Source: Ken Alltucker and Jayne O’Donnell, USA TODAY
CBD has exploded in popularity since Trump legalized the cultivation of hemp, but is it a medical miracle or just another fad? Just the FAQs, USA TODAY
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.
(Photo: Getty Images)
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’s planning 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 are using CBD, a figure projected to grow to 10% of Americans by 2025, according to investment research firm Cowen & Co. The first-growing market already generates as much as $2 billion in sales. That could grow to $16 billion by 2025, according to Cowen&Co.
With pitchesfrom 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,” says 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.”
No standard, no quality’
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 found 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 has 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, while 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 has warned CBD marketers that have 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 are selling CBD and said his agency will contact retailers and remind them that the agency’s role is to protect consumers from products that might put them at risk.
We remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.
At the same time, the warning letters announced today make clear that #FDA has and will continue to monitor the marketplace and use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk
The FDA has 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 is director of the National Institute on Drug Abuse. She sees two major challenges with the explosion of CBD products.
“There’s no standard. There’s no quality,” Volkow says. “So many of them that say they may have a high content of cannabis oil, in fact, contain none. It’s very, very inaccurate.”
Because there are no standards, people might experiment with smoking, ingesting or absorbing via skin products or patches that have varying levels of CBD.
While advocates generally claim it as safe to use, Volkow says that 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 says.
‘All-time marketing high’
Roger Henderson has arthritis in his hands that’s so painful that he has trouble opening a water bottle. The 70-year-old Carnation, Washington, resident says 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 and felt relief, he says.
“I don’t have a problem with my hands anymore,” he says.
Jocelan Carmichel, 41, of Seattle, is a big believer in the potential of CBD and cannabis.
She used a strain of cannabis called Grape Ape that “likely aided in pulling the toxins from my body” while under treatment for a form of bone marrow cancer earlier this decade.
Her cancer has been in remission for more than five years after she received conventional treatment.
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While she believes that Grape Ape helped her recover from the side effects of treatment, she knows that evidence of the therapeutic effects of CBD and other cannabis products is lacking. She has launched a career as a CBD entrepreneur and has applied for research approval from the Washington State Liquor and Cannabis Board.
“CBD is a Band-Aid,” Carmichel says. “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 says 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 has used “all the Western medications I have to take” supplemented by cannabis.
He says 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 says 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 says. “I never reached back.”
The former talk show host began a new phase of his life – cannabis activist. He testified before more than one dozen legislatures in states evaluating the switch to medical marijuana.
Williams also founded a company, LentivLabs, and launched his own line of CBD products. But even Williams 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 on April 3 agreed 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.
The ordeal has left Williams wary of some companies that are “really trying to take advantage of the consumer.” He believes 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 says. “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 just one warning in 2018 and three so far this year.
The FDA issued a warning letter in 2017 against Will Claren and his two companies, Alurent Inc. and Natural Alchemist. He says his company responded to the FDA letter, was cleared within eight months and hasn’t heard another thing.
“We said, ‘Oh, we’re sorry. We’ll never do that again,’ and never heard another thing about it,” Claren says.
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 following stroke or trauma or could treat rheumatoid arthritis, colitis, liver inflammation, heart disease and diabetes.
Claren disputes that such phrases ever appeared on his websites.
“They fumbled us with someone else because we’ve never made those claims,” he says. “There’s no way we would have put something like that on our website. We know better.”
Experts predict that the FDA will occasionally step in to halt rogue marketers of CBD. But the fast-moving market is difficult to keep pace with.
“The problem now is there are so many people doing so many things that it’s hard to police,” says Nelson, the CBD attorney.
The problem is worsened by the inconsistency that even CBD experts say they find in the products. Nelson says some of his clients who want to do the right thing have difficulty creating “clinically reproducible standards” because there’s so much variation with the quality and strength of ingredients.
He believes that the federal government will have no choice but to step in and require CBD makers to submit applications and complete testing. That will likely 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, says founder and CEO Anita Pluymen.
Cheekywell founder and CEO Anita Pluymen, right, talks about the uses of CBD. (Photo: Cate Willing)
Interviewed at SXSW’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 says.
Actually, it’s “anecdotal from clients” who buy the product from an Austin, Texas, specialty store called Enlightened Baby, she says. Though she doesn’t want to claim the anecdotal reports as fact, she says, “we know CBD does “calm the mind.”
Nelson says it’s buyer beware.
“Consumers have no idea what they’re getting,” Nelson says. “There is no control over marketing claims.”