Now that industrial hemp production is legal nationwide, there is some question over whether food and supplements containing cannabidiol (CBD) – a non-intoxicating cannabinoid derived from hemp – can be sold in the marketplace without the approval of U.S. Food and Drug Administration (FDA). FDA Commissioner Scott Gottlieb said recently that the compound was still considered illegal if added to products without following the agency’s approval process. This means all of the CBD oils and other items that have been distributed in the shadows of legality for the past few years are at risk of being rendered obsolete as a result of the government’s willingness to make hemp a legitimate part of American commerce for the first time since the late 1930s.
However, a couple of federal lawmakers are working to remedy the problem. Senators Ron Wyden and Jeff Merkley of Oregon fired a letter off to Gottlieb earlier this week demanding that the FDA change its policy on hemp-derived CBD, allowing it to continue being manufactured and sold without FDA approval. The letter suggests that the latest policy will make financial hardships rather than benefit the agriculture community, which goes against the grain the intent of the Farm Bill.
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“Farmers…nationwide are poised to make real economic gains for their communities once these regulations are updated,” the lawmakers wrote.
Although CBD has risen to new heights of popularity over the past few years, any product containing the cannabinoid is in violation of the law as long as it is without the FDA’s seal of approval, according to agency. A statement released by the FDA near the end of 2018 said, “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.”
The FDA’s primary concern is those companies that tout the medicinal benefits of CBD even though these products have not been put through the federal testing standards necessary to make those claims. There is some anecdotal evidence that CBD is useful in the treatment of conditions ranging from anxiety to chronic pains, but science has yet to substantiate all of these assertions.
Therefore, the FDA has deemed it essential for these companies to prove the efficacy of their products before continuing sales.
“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S,” Gottlieb said in a statement.
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It should be pointed out that the FDA recently approved a drug (Epidiolex) containing CBD for epilepsy patients. Doctors can now prescribe it, and it can be filled at most pharmacy chains the same as other drugs. However, it is equally important to show that the drug’s manufacturer GW Pharmaceuticals was not awarded this approval overnight. It took years, potentially billions of dollars and many clinical trials before it was given the FDA’s green light to distribute legally in the United States. Many companies selling CBD products do not have the resources to develop a product at this level.
But this is what legalization looks like in the United States. Be careful what you wish for.