Regulatory Roundup

Last week, the US Food and Drug Administration issued Warning Letters to six US medical spas and one Brazilian company for issuing misleading statements online about a medical procedure. The procedure, lipodissolve, involves a series of injections (i.e., phosphatidylcholine, deoxycholate, and other ingredients) and was promoted online as being safe and effective at removing pockets of fat from the body. “FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown,” said the agency in an press release about the Warning Letters. In addition, the agency has received adverse-event reports from patients using these drugs. The companies that received the Warning Letters were: Monarch Medspa (King of Prussia, PA), Spa 35 (Boise, ID), Medical Cosmetic Enhancements (Chevy Chase, MD), Innovative Directions in Health (Edina, MN), PURE Med Spa (Boca Raton, FL), and All About You Med Spa (Madison, IN). The Brazilian company comprised two websites: zipmed.net and mesoone.com. Read the full Warning Letters.

Last week, Pharmaceutical Technology noted that FDA had published two new guidances for industry based on the Step-4 version of the International Conference on Harmonization’s (ICH) Q4B Annexes 7 and 9. The agency has now published Annex 10 of the same ICH guideline as a guidance for industry. Annex 10 addresses polyacrylamide gel electrophoresis. FDA guidance based on ICH guidelines allow industry to use the US Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia interchangeably for the tests described, although FDA can disallow interchangeability at any point.