Until FDA Issues Guidelines, Hemp-derived CBD Industry Forced to Navigate Shifting Federal, State and Local Regulatory Environments
By Jane Wilson, Director of Program Development, American Herbal Products Association (AHPA)
As the Food and Drug Administration (FDA) sifts through the almost 4,500 comments it received during the recent public comment period requesting input on “Scientific Data and Information on Products Containing Cannabis or Cannabis-derived Compounds,” the hemp-derived cannabidiol (CBD) supplement industry remains focused on demonstrating that hemp CBD supplements can be used by consumers with the same confidence with which they purchase and use other supplement products to support their health and fitness. If the May 31, 2019, FDA public hearing on this same topic was any indication, many of the hemp industry’s leading companies, as well as the several national trade associations and advocacy groups that represent the hemp industry, submitted comments urging FDA to take prompt action to provide a critically needed regulatory pathway for these products.
While FDA contemplates the possibility of such action, numerous states and local jurisdictions are enacting legislation related to the manufacturing and marketing of dietary supplements and foods containing hemp-derived CBD. Some of these laws allow for the manufacture, marketing, and consumer use of hemp-derived CBD products, while others appear to restrict or prevent further sales to consumers. Regardless of the intent, this type of legislation is creating a confusing patchwork of conflicting or inconsistent regulations across states and localities.
States and local jurisdictions appear to be creating their own laws for hemp- or CBD-containing products due either to a perceived absence of federal regulations that pertain to these products or unfamiliarity with the existing federal regulatory frameworks for supplements and foods and how they can be applied to these products.
What makes this situation so challenging? Currently, FDA’s position is that CBD is not a legal ingredient that can be used in dietary supplements and foods because it was first approved for investigation as a drug product. The current law for dietary supplements does not allow a compound to be a dietary ingredient or to be added to food, if it was first investigated or approved for use as a drug, unless the FDA issues a regulation that allows for that to happen. While the FDA does have the ability to take this acti
n for CBD under the dietary supplement and food laws, the Agency has never used this part of the law before in the 25 years the dietary supplement rule has been in place.
FDA has taken several encouraging actions since the passage of the 2018 Farm Bill in December 2018, which marked the legalization of hemp cultivation and its removal from the Controlled Substances Act. The Agency has created an internal task force of high-level leaders to assess regulatory options, issued public communications, and conducted the May 31, 2019, public hearing and comment period, which concluded July 16, 2019. With public testimony and almost 4,500 comments submitted to the docket, FDA recently signaled they intend to expedite development of regulations for CBD and will provide an update on their progress in late summer or early fall.
In the interim, hemp-derived CBD manufacturers are taking advantage of the self-regulatory mechanisms available to them, including certification programs that provide independent verification of the authenticity and quality of their hemp products and inspection of production facilities for compliance with good manufacturing practices (GMPs). Some are seeking organic certification for their hemp crops. These activities help the operators who are already in compliance with dietary supplement regulations differentiate their products to consumers in the crowded marketplace for hemp-CBD supplements.
If you want to learn more about what’s going on in the hemp-derived CBD supplements industry, make plans to attend the American Herbal Products Association’s inaugural Hemp and CBD Supplement Congress taking place in Denver, CO, on August 15-16, 2019. The event combines the opportunity for technical workshops on applying GMPs and new dietary ingredient notifications (NDINs) to the hemp-derived CBD industry with a full day plenary that will explore the financial, supply chain, legislative and regulatory topics pertinent to this fast-growing segment of the supplement industry. More information is available here.
AHPA also provides several free resources for the growing hemp-derived CBD industry.
- Hemp-CBD Status Report
- Guidance Policy on supplements and foods containing hemp and hemp-derived CBD
- Guidance on California Proposition 65 and Cannabis Products
Note: Colorado Hemp Company, publisher of Let’s Talk Hemp and producer of the NoCo Hemp Expo and Southern Hemp Expo, is a supporting sponsor of the upcoming AHPA Hemp-CBD Congress in Denver, CO.
Jane Wilson is the Director of Program Development at the American Herbal Products Association (AHPA), the national trade association for the herbal products industry. She serves as the staff liaison to AHPA’s Cannabis Committee and supports other AHPA services and activities related to the hemp and cannabis industries. Visit www.AHPA.org.