The National Industrial Hemp Council of America (NIHC) said it will establish a standards program for CBD products in the absence of regulations from the U.S. Food & Drug Administration (FDA).
“Without any guidance from the FDA thus far, NIHC is stepping up to develop our own testing standards and labeling protocols that we believe will enhance consumer safety and protect the consumer’s right to know,” NIHC President and CEO Patrick Atagi said in a press release.
The lobbying group said it is exploring standards applicable to tests for THC, pesticides, metals, terpenes and other variables. The program will depend on third-party accreditation bodies to verify that laboratories are following testing protocols and properly calibrating testing equipment, and that those running the tests are properly trained, NIHC said. A label will be offered for products that meet the safety protocols.
NIHC announced the plan during its 2021 Hemp Business Summit held in Washington earlier this week.
Foot dragging at FDA
Stakeholders have repeatedly complained about the FDA’s failure to create a lawful path to market for CBD products, which has left producers and consumers at the whim of inconsistent rules – or no rules at all – in individual states, endangering public health.
FDA in 2018 approved the prescription-only high-CBD drug Epidiolex, which has proven effective in patients who suffer Dravet Syndrome and Lennox-Gastaut Syndrome, two debilitating forms of epilepsy. But the agency has yet to address low-concentration CBD products such as tinctures and extracts, which CBD companies say should be regulated the same as other herbal supplements.
While FDA has yet to write formal rules for such over-the-counter CBD products, the agency has put forth enforcement discretion guidance, and has engaged in enforcement actions, issuing stop-sale orders, seizing products and assessing fines in efforts it says are aimed at protecting consumers.
A bill that would make hemp-derived CBD products legal as an ingredient in dietary supplements, foods and beverages has been proposed by three U.S. Senators as a way of forcing FDA to finally establish rules.
CBD is illegal
FDA has said a gap in science-based knowledge about health effects of CBD means extensive clinical trials are still needed.
Appearing at this week’s NIHC conference, Grail Sipes, acting cannabis-product committee chair with the FDA, repeated the agency’s position that more research and safety data are required before CBD can be cleared as safe. The compound meanwhile remains illegal as an ingredient in food, as a dietary supplement, as animal feed, and for interstate commerce, Sipes warned.
NIHC said it intends to partner with world-leading standards bodies as it develops the pilot standards program.
Food Safety Net Services (FSNS), a Texas-based laboratory company, is to lead the effort under NIHC board member Barry Carpenter, FSNS senior adviser for Regulatory Affairs and Client Relations.