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story.lead_photo.caption A worker adds cannabidiol (CBD) oil to a drink at a Fort Lauderdale, Fla., coffee shop. The U.S. Food and Drug Administration has scheduled a public hearing on May 31 to discuss how the cannabis product is used in food, drinks and dietary supplements.

U.S. regulators announced Tuesday that they are exploring ways the marijuana extract cannabidiol (CBD) could be used legally in foods, dietary supplements and cosmetics.

The U.S. Food and Drug Administration said it will hold a public hearing May 31 to gather more information on the science, manufacturing and sale of cannabis compounds like cannabidiol.

In the meantime, it issued more warning letters to companies for making unapproved health claims about cannabidiol products.

Products containing cannabidiol are already in stores and sold online, but claims about its effects are largely unproven and quality control standards don't exist.

Cannabidiol is one of more than 100 compounds found in marijuana. It's extracted using alcohol or carbon dioxide in factories. It's added to oils, mixed into creams and lotions and sold in candies and liquid drops.

Widely sold online, cannabidiol now is going mainstream with major retailers offering salves and balms for the skin. Prices range from $12 to $150 an ounce at high-end shops.

The FDA announced Tuesday that it has sent warning letters to three companies marketing products with what outgoing Commissioner Scott Gottlieb called "egregious, over-the-line claims" for cannabidiol's effects on cancer, Alzheimer's disease, fibromyalgia and drug addiction. Among the cited examples: "CBD successfully stopped cancer cells" in cervical cancer.

Gottlieb said the agency "won't tolerate this kind of deceptive marketing to vulnerable patients."

Advanced Spine and Pain LLC of Mount Laurel, N.J. (doing business as Relievus); Nutra Pure LLC of Vancouver, Wash.; and PotNetwork Holdings Inc. of Fort Lauderdale, Fla., did not immediately return calls and emails seeking comment on the warning letters.

Only drugs that have been reviewed by the FDA as safe and effective can make claims that they treat or prevent diseases or medical conditions. Many cannabidiol producers attempt to sidestep the issue by using only vague language about general health and well-being.

Cannabidiol often comes from a cannabis plant known as hemp, which is defined by the U.S. government as having less than 0.3 percent tetrahydrocannabinol (THC). THC is what causes marijuana's mind-altering effect.

Cannabidiol doesn't get people high, although it may be calming. Some cannabidiol products may contain THC, whether or not the label says so. Cannabidiol products have caused people to fail urine drug screens.

Cannabidiol has been hyped for treating pain, anxiety and insomnia.

Most claims are based on studies in rats, mice or in test tubes. Some human research has been done, but in small numbers of people.

One exception: For two rare seizure disorders, the evidence for cannabidiol was strong enough to persuade the FDA to approve GW Pharmaceutical's drug Epidiolex, which contains a purified form.

Scant research means not much is known about side effects either. In epilepsy research, cannabidiol changed the way the body processed other drugs. That suggests cannabidiol could interact with medications in ways researchers still don't know about.

The most common side effects of the cannabidiol drug Epidiolex include sleepiness, decreased appetite, diarrhea, increases in liver enzymes, exhaustion, rash and infections. The FDA's Gottlieb noted Tuesday the potential for liver injury and other risks can be handled with medical supervision but less is known about how that would be managed without oversight. And there are questions about overlap if multiple cannabidiol products are used.

For now, the agency has said cannabidiol is not allowed as an ingredient in food, drinks or dietary supplements.

In stating its position, the FDA cited a provision of the law prohibiting food makers from using active drug ingredients or those that are the subject of substantial research. But the agency doesn't have the resources to police all the cannabidiol products that are already available, said Marc Scheineson, a former FDA official.

"They're not going to pull a thousand products from the market," he said.

The FDA's authority is over interstate commerce, and local officials have taken differing approaches. In New York, Los Angeles and elsewhere, officials are warning eateries to stop selling it in food and drinks. Maine passed a law allowing it in foods and other products in the state.

Skin creams and cosmetics may be on safer footing with the FDA, but that too remains uncertain, said Camille Gourdet of RTI International, a nonprofit research institute in Durham, N.C. Though cosmetics aren't subject to premarket approval by the FDA, they could run afoul of regulations if they make specific health claims.

Marijuana itself is illegal under federal law; most states that have legalized it allow marijuana-infused foods and candies, called edibles.

What you buy may contain much less cannabidiol than the label states -- or much more. It may include more THC than you want and it may be contaminated with mold or pesticides. Consumers can ask to see testing reports.

A 2017 study in the Journal of the American Medical Association found 70 percent of cannabidiol products were mislabeled. Researchers used an independent lab to test 84 products from 31 companies.

"You're really flying by the seat of your pants when you buy this stuff," said author Marcel Bonn-Miller of the University of Pennsylvania.

Business on 04/03/2019

Print Headline: FDA warns firms on pot-extract claims


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