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Warning over very trendy skincare and hair growth treatment that isn’t actually FDA approved: ‘You can’t fully predict its side effects’

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Cite

Sacks, R. (2026, October 5). Warning over very trendy skincare and hair growth treatment that isn’t actually FDA approved: ‘You can’t fully predict its side effects’. New York Post. https://nypost.com/2026/10/05/health/warning-over-trendy-skincare-and-hair-treatment-that-isnt-fda-approved/

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New York Post · collected 2026-10-05 · by Rachel Sacks

Quick Summary

The FDA has issued warning letters to companies promoting unapproved skincare and hair growth treatments containing exosomes, which are tiny bubbles derived from human stem cells claimed by celebrities like Kim Kardashian to improve skin health and hair thickness. Despite their popularity, these products lack scientific backing for their benefits and may pose risks due to unpredictable side effects and manufacturing issues. Dr. Gina Maccarone warns that without long-term safety data and proper characterization, consumers should be cautious and ensure any exosome treatment is administered by a board-certified physician involved in registered clinical trials.
Written by AI on 2026-10-05, from this article's own text only (the story summary below draws on all the coverage).

AI analysis

Story summary

The FDA has issued warnings about trendy skincare and hair growth products containing exosomes, tiny particles derived from human stem cells that are claimed to have various health benefits. Despite their popularity among celebrities like Kim Kardashian, the FDA warns that these treatments are not approved for use in the United States due to lack of safety and efficacy data. In August 2026, the agency sent warning letters to companies such as R3 Medical Companies for making false claims about exosome products and failing to meet manufacturing standards. While some companies have started producing lab-synthesized alternatives, these differ significantly from human-derived exosomes in their effects, raising concerns over potential side effects that cannot be fully predicted.

Written for “Skincare Treatment Warning” on 2026-10-31, grounded in this article and the 0 other(s) covering the same event.

Story

📰 Skincare Treatment Warning
Health · 1 article(s) covering the same event.

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How this article was measured signals, leaning charts, publisher record, byline, topics and claims

Signals How these are calculated →

Claims extracted
14
sentences that state something as happening or true
Uncertain
43%
6 of 14 hedged ("reportedly", "may", "according to")
Leaning
not political
takes no side on a contested political question
Publisher signals
66/100
New York Post's corrections and hedging, across everything collected from it. Not a measure of accuracy.
Outlets on this story
1
Health
Same framing elsewhere
1
articles that frame the event the way this one does
Analyzed 2026-10-05 · how these are computed

How this is being covered How these are calculated →

Article leaning vs. publisher reliability
Source leaning vs. consistency

Publisher

New York Post · 15525 article(s) · 35 correction(s) detected
Running correction rate · 35 correction(s)

Who wrote this

Rachel Sacks
37 article(s) here · 1 carrying a prediction
🔮 The good news is that an innovative treatment could not only replace the dental drill, but also spare those who brush off scheduling their next checkup.
🔮 The results of the phase 3 trial could offer hope for a disease that kills more than 97,000 people around the world each year.
🔮 A widespread problem, hair loss affects roughly 50 million men and 30 million women, and while there’s no special potion to reverse genetic or age-related decline, some products may slow down loss and promote regrowth.
🔮 Depressive symptoms may look similar, but there are various underlying causes.
🔮 The race is intended to give all kids the confidence boost that comes with crossing a finish line and hearing crowds cheering for them, with Collins noting that for some “it could be their first ever fitness event.”
🔮 And while a little meal before bedtime may curb your hunger in the short term, eating at the wrong time could increase the risk of a severe disease that causes permanent damage.
🔮 Massages may provide short-term relief for pain in the neck, shoulders, lower back and knees, as well as a part of supportive care for cancer patients.
2026-10-18 · assertive framing · You can now get a robot massage designed by Tom Brady
🔮 “The FDA should do whatever it possibly could do to get their hands on the actual drug that was injected by both of these patients,” associate professor at Harvard Medical School Pieter Cohen told CBS News.
🔮 Now, a revolutionary treatment may provide relief for the joint inflammation, pain, stiffness and reduced mobility that often come with arthritis or other knee injuries.
🔮 A silent yet deadly epidemic is sweeping the nation, with the number of Americans living with heart failure expected to nearly double from 6.7 million in 2024 to 11.4 million by 2050.
Also by Rachel Sacks
Nothing else under this byline is closely related to this article, so these are simply their most recent.
All 37 articles by Rachel Sacks →

