Clarifying the Federal 7-OH and Synthetic Alkaloid Proposals

WASHINGTON, D.C., November 13, 2026

The Global Kratom Coalition supports the original purpose of the federal scheduling initiative outlined by DEA, HHS and FDA on July 29, 2025: remove concentrated synthetic 7-hydroxymitragynine (7-OH) and related synthetic opioid products from the consumer market while preserving access to natural kratom leaf. We supported the original Notices of Intent (NOIs) and support the revised notices in principle because they keep that distinction intact.

On July 29, 2025, FDA Commissioner Marty Makary said:

“We’re not targeting the kratom leaf or ground-up kratom. We are targeting the concentrated synthetic byproduct that is an opioid.”

HHS Secretary Robert F. Kennedy Jr. repeated the point on October 9, 2026, when the new Notice of Intent for 7-OH and mitragynine pseudoindoxyl (MGPI) was announced:

“We are drawing a clear line between natural kratom and dangerous, enhanced opioid products.” [1,2]

GKC has drawn the same line throughout. We back targeted scheduling for the same reason we back responsible regulation of natural kratom leaf: consumer protection.

GKC supported the original action

The federal response widened after the July 2025 announcement. FDA’s initial scheduling recommendation focused on concentrated 7-OH. DEA’s July 2026 notices extended the action to MGPI, MGM-15 and MGM-16, alongside 7-OH. The three related compounds entered Schedule I on August 26, 2026. GKC supported the broader action. [5,6,18,19]

The two original notices were announced July 1, 2026 and published July 6, 2026. The 7-OH notice used a 0.050% concentration threshold, equivalent to 0.5 mg/g for solids, and an additional trigger above 1 mg per article for specified synthetic or further-processed products. The other notice proposed scheduling MGPI, MGM-15 and MGM-16 without a threshold. [3,4]

GKC backed both notices. Our August 2026 press release welcomed the order scheduling MGPI, MGM-15 and MGM-16 and called for completion of the pending concentrated synthetic 7-OH action. Matthew Lowe, GKC’s Executive Director, stated: “DEA is demonstrating bold, science-driven leadership by taking aim at these rogue synthetic opioid products.” [5]

DEA itself explained that its July initiative targeted synthesized products and products with elevated 7-OH concentrations, while excluding botanical kratom containing naturally occurring 7-OH below the specified threshold. [6]

When the MGPI order was announced in August 2026, DOJ addressed trace amounts directly, saying it “will exercise enforcement discretion when only incidental trace amounts of MGPI are confirmed in a product otherwise consistent with botanical kratom.” This was an enforcement policy, not a legal exemption or an unconditional guarantee against prosecution. It did not cover manufactured, concentrated, fortified or intentionally added MGPI, or MGM-15 and MGM-16. [7]

The synthetic alkaloid product lobby is not the ‘kratom lobby’

Groups campaigning to keep concentrated synthetic 7-OH products on the market actively opposed the scheduling action; natural kratom leaf advocates, including GKC, supported it. Lumping both together as “the kratom lobby” hides that difference. [5,13,14]

Reducing this issue to a fight for market share is misleading. The idea comes from opponents of scheduling and has made its way into coverage: Stateline reported a claim by the Holistic Alternative Recovery Trust (HART) that legacy kratom manufacturers were losing market share and creating a crisis. The past 12 months have shown otherwise, with a growing number of reports each week of deaths and adverse outcomes linked to these synthetic alkaloid products. Questions about commercial motive do not make natural kratom leaf and concentrated synthetic opioid products equivalent, and they do not cancel out the reasons the agencies gave for scheduling. Coverage should explain how the products actually differ. [2,5,6,23]

Makary told CBS News: “The Kratom/7-OH lobby ran the same playbook to undermine my efforts to make this new ‘gas station heroin’ illegal.” [12]

