FDA takes significant action to stop illegal drug sales online.

• The Food and Drug Administration has broad regulatory authority over the marketing of food, drugs, medical devices, and cosmetics in the U.S.  Although many of the Agency’s enforcement actions target physical facilities and products on shelves, FDA also has authority over e-commerce, i.e., the significant sales of FDA-regulated products that take place online.

• On June 9, FDA announced that it had taken action against 4,402 websites illegally selling unapproved prescription drugs to U.S. consumers.  The crackdown was part of a global cooperative effort led by the International Criminal Police Organization (ICPO or INTERPOL), the goal of which was to identify the makers/distributors of illegal drugs and to remove these products from the supply chain.  To implement the operation, FDA worked with U.S. Customs and Border Protection to conduct extensive inspections at International Mail Facilities (IMFs).  Working with other federal agencies, FDA screened and seized drugs received through IMFs in San Francisco, Chicago, and New York.  Ultimately, 797 packages were detained.  The Agency also sent formal complaints to domain registrars requesting the suspension of the 4,402 websites and issued Warning Letters to the operators of 53 websites.

• FDA’s significant action against illegal online sales illustrates the Agency’s authority over e-commerce and serves as a caution to the industry that online marketing should not be viewed as a means to evade the reach of the Federal Food, Drug, and Cosmetic Act.