Summation
- “The real threat to the health and safety of the kratom consumer is the lack of action by the FDA while they are hell-bent to pursue their failed attempts to classify kratom as a Schedule I substance and thereby ban access to kratom by American consumers.
- The FDA's failure to properly regulate kratom encourages this market behavior, allows clearly adulterated kratom products to be marketed without any action by the FDA, and the FDA stands by while clearly unsafe kratom products are marketed in the same space as safe and tested products.
- “What is happening in the kratom marketplace is, in the absence of any responsible regulation by the FDA to protect kratom consumers, unscrupulous vendors are deliberately misleading consumers with illegal therapeutic claims, and more recently, with super-concentrated kratom products that pose real safety risks to the public.
As the popularity of kratom products grows in America, the kratom marketplace has become increasingly complex for consumers to differentiate and understand. Along with this product type complexity, the risks of purchasing dangerously adulterated kratom products are increasing dramatically. New and existing kratom vendors are trying to increase market share or differentiate their products by pushing products making illegal therapeutic claims, or are offering super-concentrated products that pose potential safety threats to average kratom consumers.
The FDA’s role should be to help consumers understand the marketplace and remove bad actors from it. However, they have simply declared all kratom products unlawful and are therefore ignoring the reality that millions of Americans have and will continue to use kratom increasingly as they prefer the improved sense of well-being they experience compared to when they consume coffee or products like energy drinks.
“The FDA has extensive experience with economically motivated adulteration (EMA)[1] that constitutes a fraud on consumers across a broad array of regulated products,” explained Mac Haddow, Senior Fellow on Public Policy with the American Kratom Association. “What is happening in the kratom marketplace is, in the absence of any responsible regulation by the FDA to protect kratom consumers, unscrupulous vendors are deliberately misleading consumers with illegal therapeutic claims, and more recently, with super-concentrated kratom products that pose real safety risks to the public.”
The American Kratom Association (“AKA”) issued its inaugural “Consumer Guidelines for Kratom Use” today to help consumers better understand how to use kratom most effectively for themselves and particularly how to identify misbranded, adulterated, and dangerously concentrated kratom products; and issued an appeal to FDA Commissioner Robert M. Califf, entitled “FDA – DO YOUR ACTUAL JOB!”, for the FDA to take immediate steps to fulfill its statutory duty to properly regulate kratom to protect consumers.
“The Consumer Guidelines for Kratom Use will be updated regularly to alert consumers to new threats that emerge from EMA in the kratom marketplace,” Haddow announced. “The real threat to the health and safety of the kratom consumer is the lack of action by the FDA while they are hell-bent to pursue their failed attempts to classify kratom as a Schedule I substance and thereby ban access to kratom by American consumers. That is why we are calling on Commmissioner Califf to listen to our plea for the FDA – DO YOUR ACTUAL JOB! and order its implementation at the FDA.”
The AKA’s concern is focused on two areas: (1) the lack of prosecution by the FDA of the more than 80 kratom vendors who openly market kratom products with illegal therapeutic claims and who have been reported (with supporting evidence) by the AKA to the FDA; and (2) the increasing marketing of super-concentrated kratom products that do not provide adequate labeling for consumers on the serving sizes and contents of the product that are openly marketed without any FDA regulations.
Without responsible regulation of kratom by the FDA, the proliferation of product competition is encouraging the marketing of super-concentrated kratom products to maintain market share. The FDA’s failure to properly regulate kratom encourages this market behavior, allows clearly adulterated kratom products to be marketed without any action by the FDA, and the FDA stands by while clearly unsafe kratom products are marketed in the same space as safe and tested products. This FDA allows this wild west marketplace to flourish, leading to predictable consumer confusion, puts consumers at significant risk, and serves only to create a false narrative for the FDA to recreate its currently failed case to ban all kratom products.
“The AKA is calling for the FDA – Do Your Actual Job! to fulfill its statutory duty to responsibly regulate the kratom marketplace with standards consistent with other dietary and botanical supplements, and then we are launching our Consumer Guidelines for Kratom Use so consumers understand their responsibility to purchase and consume kratom products that protects their health and well-being,” Haddow concluded. “Consumers should not purchase any kratom product marketed by unscrupulous vendors who fail to properly manufacture or label their products.”
[1] https://www.fda.gov/food/compliance-enforcement-food/economically-motivated-adulteration-food-fraud