FDA Cracks Down on CBD

CBD-related news doesn’t seem to be going away anytime soon.

FDA sent a warning letter to another company, Curaleaf, who illegally made CBD medical claims on a number of products, including tinctures, patches and lotions. The company is a medical and wellness cannabis operator in the U.S. that serves over 150,000 registered patients across 12 states, according to its website.

FDA argued the products were unapproved new drugs sold in violation of the Federal Food, Drug, and Cosmetic Act as verbiage on the company’s website indicated the products were intended for use in disease prevention, cure and diagnosis.

Curaleaf is “illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases,” the FDA wrote.

The FDA took over regulation of CBD when the 2018 Farm Bill legalized hemp and immediately made it clear it views CBD as a drug, because it is the main ingredient in the only FDA-approved cannabis-based drug, GW Pharmaceutical PLC’s GWPH, a treatment for severe childhood epilepsy, reported MarketWatch (July 24).

“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 Ned Sharpless.

The FDA told companies adding CBD to food or beverages is prohibited, although it appears willing to tolerate it in topical products-minus serious health claims. In spite of the warning, CBD-based food and beverage products are increasing.

Convenience store operator Alimentation Couche-Tard, which has 9,866 convenience stores throughout North America, will  make an investment in Fire & Flower Holdings Corp., a Canadian independent cannabis retailer. Fire & Flower currently operates or licenses 23 cannabis retail stores in Alberta, Saskatchewan and Ontario, a wholesale distribution division in Saskatchewan, and the HiFyreTM digital retail platform designed to connect consumers to the world of cannabis. This investment will provide Fire & Flower with additional capital to further accelerate their expansion strategy.

Meanwhile, Canada-based Tilray recently acquired alcoholic gummy maker Smith & Sinclair to create a line of CBD edibles, reported CNBC (July 23). UK-based Smith & Sinclair sells alcoholic gummies and lollipops, edible fragrances and tablets. Tilray will work with the company to create CBD-infused edibles and distribute them in the U.S. and Canada.

Tilray partnered with brewer Anheuser-Busch InBev in 2018 to form a joint venture to research cannabis-based beverages. Additionally, the company signed a deal with Authentic Brands to develop CBD-based consumer products.

Additionally, global cannabis organization Geocann commercialized a portfolio of food and beverage cannabis formulations that utilize the multi-patented VESIsorb delivery system for improved absorption and bioavailability.

The company states it has successfully manufactured these formulations in an array of products, including chocolates, gummies, fruit bites, protein bars, stick-pack powders, wellness drinks and non-alcoholic beers.