By David Vaillencourt, CEO, The GMP Collective
September marked a pivotal moment for the cannabis and hemp industries. Senator Ron Wyden introduced the Cannabinoid Safety and Regulation Act (CSRA), reinforcing the industry’s move toward federally mandated safety standards. Simultaneously, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a comprehensive report emphasizing the urgent need for standardized practices.
The message is clear: compliance with Good Manufacturing Practices (GMPs) and ASTM International standards is no longer a nice to have—it is the bare minimum to ensure product credibility and safety.
The CSRA: Reinforcing the Path Forward
While the CSRA doesn’t establish new precedents, it significantly reinforces what industry advocates and previous legislative efforts have been emphasizing: the necessity for standardized safety and quality practices in cannabinoid products. This alignment with global regulatory practices brings the cannabis and hemp industries in line with how other consumer products are regulated worldwide—through adherence to GMPs.
Key highlights of the bill include:
- Mandatory GMP Compliance: All products must be manufactured in facilities adhering to GMP standards, ensuring consistency and safety.
- ASTM Standard Symbol Requirement: Products containing intoxicating cannabinoids must display the ASTM standard symbol, promoting transparency and uniformity.
- Facility Registration and Inspection: Enhanced oversight through mandatory facility registration and regular FDA inspections.
- Comprehensive Labeling: Strict labeling requirements to provide accurate consumer information.
Emphasizing Standards in the NASEM Report
In tandem with legislative developments, the NASEM report titled “Cannabis Policy: Public Health and Health Equity” underscores the critical need for standardized practices. The report calls for increased education, research, and the adoption of established standards to ensure product safety and efficacy.
The report calls for adoption of monographs (a type of standard) published by the U.S. Pharmacopeia (USP), who works closely with ASTM’s Cannabis Committee on developing model standards for the industry. As the Vice-Chair of the ASTM D37 Committee on Cannabis, I’ve witnessed firsthand the dedication to creating robust standards that address both quality and safety across all aspects of cannabis and hemp products.
“Many C15 customers understand that integrating GMP and ASTM standards into their quality programs today is not only essential for compliance but also key to long-term growth and success,” says Sean Samuel of C15 Solutions, an eQMS solution provider for the cannabis industry. “By acting now, they are ensuring a smoother transition into federal oversight while building a competitive advantage. Commercial benefits include unlocking new market opportunities, such as expansion into Europe, attracting new investment, and future-proofing their businesses in a rapidly evolving industry. It’s worth noting that most consumer packaged goods, dietary supplement, and pharmaceutical manufacturers also adhere to GMP and ASTM standards, which means adherence to these standards inherently makes a cannabis operation a more attractive partnership or acquisition target.”
The Writing Is on the Wall
With over a dozen states already integrating ASTM standards into their cannabis regulations, federal legislation like the CSRA underscores the inevitability of nationwide adoption. This alignment not only standardizes practices but also brings the industry in line with global consumer product regulations.
The potential rescheduling of cannabis by the Drug Enforcement Administration (DEA) adds further urgency. Rescheduling would bring cannabis closer to mainstream regulations for consumer products, making compliance with GMPs and ASTM standards essential.
A Call to Action for Operators
For cannabis and hemp companies, the time to act is now. Implementing GMPs and ASTM standards is no longer a strategic advantage—it’s a necessity for survival in a rapidly evolving market. This applies across the board:
Cultivation: Standardized growing practices to ensure consistency and purity.
Laboratory Testing: Rigorous protocols to validate product safety and potency.
Manufacturing: Adherence to GMPs to maintain quality throughout the production process.
Packaging and Labeling: Compliance with new labeling requirements to meet consumer transparency demands.
Expert Support Is Available
At The GMP Collective, we specialize in guiding companies through the complexities of adopting these standards. Our expertise ensures that your products, processes, and facilities are not only compliant but positioned for long-term success in a regulated market.
