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.
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.
More from Recalls
Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”
Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.
Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
As it has every year since FSMA was passed in 2011, FDA doesn’t plan to impose reinspection fees until it publishes guidance for small businesses to request reductions. FY2025 budget proposal includes plan “to re-structure the fee programs to make it more administratively feasible to operate.”
More from Policy & Regulation
FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.
In response to an IPA Europe complaint, European Ombudsman Emily O’Reilly finds that the Commission’s interpretation of EU food legislation in relation to probiotics is “reasonable and in line with the main goal of this legislation, which is to ensure a high level of consumer protection.”
Vitamin, mineral and supplement products “may bear nutrient content claims, including ‘healthy,’’ if they meet structure/function claim criteria “without being subject to the requirements of the ‘healthy nutrient content claim” stated in the final rule FDA published recently.