FDA Roundup: May 16, 2023

FDA News Release

• For Immediate Release: May 16, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA updated its new Rumor Control page to provide the facts and inform the public on how the growing spread of rumors, misinformation and disinformation about science, medicine and the FDA is putting patients, consumers and their families at risk.
• Today, the FDA approved the Globus Medical REFLECT Scoliosis Correction System for the treatment of progressive idiopathic scoliosis in pediatric patients. Idiopathic scoliosis is a sideways curvature of the spine whose cause is unknown. It is the most common spinal deformity in children and is most often diagnosed between ages 10 to 18, although it may occur at a younger age. The REFLECT Scoliosis Correction System is the second-of-a-kind anterior vertebral body tether device approved under the Humanitarian Device Exemption (HDE) Program.
• On Friday, the FDA issued marketing denial orders (MDOs) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action. The companies that received MDOs include: 
  • Imperial Vapors LLC 
  • Savage Enterprises 
  • Big Time Vapes 
  • SWT Global Supply Inc. 
  • Great Lakes Vapor 
  • DNA Enterprise LLC dba Mech Sauce 
  • Absolute Vapor Inc. 
  • ECBlend LLC 

The FDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).