NCL concerned Congress seeks to approve unreviewed CDB products

Sept. 17, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—On September 4, lawmakers introduced The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 (HR 8179), which directs the U.S. Food and Drug Administration (FDA) to make hemp and hemp-derived CBD lawful as a dietary ingredient or dietary supplement. The National Consumers League (NCL) has long been concerned about the public health and safety risks posed by unapproved cannabis-derived products. NCL does not support legislation that seeks to bypass FDA’s authority and circumvent the scientific rigor of an FDA review.

Under current law, manufacturers and distributers of CBD products can already petition the FDA to review and approve a new ingredient for use as a dietary supplement (21 U.S.C. 350b). For FDA approval as a dietary supplement or new ingredient, manufacturers and distributors are required to submit scientific data, including any published studies, to provide a basis to conclude that a product is generally regarded as safe (GRAS). Unfortunately, there is a disconcerting lack of research and data about the safety of CBD products already in the market, whereby millions of consumers are using to self-treat serious and life-threatening ailments.

In response to the proliferation of unreviewed and untested CBD products in the market, NCL launched the Consumers for Safe CBD program to provide greater education to consumers about CBD. As demonstrated in a white paper published by NCL, cannabis companies tend to focus their research efforts on inexpensive, low-strength studies that are ultimately used for marketing purposes, not to enhance scientific knowledge or bring new proven therapies to patients. HR 1879 would further incentivize CBD manufacturers to forego the more rigorous and costly clinical trial process for developing an FDA-approved medicine.

NCL is concerned that CBD manufacturers and distributers making claims to treat certain medical issues will seek expedited approval of CBD products as a dietary supplement, instead of as a drug. Lawmakers should encourage the development of cannabis-based medicines that have undergone the rigor of randomized controlled clinical trials to learn more about how cannabis-derived therapies can both help and harm patients. This legislation seeks to fast-track the classification of CBD products as dietary supplements or ingredients without sufficient scientific data on their safety and efficacy, potentially placing consumers further at risk.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.