The makers of the dietary supplement Vimax, manufactured by TrueForm Packaging and marketed by Rex Marketing SRL S.A., issued the following statement today, claiming that Vimax was victim of counterfeiting, resulting in the FDA’s issuance of a public notice warning against the product because of “the detected presence of the active drug ingredient Tadalafil.”
The statement reads as follows:
"Vimax, a dietary supplement manufactured by TrueForm Packaging, DOES NOT contain Tadalafil, as clearly demonstrated by product analysis performed by a federal laboratory.
"On January 28, 2014, the US Food and Drug Administration (FDA) issued a Public Notification titled “Vimax Contains Hidden Drug Ingredient.” Together with the notification was the picture of a counterfeit bottle of Vimax. The FDA explained that results from their laboratory analysis “confirmed that Vimax contains Tadalafil, the active ingredient in the FDA approved prescription drug Cialis, used to treat erectile dysfunction (ED)” and added, “This ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.”
"Trueform Packaging is the manufacturer of the original Vimax product marketed as a dietary supplement since 2002. The active ingredient in the product is Tribulus, a botanical. The product is manufactured in Canada, in a GMP approved facility and in observance of all regulatory requirements applicable to the manufacture of Natural Health Products. The product is also marketed in the USA under DSHEA and complies with the US FDA governing regulations. The Vimax product has been on the market since 2002; millions of units were sold with zero adverse events ever registered or reported. Vimax is the oldest and among the top two companies selling natural male enhancement products on the internet since 2002.
"Rex Marketing SRL S.A. is taking all necessary actions to protect their name, product and consumers. Discussions with the US FDA where held but unfortunately, the FDA cannot revise their notice. It is not standard procedure. Their position on the matter is that manufacturers carry the burden of responsibility to protect their product, to include protection from counterfeiting actions. Additional actions taken by the company include modification of their product label to add an anti-counterfeit logo, allowing the clientele to easily recognize authentic from counterfeit product.
"The FDA also stated that Vimax is not the only company victim of such criminal acts. In fact, on January 2, 2014, the FBI issued a press release warning the public about the dangers of using counterfeit cosmetics, fragrances and other personal care products. The National Intellectual Property Rights Center (of which the FBI is a partner) wants the public to know that the volume of all sorts of counterfeit cosmetics, fragrances and other customer care products (of which Vimax is one) coming into the U.S. is definitely on the rise. This is happening mainly because the Internet has given counterfeiters widespread access to customers, and because criminals increasingly view dealing in counterfeit personal care products, as well as other knock-off consumer goods as a relatively low-risk crime since many of the perpetrators are located outside of the U.S.
"For any additional information, please contact Rex Marketing SRL SA at VimaxGroup.com."
