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FDA Begins Plotting Pathway for Cannabis Product Approvals

Posted 02 April 2019 | By Michael Mezher 

FDA Begins Plotting Pathway for Cannabis Product Approvals

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday announced that the agency is looking into developing a regulatory pathway for cannabis and cannabis-derived products, including cannabidiol (CBD), in response to recent legislative changes to how certain types of cannabis are scheduled under the Controlled Substances Act (CSA).
 
Background
 
Last year, the Agriculture Improvement Act, also known as the Farm Bill, defined hemp as cannabis that contains less than 0.3 percent delta-9-tetrahydrocannabinol (THC) and removed hemp from the list of controlled substances under the CSA.
 
Around the same time, FDA approved the first cannabis-derived drug, GW Pharmaceuticals’ Epidiolex (cannabidiol), to treat seizures that present with two rare forms of epilepsy.
 
Additionally, while other forms of cannabis remain listed as Schedule I drugs, some 30 states and the District of Columbia, Guam and Puerto Rico have legalized the medical use of marijuana, and ten of those states and the District of Columbia have approved recreational marijuana use.
 
The trend toward state level legalization and the removal of hemp from the CSA has led to a proliferation of cannabis and cannabis-derived products on the market, with major pharmacies announcing plans to carry CBD products. Many of these products have been sold as foods and dietary supplements, while some have been marketed with unsupported medical claims.
 
Regulating Cannabis
 
On Tuesday, Gottlieb announced four steps FDA will take as it considers how to appropriately regulate cannabis and cannabis-derived products.
 
On 31 May, FDA will hold a public hearing to give stakeholders and opportunity to discuss potential regulatory pathways for marketing cannabis or cannabis-derived products that are “predictable and efficient.”
 
“As we’ve stated before, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” Gottlieb said.
 
Gottlieb also emphasized that it is currently illegal to market products containing CBD or THC as foods or dietary supplements, as both chemicals are active ingredients in FDA-approved drugs.
 
“The only path that the [Food, Drug and Cosmetic Act] FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use,” he said.
 
Gottlieb also said that FDA will be forming a high-level internal working group co-chaired by Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller that will be tasked with exploring potential regulatory pathways for CBD-containing foods and dietary supplements.
 
Alongside the other steps, the agency will flesh out a regulatory approach to cannabis and cannabis-derived products, Gottlieb also said the agency will continue to take enforcement action against companies that illegally market such products.
 
“I am deeply concerned about any circumstance where product developers make unproven claims to treat serious or life-threatening diseases, and where patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm,” Gottlieb said.
 
Alongside the announcement, FDA released three warning letters, in conjunction with the Federal Trade Commission (FTC), to companies marketing cannabidiol (CBD) to treat a variety of serious diseases, including cancer, Alzheimer’s, fibromyalgia and substance use disorders.
 
FDA, Warning Letters – Advanced Spine and Pain, Nutra Pure, PotNetwork Holdings

Categories: Regulatory News

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