The obstruction Makary describes was aimed at an action the natural kratom leaf community supported. It came from the concentrated synthetic alkaloid industry, and it was organized and public. HART, the leading synthetic alkaloid trade group, challenged the basis for emergency scheduling of synthetic alkaloids. Its sister organization, the 7-HOPE Alliance, mobilized a nationwide campaign of comments and contacts with federal officials and Congress, while urging regulators to reconsider scheduling altogether. HHS then extended the comment deadline to September 10, 2026 after a request for more time. 7-HOPE celebrated the extension as a victory; concentrated synthetic 7-OH seller RAW MIT told supporters: “We fought for more time. We got it.” [13–16]

That extra time has not won an exemption for the concentrated formulations at issue. Under the revised proposal, products exceeding either the concentration limit or the alkaloid-ratio limit would still be controlled. 7-HOPE is now campaigning for DEA to withdraw the revised notice. It would not be doing so if the proposal left its market intact. GKC supports completing the targeted action and enforcing it. [8,17]

The revised notices preserve the objective

The October 2026 notices bring concentrated 7-OH and MGPI under a combined concentration-and-ratio framework. The separate notice for MGM-15 and MGM-16 keeps their Schedule I status without substantive change. GKC supports the revised approach in principle because it still separates botanical kratom from concentrated synthetic opioid formulations. [8,9]

Under the revised 7-OH/MGPI proposal, either of two tests would trigger Schedule I control: [8,10]

1. Concentration: more than 1 mg/g in solids or more than 1 mg/mL in liquids.
2. Alkaloid ratio: less than 100 mg of mitragynine for every 1 mg of 7-OH, MGPI, or their combined amount.

Where both 7-OH and MGPI are present, they are added together for both tests. These are alternatives for triggering control: failing either test is sufficient. A product must satisfy both limits to fall outside this proposed scheduling provision. [10] Much of the reporting has missed or misstated this dual trigger. The second prong is what makes the new NOI restrictive, and the first prong cannot be accurately described without it.

The products remain within scope under both versions

None of the concentrated formulations below would be exempt under the revised limits. The FDA image shows the kinds of products the initiative was aimed at. [3,4,8,24]

FDA consumer guide, p. 5, reproduced without alteration. The table is GKC’s application of the notices. [24]

Product and evidence	Original NOI	Revised NOI
Smurph’s Kiwi Dragon Berry tablet Tested lot 2025-06: 25.394 mg/g combined 7-OH + MGPI. [25]	CONTROLLED	CONTROLLED
OPiA Blue Raspberry 20 mg tablet Tested lot 2025-02: 45.51 mg/g combined 7-OH + MGPI. [26]	CONTROLLED	CONTROLLED
Hydroxie Fruit Punch drink mix Tested lot 2024-10: 2.57 mg/g 7-OH. [27]	CONTROLLED	CONTROLLED
Ohmz Conez — red pack Tested lot 2024-10: 1.00 mg/g 7-OH; ratio below 0.1:1. [28]	CONTROLLED	CONTROLLED
OPiA Blackberry Lemonade 60 mg shot Label basis: 60 mg 7-OH in 30 mL = 2 mg/mL. [24]	CONTROLLED	CONTROLLED
OXIN Original tablets Label basis: 40 mg combined alkaloids in 1.5 g = 26.67 mg/g. [24]	CONTROLLED	CONTROLLED
EDP 7OH 50 mg shot Label basis: 50 mg in 30 mL = 1.67 mg/mL. [30]	CONTROLLED*	CONTROLLED*
Chew Ohmz gummies Label basis: 18 mg per 4.32 g gummy ≈ 4.17 mg/g. [24,29]	CONTROLLED*	CONTROLLED*
7OHMZ Classic tablet Tested lot 2025-12: 30.51 mg/g combined 7-OH + MGPI. [20]	CONTROLLED	CONTROLLED
Press’d Dragon Fruit Super Hulks tablet Tested lot 2025-09: 59.16 mg/g combined 7-OH + MGPI. [21]	CONTROLLED	CONTROLLED
OPiA Classic 7-OH + Pseudo shot Tested lot 2025-02: 0.41 mg/mL MGPI; ratio below 0.25:1. [22]	CONTROLLED	CONTROLLED

