Enforcement policy of hemp-based CBD products in the US was thrown into fresh confusion last week when a senior Food & Drug Administration (FDA) official directly contradicted earlier assurances that the agency would apply a light touch enforcement approach to the category.
The US natural products industry has been pushing the FDA for clarity on the legal status of hemp-derived CBD for many months. Despite the lifting of the federal ban on hemp in December, the use of hemp-derived CBD in food and drink products remains prohibited under current FDA rules.
At the beginning of April however the FDA’s Commissioner Scott Gottlieb said that the agency would use “enforcement discretion” on CBD, and signalled that the FDA wanted to apply a flexible approach to the category in recognition of federal law change on hemp.
This development was interpreted as a green light for CBD by many brands and retailers, including leading health food chain Vitamins Shoppe which in April placed a 25-product strong CBD range on sale via its website.
But at last week’s Dietary Supplement Regulatory Summit in Washington, the FDA’s director of the office of dietary supplement programs, Steven Tave, declared that the agency was not practising enforcement discretion.
“The agency continues to fail to provide a consistent and clear approach to regulating CBD. The biggest losers in this are American consumers who are interested in this product”
Commenting on this latest development, Daniel Fabricant, president and CEO of the Natural Products Association, said: “The agency continues to fail to provide a consistent and clear approach to regulating CBD. The biggest losers in this are American consumers who are interested in this product. Furthermore, the Agency has the authority to set safety levels for CBD, require Adverse Event Reporting, and good manufacturing practices. To date, the FDA has yet to establish what CBD products it considers safe or unsafe. We look forward to getting clarification from the Agency soon on this issue.”
Photo: Steve Tave speaking at the Dietary Supplement Regulatory Summit in Washington, organised by the Council for Responsible Nutrition (CRN). CRN, via twitter.