FDA Warns CBD May Overpromise and Underdeliver

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One manufacturer has been warned, but experts say this is a growing problem.

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CBD has become a popular additive to items like foods and edibles. Getty Images

Gels, creams, and pills containing cannabidiol (CBD), the non-psychoactive, potentially therapeutic compound in the cannabis plant, have proliferated at a seemingly exponential rate in the past five years.

The industry is poised to double in growth each year between now and 2024, according to cannabis consumer research firm BDS Analytics.

But CBD is still in a regulatory gray area, with the Food and Drug Administration (FDA) in the process of wading through scientific and public comment to refine its regulatory strategy toward CBD products.

In the meantime, the agency has started to issue warnings over manufacturers’ more egregious claims about CBD’s therapeutic effects.

Most recently, the agency warned a CBD manufacturer for making unsubstantiated medical claims about CBD’s health benefits, including claims that the compound could treat Alzheimer’s disease and kill breast cancer cells.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care,” said acting FDA Commissioner Dr. Ned Sharpless, in a statement.

“Additionally, there are many unanswered questions about the science, safety, effectiveness, and quality of unapproved products containing CBD,” he said.

The manufacturer, Curaleaf, responded in a statement that they “immediately began an extensive review of its website and social media platforms to remove all statements that FDA identified as noncompliant.”

They also said that many of the products cited by the FDA have been discontinued and that they’re working to ensure their products are compliant with FDA regulations.

“Our industry needs, wants, and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace,” said Joseph Lusardi, CEO of Curaleaf.

“We care deeply about our customers and making a difference in our industry. Curaleaf is committed to being an ethical and responsible company and working with the FDA to be a leader in our industry, setting the standards and guidelines to best service our customers and the communities we serve.”

But the FDA warning spotlights an ongoing issue about CBD products: Many claims about CBD-based treatments are unproven.

CBD may well have genuine applications as a medicine — and the scientific research that’s available has largely pointed in that direction, with at least one CBD-derived medicine approved for the treatment of seizures, for instance.

But for other conditions, there isn’t a lot of evidence proving CBD can be an effective treatment.

One of the sticking points of the most recent warning was how the manufacturer’s claims, “establish the intended use of your products as drugs.”

“The FDA does not allow manufacturers of dietary supplements to make any claims with regard to safety or efficacy of their supplements, since each individual manufacturer has not conducted studies,” Brian Prather, a registered pharmacist at Bedford Wellness Pharmacy in Michigan, which sells CBD products, told Healthline.

While you may have seen CBD being marketed in everything from ice cream to hamburgers, the agency pumped the brakes on the use of CBD in food products in June 2019.

They did this because it’s been approved for use in a specific drug and therefore, it cannot be used as a food additive.

“In addition, the FDA does not consider isolated CBD extract to meet the definition of a dietary supplement, so any company promoting their product as CBD — rather than hemp extract — could be subject to FDA action,” Prather explained.

Regarding “hemp extract,” CBD can also be extracted from hemp, an extremely low-THC cannabis which isn’t a federally scheduled drug. And, according to the agency’s definitions of what is and isn’t a dietary supplement, “hemp extract” may not fall under the same regulatory requirements as CBD extracted from marijuana, which are cannabis plants with higher concentrations of THC.

Hemp plants are cannabis plants with less than 0.3 percent THC. These plants are no longer defined as marijuana under the Controlled Substances Act.

Now with FDA regulations changing, some companies are giving their hemp-derived CBD a new name.

“That’s why we’ve seen a sharp increase in the number of companies promoting their ‘broad-spectrum hemp extract’ to avoid FDA sanctions,” Prather said. “But whether you’re making CBD, hemp extract, or vitamin C, FDA rules strictly prohibit marketing of supplements for specific disease states or medical conditions.”

While CBD products have proliferated and experts agree there seems to be little direct risk to using CBD, consumers should know that the science still has a long way to go, according to Dr. Morton Tavel, a clinical professor emeritus of medicine at Indiana University School of Medicine.

“Companies currently involved in the CBD market were hopeful that the FDA would eventually place CBD in the category of food additives called ‘generally recognized as safe,’ but here I must dissent, for until adequate research is performed, this product should be confined to prescription-only status until its safety and efficacy are clearly established,” he said.

“Where I think real science comes in is trying to determine what CBD actually is doing in the body, what it actually is binding to, what it is signaling through, and going at it from a very scientific point of view [to] determine what are objective viable claims,” Matthew Halpert, PhD, researcher and faculty in the department of pathology and immunology at Baylor College of Medicine told Healthline.

Halpert pointed out there are aspects of CBD that appear to be beneficial.

“But there’s clearly just a lot more research that needs to happen,” Halpert said. “And at some point, we’re going to have to move toward hard, placebo-controlled trials to really start making definitive claims.”

In the meantime, he said, one of the major problems is that we don’t understand what a good or standard “dose” of CBD is.

“For some reason that I do not fully understand, the CBD field, instead of talking about dose per serving, people advertise how many milligrams they have in the bottle — as if that means anything,” he said. “There’s this race between companies and people to just take more and more CBD.”

“The thinking seems to be that if taking some is good, then more is better,” he said. “Which is definitely not true. That’s not how biology works.”

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