The US food and Drug Administration (FDA) has announced that the distributors of two sexual enhancement drinks are withdrawing the products from the market following its censure.
The agency posted on its website a statement by Drive Total Energy on the voluntary recall of Rock Hard Extreme and Passion Coffee, the products under a cloud now.
The products contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label, the agency has said.
The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
To date, Drive Total Energy is not aware of any reports made to the FDA concerning any adverse effects associated with the use of Rock Hard Extreme or Passion Coffee. In addition, Drive Total Energy currently has not received any complaints from its customers, the firm claims. Still as a matter of abundant caution and concern for the health and welfare of our customers, the firm is voluntarily notifying its customers of the FDA's findings, the statement from Drive Total Energy said.
Rock Hard Extreme and Passion Coffee are sold on internet sites, online marketplaces, and in retail outlets.
Independently the FDA advised consumers to stop using Rock Hard Extreme and Passion Coffee immediately and to throw them away. It encouraged people who had experienced side effects from either drink to notify their doctors.
FDA Principal Deputy Commissioner Joshua Sharfstein told reporters that the FDA was concerned primarily with three types of supplements. One class is weight-loss products with active ingredients such as sibutramine, found in the drug Meridia, which was recently withdrawn from the market because of increased risk of heart attack and stroke.
The other two are body-building products that contain anabolic steroids or "steroid analogs," which can cause liver injury and increase the risk for heart attack, stroke and death; and sexual enhancement products such as Rock Hard Extreme and Passion Coffee.
Sharfstein said the products were poorly labeled, so consumers did not know what they were really buying.
Lawful dietary supplements, according to the FDA, are intended only as "an addition to a standard diet."
"If you have a drug product in it, it's not a supplement," said Judy Blatman, a spokeswoman for the Council for Responsible Nutrition, an industry trade organization. "We're extremely supportive of the FDA's actions to warn consumers about products that are masquerading as supplements.... They're illegal."
Blatman said her organization would like the FDA to get even more aggressive. "We're hoping this will put a chill on companies who are doing this," she said.
In an e-mail to Los Angeles Times, FDA spokeswoman Siobhan DeLancey said that the agency had found nearly 300 such "tainted products" among dietary supplements it has examined. Shedid not specify how many of those were sexual enhancement products.
DeLancey also said that the FDA had received reports of fatalities among people using illegal sexual enhancement products.