FDA warns Curaleaf to stop marketing CBD with unfounded claims

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Federal regulators Tuesday warned Curaleaf, one of the nation’s largest cannabis companies, to stop marketing CBD products online with unfounded claims that they treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety.

The US Food and Drug Administration said Curaleaf, based in Wakefield, was “illegally selling” more than a dozen products containing CBD — cannabidiol, a nonpsychoactive compound in cannabis — using unsupported claims such as “CBD was effective in killing human breast cancer cells.”

The FDA said the claims on social media and the company’s website could endanger patients who might choose to delay seeking medical care. The FDA has sent similar warning letters to about two dozen CBD companies since 2015, but the Tuesday letter shook the industry because of Curaleaf’s size.

“Today’s action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk,” said Dr. Ned Sharpless, acting FDA commissioner. “Consumers should beware of purchasing or using any such [CBD] products.”

The agency requested a correction plan from Curaleaf within 15 days. If Curaleaf doesn’t promptly correct the violations, the FDA said it may bring legal action and seize products.

Curaleaf said it was reviewing the FDA’s letter and would “work collaboratively” with the FDA in its requested timeframe. The company said its hemp-derived CBD products met the requirements of the Farm Bill.

“Curaleaf is fully committed to complying with FDA requirements for all of the products that it markets,” the company said. “Compliance is a top priority for Curaleaf. We can reaffirm that nothing in the letter raises any issues concerning the safety of any Curaleaf product.”

After the news broke Tuesday, Curaleaf shares fell by more than 7 percent. Curaleaf last week bought Chicago-based Grassroots for $875 million, which the company said made it the largest cannabis company in the world by revenue.

This is not the first criticism Curaleaf has received from regulators. Last week, the Massachusetts Cannabis Control Commission said the company failed to seek approval before changing its ownership structure. The company said it would work with the commission to secure its blessing.

On Tuesday, the FDA blasted Curaleaf’s claims that its CBD products can treat chronic pain, eating disorders, anxiety, attention deficit hyperactivity disorder, Alzheimer’s disease, Parkinson’s disease, depression, post-traumatic stress disorder, schizophrenia, and addiction. The company also touted CBD as effective at preventing heart disease and the spread of cancer.

For dogs, the company touted CBD as being an effective alternative to “puppy Xanax,” as well as good for treating pain, spasms, anxiety, nausea, and inflammation.

The FDA, which held its first public hearing on CBD in May, said it is “concerned” about the explosion of CBD products being marketed with unapproved claims. The agency has worked to define regulations for CBD since Congress passed the 2018 Farm Bill in December. That law legalized hemp, a type of cannabis plant that contains CBD and trace amounts of THC, marijuana’s main psychoactive ingredient. Marijuana remains illegal federally.

A high-level working group at the FDA is evaluating possibilities for lawful marketing of CBD, and plans to issue a progress update in early fall, said Dr. Amy Abernethy, the FDA’s principal deputy commissioner.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders,” Abernethy said.

The FDA is reviewing thousands of public comments, which include research that may show promise for CBD’s effectiveness for certain conditions. But those studies are not likely to satisfy the FDA’s requirements that would allow CBD to be marketed as a drug, said David Gortler, a former FDA official and pharmacologist.

Gortler said those rigorous clinical trials must include thousands of participants who represent the American public and can cost several billion dollars. Pharmaceutical companies largely don’t want to invest in those studies for a drug like a cannabinoid that can’t be patented because it’s a plant, he said.

“The jury is still out on this drug” and its effectiveness, Gortler said, adding the FDA’s standards protect the public from “snake oil salesmen.”

CBD companies say consumers should choose products with certificates of analysis that show independent lab results for the product’s CBD purity.

But Gortler said that information doesn’t mean an unregulated product is safe. He said consumers should discuss all drug decisions with a physician and a pharmacist.

Rick Ball, a lawyer in Duane Morris’s Boston office specializing in cannabis regulatory compliance, said the FDA has long said it wouldn’t tolerate unsubstantiated medical claims.

“What I find surprising is people aren’t listening to what the FDA is saying,” Ball said.

Many CBD companies say they welcome regulations to separate the bad actors from the good.

The warning “just shows that the FDA is listening and is not turning a blind eye to what is going on or being said,” said Derek DuChesne, chief growth officer at EcoGen Laboratories, a CBD manufacturer.

Continue at: https://www.bostonglobe.com/news/marijuana/2019/07/23/fda-warns-curaleaf-stop-marketing-cbd-with-unfounded-claims-about-treating-cancer-alzheimer-pet-anxiety/wiJ3zcXK4zDB84hCjk5v3I/story.html

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