Search results for: kratom

FDA announces seizure of dietary supplements containing kratom.

  • FDA has many tools in its arsenal to protect the public from adulterated, misbranded, and/or dangerous food and dietary supplement products; these include the Agency’s inspection power and various enforcement authorities (e.g., Warning Letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility registration).  Under its administrative detention authority, FDA can detain a food or dietary supplement product if the Agency has reason to believe the product is adulterated or misbranded.  The Agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.
  • Earlier this month, FDA administratively detained dietary supplement products containing “kratom” — a botanical substance from Southeast Asia that may pose a risk to public health and that has the potential for abuse when consumed.  On January 6, U.S. Marshals initiated a seizure of approximately 90,000 bottles of kratom-containing supplements.  The U.S. Department of Justice filed a complaint in federal court on FDA’s behalf, alleging — among other things — that supplements containing kratom are adulterated because there is insufficient information to provide reasonable assurance that these products do not present a significant or unreasonable risk of illness or injury.
  • FDA’s use of its administrative detention authority, followed quickly thereafter by product seizure, indicates the Agency’s willingness to take swift and highly-publicized enforcement action against supplements that may pose safety risks.
  • A group of plaintiffs has filed a lawsuit against the state of Florida following the state’s ban on 7-hydroxymitragynine (7-OH). In July 2025, the state issued an emergency rule, which took immediate effect, classifying isolated and/or concentrated 7-OH from kratom as a Schedule I controlled substance in Florida. The rule made it illegal to sell, possess, or distribute any isolated or concentrated form of 7-OH in Florida.
  • The complaint argues that “the emergency order was issued without public notice or hearings” and that the state’s actions were “unlawful, unnecessary and carried out without due process.” According to the complaint, 7-OH presents no public safety threat and has been legally sold in Florida for years under the Kratom Consumer Protection Act. Further, the rule was issued without due process and is arbitrary and inconsistent because it bans 7-OH but allows the mitragynine alkaloid, which the human body naturally converts into 7-OH. Finally, the ban has harmed consumers and small businesses.
  • FDA has requested that the Drug Enforcement Administration issue a federal scheduling action to control 7-OH products nationwide under the Controlled Substances Act. Further, in July 2025, FDA sent several Warning Letters for illegally marketing products containing 7-OH, which FDA views as a novel potent opioid that has “not been proven safe or effective for any use,” as we previously blogged. FDA Commissioner Marty Makary has said that 7-OH products are “dangerous opioids” found in every community in America.
  • Keller and Heckman will continue to monitor activity related to the sale of 7-OH and kratom products.
  • On July 15, 2025, FDA sent warning letters to seven different companies for the illegal marketing of products containing 7-Hydroxymitagynine (7-OH). 7-OH is a naturally occurring chemical component of Kratom, a tropical tree native to Southeast Asia.
  • 7-OH and Kratom are prohibited from being marketed in the U.S. as a drug product, dietary supplement, or food additive. FDA views 7-OH as a novel potent opioid that has “not been proven safe or effective for any use.”
  • The warning letters targeted a variety of products, including over-the-counter medications, dietary supplements, and drink mixes. Respectively, the warning letters pertained to using 7-OH in unapproved new drugs, in adulterated dietary supplements, and in adulterated human foods as an unsafe food additive.
  • Keller & Heckman will continue to monitor FDA warning letters related to food additives and dietary supplements.
  • On March 12, 2021 the U.S. Food and Drug Administration (FDA) published Import Alert 54-18, which relates to the detention without physical examination (DWPE) of dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients (NDIs), ingredients that were not marketed in the U.S. before October 15, 1994, that do not have an appropriate regulatory status.
  • Import Alert 54-18 prohibits two Chinese companies from importing their products that contain higenamine into the U.S.  Higenamine is a dietary ingredient found on FDA’s Dietary Supplement Ingredient Advisory List (“DSIA List”) and which FDA has determined to be adulterated under the Federal Food, Drug, and Cosmetic Act (“the Act”).  In Import Alert 54-18, FDA notes that there is inadequate information to “provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”
  • By way of background, import alerts inform FDA’s field staff and the public that the Agency has enough evidence to allow for DWPE of products that have been determined to be in violation of the Act.  When a product and/or firm are the subject of an import alert, it will be added to the Red List found on FDA’s import alert, which identifies firms and products subject to DWPE.  To be removed from the Red List, information must be provided to the Agency to demonstrate that the firm has resolved the conditions that gave rise to the violation.
  • FDA has stated that it expects the Agency to use Import Alert 54-18 to identify and deny entry of non-compliant NDIs or products containing NDIs, such as higenamine.  Similar import alerts exist for supplements containing kratom and active pharmaceutical ingredients.
  • On August 25, 2020, the Center for Science in the Public Interest (CSPI) sent a letter urging FDA to take further enforcement against manufacturers, distributors, and retailers that sell products with tianeptine.  Tianeptine, approved as a prescription antidepressant in other countries, is being marketed as a dietary supplement in the Southeastern U.S.
  • FDA has issued warnings to consumers and companies on the dangers of tianeptine in the past. In 2018, FDA issued warning letters to two companies for the illegal marketing of products labeled as dietary supplements that contained tianeptine, which companies illegally claimed to treat opioid use disorder, pain, and anxiety.  CSPI noted that one online retailer that received an FDA warning letter in 2018, jackbgoods.com, continued to sell tianeptine supplements into late July.  Tianeptine products continue to be commonly available in gas stations, vape stores, and other retail outlets in Alabama and online.
  • CSPI believes that enforcement against supplements containing tianeptine should be prioritized, as they target a vulnerable population of recovering or active drug users during a nationwide opioid epidemic.  The letter notes that the popularity of tianeptine increased in the state after Alabama prohibited the sale of kratom, a substance that provides similar effects.  A bill has been introduced in Alabama to ban the sale of tianeptine in the state.
  • On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House official. Rather Gottlieb, who commutes weekly to Washington from Connecticut, said he wants to spend more time with his family. In a letter to FDA staff, Gottlieb noted “[t]here’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family these past two years and missing my wife and three young children.”
  • Unlike some former commissioners, during his tenure, Gottlieb focused much of his time on issues related to food and tobacco. For example, as part of its 2018 Strategic Policy Roadmap, FDA signaled its intent to modernize certain standards of identity (SOI) to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat.  Relatedly, under Gottlieb’s direction, FDA requested comments on the use dairy terms in the labeling of plant-based products. See our previous posts on SOI modernization and the plant-based products labeling debate. As for food safety, examples of FDA action include plans to modernize oversight of imported food and the investigation of several product recalls, including the November 2018 romaine lettuce E. coli outbreak. And in April 2018, FDA issued its first ever mandatory recall. Additionally, Commissioner Gottlieb dedicated his efforts to reducing tobacco-related disease and death and curtailing youth access to tobacco products and e-cigarettes. Tobacco- and e-cigarette-related posts can be found here.
  • Prior to his departure, Commissioner Gottlieb vowed to continue to work to cement more of FDA’s pending efforts, to secure the 2020 budget, and to help transition the agency to new leadership. At this time, Commissioner Gottlieb’s replacement has not been announced.

