LOS ANGELES — The problem of content piracy is not a new one for adult producers and site operators, who have DMCA protections and other possible recourses for stemming this serious problem; but what happens when a physical product is being copied?
Earlier this year, the U.S. Food and Drug Administration (FDA) issued a warning advising consumers not to purchase or use Vimax, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
“FDA laboratory analysis confirmed that Vimax contains Tadalafil, the active ingredient in the FDA approved prescription drug Cialis, used to treat erectile dysfunction (ED),” the FDA states. “This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.”
The FDA explains that many men with diabetes, high blood pressure, high cholesterol, or heart disease take nitrates.
“Consumers should stop using this product immediately and throw it away,” the FDA says, adding, “Consumers who have experienced negative side effects should consult a health care professional as soon as possible.”
Vimax has been promoted by adult website operators and affiliates since at least 2004, marketed under the PillsBucks.com / PillsMoney.com affiliate program, which offers a range of products — and is not the only male enhancement product to be singled out by the FDA, which has issued at least 80 warnings against “tainted sexual enhancement products.”
A Fly in the Ointment?
The problem with the FDA action, according to a Vimax spokesperson, is that the notification depicts a counterfeit bottle of Vimax, and that legitimate bottles of the dietary supplement, manufactured by TrueForm Packaging, do not contain Tadalafil.
“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 rep says. “The product is also marketed in the U.S. under DSHEA and complies with the U.S. FDA governing regulations.”
The company notes that Vimax has been on the market since 2002, reportedly selling millions of units with zero adverse events, and is the oldest (and among the top two companies) selling natural male enhancement products on the Internet.
According to Vimax marketer Rex Marketing SRL S.A., the company is taking all necessary actions to protect their name, product and consumers, but its claims of innocence seem to be falling on deaf ears.
“Discussions with the U.S. FDA where held but unfortunately, the FDA cannot revise their notice [because] it is not standard procedure,” a spokesperson states. “Their position on the matter is that manufacturers carry the burden of responsibility to protect their product, to include protection from counterfeiting actions.”
In response, the company has modified its product label to add an anti-counterfeit logo, in hopes that it will allow customers to distinguish authentic Vimax from counterfeit products.
The vexations over bogus supplements and other consumer items are not limited to Vimax vendors, however — as also earlier this year, the FBI issued a report warning the public about the dangers of using counterfeit cosmetics, fragrances and other personal care products.
“The National Intellectual Property Rights (IPR) 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 coming into the U.S. is definitely on the rise,” the report states. “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 more information, visit www.vimaxgroup.com.