Statement By U.S. Hemp Roundtable Concerning FDA Announcement On Hemp-Derived CBD

FOR IMMEDIATE RELEASE
January 26, 2023

U.S. HEMP ROUNDTABLE STATEMENT CONCERNING FDA ANNOUNCEMENT ON HEMP-DERIVED CBD

WASHINGTON D.C. — Today, the U.S. Food and Drug Administration (FDA) announced plans to establish a new regulatory pathway for hemp-derived cannabidiol (CBD), stating that existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. The agency claims a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. The FDA also denied three citizen petitions from the Consumer Health Products Association (CHPA), the Council For Responsible Nutrition (CRN), and the Natural Products Association (NPA) requesting rulemaking to allow the marketing of CBD products as dietary supplements.

Jonathan Miller, General Counsel of the U.S. Hemp Roundtable, issued the following statement:

“We were extremely disappointed today with the FDA’s announcement concerning the regulation of CBD.

When it comes to the safety of CBD, the FDA gets it wrong. Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues. The Roundtable recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.

We therefore see no need for FDA to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD, or other hemp-derived cannabinoids. This action would be unprecedented and is unnecessary given the existing dietary supplement and food pathways provided under the Federal Food, Drug, & Cosmetic Act, which include robust, comprehensive requirements aimed at ensuring the safety and quality of products, in addition to extensive FDA regulations covering the manufacturing, labeling, and marketing of products. We strongly disagree that these are “limited tools,” with requirements that include the following:

• compliance with mandatory current Good Manufacturing Practices (cGMPS) to help prevent contamination and adulteration, as well as detailed requirements for ensuring sanitary practices, proper training of personnel, cleaning of equipment,
• and in-process controls aimed at product quality and safety;
• mandatory facility registration and compliance the Food Safety and Modernization Act, which provides FDA with mandatory recall authority and other enforcement tools aimed at ensuring compliance with food safety standards;
• assuring there is adequate safety to support the intended use of ingredients through NDI notifications or GRAS procedures, which require adherence to specific safety standards outlined in FDA regulation, law, and guidance;
• detailed requirements for nutrient content claims, health claims, and structure/function claims;
• appropriate labeling to ensure safe use of the product, as well as prohibitions on false or misleading labeling, with additional and stringent substantiation requirements covering a wide range of claims imposed by FTC;
• and for dietary supplements, adverse event reporting and recordkeeping requirements, which are enforced through GMP inspections.

With all of these tools in place as part of the existing, well-established pathways, the FDA’s decision is unwise. To the extent FDA believes its current resources are not sufficient to implement and enforce existing requirements, the Roundtable supports additional appropriations to assist FDA in its compliance efforts.

However, there is one area in which we are in strong agreement with the FDA: As we have advocated for years, a legislative solution is necessary to allow the marketing of hemp-derived cannabinoids including CBD as dietary supplements and foods. We look forward to working with the large, bi-partisan coalition that has developed in Congress to re-introduce legislation in this new Congress in the coming days to direct FDA to utilize the existing regulatory pathways for CBD and other hemp-derived cannabinoids, one that ensures the safety and quality of products. We also remain willing to work with the FDA to ensure that hemp-derived cannabinoids like CBD are safe and adequately regulated.”

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ABOUT

The U.S. Hemp Roundtable is the hemp industry’s national advocacy organization, a coalition of dozens of leading companies and organizations committed to safe hemp and CBD products. The Roundtable proudly works in partnership with the industry’s leading national, regional and state grassroots organizations, and is leading the way forward for hemp and CBD products through education and action. More at hempsupporter.com.

