FDA Regulations
10 articles on FDA Regulations, written by Shotlee and medically reviewed for clinical accuracy.
RFK Jr. and the Perils of Unapproved Peptides
The mantra 'once an accident, twice a coincidence, three times a trend' fuels bad journalism—and worse, risky medicine. A New Yorker investigation exposes clinics pushing unproven peptides for healing and longevity, backed by RFK Jr. While semaglutide proves the exception, most lack evidence and pose real harms.
5 min read
The Science Behind the Peptide Craze
Peptides are surging in popularity among influencers and biohackers for everything from injury recovery to youthful skin, but the science lags far behind the hype. With FDA bans on key ones like BPC-157 and potential changes ahead, here's what you need to know about their evidence, safety, and gray-market realities.
5 min read
RFK Jr. Big Fan of Peptides: FDA Ban May Lift Soon
Health Secretary RFK Jr. revealed on Joe Rogan's podcast that the FDA may soon act on injectable peptides, which he supports making more accessible. Banned in 2023 for safety risks, these short amino acid chains show promise in anti-aging, muscle building, and more. Here's what peptides are and the debate surrounding them.
5 min read
RFK Jr.'s Peptide Push: Risks of Bypassing FDA Trials
Robert F. Kennedy Jr., US health secretary nominee, wants to open sales of restricted injectable peptides, fitting his Make America Healthy Again agenda. While some peptides show promise, the FDA halted 17 in 2023 due to safety risks—without trials, anecdote isn't evidence. This editorial warns against sidelining regulation for wellness hucksters.
4 min read
Supplement Makers Push FDA to Allow Peptides, New Ingredients
Makers of dietary supplements are pressing the FDA to permit peptides, probiotics, and other trendy ingredients not traditionally found in food. A pivotal public meeting highlighted industry pleas, RFK Jr.'s support, and warnings from consumer advocates. Here's what to know about this regulatory push reshaping the $100B+ supplement market.
6 min read
Supplement Makers Push FDA to Allow Peptides and New Ingredients
Dietary supplement makers are pressing the FDA to broaden ingredient criteria, potentially greenlighting peptides and probiotics not traditionally found in food. A key public meeting highlighted industry pleas under RFK Jr.'s health leadership, sparking debates on safety and oversight. Here's what this means for the booming wellness market.
6 min read
RFK Jr. Plans to Unban 14 FDA-Banned Peptides, Tells Joe Rogan
RFK Jr. revealed on the Joe Rogan Experience his intent to lift FDA restrictions on 14 banned peptides from compounding pharmacies. This reversal addresses the late 2023 Category 2 list ban amid safety concerns and black market shifts. Patients and wellness advocates await formal decisions in coming weeks.
5 min read
Hims Stops Compounded Wegovy Pill After FDA Scrutiny
Telehealth giant Hims & Hers has abruptly stopped offering its newly launched compounded version of Novo Nordisk's Wegovy pill amid FDA scrutiny. The decision follows constructive industry conversations, raising questions about compounded GLP-1 availability. Patients seeking semaglutide for weight management now face shifting options.
5 min read
Novo Nordisk Shares Rebound as FDA Targets Illegal Wegovy Copies
Novo Nordisk's shares rebounded 4.7% in early trading on Friday after the FDA vowed to crack down on companies mass-marketing illegal copies of Wegovy. This followed a sharp sell-off triggered by Hims & Hers' launch of a cheap $49 compounded version. Understand the safety risks and what this means for GLP-1 patients seeking approved weight-loss treatments.
5 min read
BPC-157: Hype, Science, and Safety Risks Explained
BPC-157 promises rapid healing for injuries and inflammation, but nearly all evidence comes from animal studies with scant human trials. As hype surges in wellness circles and amid policy shifts, experts urge caution due to safety unknowns and FDA prohibitions. This guide breaks down the science, risks, and what patients need to know.
5 min read