Letter requests “information about the measures the FDA is taking to protect consumers from potentially harmful, mislabeled products”
LOS ANGELES, CA, December 23, 2024 (EZ Newswire) — The Global Kratom Coalition applauds the recent letter sent by U.S. Rep. Rich McCormick (R-GA) and Rep. Jack Bergman (R-MI) to U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf expressing concern over the proliferation of synthetic isolated 7-hydroxymitragynine products that contain other unknown substances, otherwise known as “7”, in the marketplace.
The letter, dated December 18, 2024, made a striking declaration that these novel new unapproved drugs mislabeled as kratom are potentially harmful, should be distinguished from dietary supplements, and require a “prompt and thorough response.” Rep. McCormick and Rep. Bergman requested the FDA provide information about the measures the agency is taking to protect consumers from these potentially harmful, mislabeled products. The letter can be found on the Global Kratom Coalition website here.
In the letter, Rep. McCormick and Rep. Bergman pointedly stated that 7 products are “synthetically altered to increase their potency and have no safety data to support their use. These products pose a threat to the public health of our constituents.”
These concerns align with those of the Global Kratom Coalition.
“The message delivered by two prominent U.S. Congressmen to the FDA should also serve as a warning to consumers to beware of 7 products,” said Matthew Lowe, Executive Director of the Global Kratom Coalition. “The letter should also put 7 producers on notice that their dubious business practices are in the clear sights of U.S. legislators and regulators.”
Among the key arguments for their worry is the comparison between 7 products and other kratom products.
“Consumers unfamiliar with kratom, risk purchasing and ingesting a product with a much higher potency and concentration of specific alkaloids than what a normal serving of a pure leaf kratom material product, for example, contains,” wrote Rep. McCormick and Rep. Bergman.
The letter also noted a recent statement from leading kratom researchers at the University of Florida and Johns Hopkins University which finds “7-hydroxymitragynine products aren’t kratom and should be classified as drugs.” These scientists called for regulation of kratom in the U.S. and limiting the amount of 7-hydroxymitragynine that can be in a kratom product. The statement can be found on the Global Kratom Coalition website here.
In describing the information sought from the FDA, Rep. McCormick and Rep. Bergman requested initiatives about the differences of various kratom products, actions taken to deal with manufacturers of 7, research efforts underway to understand the health impacts of 7, and additional measures the FDA intends to implement to enhance consumer protection against this new line of products.
The Global Kratom Coalition seeks to separate kratom from untested products like 7 and address industry issues through initiatives such as the Kratom Consumer Advisory Board, public statements, research, and newsletters to inform consumers.
Legislation has long been sought by federal legislators to address the health and safety of kratom. In 2023, Rep. Bergman co-sponsored the Federal Kratom Consumer Protection Act with sponsor Rep. Mark Pocan (D-WI) to protect access and regulate kratom products.
About the Global Kratom Coalition The Global Kratom Coalition is an alliance of kratom consumers, experts, and industry leaders dedicated to protecting access to kratom while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers.
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SOURCE: Global Kratom Coalition
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