FDA July 2025 highlights: FDA Reinforces Safety Oversight: Controlling Emerging Opioids and Strengthening Gene Therapy Regulation
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7/29/20253 min read
FDA Regulatory Highlights – July 2025
A Month of Strong Oversight on Emerging Opioids and Gene Therapy Safety
The month of July 2025 marked a period of intensified regulatory activity by the U.S. Food and Drug Administration (FDA). Through multiple decisive actions, the agency reinforced its mission to protect public health — from controlling unapproved and dangerous opioid derivatives to managing safety risks in cutting-edge gene therapies.
Each announcement this month demonstrates how the FDA balances innovation with safety, acting swiftly when products pose potential risks to patients while ensuring continued access to life-saving treatments.
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FDA Issues Warning Letters to Firms Marketing 7-Hydroxymitragynine Products
July 15, 2025
The FDA issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH) — a potent opioid alkaloid derived from the kratom plant. These products, often found in gas stations, vape shops, and online stores, were being sold as dietary supplements or herbal remedies.
The agency clarified that 7-OH is not lawful in any dietary supplement, food, or approved drug. Concentrated versions of the compound — such as gummies, drink mixes, and tablets — pose serious health concerns and have no recognized safety or therapeutic benefits.
The warning letters were sent to Shaman Botanicals, My Smoke Wholesale, RRR Trading, Thang Botanicals, Royal Diamond Imports, Hydroxie, and 7Tabz Retail, requiring corrective actions within 15 business days.
Through this action, the FDA demonstrated vigilance in identifying and removing dangerous, mislabeled products from the U.S. market, ensuring consumers are not misled by unsubstantiated therapeutic claims.
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FDA Takes Steps to Restrict 7-Hydroxymitragynine (7-OH) Products Threatening American Consumers
July 29, 2025
Building on earlier enforcement, the FDA took a stronger stance by recommending that 7-hydroxymitragynine be classified as a Schedule I controlled substance under the Controlled Substances Act. The decision followed a comprehensive scientific review confirming that 7-OH acts on opioid receptors and has a high potential for abuse and addiction.
FDA Commissioner Dr. Marty Makary emphasized the agency’s responsibility to prevent another wave of opioid misuse, warning that “7-OH can be more potent than morphine and must be regulated accordingly.”
The FDA’s public advisory highlighted the dangers of child-targeted 7-OH products, such as fruit-flavored gummies and ice creams, that mimic kratom but contain dangerously concentrated doses. The agency’s recommendation is now under review by the Drug Enforcement Administration (DEA) for federal scheduling.
This step reflects the FDA’s proactive role in addressing emerging opioid threats — combining regulatory enforcement with public education and interagency collaboration.
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FDA Requests Sarepta Therapeutics Suspend Elevidys Distribution and Halts Gene Therapy Trials
July 18, 2025
The FDA announced a clinical hold on Sarepta Therapeutics’ gene therapy trials and requested the suspension of Elevidys distribution following three patient deaths linked to the company’s AAVrh74 vector-based therapies.
The fatalities, reportedly caused by acute liver failure, prompted the FDA to take immediate regulatory action and revoke Sarepta’s platform technology designation, citing insufficient safety data. The agency determined that all ongoing trials using the AAVrh74 platform presented an unreasonable risk to participants until further investigation.
“We support innovation but act decisively when patient safety is at risk,” said FDA Commissioner Dr. Marty Makary.
Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research (CBER), added that protecting patient safety remains the agency’s highest priority, and gene therapy trials must be paused when the benefit–risk profile becomes uncertain.
The FDA also restricted Elevidys’ use to ambulatory Duchenne Muscular Dystrophy (DMD) patients while confirming that postmarketing data and ongoing studies would continue to be reviewed.
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FDA Recommends Removal of Voluntary Hold for Elevidys in Ambulatory Patients
July 28, 2025
After further investigation, the FDA determined that the death of an 8-year-old boy previously linked to Elevidys was unrelated to the therapy itself. Consequently, the agency recommended lifting the voluntary hold for ambulatory patients, allowing the resumption of treatment for this subgroup.
The voluntary hold for non-ambulatory patients, however, remains in place following two additional deaths. The FDA affirmed its commitment to continuous risk monitoring and stakeholder communication, emphasizing that patient advocacy groups and healthcare providers play a vital role in shaping future decisions.
The Elevidys case exemplifies the complexity of regulating advanced gene therapies — balancing rapid access to breakthrough treatments with the ethical responsibility to ensure safety and scientific integrity.
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Reflection: A Month of Regulatory Vigilance and Transparency
The events of July 2025 underscore the FDA’s evolving regulatory philosophy — one that embraces transparency, data-driven action, and proactive risk management.
In addressing 7-OH enforcement, the agency showed its determination to curb opioid misuse at its source, combining legal measures with public education. In handling Elevidys, the FDA showcased scientific agility, adjusting its regulatory stance as new safety data emerged.
For professionals in Regulatory Affairs and Pharmacovigilance, these developments reinforce core principles of modern regulation:
• Scientific consistency and ethical responsibility in product evaluation.
• Rapid signal detection and risk communication across clinical and postmarketing stages.
• Balanced decision-making that protects public health while fostering innovation.
The FDA’s actions this month demonstrate not only regulatory strength but also a commitment to collaboration and accountability — hallmarks of effective global health governance.