As the CBD industry continues to grow, a new ecosystem of rules and regulations is sure to grow along with it. The United States Food and Drug Administration has sent warning letters to some of the nations top suppliers of hemp-based CBD oil products, Natural Alchemist, Greenroads Health, That’s Natural!, and industry heavyweight Stanley Brothers, demanding that they cease and desist making health claims about the benefits of CBD oil on their websites. In doing so, they ran afoul of the FDA’s subjective definition of whether a product is being marketed as a food or a drug, a familiar complication to manufactures of other dietary supplements. In many situations, however, the statements in question were not made by the companies themselves.
The FDA has stringent regulations in place for pharmaceutical manufacturers that dictate how a drug is manufactured, tested, marketed, and distributed. Nutritional supplements, like vitamins and herbal blends, often don’t receive the same level of oversight, as they are treated and governed more like specialty foods. As such, manufacturers have to be careful about their labeling, but it appears CDB oil-related companies may be held to a higher burden than those associated with more traditional supplements.
In order to maintain their designation as a supplement rather than a drug, manufacturers can’t represent their product as being for the express treatment of a disease or condition. In fact, the label often can’t even state that they aid in the treatment or prevention of a health condition, which is where the four manufacturers ran afoul of the Feds. .“The claims on your websites establish that the products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body.” – FDA Letter To Respondents
In making their decision, the FDA relied on statements from the manufacturers’ sites touting general and specific wellness benefits, often posted as reviews and testimonials by customers, as well as social media posts, such as a retweet from CW Hemp’s twitter profile on September 17, 2016, “The NFL Could End CTE With a Strain of Marijuana . . . A cannabidiol-rich strain – Charlotte’s Web – won’t get players high, but it can protect their brains.” This is a chilling development for companies that feel they are offering helpful, natural products for their customer’s well being, as it goes beyond policing their statements and policies to regulating what and how they’re allowed to acknowledge engagement from their customer base. In doing so, the FDA seems to chart a course that holds manufacturers accountable for statements from the general public, over which the company has no control.
Under the provisions of the letter, the manufacturers have 15 days to respond to the FDA in writing with specific steps they are taking to return to compliance. A daunting task considering the highly subjective nature of the FDA’s complaint. According to the CEO of another CBD oil product manufacturer, Phivida, they attempt to avoid any direct health claim about their products, instead opting for an approach that encourages their customers toward self-education. While this path seems compliant and necessary in the view of the FDA, it does make it harder for consumers seeking relief.
Some of the very people who CBD oil is the most helpful too, the elderly, marginalized communities without access to affordable medical care, and people suffering from conditions that make everyday life harder, are the very ones who may have the most difficulty navigating the internet and evaluating products for quality and efficacy. The very policies meant to protect consumers from charlatans and snake oil salesmen may, in fact, be preventing people from getting the health information and healing products they need for a better life.
Right or wrong, the FDA sets the rules under which CBD oil products can be marketed and sold in the United States. As such, manufacturers have had to watch their step carefully and rely on the community surrounding their products to effectively spread the word, however, now that the FDA has found fault with even that passive course of action, manufacturers and distributors are left with uncertainty just as CBD oil products are finally getting widespread public recognition.