The Council for Responsible Nutrition submitted a Citizen’s Petition to the U.S. Food and Drug Administration requesting that the agency establish a regulatory pathway to legally market dietary supplements containing hemp-derived Cannabidiol (CBD). CRN’s petition asks that FDA exercise the discretion provided to it in the Food, Drug, and Cosmetic Act (FDCA) that would allow CBD to be marketed as a dietary supplement and to impose requirements and restrictions that would apply to CBD-containing supplements.
 
“Over one year has passed since FDA held its public meeting to better understand hemp-derived substances, including CBD, and how they should be regulated,” Steve Mister, president and CEO of CRN, said. “During this time, consumer interest has grown, sales have increased, and product innovation has expanded, all while FDA has taken no substantial steps toward legalizing the ingredient. CRN is disappointed in FDA’s lack of forward movement with respect to regulating CBD, as we have called on the agency repeatedly to address this regulatory gap.”
 
A provision of the FDCA (21 U.S.C. § 321(ff)(3)(B)) allows FDA to establish a regulation in which ingredients formerly marketed as drugs or studied clinically as drugs could become supplement ingredients, with the intent of preventing one drug company from forming a monopoly on an ingredient with both drug and non-drug uses. Within that provision, such substances are called “articles.” FDA takes the position that hemp-derived CBD cannot be a dietary supplement because it was the subject of substantial clinical investigations as a drug, despite the provision mentioned above.
 
“By not acting to create a regulatory framework for CBD in dietary supplements, FDA is, in effect, creating a sweeping monopoly over CBD for drug use,” CRN’s petition read. “This is not what congress intended, in general, and particularly in this circumstance. Members of Congress have emphasized to FDA, on multiple occasions, that its ‘intent was clear with the passage of the Farm Bill that [CBD products] should be legal, and our farmers, producers, and manfuacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement and potential regulatory plans for certain CBD products.’”
 
Further, CRN argues that FDA is neglecting its mission to protect public health by not enforcing existent dietary supplement regulations against CBD products, by virtue of the fact that millions of Americans consume them as dietary supplements.   
 
A meeting in March 2019 opened a public comment period in which stakeholders, regulators, and other members of the public, and, after closing it, extended the comment period “indefinitely,” yet, since that time, no regulatory steps have been made on the part of FDA to establish restrictions or standards by which CBD must legally be sold, other than the <0.3% THC content by weight restriction which was present in the 2018 Farm Bill as applied to industrial hemp as a raw material.
 
Unless FDA classifies CBD as a dietary supplement, it has no means within its jurisdiction to regulate or monitor the production and sale of the orally-ingested CBD products on the market.
 
“With this citizen’s petition, CRN is urging the agencfy to take action by providing a legal pathway to market for responsible companies, to enforce existing dietary supplement requirements for companies already marketing CBD as dietary supplements, and above all else, to ensure consumer safety to the 20 million Americans who take CBD supplements,” Mister continued.
 
“While dangerous products do not represent the majority of the CBD supplement space, some products on the market do pose risks to consumers because they are poorly manufactured, improperly labeled, or illegally deliver adulterants. At the same time, responsible CBD companies that do comply with the well-devleoped body of law and regulations governing dietary supplements and that produce beneficial products must compete with companies that repeatedly cut corners, skirt the law, and take advantage of FDA’s lack of regulatory oversight. Once FDA allows a legal pathway to market for CBD dietary supplements, the agency can begin enforcing existing regulations for dietary supplements and take enforcement action against companies that do not comply with those federal requirements.”
 
“It is critical that FDA acts immediately for the benefit of the agency, industry, retailers, and most importantly, consumers,” Mister concluded. “The longer the agency waits to act, the more complicated and uncontrollable the space can become. Numerous states are already moving to protect their own citizens with state-based requirements and restrictions that further encumber the likelihood of a single, federally uniform CBD marketplace, while a growing number of consumer class-action lawsuits being brought against CBD manufacturers, distributors, and retailers, further muddy the legal status of CBD. FDA has ample safety data in front of it to act; the agency must act quickly so it can effectively remove unsafe or illegal products and ingredients from the market and protect consumers and responsible companies in the space.”