Amazon.com, Inc.
FDA issued a warning letter to Amazon.com, Inc. (CEO Andy Jassy) regarding its distribution via Fulfillment by Amazon of seven products — marketed as energy supplements or food — that laboratory analysis confirmed contained undeclared active pharmaceutical ingredients sildenafil or tadalafil (PDE-5 inhibitors). The products were deemed unapproved new drugs and misbranded under the FD&C Act because their labeling failed to disclose the presence of prescription drug ingredients that can cause dangerous interactions with nitrates. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (12)
The labeling for these products does not declare that they contain PDE-5 inhibitors.
STRENGTH[,] ENERGY[,] ENDURANCE
Male Energy Supplement
THE POWER TO GO AGAIN! STRENGTH * ENERGY * ENDURANCE
500 MG POWER BOOST
NEVER ENDING ENERGY!
ENERGY FOR MEN
Extreme Power
Energy[,] Performance
Mens Maximum Energy Supplement
Focus . . . Energy . . . Mood
Energy Boost
Required actions (3)
Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations.
Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce or deliver for introduction into interstate commerce unapproved new drugs and/or misbranded products with undeclared drug ingredients, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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