The amendment was crafted in association with the Natural Products Association (NPA) to encourage the FDA to establish a safe use level for dietary supplement and conventional food CBD products.
“Since the passage of the 2018 Farm Act – which eliminated hemp from the definition of marijuana under the Controlled Substances Act – we’ve seen a significant increase in the production and sales of CBD products,” said Rep. McNerney.
“With more and more CBD appearing on supermarket shelves across the country, it’s time for American consumers to have accurate information on CBD and for producers to be properly regulated to make the marketplace safe and reliable.”
The amendment essentially earmarks $100,000 for the “FDA to undertake a process to make lawful a safe level for conventional foods and dietary supplements containing Cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”
Dr Daniel Fabricant, NPA’s president and CEO, commented: “With over 1,500 CBD products in the marketplace, consumers have a right to know whether the products they are consuming are safe. This fundamental language would provide companies making and selling CBD products the regulatory clarity they need and consumers the assurance that they deserve that products meet federal safety standards.”
Hemp-derived CBD (cannabidiol) has rarely been far from the headlines in 2019. While the 2018 Farm Act did remove hemp from the definition of marijuana under the Controlled Substances Act, the FDA has consistently stated that CBD is not a legal ingredient for use in dietary supplements, foods and beverage.
Despite this stance, new products are launching onto the market every week, many labeled as ‘broad or full spectrum hemp extracts’ purported to contain CBD at levels found naturally in hemp.
The FDA told this publication that it does not have a policy of enforcement discretion with respect to products derived from cannabis and its components, including CBD.
“The FDA is aware some companies are marketing products containing cannabis or cannabis-derived compounds in ways that violate the law,” the Agency told us in a statement. “Our biggest concern is the marketing of products that put the health and safety of consumers at greatest risk, such as those claiming to prevent, diagnose, treat, or cure serious diseases, such as cancer. That being said, the agency does not have a policy of enforcement discretion with respect to any of these products.
During the FDA’s public meeting on May 31, titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds”, the messages that kept being raised included:
- There are significant gaps in the safety data
- Several stakeholders struggled to clarify safe dosage ranges
- There are thousands of CBD-containing products on the market labeled as dietary supplements with quality standards all over the place. FDA must act quickly to clarify the regulatory status of the ingredient.
Speaking at that meeting, Dr Fabricant stressed that, “time is of the essence. It may be a confusing issue but it’s not an impossible issue. We’re talking about food toxicology.”