CBD products are trendy, but health benefits (and risks) are vague

Consumers today don’t have to look hard to see the growing inventory of cannabidiol-infused products being sold here and on the mainland, which includes oils and lotions, mascara and other cosmetics. There are also edibles, such as gummies; drinks, ranging from sparkling water and lattes to beer; and vaping merchandise. Even hemp-infused treats for dogs and other animals.

A component of medical marijuana, the non-intoxicating drug is derived from the hemp plant. The trouble is that much of the marketing touting the health benefits of cannabidiol, or CBD, is absent of convincing evidence.

“We’re learning more about the risks and we really know very little about the benefits,” said Hawaii Department of Health Director Bruce Anderson. “With CBD in general there’s probably more unknowns than knowns.”

The U.S. Food and Drug Administration, which has approved only one CBD product — a prescription drug product to treat two rare, severe forms of epilepsy — has yet to make federal rules on safety and effectiveness pertaining to non-prescription use.

The agency issued a consumer update last month advising: “Some CBD products are being marketed with unproven medical claims and are of unknown quality.”

Further, “The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.” Among the known potential risks: liver injury and serious side effects resulting from products impacting other medicines.

Among the unknowns: What happens if one takes CBD daily for a sustained period of time? How does it affect a child’s developing brain? In addition, the FDA maintains that potential for “male reproductive toxicity” needs further testing, as studies in laboratory animals raise questions about whether CBD use could negatively affect a man’s fertility.

FDA regulations currently bar retailers from selling food and beverage products or dietary supplements containing the drug. Even so, such CBD products, along with the rest of the infused lineup, are turning up for non-prescription purchase online and in brick-and-mortar shops at malls.

This fall, the Federal Trade Commission sent warning letters — advising that unsubstantiated health claims could be subject to law enforcement — to a group of businesses that had pitched CBD as a treatment or cure for medical conditions like Alzheimer’s, multiple sclerosis and heart disease.

With an expanding list of other claims — from seemingly feasible to far-fetched — such as chronic pain-relief and growth of eyelashes, to name a few, CBD is already a multibillion-dollar commercial business, according to Wall Street analysts.

Confusion about the status of the drug dates back to December 2018, when Congress amended the Farm Bill, removing hemp as a controlled substance and legalizing it under certain restrictions. That threw a curve ball at regulators and state officials. States are now sorting out their own takes on regulation and enforcement matters.

“Some are basically exempting CBD from regulation, and others are cracking down on it, and banning it,” said Anderson, although “most states attempting to ban it are unable to enforce those bans” because so many products are flowing into the marketplace.

In Hawaii, CBD products are easy to find — even though, according to state law, it’s illegal to manufacture, distribute or sell products containing cannibidiol. The only exception is the sale of products to holders of medical marijuana cards in the dozen cannabis dispensaries statewide.

Health Department action

While the Health Department has the authority to sweep shelves and hand out fines of up to $10,000 per violation per day, so far, it is taking the approach of educating retailers.

In one recent shop check, DOH found a retailer that had been marketing infused edibles to children; in another, a retailer offered samples — items that could be popped in the mouth or applied to skin. Both businesses were spared a penalty because they quickly complied with the state’s stop order.

Routine inspections of state-licensed food service businesses now include a check to “be sure that they’re not infusing food products with CBD,” Anderson said. However, given that the DOH has only a half-dozen workers in its Food and Drug Branch monitoring thousands of retailers, the department also relies on complaints from the public to flag non-compliance.

Unclear health effects

The FDA points out that while some side effects, such as drowsiness and gastrointestinal distress, can be noticed quickly and addressed by the consumer, others, such as liver injury, could go undetected and result in irreversible damage if not monitored by a healthcare provider.

In addition, taking CBD with other medications may increase or decrease their effects; and there’s limited research on the interactions between CBD products and herbs or botanicals in dietary supplements, according the agency.

“What we worry about is … cumulatively there may be some adverse impacts” to ingesting the drug or applying to the skin, Anderson said. “Of course, if you’re taking CBD daily, or multiple times a day, it’s almost impossible to know how much you’re being exposed to.”

Compounding worries is the surfacing of synthetic products sold as cannabidiol. “CBD is so popular now and so expensive that people are making it in their backyard,” Anderson said.

