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Drug Regulation

All articles tagged with #drug regulation

FDA Weighs Temporary Peptide Sales Amid Safety Concerns
health-and-policy5 days ago

FDA Weighs Temporary Peptide Sales Amid Safety Concerns

The Trump administration is considering temporary enforcement discretion to allow compounding pharmacies to sell specific unapproved peptides, despite FDA scientists warning that safety data is insufficient. Health Secretary Robert F. Kennedy Jr. supports broader access, while industry groups advocate for regulated sales to curb black markets. An advisory panel recommended six peptides for approval, though experts criticize the lack of clinical trials and potential conflicts of interest in the panel’s composition.

via The Washington Post|
#compounding-pharmacies#drug-regulation#fda
Ole Miss Deaths Spark Kratom Crackdown as Toxicology Tests Await
health-and-safety17 days ago

Ole Miss Deaths Spark Kratom Crackdown as Toxicology Tests Await

Two University of Mississippi students died under suspicious circumstances this week, with investigators finding packaged kratom at both scenes. While toxicology reports are pending, officials are not attributing the deaths to kratom yet. The incident has intensified scrutiny of the unregulated herbal supplement, which is sold in gas stations and vape shops across the US. In Oxford, Mississippi, police raided a tobacco shop, arresting two men and seizing over 500 units of kratom. The state is expediting toxicology tests to determine if fentanyl or other narcotics were involved, potentially triggering strict anti-fentanyl laws.

via BBC|
#drug-regulation#fentanyl#health-and-safety
LA targets phenibut with new rules for an unregulated gas-station drug
local1 month ago

LA targets phenibut with new rules for an unregulated gas-station drug

Los Angeles City Council unanimously voted to have the city attorney draft regulations for phenibut, an unregulated CNS depressant sold widely in convenience stores and gas stations. The proposed rules would restrict sales to people under 21, ban sales near schools and daycare centers, and require warning labels. A final council vote on the ordinance language is needed before it becomes law, as phenibut is marketed as a “smart drug” but poses risks including addiction and potential severe health effects.

via Los Angeles Times|
#city-council#drug-regulation#gas-stations
FDA panel backs broader access to six peptides through compounding pharmacies
health2 months ago

FDA panel backs broader access to six peptides through compounding pharmacies

An FDA advisory committee voted to recommend expanding access to six peptides (BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon) by adding them to the 503A Bulks List, potentially enabling licensed pharmacies to prepare prescriptions instead of relying on unregulated online sources. The vote covers six of seven peptides reviewed; the FDA must still issue a final decision. While supporters view it as progress toward safer access, experts caution that safety and efficacy data vary across peptides and emphasize requiring qualified clinicians, licensed pharmacies, quality testing, and patient monitoring—without treating this as blanket approval.

via Fox News|
#compounding-pharmacies#drug-regulation#fda
Clarke’s Kratom Episode Pushes the Controversial Plant Into Regulatory Spotlight
health4 months ago

Clarke’s Kratom Episode Pushes the Controversial Plant Into Regulatory Spotlight

NBA forward Brandon Clarke’s Arkansas arrest over kratom capsules—he told deputies, 'it's just kratom'—highlights a fiercely debated, poorly regulated plant that critics say can be addictive and dangerous. With Tennessee and other states weighing bans, the FDA warns of serious risks, while Arkansas already criminalized kratom; Clarke later died in California, with toxicology results pending and officials not confirming kratom as a factor. The case underscores ongoing questions about kratom’s medical value, safety, and the integrity of industry practices and sponsorships in sports.

via The New York Times|
#7-oh#brandon-clarke#death
Melatonin's regulatory crossroads: drug status vs. sleep supplement
health4 months ago

Melatonin's regulatory crossroads: drug status vs. sleep supplement

Melatonin, a natural sleep hormone, is treated as a dietary supplement in the U.S. with limited pre-market safety testing, while other countries regulate it as a medication. Experts warn that variable labeling, unknown long‑term safety—especially for children—and potential misuse due to perceptions of harmlessness argue for tighter oversight or even drug status. A reclassification could improve dosing clarity and safety, but proponents contend it might limit access and raise costs; meanwhile, labeling guidelines exist but aren’t mandatory, and the regulation landscape remains unsettled.

via Live Science|
#drug-regulation#fda#health
FDA weighs loosening rules on unproven peptide injections
health6 months ago

FDA weighs loosening rules on unproven peptide injections

The FDA says it will convene a July advisory panel to decide whether seven popular but unproven peptide injections should be added to a list allowing pharmaceutical compounding, potentially easing restrictions. The move aligns with Health Secretary RFK Jr.’s push to loosen peptide regulations and the stance of MAHA supporters, though critics warn that most peptides lack safety data and could bypass traditional drug testing. Even if advisers approve, the agency must still complete formal rulemaking. Some peptides are banned by sports bodies and have previously been placed on restricted lists due to health risks, underscoring ongoing safety concerns around this market.

via PBS|
#drug-regulation#fda#health
Vinay Prasad's FDA tenure ends amid data-purity clashes and controversy
health7 months ago

Vinay Prasad's FDA tenure ends amid data-purity clashes and controversy

A STAT opinion piece assesses Vinay Prasad's tumultuous FDA tenure, noting his push for clearer, stronger data in rare-disease approvals but arguing his impulsive, confrontational approach caused chaos and eroded the agency's credibility; his upcoming departure leaves a controversial legacy about balancing rigorous evidence with regulatory pragmatism.

via statnews.com|
#clinical-data#drug-regulation#fda