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A recent industry study predicted the global market for cannabidiol, or CBD, will grow from $311.7 million this year to $1.25 billion by 2024. Hemp farming quadrupled in 2019; the crop, which was legalized in the 2018 farm bill, was seen as a huge new growth opportunity for beleaguered American farmers. More than 1,000 CBD-infused products are now available online.

This week, though, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing CBD, saying they had violated the Federal Food, Drug and Cosmetic Act. At the same time the FDA published a revised Consumer Update detailing broad safety concerns about CBD products.

Bottom line: The federal government has not concluded that CBD is "generally recognized as safe" for use in human or animal food. Thus, CBD in food and drink is still illegal.

"It came out of the blue. We were just at a CBD show last week, and there were hundreds of similar products and websites," said Brad Ridenour, chief executive of Koi CBD, one of the 15 companies to receive warning letters.

Companies that have charged ahead on developing and marketing CBD-infused food and drink say they have been waiting for direction from the FDA on how to label and market products and are increasingly frustrated with the agency's lack of clear regulations.

Brands such as Ben & Jerry's, Unilever and Anheuser-Busch have announced CBD products in development, and stores such as Walgreens, Kroger and CVS have vowed to sell them.

"They keep telling us they're going to come out with guidance, and they don't," Ridenour said. "They just tell us what not to do. We're ready to comply with anything they throw at us."

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations.

In May, Amy Abernethy, the FDA's principal deputy commissioner, used a string of tweets to convey the agency's reservations about CBD, saying: "We are reviewing available databases and medical literature about CBD's safety. Thus far, the data appear insufficient."

In June, an FDA document called What You Need to Know (And What We're Working to Find Out) amplified the warning that the agency considered CBD products illegal, saying: "We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is currently illegal to market CBD this way."

And then the FDA fell mostly silent on the subject, until now.

"As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we'll continue to monitor the marketplace and take action as needed against companies that violate the law," Abernethy said in a statement this week. "We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD 'can't hurt.'"

The Center for Science in the Public Interest applauded the FDA's move. While CBD has been found effective and is legal in prescription form for two rare forms of epilepsy, the center says there is no evidence that cannabidiol will lower the risk of diabetes, shrink tumors, wean a person off opioids, ease schizophrenia or calm anxious pets -- despite the claims of companies actively marketing CBD products.

"The marketplace is full of products that are essentially unknown," said Laura MacCleery, policy director for Center for Science in the Public Interest. "What that means is they are experimenting on consumers and I don't think people are aware that they are guinea pigs."

MacCleery said CBD products have been marketed for children's use and for pregnant women and that researchers haven't adequately studied either use. She said there are concerns about CBD and liver toxicity, and problems with supply chain quality control. Some products may be mislabeled, with more or less CBD than indicated. There are also concerns about contaminants, and since labels are often unclear whether the CBD is derived from marijuana or hemp, heavy metals may be a concern (marijuana is an effective extractor of heavy metals from soil).

"It's an industry that is untethered to relationships of oversight," MacCleery said.

Business on 11/28/2019

Print Headline: FDA jolts CBD product sellers, warns against safety unknowns

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