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Home / Business / FDA kicks through review of CBD at first public hearing Friday

FDA kicks through review of CBD at first public hearing Friday



A matcha store offering drinks with drops of CBD oil.

Angelica Lavito | CNBC

The Food and Drug Administration will hear from CBD producers, researchers, farmers, dealers and more on Friday when the agency holds its first public hearing and looks at the sale of what is being spied on as a magic elixir that can handle everything from inflammation to epilepsy.

The congress in December legalized CBD, or cannabidiol, derived from hemp. The non-toxic cannabis compound is added to just about anything, including makeup, tea, pets and soft drinks, although the FDA has explicitly prohibited the addition of food, beverages and supplements.

The industry is booming and has the potential to become a $ 22 billion business by 2022, according to the cannabis-focused research firm Brightfield Group. Businesses are pushing the agency to change its rules so they can legally add CBD for food and drink.

Skyrocketing interest

"The interest continues to fire," said DC lawyer Miriam Guggenheim, co-chair of the food, drug and unit practice group at Covington & Burling. "It's common, interest is common. It's no longer fringe, which does not mean regular companies are ready to jump in. But they will be prepared to do so when the legal landscape is clarified."

David Spangler, senior executive director of the Consumer Health Product Association, said he has not seen so much interest in a problem he has been dealing with since 2007 when child teachers urged the FDA to ban cold and cough medications for children under the age of 6.

The FDA, which takes public comments on how to regulate the industry through July 2, has about 1

40 people planned to witness Friday. Preparation and implementation of a rule may take years, officials have said.

"I think many people hold out what I consider some false hope that we are coming out of this hearing with all the answers to our burning questions," said Jonathan Havens, co-chairman of the cannabis law at Saul Ewing Arnstein & Lehr.

Long-Term Use

Former FDA Commissioner Scott Gottlieb formed a working group in April to evaluate how to regulate the CBD. They are investigating the potential risks, including impact on the liver from prolonged use, chief executive FDA commissioner Amy Abernethy said in a tweet last week.

The agency has focused its CBD enforcement on companies that make "egregious" claims, such as using it to treat Alzheimer's, cancer and other diseases for which it is not approved. The issued letter of warning to three companies earlier this year.

Regulatory uncertainty has not stopped countless companies from adding CBD for food and beverages, although it has kept most major companies such as Coca-Cola and PepsiCo on the sidelines for now. [19659006] Vitamin C

The Consumer Health Product Association lobbyes the FDA to regulate CBD similar to vitamin C, and possibly establish guidelines such as dosage levels that it considers appropriate for use outside the counter, Spangler said.

Numerous studies have found Some products do not meet their requirements – sometimes contain too little CBD, too much or none at all. Some CBD products even contain enough THC to produce high.

The FDA has not allowed more than 1,500 new CBD products to enter the market over the past three years, said Daniel Fabricant, Managing Director of the Natural Products Association in Washington, DC

"These companies are not your Fortune 100 companies. These people in many ways fly at night, "he said. "It's not how a regulatory agency should work."

Looking for clarity

People who look for clarity do not come to Friday. The public hearing is simply a listening session for regulators.

Abernethy said in her tweet that the FDA will communicate "experiences and next steps as soon as possible after each step."

The FDA could decide not to act on everything and ask Congress to legislate a correction, which Gottlieb swam to lawmakers earlier this year.


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