This article was written prior to the tragic events of September 21, 2026. If you or anyone you know is struggling with substance abuse, please seek help at samhsa.org or call 1-800-662-HELP (4357).

“[T]hey don’t realize it’s going to be addictive when it’s sold on the shelf next to an energy drink and beef jerky…”.[1]

Sold in gas stations, convenience stores, and smoke shops, Kratom is a substance made by pulverizing kratom leaves, and it is available in several forms, including powders, capsules, tablets, gummies, and liquid concentrate.[2] In any form, Kratom’s effects are unpredictable, partially because the dosage level can result in drastically different effects.[3] In addition to products made from plant-derived, “natural” kratom, there are synthetic products made from kratom, such as products containing 7-hydroxymitragynine (“7-OH”). 7-OH is one of the atypical opioid alkaloids found naturally, albeit in very small quantities, in the kratom plant.[4] Because of 7-OH’s opioid-like effects, companies extract and multiply the naturally occurring 7-OH to create extremely potent and addictive products that are often still labeled as kratom, leading to confusion regarding the risks and potency of a given product.[5]

Although some have suggested that kratom could be a promising treatment option for opioid-dependence disorders, much like methadone or suboxone, it has yet to be clinically proven as an effective treatment.[6] The lack of clinical research on possible medical benefits, combined with kratom’s known addictive properties, raises questions about the seemingly lacking widespread awareness and regulation. 

Because kratom is considered a dietary ingredient, it is not subject to the U.S. Food and Drug Administration’s (“FDA’s”) premarket approval needed by medical drugs.[7] Under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), manufacturers and distributors of dietary supplements and ingredients are fully responsible for ensuring that the products they market are safe, unadulterated, and not misbranded.[8] If an adulterated or misbranded dietary ingredient hits the market, the FDA is then permitted under DSHEA to take discretionary enforcement action, including warning letters, public recalls, or judicial actions.[9]

Kratom is subject to slightly heightened regulation compared to other dietary ingredients because it’s considered a new dietary ingredient (“NDI”).[10] This means that it was not marketed in the U.S. as a dietary ingredient before October 15, 1994.[11] Under NDI-specific rules, manufacturers have one additional requirement: they must demonstrate why that they reasonably believe that the NDI is “expected to be safe under the conditions recommended” by the product’s labeling.[12] Based on the information supplied by kratom manufacturers, the FDA determined that there was not adequate information “to provide reasonable assurance that [kratom] does not present a significant or unreasonable risk of illness or injury.”[13] As a result, the FDA labeled kratom products as adulterated, making it unlawful to market it as a dietary supplement.[14] The FDA has sent warning letters to several firms that continue to market these products, yet kratom and 7-OH products continue to be sold with misleading information.[15]

Researchers in Florida found that thirteen out of twenty kratom products tested had no information on potency and eight had synthetically heightened  concentrations of alkaloids like 7-OH and mitragynine.[16] Mitragynine is an alkaloid that binds to the brain’s mu-opioid receptors, creating effects similar to oxycodone and fentanyl.[17] One of the Florida researchers likened this product and several others to “legal morphine.”[18] As a result of these products remaining on the market, calls to the Poison Control Center for kratom-related poisonings rose by 1,200% from 2015 to 2025, and several lawsuits have been filed by consumers and their family members for wrongful death, failure to warn, and deceptive marketing.[19]

Actions have not been brought against the FDA for failure to adequately enforce the sale of adulterated NDIs or against the Drug Enforcement Administration (“DEA”) for failure to timely schedule a substance with a known public health risk. This is because the enforcement and scheduling authorities of those agencies are considered discretionary powers, which precludes them from judicial review under the Supreme Court’s holding in Heckler v. Chaney.[20]

