Lengea Law

We make your legal worries go away as you launch and scale healthcare companies.

09/03/2026

The FDA just issued a detailed Warning Letter to an Arizona-based regenerative medicine company and its CEO over four umbilical cord-derived products marketed to treat everything from arthritis to autism.

The most important detail for practices is where the FDA gathered its evidence. Alongside facility inspections, regulators built their case from the company's public marketing, including websites, YouTube videos, Instagram, Facebook, and TikTok posts. Promoting an unapproved biologic anywhere online can establish objective intent under federal law.

Any practice offering exosome or stem cell therapies should treat this as a moment to audit inventory, verify suppliers, and review marketing carefully.

Full breakdown on the blog: https://lengealaw.com/fda-warning-r3-medical-unapproved-regenerative-products/

09/02/2026

Coming this October, No Filter: What It Takes to Win in Medical Aesthetics.

Sara Shikhman, Managing Partner of Lengea Law, is releasing a new book alongside Lisa McMillan, APRN, CANS, drawn from decades of building, running, advising, and selling aesthetic practices.

The book was written for anyone considering a career as an injector, currently working in aesthetics, or thinking about opening a practice of their own. It covers the questions most people do not think to ask until they are already in it.

Aesthetics is very good at showing the before and the after. This book is about the part in between.

More details coming soon.

09/01/2026

"Research-grade" is no longer a shield in Mississippi.

All three of the state's healthcare licensing boards: Medical Licensure, Nursing, and Pharmacy, jointly confirmed that recommending, supplying, prescribing, or administering non-FDA-approved peptides is the practice of medicine, and that patient consent waivers do not eliminate provider liability.

If your practice offers peptides in any form, this one is worth a careful read.

Full breakdown on the blog: https://lengealaw.com/mississippi-research-grade-peptides-med-spas/

08/28/2026

We are heading to Massachusetts.

Samara Bell, Esq. and Emily Wright, Esq. will be joining the Aesthetic Medical Providers of Massachusetts Member Event on September 15, 2026 from 6 to 9 PM EST.

An evening dedicated to connection, collaboration, and community with licensed aesthetic medical providers across the state. If you are in the Massachusetts aesthetics space, this is a room worth being in.

Learn more: https://ampmass.org

08/26/2026

Guidance that leads to real, tangible outcomes is what we aim for with every client we work with.

Thank you to Far Flung Finances for sharing your experience.

If you are navigating a business decision that could use a knowledgeable, responsive perspective, connect with us today at [email protected]

08/24/2026

A wonderful few days at The Tell All Genesis Conference.

We came away with fresh perspective on where medical aesthetics is heading, the challenges practices are navigating right now, and the questions founders are asking as they build for the long term.

Grateful to the organizers, speakers, and everyone we had the chance to connect with. Conversations like these are a reminder of how much this industry benefits from being in the same room together.

Looking forward to what comes next.

08/21/2026

Revance and Teoxane have announced FDA approval of RHA Redensity Eye, the first HA filler specifically indicated for moderate to severe infraorbital hollowing in adults 22 and older.

The infraorbital region is one of the most technically challenging areas in facial aesthetics, and undereye hollowing has historically been treated off-label. An FDA-indicated option gives practices defined dosing guidelines, a stronger regulatory foundation for marketing, and reduced malpractice exposure when protocols are followed carefully.

For practices considering adoption, this is a good moment to refresh informed consent, verify anatomical training for every injector working the periorbital region, and confirm that all product sourcing runs through authorized channels.

Read the full breakdown: https://lengealaw.com/rha-redensity-eye-fda-approval-aesthetic-practices

08/14/2026

A recent ruling from the U.S. District Court for the Southern District of Texas in Eli Lilly and Company v. Revive Rx gives the clearest answer yet on when brand-name manufacturers can bring unfair-competition claims against compounding pharmacies.

The court confirmed that compounded medications can still qualify as "new drugs" depending on their composition, safety, and effectiveness. Legitimate, patient-specific compounding remains protected, but the line between that work and large-scale activity that resembles unauthorized manufacturing is coming into sharper focus.

Full breakdown: https://lengealaw.com/navigating-unfair-trade-claims-what-the-eli-lilly-v-revive-rx-ruling-means-for-compounding-pharmacies-and-the-practices-that-buy-from-them/

08/13/2026

Eli Lilly recently escalated its fight against the black-market trade in retatrutide, filing six new lawsuits against a California medical spa, a compounding pharmacy, and four peptide sellers, and referring more than two hundred entities to regulators and law enforcement.

Retatrutide is still in Phase 3 clinical trials and is not approved by the FDA in any jurisdiction. The FDA has stated clearly that sales of unapproved retatrutide are illegal, that it cannot be lawfully compounded, and that so-called "research use only" versions are of unknown quality and may pose real risk to patients.

For aesthetic and wellness practices, the message aligns with the recent federal sentence in the Paradigm Peptides case. The "research use only" label does not shield the supplier, the pharmacy, or the practice that administers the product. Any GLP-1 or peptide currently on a service menu deserves a careful review of its regulatory status and sourcing.

Full breakdown: https://lengealaw.com/eli-lilly-escalates-fight-against-black-market-retatrutide-what-aesthetic-practices-and-wellness-clinics-need-to-know/

Address

New York, NY
10002

Telephone

+16463960804

Website

http://www.lengealaw.com/

Alerts

Be the first to know and let us send you an email when Lengea Law posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Practice

Send a message to Lengea Law:

Featured

The Law Office of Richard M. Kenny
363 7th Avenue 16th Floor

Want your practice to be the top-listed Law Practice in New York?