In this new regular dispatch, I’ll be checking out some of my favorite topics that are impacting and shaping the medspa industry.
FDA Skepticism Over Unapproved GLP-1 Drugs for Weight Loss
The FDA says the party’s over, or is it? If you’ve seen an unprecedented number of patients in tears lately, it may have something to do with the recent FDA ruling about dispensing compounded alternatives for semaglutide or tirzepatide1. On Dec. 19, the FDA changed its ruling in favor of Lilly and Novo Nordlsk and made it abundantly clear to patients of the potential risks.
The ruling is as follows:
For a state-licensed pharmacy under section 503A of the FD&C Act compounding, distributing or dispensing tirzepatide injections within 60 calendar days from today’s announcement, until Feb. 18, 2025.
For outsourcing facilities under section 503B compounding, distributing or dispensing tirzepatide injections within 90 calendar days from today’s announcement, until March 19, 2025.
While some insurance plans may cover these medications for diabetic patients or present with other serious conditions, most will decline to approve them for weight loss or “obesity,” which are not considered a medical condition.
For example, at the time of this printing, the Single Care “discounted” price for Ozempic at the lowest dosage offered—2 mg/3 ml (0.25 or 0.5 mg/dose)—ranged from $822 at RiteAid all the way up to $962 at Costco Pharmacy.
According to plastic surgeon Mark Schwartz, MD, in New York City, who practices in the tony Upper East Side, “Although compounded GLP-1s may be substantially more affordable for patients, they can come with some risks if they are not monitored properly. To date, the retail price at most pharmacies for patients who are not diabetic and thus, not insured, is cost prohibitive for many people who want these medications.”
According to the maker of Ozempic2 at this time, in a pharmacodynamic study with adults with T2D treated with diet and exercise ± metformin, Ozempic provided a similar insulin response to people without type 2 diabetes.
To date, GLP-1 agonists are not currently FDA-approved for type 1 diabetes treatment. However, the research is ongoing3. This may prove to be the answer we have been waiting for to treat patients on-label.
L’Oreal and K-Beauty: Perfect Together
In case you haven’t been paying attention, Korea has been emerging as a key source for innovation in skincare and trendsetting ingredients at affordable prices. These include the coveted ‘glass skin’ look, unique cleansing balms and refreshing toners, to name a few. In December 2024, L’Oreal Groupe announced its acquisition of the South Korean Dr. G skin care brand, which will be folded into the multinational giant's consumer products division.
New York dermatologist Jane Yoo, MD, FAAD, shares her insights about why this may be a game changer, having seen firsthand how the brand is experienced in her clinic.
“Dr. G is not just another ‘me too’ brand,’” she says. “They are keen to distinguish themselves in the U.S. market with a forceful presence under the L’Oreal umbrella. It offers something unique and is backed by science.”
According to L’Oreal, Dr.G skin care is ranked as the no.1 Korean dermacosmetic brand, "known for providing dermatological solutions that understand the minds of people with skin problems.”
According to a 2024 report from Landing, K-beauty's popularity comes down to its “innovative formulations and emphasis on natural ingredients,” as well as general affordability, which has made it a favorite of millennials and Gen Z.
Landing reports that, “K-Beauty exports to the U.S. have doubled from $622.3 million in 2020 to $1.2 billion in 2023.”a
About the Author
Wendy Lewis, president of Wendy Lewis & Co Ltd. ([email protected]), leads the strategic marketing communications firm and is the author of “Aesthetic Clinic Marketing in the Digital Age,” 2nd edition (CRC Press).
Footnote
ahttps://welcome.landinginternational.com/second-wave-of-k-beauty-report
References
2 - https://www.novomedlink.com/diabetes/products/treatments/ozempic/about/mechanism-of-action.html
