Is The FDA Unfairly Targeting CBD Oil & Products?
FDA’s announcement that products containing CBD oil cannot be sold as dietary supplements has many CBD advocates up in arms:
Is The FDA Unfairly Targeting The CBD Industry?
The answer to this question requires some breakdown in order to see it clearly.
Let’s first explore the FDA.
The FDA was created as an agency paid by us, taxpayers, to protect us from harmful drugs that might enter the market.
The FDA's mission statement reads as follows:
"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."
In 2007, a report bearing the revealing title "FDA Science and Mission at Risk" by the Subcommittee on Science and Technology, detailed how the FDA cannot fulfill its stated mission because:
- Its scientific base has eroded and its scientific organizational structure is weak
- Its scientific workforce does not have sufficient capacity and capability, and
- Its information technology (IT) infrastructure is inadequate
Furthermore, the report found that "the development of medical products based on 'new science' cannot be adequately regulated by the FDA, and that the agency does not have the capacity to carry out risk assessment and analysis. Additionally, the agency's science agenda "lacks coherent structure and vision, as well as effective coordination and prioritization."
Now that we see the integrity of the organization is compromised, I think it’s important to explore the consequences of a weak agency.
Who controls the the FDA?
All signs point to the pharmaceutical industry for a number of reasons. Let’s take a closer look…
The pharmaceutical industry's influence gets exerted in a number of ways.
One, starting in 1992 with the Prescription Drug User Fee Act (PDUFA), the influence was exerted by their directly funding, paying cash right up front, for an FDA review. So in many ways, the FDA started looking upon the pharmaceutical industry as their client, instead of the public and the public health, which should be the client.
A second way in which the industry influence occurs is by having leaders in the drug division who are spineless and gutless, and who don't like controversy. They don't like to take on the very awesome forces of the drug industry and a lot of its indentured servants, so to speak, in academic medicine. So the attitude by the leaders there is to avoid conflict. This translates into doing what the pharma industry wants.
A third way in which the pharmaceutical industry's influence has been allowed to grow considerably is the absence of congressional oversight.
The culture at the FDA has become, "Please the industry. Avoid conflict. Look upon our role as getting out as many drugs as possible." ...
Now that we exposed the flaws in this agency and its clear control by the pharmaceutical industry let’s turn our attention to CBD and why the FDA might want to banish this plant extract from the hands of retailers.
The Food and Drug Administration (FDA) announced that products which contain cannabidiol (CBD) cannot be sold as dietary supplements. The agency, however, left open the possibility that would it consider contrary evidence.
Big pharma wants to sell their own and control the market.
The real drug dealers want a piece of the action!
The FDA has begun two promising trials of CBD formulations: GW Pharmaceuticals’ Sativex and Epidiolex. Both pharmaceutical tinctures contain CBD isolated from medical cannabis plants.
Interesting correlation: We know that CBD import into New Zealand was allowed (even though not 100% legal) for quite some time. It was helping many people. Suddenly, import of CBD product was getting seized by the customs. Some might say the protection agencies just caught on. But there is an interesting coincidence of GW Pharmaceutical CBD launching at this exact time.
Recently more letters were sent to companies selling CBD and making claims. While we respect that law, we find it absolutely absurd to be prevented from sharing REAL success stories.
It’s important to remember there is no cure all. This substance and all others work depending on your personal biological DNA. For some it will be a miracle, for others nothing will happen.
But this isn’t an article about effectiveness so I’ll digress.
Hemp Industries Association (HIA), the non-profit North American hemp trade association, has published its statement in response to recent warning letters sent by the FDA to manufacturers of CBD products, regarding mis-labeling of drug claims on said products. Available on the FDA website, the letters explain that per the Federal Food, Drug and Cosmetics Act, CBD products may not be marketed as drugs, meaning manufacturers cannot make claims regarding CBD products’ efficacy in the cure, mitigation, treatment or prevention of disease. Furthermore, the FDA asserts that cannabidiol products may not be marketed as supplements, because ‘new drug’ consideration is currently pending for CBD. To view these letters in their entirety, dated February 4, 2016, please visit: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/#browse.
It is the position of the HIA that legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a ‘new drug.’ As such, CBD products are exempt from laws that preclude CBDs from product status as dietary supplements pending ‘new drug’ approval by the FDA.
Though none of the companies in receipt of these warning letters are current or former HIA members, the HIA urges these CBD product manufacturers to revise their product labeling and marketing such that no medical claims are made.
“There is great potential for the CBD market to expand in the U.S., but we need to move forward as an industry on a path that defines cannabidiol products as dietary supplements, much like multi-vitamins and herbal products,” said Eric Steenstra, Executive Director of the Hemp Industries Association.
Unlike FDA approved pharmaceutical drugs, which are new compounds developed and patented by drug companies and go through rigorous clinical trials before reaching the market, and can only be administered with a prescription; cannabidiol is a botanically derived, floral extract that exists organically in nature.
The Dietary Supplement Health and Education Act of 1994 explicitly defines ‘supplements’ as an extract of a botanical. As such, the HIA maintains that CBD products are indeed supplements, and that attempts by the FDA, or other agencies, to discourage lawful manufacturing and marketing of these products demonstrates unjust bias toward the hemp industry.
SOL CBD will continue to provide this medicine as long as we can. We care about quality, respect the law of the land, and will not pack down to manipulation of the market based on greed an corruption.
We believe that people should be able to use plants as they wish without intervention from a false authority.
Our political system is corrupt and broken. The way to freedom is to spread awareness of these crimes.
The more that people know the more of our voices can be heard.
Power to the people!
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