Topics

American FDA Korean R3 Medical Companies USA Today

Subjects

FDA ORG · 3× Maccarone PERSON · 2× American NORP · 1× Gina Maccarone PERSON · 1× Kim Kardashian PERSON · 1× Korean NORP · 1× Melissa Gorga PERSON · 1× R3 Medical Companies ORG · 1× USA Today ORG · 1×

Narrative

Its applicable uses range from neurodegenerative diseases like Alzheimer’s, osteoarthritis and spinal cord injuries to skin regeneration. And because human-derived exosomes originate from human tissue, the market has seen an influx of lab-synthesized and plant-derived alternatives on the market, though they function differently.
framing: mixed · carried by 1 article(s) · first seen 2026-10-05
🔮 While injections may cause typical reactions like mild redness or irritation at the injection site, they also carry a risk of allergic reactions.

Claims (14 extracted, 6 hedged)

From Korean staples to unlikely remedies promising luscious locks and glowing skin, trendy new skin and hair care ingredients are popping up on social media every day. asserted
ingredients → promise → media
Some are downright risky, though, with no science to back up their purported benefits — prompting the FDA to send warning letters to companies promoting an unapproved additive. asserted
Some → back → additive
While American consumers are reportedly more label-conscious than ever of what goes into their facial serums and lotions, some are still reaching for the latest high-end trend: exosomes. uncertain
some → go → trend
At the heart of today’s buzzed-about regenerative treatment are exosomes — tiny, fluid-filled bubbles derived from human stem cells that distribute lipids, proteins and genetic material throughout the body. asserted
that → buzz → body
Beloved by celebrities like Kim Kardashian and Melissa Gorga, exosomes are said to expedite cell turnover, snatch sagging skin, fade hyperpigmentation and even beef up thinning hairlines. asserted
exosomes → belove → hairlines
Following a 2019 public safety notification against unapproved exosome treatments, the FDA continued its crackdown in August 2026 by issuing warning letters to clinics like R3 Medical Companies for false product claims and manufacturing failures. uncertain
FDA → follow → claims
First introduced to aesthetics over a decade ago, exosomes are believed to signal cells to regenerate tissue, whether injected or applied topically. asserted
exosomes → introduce → tissue
However, the danger lies not only in the products’ claims, but also in potential user reactions. uncertain
danger → lie → reactions
“The honest problem is that when a product is poorly characterized, you can’t fully predict its side effects because you don’t reliably know what’s in it,” Dr. Gina Maccarone, a triple board-certified cosmetic surgeon, told USA Today. asserted
Maccarone → characterize → Today
While injections may cause typical reactions like mild redness or irritation at the injection site, they also carry a risk of allergic reactions. uncertain
they → cause → reactions
The lack of scientific data supporting the aesthetic and medical claims also points to a lack of safety, with Maccarone noting that most of the published data comes “from small, short-duration studies.” “We simply don’t yet have the years-long follow-up that would let me tell a patient with confidence that a given product is safe over time,” she added. uncertain
she → support → time
Since there are no FDA approvals for exosomes, consumers should be extra careful and check for transparency about the source of the cells, manufacturing quality and whether a board-certified physician is administering it. asserted
physician → be → it
The strongest sign that a product is safe to use is its inclusion in a registered clinical trial, according to Maccarone. uncertain
product → use → Maccarone
Its applicable uses range from neurodegenerative diseases like Alzheimer’s, osteoarthritis and spinal cord injuries to skin regeneration. And because human-derived exosomes originate from human tissue, the market has seen an influx of lab-synthesized and plant-derived alternatives on the market, though they function differently. asserted
they → range → market
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