Kratom, the tropical tree native to Southeast Asia, isn’t lawfully marketed in the U.S.— not as a drug product, a dietary supplement, or a food additive in conventional food. However, products prepared from kratom leaves are available in the U.S. through sales on the Internet and at brick-and-mortar stores.
Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal.
According to the American Kratom Association, the U.S. Food and Drug Administration is putting consumers at risk because it refuses to regulate kratom properly.
Mac Haddow, the association’s senior fellow on public policy, says: “Since the FDA treats all kratom products as the same, consumers have to navigate an increasingly complex marketplace alone.”
The AKA says the FDA should help consumers understand the marketplace and remove bad actors from it. However, the FDA has instead declared all kratom products unlawful and is 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) that constitutes a fraud on consumers across a broad array of regulated products,” explained Haddow. “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 AKA has issued its first “Consumer Guidelines for Kratom Use” 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 Califf, entitled “FDA – DO YOUR ACTUAL JOB!” for the FDA to take immediate steps to fulfill its statutory duty to regulate kratom to protect consumers adequately.
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 adulterated kratom products to be marketed without any action by the FDA, and the FDA stands by while 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.
About AKA: The American Kratom Association (AKA), a consumer-based, nonprofit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom. AKA claims to represent millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives.
(To sign up for a free subscription to Food Safety News, click here.) ori
