Washington D.C., June 17, 2020 —The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, yesterday submitted a Citizen’s Petition to the U.S. Food and Drug Administration (FDA), requesting that the agency establish a regulatory pathway to legally market dietary supplements containing hemp-derived cannabidiol (CBD). CRN’s petition once again formally calls on FDA to take action, and to exercise the statutory discretion provided to it in the Food, Drug & Cosmetic Act (FDCA) that would allow CBD to be marketed as a dietary supplement and to impose the regulatory requirements and restrictions that apply to supplements to this new legal category of CBD dietary supplements.
CRN’s Citizen Petition specifically requests the FDA to:
Exercise FDA’s statutory authority and discretion under 21 U.S.C. § 321(ff)(3)(B). This provision of the FDCA creates a general presumption against the lawful marketing of an ingredient in a supplement if it was first marketed as a drug or was first studied in substantive clinical investigations as a drug; however, the statute permits FDA, in its discretion, to establish a regulation under which hemp-derived CBD may be legally marketed as a dietary ingredient.
Provide guidance to clarify when a substance is considered “an article” as that term is used in 21 U.S.C. § 321(ff)(3)(B). FDA’s reluctance to provide clarity on this definition has led to confusion among consumers and industry alike, and may be preventing firms from filing new dietary ingredient (NDI) notifications for hemp-derived products that would not be subject to the exclusion provision of section 321(ff)(3)(B) anyway.
Enforce existing dietary supplement regulations with respect to CBD-containing products being marketed as dietary supplements.
Statement from Steve Mister, president & CEO, CRN:
“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. During this time, consumer interest has grown, sales have increased, and product innovation has expanded, all while FDA has taken no substantial steps towards 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. With this Citizen’s Petition, CRN is urging the agency 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 dietary supplements.
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-developed 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. 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.”
Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.