FDA: Amazon, Walmart Selling Unapproved New Drugs

FDA says its review of labeling for nine drugs it purchased from the Amazon Web site and three drugs purchased from the Walmart Web site found that the two online retailers were selling unapproved new drugs. A 10/1 Warning Letter issued to Amazon says the agency brought nine herpes treatments in July. It quotes from the labeling for each product to demonstrate that they are legally considered to be drugs and are unapproved for introduction into interstate commerce. The Walmart Warning Letter says FDA purchased three herpes treatments online in July and quotes from the product labeling to demonstrate their status as unapproved new drugs.

Both companies were told to address the violations without delay and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.