“This is a huge and surprising step backwards,” says Natural Products Association
WASHINGTON – The Food and Drug Administration today announced that it will reopen the comment period for last year’s CBD hearing. The original comment period, which collected nearly 4,500 comments from public health experts, the natural products industry, and the general public, ended last July and will remain open indefinitely, according to the FDA.
“This is a huge and surprising step backwards. Reopening the comment period will do nothing to protect public health when the FDA is already sitting on a ticking time bomb. The longer FDA waits the greater risk we have of seeing another public health crisis. If the FDA wants to do something constructive then it can get to work on setting a safe level of daily consumption for CBD,” said Daniel Fabricant, Ph.D., President and CEO of NPA.
NPA supports legislation passed by the U.S. House of Representatives that provides resources so the FDA can perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. With the exception of Epidiolex, all CBD products in the U.S. are considered illegal by the federal government.
A new report out today from the Food and Drug Administration (FDA) fails to offer a concrete plan on how the Agency will regulate CBD products. Congress instructed the FDA in last year’s spending bill to adopt an enforcement discretion policy within 120 days and provide an update of its progress after 60 days. The Agency missed the 60-day deadline by two weeks.
New developments related to CBD are also providing policymakers with more urgency to act:
- The UK’s Food Standards Agency recently set deadline for the CBD industry to provide more information about CBD products and their contents. It also advised vulnerable groups not to take CBD, and healthy adults to take no more than 70mg a day.
- The Food Safety Authority of Ireland (FSAI) recently recalled various CBD foods and food supplements due to unsafe levels of delta‐9‐tetrahydrocannabinol (THC).
- A new study from Cornell University revealed that high THC levels in hemp may be more likely due to genetics than growing conditions. During the research, the team also learned that as many as two-thirds of the seeds they obtained of one hemp variety – which were all supposed to be low-THC hemp – produced THC above the legal limit of 0.3 percent, underscoring how risky is it for farmers to grow the plant.
- A recent Freedom of Information Act (FOIA) request filed by NPA for CBD inspection data revealed that the FDA had only inspected four firms that manufactured CBD and only tested three CBD products for THC. There are over 1,500 products that contain CBD on the market.
- The Department of Transportation recently warned workers about using CBD, saying Federal employees could still lose their jobs if they test positive for THC.
Recent NPA Actions on CBD:
- NPA led a legislative effort to secure language in the FY 2020 House Agriculture Appropriations bill to appropriate $100,000 for the FDA to perform an HHE and is leading a grassroots efforturging the Senate to act.
- On Oct. 17, 2019, NPA published a pollthat shows 70 percent of registered voters believe FDA should have already established safety standards for CBD products.
- On May 31, 2019, NPA testified at the FDA’s first public hearing on CBD.
- On March 14, 2019, NPA submitted official commentsto the FDA concerning approaches to CBD regulation that will also help facilitate the discussion.
- On October 24, 2018, NPA sent a letterto FDA asking for regulatory leadership on CBD products.
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Natural Products Association
The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents over 700 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Visit www.npanational.org.