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    America’s CBD boom: brazen claims, fake products, regulatory scrutiny

     Boston 02/13/19 The National Cannabis Industry Association Seed to Sale covention was held at the Hynes Convention Center. Bottles of CBD tincture from Vermont Pure CBD that were available for purchase there. Photo by John Tlumacki/Globe Staff(metro)
    John Tlumacki/Globe Staff
    Bottles of CBD tincture from Vermont Pure CBD that were available for purchase at the National Cannabis Industry Association Seed to Sale convention.

    Got arthritis? Dry skin? Menstrual cramps? Trouble sleeping or feeling stressed? The CBD industry claims it has the cure for you.

    Such assertions are becoming increasingly common — and brazen — as the cannabis compound commonly known as CBD proliferates in drinks, baked goods, tinctures, body lotions, and even bath salts. To some, the hype echoes 19th-century snake oil advertisements that promised to cure “all aches and pains!”

    While CBD is generally believed to be safe, scant research has been conducted on its medical and health benefits because cannabis has long been prohibited at the federal level. The only clinically proven remedy is a treatment for two rare forms of childhood epilepsy. All other claims are anecdotal.

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    Now regulators are starting to pay closer attention. Earlier this month, New York health officials ordered bakeries and restaurants to stop adding cannabidiol, the formal name for CBD, to beverages and food. In December the Food and Drug Administration made clear that it’s illegal to market CBD products as dietary supplements.

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    “Nobody’s been allowed to do the research for all these years, so it’s a big open space where companies can say things without the data to back it up,” says Kent Hutchison, co-director of the University of Colorado’s CU Change Lab.

    CBD has been sold online for years, mostly to people already familiar with THC, the psychoactive sibling that gets you high. More recently, the legalization of marijuana in several states and the boom in so-called wellness products have pushed CBD into the mainstream. Consumers are putting it under their tongues, rubbing it on their sore muscles, and guzzling seltzer infused with the trendy ingredient. Retail sales of CBD more than quadrupled last year, according to the data firm SPINS, with most purchases taking place at natural grocery stores.

    The stuff doesn’t come cheap: A bottle of oil with 1,500 milligrams of “full-spectrum hemp oil” sells for $160 on the new website Standard Dose, while a container of Seventh Sense eucalyptus spearmint body lotion made by the cannabis firm Green Growth Brands, with 75 milligrams of CBD, retails for $16.50. A California company called Good Bites sells bags of four CBD macaroons for $20, which gets you a total of 100 milligrams. Populum, based in Tempe, Arizona, sells a 1 fluid ounce bottle that contains 19 milligrams of CBD for $99. With prices like that, it’s easy to see why analysts expect the CBD market to be worth more than $20 billion by 2022, up from roughly $600 million now.

    The growing demand for CBD dovetails with Americans’ long-standing appetite for super foods and ingredients that promote wellness. In a divided and anxious nation, moreover, many people are willing to try products that claim to ease insomnia and stress. CBD is following a path already traveled by turmeric, acai berries, ginkgo biloba, and so on. People tell each other the stuff works, word travels, and the cash registers keep ringing.

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    “America has always had a population looking for the silver bullet,” says Kara Nielsen, who tracks food trends at CCD Helmsman in California. “The hype follows a similar pattern: It has a lot going for it, but it’s unclear exactly what it does so it allows people to imagine it’s their solution.”

    The decade-old boom in dietary supplements could be a harbinger of what happens next with CBD. Makers of supplements have long made dubious claims and drawn the ire of regulators. This month, the FDA issued 12 warning letters and five online advisories to foreign and domestic companies for selling products that claim to prevent, treat or cure Alzheimer’s, among other diseases and health conditions. 

    The FDA has adopted a fairly benign posture toward CBD — occasionally sending letters warning companies not to make unsubstantiated claims and reminding them that the chemical remained prohibited under the Controlled Substances Act. Then in December, Congress passed the Farm Bill, which makes the chemical compounds found in hemp, including CBD, legal under certain circumstances.

    The new legalization places hemp-derived CBD squarely under the authority of federal agencies including the FDA, which said in December that any CBD product marketed as having therapeutic benefits must be approved for its intended use before it’s introduced into interstate commerce.

    Regulators are paying more attention at the state level as well. Besides New York, Maine, and Ohio have cracked down on the sale of CBD as officials sort out the legal status of a substance that the FDA hasn’t approved as a food additive.

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    If the dietary supplement industry is any guide, the crackdown is unlikely to deter makers and purveyors of CBD products. So long as they keep their claims vague, they should be able to continue selling their products, especially ones that are applied externally and not ingested.

    Dr. Yasmin Hurd, director of the Addiction Institute at Mount Sinai, has watched all the CBD hype with bemusement. She’s studied the substance for 10 years and thinks it could help treat opioid addiction. Her biggest fear is that the “commercialization” of CBD could prevent serious medical research on a drug that she thinks has immense potential.

    The problem, in her eyes, is that there might not be funding for CBD studies if the product is already widely available. “A lot of people are making money but they’re not willing to actually do the research,” she says. “Everyone is missing the more important point here.” Apart from the epilepsy drug from GW Pharmaceuticals Plc, drug makers have so far adopted a wait-and-see position. If and when clinical trials have been completed, chances are good they’ll swoop in and acquire some of the leading marijuana companies.

    The studies that have been done suggest CBD can help boost the immune system and reduce inflammation, but with one important caveat: those studies haven’t been done on humans. Existing research also indicates that 500 milligrams of CBD is required for it to be effective, a far higher dose than typically found in most consumer products. Meanwhile, with oversight lax, fake products containing no CBD whatsoever have proliferated, according to industry observers.

    Joe Dowling runs CV Sciences, a publicly traded company that sells a top-selling oil called Plus CBD Oil that’s available in 2,000 stores around the United States. Dowling says it’s “irritating” that unscrupulous companies are rushing into the market, making health claims and selling fake products. CV Sciences consults with attorneys who understand FDA rules, he says, and is deliberately vague about CBD’s benefits, calling the chemical a “key supplement to maintain a healthy lifestyle.”

    Dowling welcomes more FDA oversight as well as clinical trials that will prove CBD’s benefits and provide a basis for more accurate marketing.

    “It’s going to be the Wild West for a while,” he says.