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March 2020

FDA rulings raise questions on CBD promotions

By Scott Kauffman

Marketing mania surrounding the hemp plant’s high-profile curative compound, cannabidiol or CBD, is starting to catch the attention of the feds – the Food and Drug Administration and U.S. Department of Agriculture to be specific.

After the U.S. government passed the 2018 Farm Bill in December 2018, making hemp production legal after an 80-year hiatus, growers, entrepreneurs and businesses are making a mad dash to hop on this hot, new health and wellness trend, marketing and selling the therapeutic value of cannabidiol from stress and anxiety relief to various qualities as it relates to relieving pain and other ailments. These CBD-infused products are even making their way into pet-related products, touting a multitude of similar health-related benefits.

“CBD is the rock star (compound) and everybody is promoting it,” says Nathan Phillips of Asheville, North Carolina-based Amazing Grace Hemp Co., an early adopter of the hemp plant’s various health and wellness qualities. “That’s what gets people’s attention.”
Is this form of hemp just hype? For consumers, who to believe and what? That’s where the FDA fits into the fast-moving marketing landscape.

For now, there are no standards or regulations to speak of as it relates to the marketing of CBD. That’s because many of the CBD products being sold don’t fall under the purview of the FDA. At least, that’s until CBD or the other well-known psychoactive compound, THC, is “added to a food or cosmetic, marketed as a drug or, otherwise added to an FDA-regulated product in interstate commerce,” FDA Commissioner Ned Sharpless said during a well-attended public hearing last May.

Sharpless added: “You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics and animal health products. Other than one prescription drug product to treat two rare, severe forms of epilepsy, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.”

Nevertheless, hemp plant production is booming as a legal agricultural crop, with 2019 licenses for hemp cultivation topping a half-million acres, more than 450 percent above 2018 levels, according to government reports. But just like the FDA, the USDA is raising concerns among farmers, processors and retailers if federal policymakers move forward with proposed new draft regulations to ensure the THC-free purity of hemp being grown in the 46 states that currently allow this crop to be grown.

Most of the anxiety involves how the federal government plans to test for THC, the high-inducing compound found in both of the cannabis plants, marijuana and hemp. The federal government and most states consider plants with tiny amounts of THC – 0.3 percent or less – to be hemp. Anything with higher concentrations is defined as marijuana and illegal under federal law.

The FDA is concerned that people may mistakenly believe that trying CBD “can’t hurt.” The agency wants to be clear that it has seen only limited data about CBD’s safety and it says this data points to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a health care provider. Consumers should be aware of the potential risks associated with using CBD products, states the FDA.

Attorney Rod Kight of Asheville, North Carolina, a personal user of CBD products and one of the country’s leading experts on the industry, says FDA oversight is a “significant issue” in how the product is going to be marketed and sold going forward.

“I believe that the FDA is likely to create a narrow pathway for the lawful use of CBD as a food ingredient and/or dietary supplement,” Kight told Golf Business in a written statement. “With respect to hemp extracts that contain CBD among other phytonutrients (other cannabinoids, terpenes, sesquiterpenes, etc.), I expect that the FDA will maintain its posture of continuing to utilize the term ‘CBD’ while not making a distinction between food products formulated with purified CBD ‘isolate’ and products formulated with hemp extract that contains CBD. In other words, ‘hemp extract’ will remain in a legal grey zone for the foreseeable future.”

That’s one reason Phillips is already adjusting how he plans to market and sell CBD-related products.

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