CBD HYPE
Is this hemp plant derivative snake oil or a legit remedy?
It’s hard to find something CBD can’t treat. ❚ That’s if you believe the hype. Problems with aches and pains, inflammation, stress, unsatisfying sex and PMS? Try CBD. ❚ It comes in many forms: skin creams, lotions, oils, tinctures, pills and even a powder or liquid food additive. You can get it nearly everywhere. Neighborhood coffee shops splash CBD in lattes. Amazon delivers it to your doorstep. Walgreens and CVS will stock it in stores nationwide. ❚ Although marketers hype the hemp plant derivative cannabidiol as a natural remedy for just about anything they might imagine, their therapeutic claims are rarely supported by medical evidence that CBD is significantly better than a placebo.
When it comes to over-the-top claims, “there are probably some people taking advantage,” said Jay Hartenbach, CEO of Medterra, one of the largest marketers of CBD. It’s important to “come back to the science.”
Indeed, it’s an industry mostly built on testimonials. Kim Kardashian said she plans a CBD-themed baby shower. Former talk show host and cannabis activist Montel Williams has his own brand of CBD products and filed a federal lawsuit that says an unauthorized marketer co-opted his likeness and image to sell lower-quality versions.
Nearly 7% of Americans use CBD, a figure projected to grow to 10% by 2025, according to investment research firm Cowen. The fast-growing market generates as much as $2 billion a year in sales. That could grow to $16 billion by 2025, according to Cowen.
Pitches come from nurse practitioner Alex Capano – chief science officer of EcoFibre and Ananda Hemp, a company that sells a product it describes as the “first-and-only cannabis-infused intimate oil formulated by a reproductive medicine and cannabis clinician.”
It’s hard to imagine the hype going higher.
“It’s a free-for-all right now,” said Harry Nelson, a Los Angeles attorney who has represented several companies selling CBD products. “People have to be careful. There are good products, and there’s also a lot of snake oil being sold.”
Patchwork regulations
The Agricultural Improvement Act of 2018, signed by President Donald Trump in December, loosened restrictions on the use of hemp products that contain less than .3% THC. THC is the psychoactive component in marijuana – the chemical that produces a high when smoked or ingested.
The farm bill removed products made with low-THC hemp, used to extract CBD, from the schedule 1 category that includes marijuana and other drugs such as cocaine and heroin.
This move accelerated the use of CBD, but these products are still subject to federal and state oversight. That’s left a patchwork of regulations: Most states allow CBD, but a handful of states still restrict its use.
The Food and Drug Administration regulates CBD products, much like it regulates nutritional supplements. The federal agency warned CBD marketers that made false claims that their products can cure cancer and other ailments.
FDA Commissioner Scott Gottlieb, whose last day was Friday, said early last week that he was concerned to hear major pharmacies and retail stores sell CBD, and his agency will contact retailers and remind them that the FDA’s role is to protect consumers from products that might put them at risk.
The FDA approved the use of one cannabidiol drug, Epidiolex, to treat seizures from Lennox-Gastaut syndrome and Dravet syndrome, two rare kinds of epilepsy. But research that has passed FDA muster is the exception in an industry that typically puts marketing ahead of science.
Nora Volkow, director of the National Institute on Drug Abuse, sees two major challenges from the explosion of CBD products. “There’s no standard. There’s no quality,” Volkow said. “So many of them that say they may have a high content of cannabis oil in fact contain none. It’s very, very inaccurate.”
People might experiment with smoking, ingesting or absorbing via skin products or patches that have varying levels of CBD.
Volkow said medical evidence still needs to be collected and examined.
“This is leading to a very significant amount of variability and resulting in adverse outcomes because people don’t know how to dose themselves,” Volkow said.
‘All-time marketing high’
Roger Henderson has arthritis in his hands that’s so painful he has trouble opening a water bottle. The 70-year-old Carnation, Washington, resident said he sought relief from other treatments that provided little comfort.
Then he spent $45 on a 3-ounce jar of CBD cream called Solace from a suburban Seattle retail shop. He took a dab and spread it across his arthritic hands.
“I don’t have a problem with my hands anymore,” he said.
Jocelan Carmichel, 41, of Seattle is a big believer in the potential of CBD and cannabis.
“There’s no standard. There’s no quality. So many of them that say they may have a high content of cannabis oil in fact contain none. It’s very, very inaccurate.”
Nora Volkow Director of the National Institute on Drug Abuse
She used a strain of cannabis called Grape Ape that “likely aided in pulling the toxins from my body” while she was treated for bone marrow cancer this decade. Her cancer has been in remission for more than five years after she received conventional treatment.
Though she said Grape Ape helped her recover from the side effects of treatment, she acknowledged that evidence of the therapeutic effects of CBD and other cannabis products is lacking. She launched a career as a CBD entrepreneur and applied for research approval from the Washington State Liquor and Cannabis Board.
