FDA Warns Manufacturer Regarding Its Marketing And Distribution Of "Zencore Plus"
The Food and Drug Administration (“FDA”) has issued a warning letter to Bodee, LLC, a company based in Century City, California, regarding the marketing and sale of its dietary supplement Zencore Plus (“Zencore”). The FDA alleges that laboratory analysis of the product concluded that five lots of Zencore contain benzamidenafil, which is in the same class of pharmaceutical ingredients that include phosphodiesterase type 5 inhibitors. Pharmaceutical ingredients that include type 5 inhibitors include sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra), which are all FDA approved drugs for the treatment of erectile dysfunction (“ED”).
The FDA states in its warning letter that Zencore -- marketed as a dietary supplement -- is misbranded because it is in fact a drug under the FDA Act. For example, as the FDA letter points out, statements on Zencore’s labeling and on its website claim, among other things, that Zencore, “contains a combination of powerful natural herbs that supports long lasting, hard and firm erections . . .” and “stimulates the production of nitric oxide, leading to the production of cyclic GMP (cGMP). It is the cGMP which ultimately affects smooth muscle relaxation, allowing the penile arteries to expand and fill with blood.” In fact, as the FDA alleges, it is the undisclosed ED ingredients in Zencore that may aid men suffering from ED, not any herbal supplements contained in the product. And because Zencore labeling does not declare that it contains benzamidenafil (an ED drug) and falsely asserts that it does not have the potential to cause side effects, the FDA alleges that Zencore’s labeling is “false and misleading” under the FDA Act.
Moreover, the FDA warning letter further alleges that because Zencore is misbranded in that it’s labeling lacks adequate warnings for users of the product, there is a potential for adverse events associated with its use. For example, patients who take nitrates and consume Zencore may be at risk of life-threatening hypotension.
If you have purchased Zencore Plus, or have been injured as a result of using Zencore Plus, please contact us to discuss your legal options