Recalls, Investments, Verifications: Health And Wellness Industry News

Supplements spiked with ED drugs recalled; Agritek Holdings purchases nutrition and supplement marketer Performance Nutrition Center; more dietary supplement recalls and other news in brief.

FDA received adverse event reports on one of two products marketed as dietary supplements that were recalled on Sept. 20 after being found spiked with drug ingredients indicated for erectile dysfunction. Gadget Island Inc. recalled five male sexual enhancement products found containing undeclared pharmaceutical ingredients sildenafil and tadalafil, which are approved by FDA for ED drugs, and desmethyl carbodenafil, a chemical structurally similar to sildenafil that is not an approved drug. The products are branded Rhino 7, Platinum 5000, Papa Zen 3000, Fifty Shades 6000 and Grande X 5800. The Newark, Calif, firm, which does business as Gear Isle, says it has received no AERs from consumers about the product but it is notifying customers by email and arranging returns and refunds all recalled products.

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 Recalls

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.