“CBD is a Band-Aid,” Carmichel said. “Right now, it is an all-time marketing high. People are getting away with all these claims on what the cannabidiol actually does. It’s giving people false hope and false information.”
‘I never reached back’
Williams said cannabis and CBD are essential ingredients in his regimen to fight multiple sclerosis.
Diagnosed with relapsing MS in 2000 and a more advanced form, primary progressive, in 2007, Williams said he has used “all the Western medications I have to take” supplemented by cannabis.
He said doctors prescribed opioids for pain relief when he was first diagnosed. He didn’t find pain relief, only dependency on a medication that has ensnared millions in a cycle of addiction. He discontinued the pain pills and began using cannabis. He said it relieved his pain and reduced muscle spasticity from his neurodegenerative disease.
“I noticed immediately in me a difference in how I felt when I started using cannabis instead of opioids,” Williams said. “I never reached back.”
The former talk show host began a new phase of his life – cannabis activist. He testified before more than a dozen legislatures in states evaluating the switch to medical marijuana.
Williams founded a company, LentivLabs, and launched his own line of CBD products. He is perplexed by the “green rush” of new CBD marketers, including quick-buck artists looking to take advantage of the popularity.
In 2017, the Navy veteran filed a federal lawsuit against five companies connected to an Arizona man, Timothy Isaac, accusing the companies of using Williams’ name and likeness to sell CBD products. The two sides settled the case and agreed on April 3 to a stipulated order that prohibits Isaac and the five companies from using Williams’ name, image or likeness in advertising, according to court records and Jonathan Franks, a spokesman for Williams.
Isaac’s attorney who signed the order did not immediately return messages from USA TODAY.
Williams is wary of companies that are “really trying to take advantage of the consumer.” He said it could harm perceptions about the industry.
“You have seen a little bit of pushback in the past couple of months from people all over the country who are saying, ‘You know, I don’t really believe in this whole CBD thing,’ ” Williams said. “You check and see what product they have been using. It’s a product that is adulterated with all kinds of caustic chemicals and garbage and things that are really deleterious.
“The bottom line is we have a long way to go before this industry is regulated the way it should be and the industry starts self-regulating the way it should. I’m hoping to be a part of that whole effort.”
FDA warns marketers
The FDA has issued four dozen warning letters since 2015, claiming that marketers improperly sold CBD products with therapeutic claims that weren’t approved. Most of those warnings came in 2015 and 2017. The agency issued one warning in 2018 and three this year.
The FDA issued a warning letter in 2017 against Will Claren and his two companies, Alurent and Natural Alchemist. He said his company responded to the FDA letter and was cleared within eight months.
“We said, ‘Oh, we’re sorry. We’ll never do that again,’ and never heard another thing about it,” Claren said.
The FDA’s warning letter against Claren cited several website claims as evidence the CBD products were intended to be used as drugs. The website claimed CBD “combats tumor and cancer cells,” limited damage after stroke or trauma and could treat rheumatoid arthritis, colitis, liver inflammation, heart disease and diabetes.
Claren disputed that such phrases ever appeared on his websites.
“They fumbled us with someone else because we’ve never made those claims,” he said. “There’s no way we would have put something like that on our website. We know better.”
Experts said the FDA will occasionally step in to halt rogue marketers of CBD, but it’s difficult to keep pace with the fast-moving market.
“The problem now is there are so many people doing so many things that it’s hard to police,” said Nelson, the CBD attorney.
The problem is worsened by the inconsistency that even CBD experts said they find in the products.
Nelson said some of his clients who want to do the right thing have difficulty creating “clinically reproducible standards” because there’s so much variation in the quality and strength of ingredients.
He said the federal government will have no choice but to step in and require CBD makers to submit applications and complete testing. That will probably favor the larger cosmetic and therapeutic providers.
Cheekywell, which sells CBD to address PMS, motherhood, menopause and sexual pleasure, is trying to find its niche by bringing an “incredible amount of light and brightness” to emotionally challenging times in women’s lives, said founder and CEO Anita Pluymen.
At South by Southwest’s Wellness Expo in March, Pluymen pointed to a bath salts soak on a shelf and noted it “helps clear mastitis,” the breast tissue inflammation that sometimes becomes infected and affects some breastfeeding women.
“We were shocked by that,” she said. Actually, it’s “anecdotal from clients” who buy the product from an Austin, Texas, specialty store called Enlightened Baby, she said. Though she doesn’t want to claim the anecdotal reports as fact, she said, “we know CBD does calm the mind.”
Nelson said it’s buyer beware. “Consumers have no idea what they’re getting,” Nelson said. “There is no control over marketing claims.”