CONTROLLED means within Schedule I scope if each framework is implemented. The revised thresholds remain proposed; existing MGPI and MGM controls remain in force. [8–10]

Higher mg/g or mg/ml limits do not erase the distinction

The increase sounds substantial when described as a “doubling.” However, it is a move from 0.05% to 0.1% by weight, with the revised ceiling applying to the combined 7-OH and MGPI amount. These remain very small concentrations compared with the products originally targeted. The tested Smurph’s and Press’d tablets listed above contained approximately 25 and 59 times the revised concentration limit, respectively. [3,8,21,25]

Secondly, the 1mg/g and 1mg/ml concentration figures have to be read alongside the ratio test. With 50 mg of mitragynine, the ratio test permits no more than 0.5 mg of combined 7-OH and MGPI, and the concentration limit still applies. Compare that with concentrated synthetic 7-OH tablets FDA identified as labeled with 15, 20 or 60 mg, or pseudoindoxyl tablets DEA cited as marketed at 100 mg per tablet. Nothing in the revised framework lets concentrated 7-OH or MGPI products carry on unchanged. Products exceeding either test would still be controlled. [4,10,11; calculations]

GKC does not see these particular numbers as the only workable thresholds. Lower limits could preserve the same botanical distinction, and we would support evidence-based refinements grounded in validated botanical data and reliable testing. We can support the framework’s principle without arguing that every number in it is the right one.

Falling outside a scheduling threshold is not a finding of safety or an authorization to sell. FDA retains its separate enforcement authority. As of November 9, 2026, the August 2026 controls on MGPI, MGM-15 and MGM-16 remain in effect; the revised 7-OH/MGPI thresholds have not taken effect. [7,8,10]

The Mississippi products remain controlled

The revised notices do not create an exemption for the MGM-15-containing products identified in the Oxford, Mississippi case.

An October 20, 2026 federal indictment charges two Oxford vape-store employees with possessing a mixture containing MGM-15 and MGPI with intent to distribute. Reporting on the court records identifies SMAX Pseudo-DHM Mango Breeze tablets among the products found during the investigation. [31,32]

Modus SMAX Pseudo-DHM Mango Breeze packaging. Photograph: U.S. District Court for the Northern District of Mississippi, via Fox News. [33]

The key compound here is MGM-15. The original action placed MGM-15 in Schedule I without a concentration threshold. The revised October notice expressly preserves that control without change. The new 7-OH/MGPI limits therefore provide no exemption for an MGM-15-containing formulation. In fact, these product would be controlled under both the MGM-15 order and the revised 7-OH rule. [4,9,19]

Product formulation	Original action / existing order	Revised notices
MGM-15-containing SMAX formulation identified in the Mississippi case	Controlled: MGM-15 is Schedule I, with no concentration or ratio exemption.	Still controlled: MGM-15 control is unchanged. The revised 7-OH/MGPI thresholds do not apply to MGM-15.

The Mississippi case shows that these controls are already enforceable. [9,19,31]

The scheduling debate does not need to be reopened. What is needed now is strong, sustained enforcement. GKC calls for enforcement of the controls already in force, swift finalization of the concentrated synthetic 7-OH rule and sustained enforcement once it takes effect, while preserving access to natural kratom leaf.

