Dear Mr. Jassy,
We have identified several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding products sold on Amazon.com. The FDA purchased products labeled as energy enhancing supplements or food from your website, but laboratory analyses revealed that they contained undeclared and potentially harmful active pharmaceutical ingredients. The products in question violate sections 301(a), 301(d), 502, and 505(a) of the FD&C Act and are considered unapproved new drugs and misbranded drugs. Additionally, one of the products violates section 301(ll) of the FD&C Act, as it contains a drug ingredient without appropriate approval. We expect you to take immediate action to address these violations, and failure to do so may result in legal action, including seizure and/or injunction.
Please respond to this letter within fifteen working days, detailing the steps you have taken to rectify the violations and prevent their recurrence. If you believe the products are not in violation, provide your reasoning and supporting information for our consideration. Your response should be addressed to the U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance.
Sincerely,
Jill Furman
Director, Office of
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023