FDA with devastating enforcement actions that could land their executives in prison.
This is all part of the FDA’s war on natural medicine that systematically criminalizes molecules found in nature and the people who seek to make those molecules available to patients in need. While disease suffering skyrockets across America and medical expenses push more and more families over the threshold of bankruptcy and destitution, isn’t it comforting to know that your federal government is doing everything in its power to deny you access to safe, affordable natural medicine while protecting the profits of the drug giants?
None of this is ever going to change, by the way, if we keep electing establishment politicians to the White House. If you want to see real change in the legalization of hemp extract components such as CBDs, you’d better vote for someone who terrifies the establishment and threatens to tear it down.
At the same time, you need to support health freedom organizations like the Alliance for Natural Health, which is fighting to keep dietary supplements legal in America.
You should also watch this video animation that exposes the anti-dietary supplement bias of PBS Frontline, which recently ran a totally dishonest hit piece documentary attacking supplements.
There is a nationwide effort under way right now to criminalize ALL dietary supplements and force every plant extract, vitamin or food concentrate to be regulated by the FDA as if they were prescription drugs. This would utterly wipe out the entire dietary supplements industry and plunge America into an era of runaway disease, suffering and death as people are denying access to the healing nutrients that are presently preventing disease (and even reversing serious disease in some cases).
Finally, share this story and join the Natural News email list (below) to stay informed on all this. As the editor of Natural News, I am fighting for your right to access CBDs and hemp oil extracts, as they are amazing natural medicines that can treat, prevent and in some cases even help cure serious health conditions.
We have a fundamental human right to access healing plants found in nature, and the FDA has systematically sought to destroy that right and criminalize those who seek to express it. Access to Mother Nature’s healing molecules is a fundamental human right that exists above and beyond the Bill of Rights. It is a DIVINE right.
To reestablish our access to these rights, we need a political revolution in Washington that puts people in power who are ready and willing to dismantle the FDA and end its devastating monopolies over dietary supplements, medicinal herbs and natural molecules found in nature.
We need to legalize health freedom in America and set this nation on a new path of disease prevention and drastically reduced health care costs through access to affordable, natural medicines. The only way to accomplish this is to end the FDA’s reign of tyranny over the dietary supplements industry.
We need a new health freedom revolution in America, and it starts at the ballot box. It’s time to start electing outsiders, not insiders… people who the terrify the Washington establishment because they know their insidious grip on regulatory power will be challenged. If you want medical marijuana legalized, or if you want access to CBD oil as an affordable dietary supplement, it’s time to start voting for people the establishment is desperately trying to destroy. Because it is only those people who have any real hope of achieving the kind of political and legislative goals that will end the FDA’s stranglehold on natural medicine in America.
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