 

  • The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements.  DSHEA established a new category of permitted claims for dietary supplements called “statements of nutritional support.”  Claims of mitigating or treating a disease, however, are “drug claims” and are not permitted on products marketed as dietary supplements.  As reported on this blog, FDA has recently stepped up enforcement action against kratom dietary supplements with label claims indicating they are drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (namely, opioid use withdrawal in the case of the kratom products).
  • Last week FDA posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies claim treats opioid use disorder (OUD), pain and anxiety, and other conditions.  As was the case with kratom, FDA actions against products containing tianeptine follow reports of serious adverse events associated with the use of the dietary supplement products.
  • In a November 20, 2018 press release, FDA Commissioner Scott Gottlieb characterized the action against tianeptine as part of a broader effort to protect consumers from products illegally marketed as dietary supplements and he promised an upcoming announcement of a new FDA enforcement policy.  Further, Dr. Gottlieb indicated that FDA is re-examining its resources and authorities related to products marketed as dietary supplements.
  • FDA’s actions against opioid-related dietary supplements harkens back to its release on November 9, 2004 of a “strategy for dietary supplements (discussed here) that followed enforcement action against products containing androstenedione.  FDA’s 2004 strategy has three prime components: (1) monitoring and evaluating product and ingredient safety; (2) assuring product quality; and (3) monitoring and evaluating product labeling.  Since FDA is faced with statutory limits on its authority to regulate dietary supplements, the major effect of FDA’s revamped strategy is likely to be the devotion of more resources to enforcement efforts.  At the very least, product manufacturers can expect FDA to increase its scrutiny of claims made for dietary supplements and to be more aggressive in pursuing enforcement action against products that do not meet the current standards.

 

  • The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to the food will cause serious adverse health consequences or death to humans or animals (a Class I recall).
  • On November 5, 2018, FDA released a final guidance, in the form of questions and answers, on how the Agency will use its mandatory recall authority. (Also see: 83 Fed. Reg. 55551, November 6, 2018.) FDA issued a draft guidance on this topic in 2015 and requested comments at that time (see our May 7, 2015 blog for more information on the draft). The final guidance provides additional clarity, including some modifications based on comments received.
  • In addition to explaining the mandatory recall process, the final guidance identifies evidence that FDA “might” consider when making the decision to proceed with a mandatory recall, namely: 1) observations made during inspections, 2) results from sample analyses, 3) epidemiological data, 4) vulnerability of the populations that normally consumes the food, 5) nature of the product, 6)Reportable Food Registry data, 7) consumer and trade complaints, and 8) whether the responsible party has failed to initiate a voluntary recall. (See Q&A #8 in the final guidance.)
  • FDA has only issued a mandatory recall order of a food product once. (See our April 4, 2018, blog on FDA’s recall order for kratom products.). In two other instances, FDA began the process to initiate a mandatory recall authority under FSMA but the companies ultimately chose to voluntarily recall their product.

FDA warns companies marketing dietary supplements that contain methylsynephrine.

  • As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients in dietary supplements.  In the last year, FDA has taken action against beta-methylphenethylamine (BMPEA), 1,3-Dimethylbutylamine (DMBA), and kratom, to name a few prominent examples.
  • FDA recently sent Warning Letters to seven companies marketing dietary supplements that contain the stimulant, methylsynephrine (also called oxilofrine).  FDA’s position is that methylsynephrine does not meet the statutory definition of a “dietary ingredient” permitted for use in dietary supplements.  By law, a dietary supplement is defined as a product intended to supplement the diet that bears or contains one of the following dietary ingredients:  a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.
  • Although the Warning Letters do not cite the potential health risks associated with methylsynephrine consumption, the substance is known to be a powerful stimulant and has been banned by the World Anti-Doping Agency, Major League Baseball, National Football League, and other sports organizations.  An FDA spokesperson indicated that the Agency had learned of 47 adverse reactions associated with the stimulant.  Some media reports are characterizing methylsynephrine as the latest in a string of stimulants intended to replace ephedrine, which was banned in 2004 due to its serious side effects.

The Daily Intake will be on hiatus during our Practical Food Law Seminar — we will return on Monday, April 18.