Natural Products Association Calls for FDA to Set Safe Level of Daily Consumption

WASHINGTON – The Food and Drug Administration (FDA) failed to meet its deadline to provide a Congressionally mandated report on how it plans to regulate CBD. 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’s first report was due on February 20, 2020.

“Unfortunately, this is more of the same from FDA. Each day that goes by elevates the risk of a public health crisis,” 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.

“Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers,” added Dr. Fabricant.

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.

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 effort urging 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.