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

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

News RoomBy News RoomOctober 5, 20264 ViewsNo Comments

A holy grail that’s too good to be true.

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.

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.

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.

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.

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.

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.

First introduced to aesthetics over a decade ago, exosomes are believed to signal cells to regenerate tissue, whether injected or applied topically.

However, the danger lies not only in the products’ claims, but also in potential user 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.

While injections may cause typical reactions like mild redness or irritation at the injection site, they also carry a risk of allergic 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.

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.

The strongest sign that a product is safe to use is its inclusion in a registered clinical trial, according to Maccarone.

Although the approvals aren’t there yet, the science behind the treatments is promising.

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.

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