Search kratom

  • A class-action lawsuit was filed against 7Tabz on January 23, 2026, for alleged false and deceptive marketing practices related to the sale of what Plaintiff describes as “kratom” products.  Specifically, the complaint (Law360 Subscription required) alleges that the company conveys that “the Products are natural, safe, and suitable for ingestion” by “prominently displaying plant imagery and natural flavor descriptors,” when in fact there is a significant risk of addiction and toxic effects from consumption of the product.
  • The Plaintiffs characterize the main ingredient of the 7Tbaz products as “kratom,” but the product packages included in the complaint do not use the word “kratom.” Instead, they advertise the products as a source of 7-hydroxymitragynine (7-OH), which is an opioid-like chemical found in the kratom plant. However, online materials indicate that the 7Tabz products are kratom extracts (7-OH is also synthetically produced) and that they are also advertised as kratom products (e.g., “Experience fast-acting, ultra-potent kratom extract” and “great-tasting kratom experience”).
  • FDA has taken the position that Kratom products are adulterated when used in conventional food or dietary supplements (see e.g., FDA and Kratom | FDA). However, in July 2025, FDA commissioner Dr. Makary indicated that the focus on the agency is “not on Kratom” but “on 7-OH” (see also “We’re not targeting the Kratom leaf or ground-up kratom. We are targeting a concentrated synthetic product that is an opioid.”).
  • FDA also voluntarily dismissed a long-running seizure civil forfeiture action against a company selling kratom products earlier this month and its news release related to 7-OH similarly indicates that the agency intends to target products with concentrated 7-OH, but that it is “not focused on  natural kratom leaf products.”
  • A civil forfeiture action filed by the government (Plaintiff) in 2023 to seize kratom products held by Botanic Tonics, LLC came to an end on January 5th when the Court issued a judgment ending the action in response to the Plaintiff’s notice of dismissal (without prejudice). The Plaintiff’s notice indicated that Botanic Tonics had represented that the products in question were expired, and that Plaintiff had therefore determined that “it would not be a prudent use of government resources to sustain the action.”
  • The original action had alleged that seizure was appropriate because the products contained a new dietary ingredient (Kratom) for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury (21 USC 342(f)(1)(B)). The government alleged that there were “serious safety concerns” regarding the effect of kratom. A motion to dismiss the action was denied in December of 2025.
  • The case is United States v. 250,000 filled bottles of liquid product (4:23-cv-00168) and was filed in the District Court for the Northern District of Oklahoma.
  • A class action lawsuit filed earlier this year against Mitra-9 Brands, LLC, alleged that the company’s Kratom-containing seltzers, powders, and shots were falsely and misleadingly advertised, primarily because they failed to disclose the allegedly addictive properties of Kratom. Plaintiff alleges that Kratom has addictive properties similar to opioids and that he suffered from withdrawal symptoms after discontinuing use of Defendant’s products.
  • Defendant argues in a motion to dismiss (Laws360 subscription required) filed this week that no express representation relating to addiction was made, that Plaintiff has failed to allege that the product as formulated is addictive, and that Plaintiff had not alleged anything suggesting that Defendant had a duty to disclose Kratom’s addictive properties.  
  • We note that FDA takes the position that conventional foods and dietary supplements containing kratom are adulterated and has initiated enforcement actions against Kratom-containing products. 
  •  FDA has warned consumers for years against using products containing Mitragyna speciosa, a plant from Southeast Asia that is commonly known as kratom, or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, which affect the same opioid brain receptors as morphine.  Since identifying kratom on an import alert for unapproved drugs in 2012 and on a second import alert for kratom-containing dietary supplements and bulk dietary ingredients in February 2014, FDA has taken numerous enforcement actions.
  • Most recently, on May 21, 2021, FDA announced the seizure of approximately $1.3 million worth of products including over 34,000 kilograms of bulk kratom and more than 207,000 units of dietary supplements containing kratom with the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo manufactured by Atofil, LLC located in Fort Myers, Florida.
  • The latest activity shows that FDA remains ready to initiate enforcement action against supplements that are believed to pose safety risks.
  • On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies also made claims about treating pain, as well as other medical conditions like depression, anxiety, and cancer.
  • In FDA’s press release, Acting FDA Commissioner Ned Sharpless noted that there are no FDA-approved uses for kratom and the agency has been active in warning consumers about the serious risks associated with kratom. For example, as our readers may know, FDA has warned about both the high levels of heavy metals found in kratom products and the contamination of certain kratom products with salmonella. Indeed, FDA issued its first ever mandatory recall order for the salmonella-containing kratom products.
  • The June 25 warning letters allege that the companies used their websites and social media to illegally market kratom products and made unproven claims about the ability of the products to cure, treat, or prevent disease. Examples of the claims include:
    • “Kratom acts as a μ-opioid receptor-like morphine.”
    • “In fact many people use kratom to overcome opiate addiction.”
    • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
    • “Usage: It is for the management of chronic pain, as well as recreationally.”
  • FDA reiterates that “[t]hese products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.” FDA has requested responses from both companies within 15 working days.
  • In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels.  Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia and has opioid-like properties.  The Daily Intake blogged on the topic here.
  • Besides concerns regarding kratom’s opioid-like properties, FDA also has taken action and issued its only mandatory recall order due to Salmonella contamination.
