FDA warns against unproven medical claims for marijuana. “Prohibition” didn’t work, remember?

kidjack / Pixabay



The News:

Four companies selling dozens of various marijuana-derived dietary supplements have been officially warned by the US Food and Drug Administration to stop plugging their products as cures for cancer, a common but unproven claim in the industry. Included among the products are Everyday Advanced Hemp Oil, Bosom Lotion and CBD Edibles Gummie Men, according to the New York Times.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” said Dr. Scott Gottlieb, the agency’s commissioner, in a news release last week. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substances can shrink or cure cancer.”

The businesses–Stanley Brothers Social Enterprises, Green Roads of Florida, That’s Natural and Natural Alchemist–each sell products that falsely claim to cure cancer, Alzheimer’s disease or other illnesses, the agency said.

The supplements allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not approved by the FDA for any use. Unlike medical marijuana, CBD contains only a fraction of the tetrahydrocannabinol, known as THC, needed to cause a high, according to the manufacturers.

The companies sell CBD over the internet in a wide range of oil drops, capsules, syrups, teas and creams. The websites feature endorsements from people–generally identified only by first names and last initials–who claim that they or their loved ones have been miraculously cured of terminal diseases and other illnesses.

“There are a growing number of effective therapies for many cancers,” said Dr. Gottlieb, a cancer survivor himself. “When people are allowed to illegally market agents that deliver no established benefit, they may steer patients away from products that have proven, anti-tumor effects that could save lives.”

John Hudak, a senior fellow at the Brookings Institution and the author of “Marijuana: A Short History,” said companies that sell traditional cannabis products and those derived from hemp often skirt the edges of the law or violate it outright.

“I think it’s a very difficult argument to say that they are not working in a way that is in violation of FDA standards and practices,” Mr. Hudak said. “Having one disclaimer on a website and then having other claims elsewhere on a website is not what the FDA allows.”

Tisha Casida, the CEO of That’s Natural, which markets CBD All-Natural Hemp Oil, said she would comply with the FDA’s request, albeit under protest. One of the company’s claims, according to the FDA, was that the hemp oil contained an ingredient that “makes cancer cells commit suicide.”

Ms. Casida adds that: “All free people have a right to experience health and wellness from naturally derived cannabinoids. We should not have to only take FDA-approved synthesized drugs. We should be able to experience natural plant-based medicine in its truest form.”

Steve’s Take:

Remember the term “Prohibition?” So far, it’s never worked in this country.

We all realize the FDA has a job to do. And coming down on companies making unproven claims about their marijuana-based products is their job. But, other than Commissioner Gottlieb and his employees, who cares?

The fact is that the tidal wave among the states for legalizing recreational use of marijuana is building, and an increasing number of them are joining as the wave gathers steam.

This past July, Nevada became the fifth state to allow the recreational purchase of marijuana. The Department of Taxation anticipates up to $60 million dollars in tax revenue in just two years. But if the legal sale of marijuana in Colorado, Washington and Oregon is any clue, Nevada could generate a lot more. Possession of marijuana up to an ounce has been legal in Nevada since January.

Last November, California, Massachusetts and Maine all voted to make recreational weed legal, joining Alaska, Oregon, Washington, and Colorado. For a faster rollout, Nevada is modeling its implementation after Colorado and Washington, which limits dosage and advertising.

When recreational cannabis becomes legal in California on Jan. 2, part of the focus–in Los Angeles, at any rate–will be on “social equity.” That’s the term for a set of guidelines meant to spread legalization’s wealth to neighborhoods that have gotten the worst of the drug wars, says the Los Angeles Times.

According to draft legislation currently moving through the City Council, for every general license approved for a pot shop, one license must also be approved for social equity reasons.

“Across the board decriminalization would allow us to reframe addiction as a medical issue, and treat it as such,” says the LA Times Op-Ed piece. “No more mandatory sentences, no more addicts in prison simply because of drug use. It would also undermine the black market, and raise tax revenues that could be channeled, in part–as Los Angeles plans to do with 20% of its marijuana taxes–into recovery and rehabilitation,” the LA Times continues.

“Contrary to the prohibitionist rhetoric of the Department of Justice under Jeff Sessions, good people do smoke marijuana,” the LA Times asserts.

Social equity adds a measure of humanity to that economic enterprise, encouraging it to operate according to more than merely commercial concerns. Case in point: Dispensaries in Washington state earned more than a billion dollars in sales in the first two years after recreational marijuana was legalized there in 2014; about a quarter of that went to excise taxes. Southern California alone, with close to 20 million residents, is expected to bring in significantly more in sales and tax revenue.

As the trend continues of states generating success from cannabis, where could we see future expansion of recreational use? Here’s a list of 10 states most likely to pass recreational marijuana next, comprised by Civilized Life:

  • New York
  • Rhode Island
  • Delaware
  • Maryland
  • Connecticut
  • Illinois
  • Missouri
  • Michigan
  • Vermont
  • Arizona

Bottom Line:

Prohibition has never worked, from the Volstead Act (1919) to the Uniform State Narcotic Drug Act (1934), from the Marihuana Tax Act (1937) to the war on drugs.

Add to that, researchers last month said only half of the cancer drugs approved by European regulators in the past few years have shown to help patients. Many of the drugs were approved without any conclusive evidence of their efficacy, I wrote in a piece for this site.

The new study by scientists in Britain and Latvia showed that the European Medicines Agency (EMA) approved 39 new cancer drugs between 2009 and 2013 without evidence that they worked. A total of 68 cancer drugs were given a nod by the European drug regulator during the period.

The researchers found that only about half of the approved drugs significantly improved patient survival or their quality of life. The efficacies of the remaining drugs were “uncertain,” they they concluded in the study published online (October 5, 2017) in The BMJ medical journal.

So, unproven claims clearly were made and sanctioned by the EMA for drugs that ultimately didn’t work. I can see why many Americans would be mighty suspicious about FDA-approved, new cancer drugs as well. That mistrust is exactly what motivates people to turn to marijuana, even if testimonials are nothing but hearsay. In their minds, who knows; perhaps it might work. At least it’s safe.

Steve's Take: @US_FDA can't stop push for legalized #Marijuana Click To Tweet

President Nixon labeled drug abuse “public enemy number one” in 1971, and succeeding administrations pursued an unworkable and discriminatory policy, says the LA Times.

Former Nixon advisor John Ehrlichman in 1994 said about the drug war, “We knew we couldn’t make it illegal to be either against the [Vietnam] War or [to be] black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities.”

Times have changed, and a lot of good people do smoke marijuana. As far as the FDA’s warning about companies making false medical claims? Yes, they should stop doing that. But it’s much ado about nothing as we morph, inexorably in my opinion, into one nation under recreational pot.