FDA Warns Consumers to Avoid Magic Power Coffee

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

Consumers who have Magic Power Coffee should stop using it immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.

When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.

"Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. "In fact, Magic Power Coffee can cause serious harm.”

To date, the FDA is not aware of any adverse events associated with the use of this product.

The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.

The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.”

“The FDA is committed to protecting public health and stopping the illegal marketing of unapproved drugs,” said Autor. “We support vigorous law enforcement and criminal prosecution of violators of safe drug laws.

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FDA Warns Consumers on Sexual Enhancement Products

The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.

Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.

Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death.

In the case of Stiff Nights, following a consumer complaint, the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

The FDA remains committed to stopping the illegal marketing of unapproved drugs and will continue to protect the public with vigorous law enforcement and criminal prosecution of violators.

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