The makers of a dietary supplement called Zencore Plus claim that their product is a safe, “natural” solution to impotence, or erectile dysfunction. And, although the law regarding dietary supplements states that manufacturers may not claim that their product will diagnose, cure, mitigate, treat, or prevent a disease, the website for Zencore Plus implies that the product will cure a man’s problems.
Despite the claims of natural purity, Bodee LLC, the company that markets Zencore Plus, has recently issued a voluntary recall because the product poses a danger of personal injury or wrongful death to uninformed users.
And despite this alleged recall, the product is still easily available. More than 2 months after Bodee issued its recall, a phone representative at Calcompnutrition.com said that she had not heard of any problems or a recall for Zencore Plus.
Bodee announced the recall because FDA investigators found that it contains benzamidenafil, a drug that is very similar to sildenafil, tadalafil and vardenafil, which are the drugs found in the prescription medications Viagra, Cialis, and Levitra.
All of these drugs are called PDE5 inhibitors, and they present a significant danger to anyone taking nitrates which are used to treat the pain of angina and congestive heart failure.
The combination of nitrates and PDE5 inhibitors can cause a sudden, severe, and potentially deadly drop in blood pressure. Men who have angina and heart problems are primary candidates for erectile dysfunction, so some men who would use Zencore Plus might already be taking nitrates and thereby exposing themselves to an unknown danger.
This recall isn’t the first one that Bodee has issued for the same product. In 2007, the company was using the name Zencore Tabs when the FDA issued an alert because the tabs contained a drug called aminotadalafil. Like benzamidenafil, aminotadalafil can combine with nitrates to cause a sudden drop in blood pressure.
So Bodee reformulated the product, changed the name, and marketed Zencore Plus as an improved version of Zencore Tabs. Men who have used Zencore Plus have had overwhelmingly negative results, but Bodee has two very good reasons for continuing its deceptive marketing practices.
First, by failing to list the active prescription drugs in Zencore, Bodee has been able to market the product as a natural supplement and to claim that users have no fear of the side effects associated with prescription drugs for impotence.
Bodee can get away wtih this because of the provisions contained in the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA holds thatmarketers of supplements do not have to provide the FDA with research that shows that their products are safe. Instead, the FDA must wait until it receives adverse event reports about a supplement before it can take any action against the product.
For prescription drugs, the situation is completely opposite. Pharmaceutical companies must conduct research and show that their products are safe before taking them to market. The FDA has frequently failed to prevent dangerous drugs from harming consumers, but the law does give the agency the power to stop a drug before it reaches the market.
Second, because Bodee has marketed Zencore Plus as a dietary supplement that men can buy without a prescription, the company has attempted to give itself an illegal and very dangerous advantage over prescription medications for the same condition. Viagra, Cialis, and Levitra require a doctor’s prescription, and many men would rather ask for directions than talk to their doctors about impotence. So, Zencore cleverly positioned itself as the pill that spared men a conversation with their doctor.
In the process of deceiving its customers by not revealing all the ingredients in Zencore Tabs and Zencore Plus, Bodee deliberately put men at risk because it didn’t warn them of the possibility of the dangerous interaction between aminotadalafil, benzamidenafil, and nitrates.
important messages. The first is that the Dietary Supplement Health and Education Act of 1994 leaves consumers vulnerable to the deceptive practices of companies such as Bodee and MuscleTech, the maker of Hydroxycut.
The second is that the word “natural” is often a dishonest marketing ploy. Everyone should be aware that “natural” does not mean safe. The poison hemlock that Socrates drank was natural, but it certainly wasn’t safe and the same is true for arsenic, a chemical found in nature.
If Zencore Plus or any product has caused personal injury or wrongful death to you, a family member or a friend, contact us to see if we can help.
Onward,
Richard Alexander
