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The FDA and Medical Aesthetics: 2017 Regulatory Roundup

Posted By Administration, Wednesday, January 3, 2018

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

In recent months, the U.S. Food and Drug Administration (FDA) has begun to focus in on the medical aesthetic industry with a number of rulings on products and procedures, as well as some enforcement efforts. Here’s a quick rundown of the stories from just the past few months:


On September 15, the FDA issued a guidance document that suggested that in the near future, it will begin regulating the use of in-home microneedling devices to prevent injury to consumers.


In October, the agency raided a number of pharmacies in Florida that helped customers order relatively inexpensive prescription drugs from Canada and overseas. This may represent a reversal of a long-standing “non-enforcement” policy regarding this particular form of parallel importation. 


On November 14, the FDA warned consumers and health care practitioners about serious injuries and disfigurement that can result from the illegal use of injectable silicone or fake dermal fillers.


Also in November, the agency issued a consumer update expressing concern about stem cell treatments that are potentially harmful to patients. In it, the FDA outlines its stance on stem cell treatments and offers advice to those seeking them out.


On December 11, the FDA issued three policy papers designed to clarify its approach to the evolving oversight of digital health tools, including fitness trackers and patient support software. This is an advancement of the agency’s Digital Health Action Plan, which was introduced in the summer.

The FDA has also issued approvals for a number of products used medical esthetic treatments.


Merz North America’s Describe PFD patch was approved for use with all tattoo removal lasers; this patch is positioned over tattoos prior to laser removal, enabling multiple rapid laser passes in each treatment session. 


Aclaris Therapeutics’ Eskata (hydrogen peroxide) topical solution has been approved for the treatment of raised seborrheic keratoses


And perhaps most significantly for the medical esthetic industry, Allergan’s Botox neurotoxin has been approved for the temporary treatment of forehead lines.

Given the FDA’s recent increase in activity that could affect med spas, we feel it is important to hear directly from the agency regarding its enforcement efforts. To that end, we have booked Dr. Sangeeta Chatterjee, branch chief in the division of supply chain integrity, to speak on February 11, 2018, at The Medical Spa Show, which will take place at Aria Resort and Casino in Las Vegas. Dr. Chatterjee’s presentation will cover:


Threats to the U.S. drug supply chain;


Public health risks and potential legal consequences associated with purchasing unapproved prescriptions drugs from unlicensed sources;


Safe purchasing practices to ensure the drugs administered to patients are safe, effective, and FDA-approved; and


How to recognize drugs that may be counterfeit or not approved by FDA.

Registration for the show is currently open; click here to learn about the various registration options for the show, see the full schedule, and find out how to reserve a room in AmSpa’s room block at the Aria. Sign up for AmSpa’s email newsletter to continue to get the latest news on medical aesthetic regulations directly to your inbox

Tags:  fda 

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