“There’s no oversight on the production. So we don’t know what’s actually in the product that’s being sold. It could contain harmful solvents or other chemicals that could have adverse health effects on individuals,” he said, noting that nationwide CBD has so far been linked to at least 30 deaths, many involving synthetic products.

In an effort to establish oversight in Hawaii, the Health Department, in tandem with other state agencies, is drafting part of an omnibus bill that will include regulation for production and processing of hemp into CBD. The measure is expected to be introduced as part of Gov. David Ige’s administrative package submitted to the 2020 Legislature.

“We’ve already put out the guidance, and we’re now working on some statutory provisions that will give us more authority to regulate it. And ultimately, we’ll probably need to develop some rules, too, to go along with the statute,” Anderson said. “This is certainly on our front-burner in terms of issues we want to address.”

The Drug Policy Forum of Hawaii, which has advocated for the legalization of recreational marijuana for adult use, supports CBD-focused legislation that stresses truth in labeling, testing and certification, said the nonprofit board’s president, Nikos Leverenz.

However, he added, “The idea here should not be to put local companies out of business, but to give them a regulatory framework where they can thrive. Also, we would support that the Department of Health allow products to be imported, and not just be generated exclusively in-state.”

Restricting the sale of hemp products to plants grown in-state “could potentially kill CBD entirely in Hawaii in the near-future” because the state has yet to establish a viable hemp economy, Leverenz said.

Hemp restrictions ease

Hemp production was banned throughout the country in 1937 as part of the criminalization of marijuana, but restrictions began to ease with the 2014 Farm Bill allowing states to begin growing hemp as part of research pilot programs. Most states, including Hawaii, have set up such programs.

Currently, the only legal means of cultivating hemp in the islands is through the state Agriculture Department’s Industrial Hemp Pilot Research Program, which was created by state law enacted three years ago. Since June 2018, the program has issued 37 licenses to companies interested in growing the crop.

While hemp can be used for a wide range of products including building materials, paper, fiber and insulation, CBD products are the main attraction, Anderson said.

“Most of the people who are growing hemp in the state are intending to extract CBD from it,” he said. If Hawaii enacts and enforces particularly restrictive laws, “it’s not clear where they’re going to be selling the CBD. Probably a lot of it would be going overseas,” to places that have few, if any, restrictions on such products.

Other proposed legislation

Also in the works is proposed state legislation to impose more regulation on vaping materials that would align the nicotine-based industry, which includes CBD-infused products, with laws in place for tobacco cigarettes. Hawaii prohibits online sales of cigarettes, and levies a relatively hefty tax on sales — $3.20 per pack, the sixth-highest tax in the nation.

While purchase of both traditional cigarettes and electronic cigarettes in Hawaii is illegal for anyone under age 21, currently there’s no consumer-related tax or shipping restriction tied to vaping devices and their liquid cartridges.

Hawaii’s medical marijuana dispensaries sell cannabis oil cartridges, which are subject to regulatory scrutiny, so that patients can legally take THC (tetrahydrocannabinol) — the principal psychoactive component in cannabis — and CBD through vaping.

Commercially legal hemp contains less than 0.3% THC. But, of course, in the absence of tough regulation, any legal limit can be less than dependable in sprouting CBD products.

Levenrenz said earlier this year, he was able to purchase Barlean’s CBD hemp oil, a nationally known brand, at a grocery market in Hawaii. He views the product as trustworthy because the Washington state-based company has it third-party tested for heavy metals, toxins and cannabinoid levels (including CBD and THC) — and posts lot-specific results on Barlean’s website.

The Drug Policy Forum, he said, “doesn’t think that CBD is a cure-all,” but maintains it benefits appear to include helping to ease chronic pain, and manage conditions such as anxiety and insomnia. “I’ve used CBD myself (as a sleep aid), and it’s helped me,” Leverenz said.

Anderson said as the state’s handling of CBD-infused products evolves, any consumer considering use should first consult their doctor, as with every drug there’s a risk-benefit assessment to consider.

“I can’t think of a single drug out there that doesn’t have some adverse effects, particularly in high concentrations. And then, you weigh the benefits.” People need to understand, he said, that CBD “is not just a benign, harmless product. It’s a drug, and it can have serious adverse health effects.”