  • On April 3, FDA released a summary of the heavy metal testing – now on 30 products.  In his comment accompanying the data release, Dr. Scott Gottlieb, the outgoing Commissioner of FDA, noted that FDA has “been attempting to work with the companies whose products were found to contain high levels of heavy metals”
  • FDA’s attention on kratom brings to the fore important reminders for all food and dietary supplement producers regarding raw materials testing, supplier verification and validation, and FDA recall authority.
  • In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, and has been marketed in the U.S. to treat muscle pain, diarrhea, and opiate withdrawal.
  • Over the past year, FDA has issued numerous warnings about the serious risks associated with the use of kratom. The agency has also issued an import alert, seized product containing kratom, and issued warning letters to kratom marketers. Most notably, earlier this year, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
  • Continuing its actions to address the regulation and enforcement of kratom, the Commissioner’s November 27th statement notes that FDA scientists tested 26 separate kratom products obtained by field investigators. Lead and nickel were found at levels not considered safe for human consumption. In addition to those 26 products, the Commissioner noted FDA’s concern that there may be other kratom products on the market that also contain heavy metals. In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider.
  • In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there is evidence that certain substances found in kratom are opioids and out of concern for the public health, FDA has advised consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. FDA notes that they are not alone in their concern about the opioids found in kratom, as it is already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.
  • Kratom has been sold as dietary supplements (e.g., teas, powders, capsules) that are marketed to relieve opium withdrawals and to treat ailments including diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, and alcoholism, among others. However, according to FDA, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in human. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs. Thus, marketers are selling kratom with unsubstantiated claims. Selling unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law.
  • On September 4, 2018, FDA issued warning letters to two companies, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims. In the letters, FDA states that the claims made establish that the kratom products 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. Even more, FDA stated that the kratom products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • These warning letters are the latest action in FDA’s regulation and enforcement of kratom manufacturers and marketers. In May of 2018, FDA announced it had issued warning letters to three companies marketing kratom products with medical claims, similar to the claims presently at issue. Additionally, on April 2, 2018, FDA issued its first ever mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
  • In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider, as well as take action against those who put the safety of American consumers at risk.
  • Kratom is a botanical substance that grows naturally in Southeast Asia. FDA classifies kratom as an opioid, noting that it is addictive and has been linked to severe health consequences and deaths among users. Nevertheless, the popularity of kratom has grown in recent years despite kratom not being legally marketed as a drug or dietary supplement in the United States. In February 2014, the FDA issued an import alert that allows U.S. officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.
  • As reported on this blog, FDA began cracking down on kratom importers with an administrative detention and seizure in January 2016, and escalated enforcement activity two years later with a voluntary recall and destruction announced February 21, 2018 of several kratom products illegally marketed as dietary supplements and May 22, 2018 warning letters against three kratom products making medicinal drug claims.
  • Salmonella risk became a new focus of concern with kratom for FDA with a mandatory recall order (FDA’s first mandatory recall order ever) announced April 12, 2018 against a kratom product associated with salmonellosis. Throughout the year, FDA announced additional kratom recalls due to salmonella contamination of products from multiple different companies and brands.
  • A Statement From FDA on the Ongoing Risk of Salmonella in Kratom Products (July 2, 2018) outlines the scientific basis for FDA’s conclusion that kratom consumption presents a significant risk of exposure to salmonella. According to FDA, salmonella contamination of kratom has probably been occurring at a significant level for some time and is ongoing. A total of 81 samples of kratom were collected and tested as a direct result of FDA’s investigation of 199 cases of salmonellosis linked to kratom consumption as of May 2018 and 42 (52%) were found to be contaminated with salmonella. FDA further found that kratom is grown and harvested mainly under conditions promoting widespread contamination of foodborne pathogens and that further processing steps to manufacture capsules, powders, and herbal remedies do not appear to eliminate microbial contamination.
  • Since FDA considers kratom to be a dangerous and addictive opioid, it is unlikely that any steps to make kratom products safer with respect to microbial contamination would result in reduced FDA enforcement.
  • On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims.  FDA’s letter asserts that the claims that the products could be used as pain killers, to reduce opioid dependence, to treat diabetes, to lower blood pressure, and to treat other ailments; are medical claims that have not been reviewed by the Agency.  Such claims, when not approved by FDA, render the products unapproved new drugs.
  • FDA Commissioner Gottlieb indicated that these warning letters are part of a concerted effort to fight the opioid epidemic.  The effort by FDA includes a commitment to “make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies.”  Commissioner Gottlieb encouraged kratom manufacturers to provide FDA a new drug submission if the manufacturers have data that can substantiate medical claims.  Commissioner Gottlieb’s call for submissions specifically noted pain treatment or opioid addiction claims.
  • These warning letters come on the heels of widespread salmonella contamination of kratom containing products, resulting in multiple recalls, a 2016 seizure of kratom products promoted with unapproved drug claims, and FDA’s general emphasis on addressing the opioid crisis.  The actions are also consistent with FDA’s recent crackdown on youth tobacco use, another FDA strategic priority.  It is clear that FDA is taking, and will continue to, take, aggressive steps to pursue its strategic priorities.  For manufacturers, distributors, and retailers of products that might be impacted, increased vigilance to ensure compliance with all regulations and laws impacting the your products is in order.  Those wishing to make medical claims on products will need to determine if such claims will render their product a new drug and take actions (potentially including submitting new drug application to FDA) consistent with this assessment.

The Daily Intake will return on Tuesday, May 29.  We extend our best wishes to those of you celebrating the Memorial Day holiday.