The 2018 Farm Bill set the U.S. on a path toward significantly greater national exposure to cannabidiol (CBD) when it authorized cultivation of varieties of cannabis (or “industrial hemp”) bred to have minimal concentrations of tetrahydrocannabinol (THC). However, despite some specific funding earmarked for FDA and its work with CBD, we have seen little federal movement toward establishing a pathway for using CBD in foods and beverages.
But that hasn’t stopped some companies from establishing a strong framework for development of cannabis-infused foods and beverages, including work related to compliance with FDA’s current good manufacturing practices (cGMPs).
A Known Framework
As noted by FDA: “Following current good manufacturing practices (cGMPs) helps to ensure the safety of food. cGMP regulations generally address matters including appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary operations, facility sanitation, and production and process controls during the production of food.” A comprehensive overview of cGMPs, as well as the rule for “Hazard Analysis and Risk Based Preventive Controls for Human Food,” is published in 21 CFR Part 117, as well as in 21 CFR Part 111 for dietary supplements.
Establishing FDA certifications for cGMPs is a good first step for companies working in cannabis as part of establishing key aspects of a food safety program.
CANNABIS COMPANIES WITH DOCUMENTED, REGISTERED GMP CERTIFICATION INCLUDE:
|Charlotte's Web||Hemp oils; CBD||NSF Dietary Supplements GMP|
|Hemp Depo||Hemp seeds/oils; CBD||NSF Dietary Supplements GMP|
|Mile High Labs||CBD and hemp extracts||SGS GMP|
CANNABIS COMPANIES WITH GMP AUDITS INCLUDE:
|Bluebird Botanicals||Hemp extracts||Eurofins GMP audit/GMP for Dietary Supplements audit|
|Commonwealth Extracts||Hemp oils; CBD products||AIB International GMP audit|
|Stillwater Brands||THC- and CBD-infused foods and beverages||Eurofins Dietary Supplements GMP audit|
“With the 2018 U.S. Farm Bill’s passage federally legalizing hemp production and interstate transport, consumer products containing hemp-derived compounds such as cannabidiol (CBD) have expanded, and the variety and number of CBD health, nutrition, and food products are readily accessible through a number of retail and online outlets has exploded,” says Steve Schain, Esq., senior attorney, Hoban Law Group, with offices in Philadelphia and Cherry Hill, NJ.
Establishing cGMPs lays the groundwork for the requisite level of corporate transparency that U.S. consumers need in order to fully embrace CBD-infused foods and beverages. This is a new area of product development, and people need assurances that the products meet federally structured rubrics for safety.
“As the global hemp industry matures, companies scaling for future growth and looking to remain competitive and align with international industry standards are embracing cGMP regulations, helping ensure food product quality, safety, and efficacy through addressing all production process aspects,” says Schain.
For many of the companies working in cannabis-infused foods and beverages, establishing cGMPs is new territory.
Legal Cannabis Insights
During the inaugural Cannabis Products Exchange (CPX), taking place July 30–31, Justin J. Prochnow, shareholder, Greenberg Traurig, and Steve Schain, senior attorney, Hoban Law Group, will participate on a panel discussion on the topic of “Legal Insights into the Cannabis Edibles & Beverages Industry.”
In the absence of unified federal clarity regarding several aspects of legal cannabis food and beverage product development, processing, and sale, companies working in this industry—or seeking to enter it—need insight into the legal hurdles and challenges they currently face. Topics of discussion will include:
- Current federal perspectives on banking
- Cannabis business taxation protocol and requirements
- Using CBD in foods and beverages
- Brand and trademark protection for cannabis foods and beverages
- Federal pathways toward a medical and recreational cannabis regulatory framework
These guidelines are not specific to CBD or cannabis. They simply create a structure for the safe development and manufacture of cannabis-infused foods and beverages in general. “Companies manufacturing products containing CBD or hemp must comply with the cGMPs in 21 CFR Part 117 for food and beverages or 21 CFR Part 111 for dietary supplements,” says Justin J. Prochnow, shareholder, Greenberg Traurig, LLP, Denver. “Many companies in the CBD and hemp industry are not coming from a position of previous compliance, so this is new for them.” He notes that NSF International has started inspecting cannabis companies for compliance.
While we have not seen any movement from FDA in the area of establishing a structure for use of cannabis-derived compounds like CBD in foods and beverages, FDA has made a point of issuing warnings to companies making health and medical claims. “Several companies manufacturing products with CBD and hemp have received warning letters from the FDA due to claims related to the treatment or prevention of the coronavirus,” says Prochnow. “In those letters, the FDA was only focused on the coronavirus, and didn’t even raise the issue of whether CBD or hemp is permissible in a dietary supplement or a food or beverage.”
We have seen some action taken at the state level, though, regarding CBD-containing products. “Virginia recently passed legislation making it legal to sell products with CBD and hemp, and several states have issued recent regulations regarding the labeling of products with CBD and hemp, such as Alaska and Vermont, which goes into effect July 1.”
These labeling rules often seek to provide more transparency, clarity, and assurance for consumers. For instance, in Vermont, labeling for CBD products will need to include the name and address of the manufacturer, an ingredient statement, manufacturing and expiration dates, a process lot number, and verified levels of cannabinoids present in the product traceable to a certificate of analysis.
Companies that take steps toward establishing a strong regulatory awareness will likely find themselves better prepared to quickly enter the federal marketplace once FDA provides guidelines for use of non-psychoactive cannabis-derived compounds in foods and beverages.