FDA Commissioner Urges DEA to Classify 7-OH Ingredient Used in E-Cigarettes as a Schedule I Controlled Substance

Jul.30.2025
FDA Commissioner Urges DEA to Classify 7-OH Ingredient Used in E-Cigarettes as a Schedule I Controlled Substance
FDA Commissioner Robert Califf urged the DEA to classify 7-OH, an opioid-like compound found in vapes, drinks, and gummies, as a Schedule I substance. The FDA plans national warnings for doctors and tighter control of high concentrations.

Key points:

 

·FDA recommends: FDA Commissioner Marty Makary announced that 7-hydroxymitragynine (7-OH) will be classified as a controlled substance due to its opioid-like properties. 

 

·Widespread availability: 7-OH can be found in e-cigarette stores, beverages, and children's gummies. 

 

·Regulatory measures: FDA recommends that 7-hydroxymitragynine above a certain concentration threshold be classified as a Schedule I controlled substance. 

 

·Public education: FDA has issued a report and warned healthcare providers, emphasizing the risks of abuse associated with 7-OH.

 


 

【2Firsts News Flash】On July 30th, according to Reuters, Marty Makary, director of the FDA, suggested that 7-hydroxymitragynine (7-OH) be classified as a controlled substance due to its opiate-like properties.

 

He stated at a press conference held at the Department of Health and Human Services in Washington D.C. that many products containing 7-OH are sold in e-cigarette stores, and this compound is also present in beverages and children's gummy candies.

 

The FDA's letter to the DEA will recommend classifying 7-OH above a certain concentration threshold as a Schedule I controlled substance.

 

The FDA stated that the abuse potential of 7-OH is increasingly being scrutinized due to its ability to bind to opioid receptors.

 

"It is sold in e-cigarette shops, tobacco shops, convenience stores, and gas stations across the United States," said Macari.

 

The FDA is in the process of releasing a report and sending warning letters to every doctor in America. Markari stated that the FDA will continue its efforts to educate the public.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy's proposed 2027–2029 budget would bring forward scheduled tax increases for e-cigarette liquids and heated tobacco products from January 1, 2028, to July 1, 2027. The consumption tax coefficient for nicotine-containing e-liquids would rise from 20% to 22%, that for nicotine-free liquids and applicable flavorings from 15% to 17%, and the heated-tobacco coefficient from 41% to 42%. The bill would also introduce official retail price schedules for e-liquids, restrict exclusive agreements between retailers and suppliers, and limit single-brand-dominated displays, sales incentives and bundled offers. Importing, authorized warehousing and retailer sourcing arrangements would also change. The proposals remain subject to parliamentary approval and subsequent implementing regulations.
Regulations
Nov.04
UK-Listed Consumer Goods Group Supreme Sees Vape Duty as Potential Consolidation Opportunity, Holds FY27 Outlook
UK-Listed Consumer Goods Group Supreme Sees Vape Duty as Potential Consolidation Opportunity, Holds FY27 Outlook
UK-listed consumer goods group Supreme plc says it continues to expect FY27 trading to meet market expectations as the Vaping Products Duty takes effect on October 1, while maintaining a comparatively positive view of the new tax and compliance regime. Supreme has said the framework could increase compliance complexity for smaller operators and contribute to market consolidation, while its manufacturing, compliance and distribution scale may allow it to gain share. Its 88Vape brand will retain its value positioning.
Sep.18
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Technology reported FY2026 revenue of about $96 million, down 24.7% year over year, as U.S. cannabis-vapor hardware and European e-cigarette sales declined by $17.4 million and $12.7 million, respectively. Fourth-quarter revenue rose 32.5% to $26.7 million, while quarterly gross margin fell to 6.3%. For FY2027, the company is prioritizing Malaysia manufacturing and vapor ODM while continuing to develop nicotine pouches, IKE Tech age-verification technology and G-Mesh licensing. Ispire has not separately disclosed the revenue or profit contribution of those newer businesses.
Regulations
Sep.17 by 2Firsts Perspectives
Swedish Match Faces Broader Labeling Order After ZYN Inspection, Documents Obtained by 2Firsts Show
Swedish Match Faces Broader Labeling Order After ZYN Inspection, Documents Obtained by 2Firsts Show
Documents obtained by 2Firsts show that Sweden's Public Health Agency ordered Swedish Match to revise ingredient labels beyond the five ZYN products inspected. The dispute centers on whether flavoring ingredients must be individually disclosed, with Swedish Match citing trade-secret protection and the regulator insisting on full ingredient disclosure. The company faces a conditional penalty of SEK 2 million per month for noncompliance. As of October 22, the agency had received no appeal, despite the company's stated intention to challenge the decision.
Oct.22
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 by 2Firsts Perspectives
Why Does JPMorgan Favor BAT Over Philip Morris Despite Forecasting Slower Growth of 3.9% Versus 6.2%?
Why Does JPMorgan Favor BAT Over Philip Morris Despite Forecasting Slower Growth of 3.9% Versus 6.2%?
JPMorgan resumed equity research coverage of British American Tobacco (BAT), Philip Morris International (PMI) and Imperial Brands in November 2026, assigning BAT an Overweight rating and the other two companies Neutral ratings. The bank forecasts like-for-like sales growth of 3.9% for BAT and 6.2% for PMI in 2027, but estimates the two companies will trade at approximately 11 times and 21 times 2027 earnings, respectively. JPMorgan cited BAT's improving position in US nicotine pouches and vaping products as a driver of its investment outlook. BAT reported a 220% constant-currency increase in US modern oral nicotine revenue in the first half of 2026, while PMI's ZYN US shipments returned to growth in the third quarter. Imperial expects NGPs to represent 4% to 5% of sales and has expanded its oral portfolio through acquisitions.
Capital Markets
Nov.12