Contact: Alyssa Erickson
Public Affairs & Marketing Coordinator
U.S. Hemp Roundtable
[email protected]
[email protected]

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Press Coverage

New York Times
By Andrew Jacobs
F.D.A. Seeks More Authority to Oversee CBD Products

The Washington Post
By Laura Reiley and Daniel Gilbert
CBD not shown to be safe enough for use in food or supplements, FDA says

Politico
By Mona Zhang, Paul Demko and Natalie Fertig
FDA’s rejection of dietary supplement pathway for CBD frustrates industry groups

Axios
By Tina Reed
FDA declines to regulate CBD products

STAT News
By Nicholas Florko
After nearly 4 years of deliberation, FDA punts on how to regulate CBD

Agri-Pulse
By Steve Davies
FDA can’t make decision on CBD, seeks ‘new regulatory pathway’

Natural Products Insider
By Josh Long
FDA denies CBD dietary supplement petitions, looks to Congress for new pathway

New Hope Network
By Josh Long
FDA denies CBD dietary supplement petitions, cites safety concerns

NutraIngredients-USA
By Danielle Masterson
Drumroll, please… waiting game continues to plague CBD industry

FoodNavigator-USA
By Danielle Masterson
Drumroll, please… waiting game continues to plague CBD industry

Law360
By Sam Reisman
In Blow To Hemp Industry, FDA Punts On CBD Rules

HBW Insight
By Malcolm Spicer
Is US Hemp Policy Heading For Farm Bill, Act III?

Cannabis Business Times
By Andriana Ruscitto
FDA Calls for Congress to Regulate CBD

The CBD Insider
FDA says it can’t manage regulation of CBD, calls on Congress to act

Hemp Today
FDA says it can’t manage regulation of CBD, calls on Congress to act

Hemp Gazette
By Steven Gothrinet
USA FDA Passes The Buck On CBD Regulation

Press Features

Politico
By Mona Zhang, Paul Demko and Natalie Fertig
Featuring Jim Higdon — Co-founder of Cornbread Hemp
Cornbread Hemp: FDA Inaction ‘Super Frustrating’

AP News
By Jonel Aleccia
Featuring Steve Mister — Chief of the Council for Responsible Nutrition (CRN)
FDA declines to regulate CBD; calls on Congress for fix

TIME
By Jonel Aleccia
Featuring Steve Mister — CEO/President of the Council for Responsible Nutrition (CRN)
FDA Declines to Regulate CBD and Calls on Congress Instead for a Fix

FOX Business
By Paul Best
Featuring Chase Terwilliger — CEO of Balanced Health Botanicals
FDA calls on Congress to create new regulations for hemp-derived CBD products

Digital Journal
By Karen Graham
Featuring — New York Times Article
FDA seeks new regulatory framework for use of CBD products

DailyWire
By Charlotte Pence Bond
Featuring — The Washington Post Article
FDA Questions Safety Of CBD, Says It Is Ready To Work With Congress On Regulation

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Congressional Statements

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U.S. Senator Ron Wyden (D-OR)

“The current regulatory gray zone for hemp-derived CBD isn’t working. Regulations are needed to protect consumer safety and to make sure the hemp producers and farmers in Oregon and across the country are on a level playing field with other legal products. The FDA has asked for Congress to act, and I plan to reintroduce my Hemp Access and Consumer Safety Act to ensure the FDA can regulate food and dietary supplements containing CBD.”

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U.S. Senator Jeff Merkley (D-OR)

“Farmers, producers, and consumers need certainty about when and how CBD is safely included in products. Sen. Merkley will continue pushing, because stakeholders need action from FDA, not a plan to wait for Congress. They have the authority they need and should use it.”

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U.S. Representative Morgan Griffith (R-VA)

“In the past 24 hours, I have been in contact with the FDA regarding their recent cannabidiol (CBD) market announcement and their willingness to work with Congress to create a regulatory pathway for CBD products. I look forward to working with the FDA so we may create a safe pathway for these products to come to market.”

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U.S. House Committee on Oversight and Accountability James Comer (R-KY)

“The FDA failed for too long to take steps to ensure the safety of hemp-derived dietary products, putting the health and safety of the American people at risk. The Committee on Oversight and Accountability will investigate this decision to understand why exactly the FDA has decided to abdicate their regulatory responsibilities. We need to be sure that the FDA is not using this as an opportunity simply to leverage more authority and resources from Congress.”

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U.S. Representative Chellie Pingree (D-ME)

“After years of pushing FDA to issue CBD regulations, today’s announcement affirms the need for Congress to pass legislation and finally provide a regulatory path for CBD.”