Private individuals should have greater ability to sue government agencies that fail to act decisively when public health and safety are at stake. Specifically, private consumers harmed by unlawful kratom and 7-OH products should be permitted to seek legal remedies from the court against the FDA for failure to enforce bans on adulterated products and against the DEA for failure to timely schedule a known dangerous substance. For this reason, the holding of Hecklershould be reevaluated, and the Court should instead consider adopting Justice Thurgood Marshall’s concurring interpretation of 5 U.S.C. § 701(a)(2) of the Administrative Procedure Act (“APA”).[21]

In Heckler, death-row inmates, fearing that use of an unapproved drug in capital punishment lethal injections would result in a long and painful execution, asked the FDA to enforce its restrictions.[22] The FDA declined, and the inmates filed suit, arguing that the APA permits judicial review of agency decisions and that the exception for discretionary actions does not apply when those agencies publish their own policies and standards for exercising discretion.[23] The Supreme Court, in a unanimous decision, held that discretionary acts of executive branch agencies are presumptively unreviewable when Congress, not the agency, has been silent on a legal standard to judge the agency’s exercise of discretion against.[24]

The Court argued that agencies primarily exist to make such discretionary decisions, by balancing their expertise on the risk to public safety with the agencies’ limited resources.[25] Similarly, the Court interpreted the APA as primarily serving to assert the separation of powers, stating that “the danger that agencies may not carry out their delegated powers with sufficient vigor does not necessarily lead to the conclusion that courts are the most appropriate body to police . . . their performance.”[26]

In his concurrence, Justice Marshall argued that 5 U.S.C. § 701(a)(2) of the APA should instead be construed as a narrow exception, allowing for judicial review in all cases, in the absence of clear and convincing congressional intent to preclude it.[27] Marshall points out that the APA’s essential purpose was to alter the judicial reluctance to constrain agency discretion, specifically to “rationalize and make fairer the exercise of such discretion.”[28] Marshall also observed that since the passage of the APA, administrative law has continually moved towards limiting what actions are exempt from judicial review, stating that “[d]iscretion may well be necessary to carry out a variety of important administrative functions, but discretion can be a veil for laziness, corruption, incompetency, lack of will, or other motives.”[29]

In the case of kratom, it’s quite possible that other motives have prevented the FDA and DEA from enforcing or scheduling the substance. The American Kratom Association (“AKA”) is a powerful lobbying group that advocates on behalf of the $1.5 billion kratom industry and keeps close financial ties with several scientists who research the possible benefits of kratom, at the exclusion of emphasizing the potential harms.[30]

Although some argue that Marshall’s position erodes the separation of powers, it arguably supports separation through checks and balances. While the separation of powers does ensure that no single branch is above any other, it also functions to hold other branches accountable.[31] Consequently, when an executive branch agency’s negligence in failing to enforce its regulations results in measurable public harm, another branch should be permitted to step in and remedy the abuse of discretion. 

This interpretation seemingly aligns with Marshall’s view of our judiciary: that “law has reached its finest moments when it has freed man from the unlimited discretion of some ruler, some civil or military official, [or] some bureaucrat.”[32]

[1] Rob McMillin, Family blames kratom product for mother’s death, files lawsuit, Eyewitness News ABC 7 (Sept. 2, 2026), https://abc7ny.com/story/lauren-dominguez-family-file-lawsuit-california-womans-death- linked-kratom/19780783.

[2] Carrie MacMillan, Kratom: What Is It and Is It Safe?, Yale Med. (June 17, 2026),

[3] MacMillan, supra note 2 (contrasting that at low doses, kratom acts as a stimulant by lifting mood and energizing the user, while at higher doses, kratom has sedative and pain-relief properties because its primary alkaloids are considered atypical opioids.).

[4] Id.

[5] Id.

[6] Id.; A. C. Borges & D. Machado, Kratom use disorder as a gateway to an opioid use disorder, 66 Eur. Psychiatry S657, (July 19, 2023), https://pmc.ncbi.nlm.nih.gov/articles/PMC10661217 (indicating that early studies may show that kratom actually acts as a gateway to opioid dependence.).

