I was importing and selling the Mamivac nipple shields (including the 28s) in the USA until the FDA requirements changed in January 2013. I was going to be charged $2500 to be an initial importer and then had to meet requirements as a manufacturer including hiring my own independent quality assurance provider. It became more than I could do which was very disappointing. Mamivac could not assist us with any of the regulations as much as they tried. I do believe someone else has taken over the USA but at a higher per product fee than I was charging. It must be due to the fees imposed. Dana Schmidt, RN, IBCLC *********************************************** Archives: http://community.lsoft.com/archives/LACTNET.html To reach list owners: [log in to unmask] Mail all list management commands to: [log in to unmask] COMMANDS: 1. To temporarily stop your subscription write in the body of an email: set lactnet nomail 2. To start it again: set lactnet mail 3. To unsubscribe: unsubscribe lactnet 4. To get a comprehensive list of rules and directions: get lactnet welcome