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Senators urge FDA to secure pathway for CBD in supplements, foods

In a letter to FDA Commissioner Scott Gottlieb, M.D., Sens. Ron Wyden and Jeff Merkley said farmers in Oregon and the rest of the nation stand to make solid economic progress for their communities if FDA loosens the regulations on hemp and CBD.

The two U.S. senators from Oregon who worked with Sen. Majority Leader Mitch McConnell (R-Kentucky) to pass the Hemp Farming Act have asked FDA to update regulations to allow for the use of hemp products, namely cannabidiol (CBD), in food, beverage and dietary supplement products.

In a letter to FDA Commissioner Scott Gottlieb, M.D., Sens. Ron Wyden and Jeff Merkley said farmers in Oregon and the rest of the nation stand to make solid economic progress for their communities if FDA loosens the regulations on hemp and CBD.

“In recent years, the public has developed a widespread interest in the production and use of CBD, one of the primary non-psychoactive compounds in Cannabis sativa L.,” the senators, both Democrats, wrote in the letter. “We therefore request the FDA immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption and sale of hemp products.”

The senators assured such a move by FDA would honor the spirit and intent of the Hemp Farming Act, which is a provision in the Farm Bill (Agriculture Improvement Act of 2018) President Trump signed into law on Dec. 20, 2018. The act expanded federal authority over the production and marketing of hemp, which was defined as cannabis (Cannabis sativa L.) with low concentrations of the psychoactive constituent THC (delta-9-tetrahydrocannabinol). Under this new law, hemp is no longer a controlled substance.

“We will be closely engaged in the ongoing implementation of our legislation, as it was Congress’ intent to ensure that both U.S producers and consumers have access to a full range of hemp-derived products, including hemp-derived cannabinoids,” the senators wrote to Gottlieb.

Though the new law loosened restrictions on the hemp industry, it did not limit FDA’s authority to regulate CBD. Since 2015, the agency has asserted products containing CBD and THC can’t be sold in dietary supplements and that it’s illegal in interstate commerce to sell a food to which either of the compounds has been added.

“Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act,” Gottlieb noted in a statement released after the Farm Bill was signed into law. “This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.”

But Gottlieb offered hope to marketers of CBD. He disclosed his agency is considering whether it should pursue issuance of a regulation that would authorize the use of CBD in foods and dietary supplements. The possibility of a pathway—the secretary of the U.S. Department of Health and Human Services would have to issue a regulation following notice and comment—for CBD in foods, beverages and dietary supplements further emboldened a burgeoning market for CBD products that has been growing in scope and popularity despite the regulatory hurdles.

According to Hemp Business Journal, the hemp-derived CBD market generated $390 million for 2018 in the United States. The publication is projecting $1.4 billion in sales in 2022, though its founder, Sean Murphy, said in an email that one could reasonably argue the market will generate between $1.5 billion and $3 billion by 2022 depending on various factors, including what happens with FDA.

Despite the passage of the Farm Bill, "current, outdated regulations limit producers from taking full advantage of the industrial hemp market by, for example, prohibiting food products containing CBD from being sold across state lines," Merkley and Wyden wrote in their letter to Gottlieb.

While Gottlieb has suggested a possible legal pathway for CBD products in beverage, food and supplement products, the letter from Merkley and Wyden sought more details. Acknowledging FDA is running lean during the government shutdown, the senators asked the agency to respond to several questions within 30 days of the government’s reopening:

  1. What steps is FDA advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverage or dietary supplement, including into interstate commerce?
  3. Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverage or dietary supplement by the agency?
  4. Will the agency consider issuing a regulation, or pursing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

A marketer of CBD-containing supplements welcomed the senators' letter to FDA. 

“We have been preparing for this moment since 2014 and could not be happier with the good news," said Stuart Tomc, vice president of human nutrition with CV Sciences Inc., in a statement. "CV Sciences is thrilled that the FDA is open to regulating hemp extracts as dietary supplements, first because they are, and second, because we currently meet all of the dietary supplement requirements.”

 

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