FDA regulates over 20% of products sold at retail.  In the past, FDA focused its compliance and enforcement efforts primarily on manufacturers and distributors of products, even though retailers are also liable under the Federal Food, Drug, and Cosmetic Act for the violative products they sell in their stores or online.  FDA has dramatically shifted its focus to retailers in recent years, forcing these companies to develop policies and strategies, including developing contacts within FDA, to keep violative products off the market.  HPM frequently counsels retail clients on these issues to help avoid FDA enforcement.

Our services include

  • Respond to FDA enforcement actions
  • Develop policies, such as internet filters and restricted product lists, to keep violative products of internet retail sites
  • Coordinate meetings with FDA to develop cooperative ties with FDA compliance personnel
  • Monitor websites to identify potential problems

for products like:

  • Dietary supplements
  • Food
  • OTC drugs
  • OTC devices
  • Cosmetics