[7] Dietary Supplements, U.S. Food & Drug Admin. (Oct. 1, 2024), https://www.fda.gov/food/dietary-supplements. 

[8] Id.; Questions and Answers on Dietary Supplements, U.S. Food & Drug Admin. (Aug. 27, 2026), https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements. 

[9] Dietary Supplements, supra n. 7; Questions and Answers on Dietary Supplements, supra note 8; Heckler v. Chaney, 470 U.S. 821, 835 (1985); FDA Seizes 7-OH Opioids to Protect American Consumers, U.S. Food & Drug Admin. (Dec. 2, 2025), https://www.fda.gov/news-events/press-announcements/fda-seizes-7-oh-opioids-protect-american-consumers.

[10] FDA and Kratom, U.S. Food & Drug Admin. (Dec. 2, 2025), https://www.fda.gov/news-events/public-health-focus/fda-and-kratom.

[11] New Dietary Ingredients in Dietary Supplements- Background for Industry, U.S. Food & Drug Admin. (Feb. 9, 2023), https://www.fda.gov/food/new-dietary-ingredient-ndi-notification-process/new-dietary-ingredients-dietary-supplements-background-industry#what_is.

[12] Id.

[13] FDA and Kratom, supra note 10. 

[14] Id.

[15] FDA Issues Warning Letters to Firms Marketing Products Containing 7-hydroxymitragyine, U.S. Food & Drug Admin. (July 15, 2025), https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine; Helen Freund et al., How the Tampa Bay Times investigated the kratom industry, Tampa Bay Times, (Dec. 7, 2023), https://project.tampabay.com/investigations/deadly-dose/kratom-overdose-deaths-florida-mitragynine-testing.

[16] Freund et al., supra note 15.

[17] Id.

[18] Id.

[19] Eleanor B. Towers et al., Increases in Kratom-Related Reports to Poison Centers, CDC Morbidity and Mortality Weekly Report, (Mar. 26, 2026), https://www.cdc.gov/mmwr/volumes/75/wr/mm7511a1.htm; Judge Awards $11-Million in Florida Mother’s Kratom Wrongful Death Lawsuit, mctlaw (July 27, 2023), https://www.mctlaw.com/blog/product-liability/kratom-lawsuits/11-million-award-florida-wrongful-death; A $2.5-Million Jury Verdict in the First Kratom Wrongful Death Trial in the US, mctlaw (July 19, 2023), https://www.mctlaw.com/blog/product-liability/kratom-lawsuits/a-2-5-million-jury-verdict-in-the-first-kratom-wrongful-death-trial-in-the-us.

[20] Heckler, 470 U.S. at 837.

[21] Id. at 840 (Marshall, J., concurring); 5 U.S.C. § 701(a)(2).

[22] Heckler, 470 U.S. at 823.

[23] Id. at 825.

[24] Id. at 832.

[25] Id. at 831.

[26] Id. at 834.

[27] Id. at 840 (Marshall, J., concurring). 

[28] Id. at 849.

[29] Id. at 848 (Marshall, J., concurring).

[30] Anjeanette Damon, The Scientist Trying to Keep Kratom Legal Has Not Disclosed Longstanding Ties to Kratom Lobbyists, ProPublica(Sep. 1, 2026), https://www.propublica.org/article/kratom-legalization-christopher-mccurdy-research-conflict-of-interest-aka; Freund et al., supra note 15; American Kratom Association, Our Mission, AKA: About Us (Jan. 1, 2022), https://www.americankratom.org/about (explaining that AKA has filed suit against the DEA to prevent certain restrictions from being applied to “natural” kratom products and has successfully lobbied to convince the DEA to withdraw its 2016 notice to classify kratom as a Schedule I substance.).

[31] Cong. Rsch. Serv., Constitution of the United States: Analysis and Interpretation, https://constitution.congress.gov (last visited Sep. 9, 2026).

[32] Heckler, 470 U.S. at 848 (Marshall, J., concurring).