The organization said it will now provide a variety of testing, auditing, verification and certification services to manufacturers of consumer products containing hemp and hemp-derived CBD.
The need for such services is apparent from the number of questions about quality that continue to swirl around the sector. In July, the US Food and Drug Administration announced a spate of warning letters sent to CBD companies. The agency also took the step of testing the products and found that few met label claim in terms of CBD content.
A session at the recent NoCo Hemp Expo, held in Denver CO in late March, is a case in point. The session, which was put on by a trio of quality experts, delved into issues of GMP certification and compliance, testing protocols, quality control procedures and the like. Judging from the questions that came from people in the audience, it was obvious that some of these concepts were entirely new to them.
Dearth of experience
And a number of the manufacturers who were displaying at the show were brand new to the manufacture of ingestible products as well. The hemp industry in its rapid expansion has sucked in a host of players with a wide range of capabilities.
“These products can be manufactured and marketed by small start-ups with little expertise in quality management, Good Manufacturing Practices (GMPs) and labeling requirements, which creates potential risk and confusion for consumers,” said Lori Bestervelt, PhD, executive vice president and chief technical officer at NSF International. “Even established brands may have limited experience sourcing, authenticating, producing and packaging products containing hemp or hemp-derived CBD.”
Jesse Miller, PhD, director of NSF’s Applied Research Center, said that while this is the organization’s first foray into hemp quality issues, it did begin offering organic crop certification last month through its subsidiary, Quality Assurance International, Inc.
THC level of prime concern
Miller said that CBD products are sourced from an agricultural commodity grown in a wide variety of regions and in many cases little history of the performance of the crop in those regions, rigorous testing is necessary. The new program will certify test results for the following parameters:
- Pesticides, heavy metals and other contaminants
- E. coli, Salmonella and other microbes
- Undeclared ingredients
- Quantities of ingredients that conflict with labeled amounts
- THC verified to be less than 0.3% by dry weight.
The last is especially important for products in this sector. Over the counter CBD/hemp products sold as dietary supplements still inhabit a regulatory grey area, but one thing is clear: Products above that 0.3% do not qualify as industrial hemp-derived products. THC, the psychoactive component of cannabis, is still a schedule one controlled substance according to the federal Drug Enforcement Administration.
“For CBD products, verification of THC content is extremely important. Unfortunately, most manufacturers and suppliers currently do not have access to validated test methods to verify the THC content of hemp extracts — so consumers have no way to know what’s really inside most hemp and CBD products,” Miller said.
The NSF program will begin in October, and waits upon toxicological studies in which NSF said it will determine what it believes to be an upper safety limit for CBD.
Methods adapted from AOAC standards
Miller also stressed that NSF will be using a test method derived from an AOAC method. There is little standardization at teh moment in the hemp testing sphere, which can result in erroneous results, he said. In addition, NSF is licensed by DEA to have cannabis reference standards on site.
“There is a test method championed by AOAC International that NSF International has modified for use in our laboratories: AOAC Official Method 2018.11 - Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils Liquid Chromatography–Diode Array Detection Technique with Optional Mass Spectrometric Detection, First Action 2018.11. It is our desire that all labs align to a single testing protocol so that testing results in the industry are harmonized and are comparable across labs,” he said.