Can we avoid getting dopey about hype, use, regulation of dope-derived CBD?

cbdThe federal Food and Drug Administration has waded into its potential oversight of a substance that already is becoming wildly popular. The process of figuring government rules for cannabidiol, aka CBD, well could be called Confusion By Design.

The New York Times and Washington Post both reported on the parade of dozens of parties, pared from hundreds of aspirants, wanting to influence the FDA’s path with the agency’s first hearing on CBD. It already is sold in thousands of products on the market now. These include pet foods, soft drinks, bath salts, and oils and solutions that users add to food and rub on themselves.

Of great concern to the FDA are the extreme and proliferating claims that vendors are making for unproven health-related benefits of use of CBD, which is a nonintoxicating extract that can be derived from hemp and marijuana. As the popular health information WebMD site reported:

[CBD] is being credited with helping treat a host of medical problems — everything from epileptic seizures to anxiety to inflammation to sleeplessness. But experts say the evidence is scant for most of these touted benefits. Worse, CBD is being produced without any regulation, resulting in products that vary widely in quality.

The FDA will have clear sway over many ways that CBD might be allowed, and claims made about it. But aspects of the substance also fall under the purview of the Agriculture Department and the Drug Enforcement Administration.

WebMD quoted Governing magazine’s finding that CBD oil is legal in 30 states where marijuana has been broadly legalized, and cited Prevention magazine for saying that 17 more states have CBD-specific laws on the books. Those are Alabama, Georgia, Indiana, Iowa, Kentucky, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin and Wyoming.  Governing, a media outlet focused on lawmakers and lawmaking, reported this about CBD and the states, a growing number of which already have dashed ahead and legalized marijuana itself for medicinal or recreational use:

[S]tate and city lawmakers are making their own [CBD] rules. A 2018 Colorado law contradicts federal rules, saying all parts of hemp plants can be added to food for sale. Regulators in California, Maine, and New York City have sided with the FDA and banned adding CBD to food. Many states don’t allow hemp CBD to be sold to the public at all, whether as an oil, pills or mixed into smoothies. Ohio’s medical cannabis law, for instance, includes hemp-derived CBD in its definition of marijuana, which means it can only be bought with a doctor’s permission. Hemp industry lobbyists are pushing lawmakers in more than a dozen states to approve bills that would expand hemp farming and access to CBD products.

The Atlantic magazine found the substance so ubiquitous now — a commodity with such potential wide-spread appeal that it has gained the attention of Coca-Cola, CVS, Walgreen’s, Carl’s hamburger chain, and Martha Stewart — that it reported on risks that travelers might subject themselves to by packing it in its various forms and products for domestic and international sojourns. Hint: Be careful, especially if carrying CBD materials overseas.

The FDA has made it clear that it may take years for the agency to develop the research and rules it will use to oversee CBD, which some experts estimate will burgeon into a market worth $22 billion in the next five years. Regulators’ work hasn’t been made any easier by the heavy breathing about CBD coming from lawmakers, including powerful politicians from hemp-growing states.

But for the FDA at least two public health menaces hang over its actions on CBD:

  • the opioid crisis, and how regulators fell down on protecting the nation from what has become a leading killer of Americans younger than 55
  • the explosive growth of vaping and its devices, notably e-cigarettes as exemplified by the market-dominating Juul product. Vaping’s skyrocketing growth, experts fear, has hooked on highly addictive nicotine millions of young people who otherwise wouldn’t have used it. E-cigarettes, which were supposed to offer adults an alternative to dangerous burning cigarettes, are proving to be a gateway for youths to get hooked on that very tobacco product.

Further complicating FDA oversight of CBD was the agency’s decision to approve the prescription drug Epidolex for treatment of seizures related to rare forms of epilepsy. The drug uses CBD derived from marijuana. The agency forced Epidolex’s maker to conduct rigorous and randomized clinical trials to win approval for its use. Is that now a precedent?

The agency also already has set parameters on CBD, declaring the FDA does not see the substance in the same light as dietary supplements or as a foodstuff. Over-the-counter supplements have become a major problem for the FDA, booming into a $40 billion industry of products with few proven benefits for consumers. They still eat them up daily and have been subjected to relentless hype about their preventative and even disease “curing” benefits. These claims are wrong and false, and the agency is struggling to keep up with them.

CBD regulation also will be a mess for who knows how long because of the federal government’s view of marijuana as a dangerous drug. This has prevented extensive research on it, making serious studies of it onerous at best. As the Washington Post reported:

At [the FDA’s first public] hearing, scientists and consumer advocates … warned that for the thousands of CBD products being sold, there is little data to guide [regulators on concerns like] dosage levels, expiration dates, and manufacturing protocols to make sure they don’t also contain other elements like tetrahydrocannabinol, or THC, the main psychoactive component in marijuana, which has been found in some CBD products.

Oh, my. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the injury that can be inflicted on them by dangerous drugs. Consumers should advance with care in their adoption of a substance like CBD, not because of bogey man claims about the evils of devil weed but due to a dearth of scientific evidence that it does anything, including anything good. Let’s not veer to the other extreme and be dopey about unproven benefits of a dope-derived product.

Unless and until vendors can offer hard proof, the FDA would do patients a real service by cracking down on unfounded medical claims about CBD products. The agency also should be vigorous in determining if they cause harms.

As experts from UC San Diego’s medicine department have pointed out in a viewpoint published on the JAMA network, a key goal for the FDA to tackle with CBD in the days ahead is policing the advertising, marketing, and promotion of such products, especially as it targets vulnerable audiences like the young. They wrote: “The time for a response is now, for delayed reaction will yield lingering exposure to potentially hazardous marketing claims.”

That’s good advice, and maybe it should go further: Consumer and safety advocates may wish to be respectful of free speech rights while seeking to change laws and regulations that allow direct-to-patient advertising and marketing of prescription drugs — and, for now, let’s apply that stricture to CBD, too. Cutting out huge and wasteful spending like this by Big Pharma might, on the one hand, let the industry reduce the skyrocketing costs of prescription drugs, while also limiting their stretching of the truth in their relentless product pitching. CBD seems a hot enough commodity that it doesn’t need the ad boost, either.

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