Amazon Receives Year-End Greetings From US FDA

Warning references consumer alerts FDA published in February and August about products agency officials purchased on Amazon.com and determined to contain undisclosed sildenafil or tadalafil, PDE-5 inhibitors approved for use in Rx drugs with an ED indication.

• Source: Shutterstock

The US Food and Drug Administration has warned Amazon.com about its distribution of products labeled as dietary supplements but containing undisclosed erectile dysfunction drugs 10 months after it began warning consumers about the products bought on the e-commerce giant's site. 

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Compliance

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

 

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

 

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

More from Policy & Regulation

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

US Plans End To Petroleum-Based Dyes In Food

 

HHS Secretary Robet F. Kennedy Jr. and FDA Commissioner Marty Makary to announce planned changes as “a major step forward” as part of Kennedy’s “Make America Healthy Again” campaign President Trump has adopted for his administration.

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.