Sources

[1] Marty Makary, July 29, 2025 press conference; video and transcript. View source

[2] HHS, updated threshold recommendation and Robert F. Kennedy Jr. statement, October 9, 2026. View source

[3] DEA, original 7-OH Notice of Intent, July 6, 2026; 91 FR 40917. View source

[4] DEA, original MGPI/MGM-15/MGM-16 Notice of Intent, July 6, 2026; 91 FR 40909. View source

[5] GKC press release supporting the scheduling action, August 25, 2026. View source

[6] DEA, announcement of original notices, July 1, 2026. View source

[7] DOJ, emergency scheduling announcement and trace-MGPI enforcement policy, August 25, 2026; updated September 1. View source

[8] DEA, revised 7-OH/MGPI Notice of Intent, October 14, 2026; 91 FR 65370. View source

[9] DEA, reissued MGM-15/MGM-16 Notice of Intent, October 14, 2026; 91 FR 65381. View source

[10] FDA, Hiding in Plain Sight: 7-OH Products; explanation of updated thresholds and continuing controls. View source

[11] FDA warning letter to Royal Diamond Imports, June 25, 2025; labeled amounts in commercial 7-OH tablets. View source

[12] Marty Makary statement supplied to CBS News, included in the November 8, 2026 Face the Nation transcript. View source

[13] HART, response opposing DEA’s Notice of Intent, July 1, 2026. View source

[14] 7-HOPE Alliance, statement celebrating the comment extension and urging reconsideration of scheduling, September 3, 2026. View source

[15] HHS, extension of the threshold comment period to September 10, published August 26, 2026; 91 FR 55104. View source

[16] RAW MIT, public campaign updates celebrating additional time to oppose scheduling, August–September 2026. View source

[17] 7-HOPE Alliance, current federal action campaign calling for withdrawal of the revised notice; accessed November 9, 2026. View source

[18] FDA, initial 7-OH scheduling recommendation announced July 29, 2025. View source

[19] DEA, temporary scheduling order for MGPI, MGM-15 and MGM-16, effective August 26, 2026; 91 FR 54948. View source

[20] NN Analytics, 7OHMZ Classic tablet, lot 2025-12, sample 2601-035; testing January 5–7, 2026. View source

[21] Anresco Laboratories, Press’d 60mg Dragon Fruit Super Hulks tablet, lot 2025-09, sample 1340780; September 19, 2025. View source

[22] Anresco Laboratories, OPiA Classic 7-OH + Pseudo liquid shot, lot 2025-02, sample 1277762; February 14, 2025. View source

[23] Stateline, Kratom faces increasing scrutiny from states and the feds, August 11, 2025; reporting HART’s market-share allegation. View source

[24] FDA, Preventing the Next Wave of the Opioid Epidemic: What You Need to Know About 7-OH, p. 5; original collage and visible product labels. View source

[25] Cora Science, Smurph’s Kiwi Dragon Berry tablet, lot 2025-06, sample I11527; June 30, 2025. View source

[26] Anresco Laboratories, OPiA Blue Raspberry 7-OH tablet, lot 2025-02, sample 1277778; February 14, 2025. View source

[27] Anresco Laboratories, Hydroxie Fruit Punch Drink Mix, lot 2024-10, sample 1251495; October 29, 2024. View source

[28] Anresco Laboratories, Eat Ohmz Conez, lot 2024-10, sample 1246615; October 14, 2024. Report photograph shows red packaging, unlike the variants in FDA’s collage. View source

[29] Anresco Laboratories, Chew Ohmz 7-OH gummy, lot 2024-10, sample 1251504; October 29, 2024. View source

[30] Cora Science, EDP 7-OH liquid shot (50 mg), lot 2024-08, sample I05574; August 15, 2024. View source

[31] United States v. Mosleh, No. 3:26-cr-00170-GHD-RP, indictment, Doc. 45, October 20, 2026; MGM-15 and MGPI charge. View source

[32] Action News 5, report on Oxford court records identifying SMAX Pseudo-DHM Mango Breeze products, October 2, 2026. View source

[33] Fox News, October 10, 2026; SMAX packaging photograph credited to the U.S. District Court for the Northern District of Mississippi. View source

About the Global Kratom Coalition

The Global Kratom Coalition is an alliance of natural kratom consumers, experts, and industry leaders dedicated to protecting access to natural kratom leaf while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers. For more information, visit globalkratomcoalition.org.

Source: Pinion Newswire

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