•  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.

  • On April 2, 2018, 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. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory recall.
  • Under the FDA Food Safety Modernization Act (FSMA), FDA has the authority to order the recall of certain food products when FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
  • Mitragyna speciosa, commonly known as kratom, 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. Out of concern for the public health, FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use.
  • Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found related to this recall are not currently linked to the outbreak.
  • On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity
  • The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom
  • As discussed previously in this blog, FDA has used its administrative detention power followed by seizure against large volumes of kratom containing dietary supplements
  • In its current press release, FDA stressed the potential dangers of kratom as having opioid-like properties and indicated that there are no FDA-approved therapeutic uses of kratom
  • FDA urged all manufacturers of kratom containing supplements to cease marketing and to submit New Dietary Ingredient Notifications to FDA for kratom prior to marketing

Clients who are interested in pursuing appropriate regulatory status for their dietary ingredients or dietary supplements are invited to contact Mel Drozen at drozen@khlaw.com or 202-434-4222 for assistance.

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.