Dangerous Cup o' Joe? Aphrodisiac Coffee Receives FDA Warning

Jun. 23, 2010— -- A cup o' joe to put you in the mood? Coffee isn't normally thought of as an aphrodisiac, but Magic Power Coffee, the self-proclaimed "romance enhancer" herbal supplement, promises a different kind of java perk-up.

Their website promises "increased arousal," "stimulating buzz," "improved endurance," and for women, "multiple-releases" during sex, but whether these claims are true, this so-called supplement may also cause some very unsexy side effects, the Food and Drug Administration warned consumers Saturday: dizziness, dangerously low blood pressure and potential death.

The drink, sold only online, contains goji berry, horny goat weed and ginseng, according to the company website, but the FDA says tests uncovered a non-listed ingredient, hydroxythiohomosildenafil, a chemical cousin of the active ingredient in Viagra, sildenafil.

"The active ingredient in Magic Power Coffee is not approved by the FDA and poses a Class I danger, that is, it could result in serious harm to health and death," FDA spokesman Ira Allen said.

"We asked [Magic Power Coffee] to do a voluntary recall and they declined to do that," he said.

In a press release Saturday, the FDA advised consumers of the product to "stop using it immediately" as it "can cause serious harm." No adverse events have yet been associated with the use of this product, the press release noted.

"It's an unapproved drug, that's the essential issue here, and it's being advertised as a supplement," Allen said. The FDA is investigating the issue further.

Email and phone inquiries to Magic Power Coffee were not immediately returned.

A Dangerous Coffee Buzz?

This isn't the first time the FDA says it has found Viagra or a Viagra-like compound in "herbal" supplements for sexual enhancement.

A survey by the organization's Internet and Health Fraud Team found that more than one-third of libido-enhancing "dietary supplements" contained undisclosed prescription drug ingredients. Six of the 17 products tested contained sildenafil or a substance similar.

In December 2009, at the FDA's suggestion, a number of Atlas Operations products for sexual enhancement -- including Rock Hard, Stamin, Finally On Demand, Sexual Surge and Virect -- were recalled for containing sulfoaildenafil, another chemical cousin of sildenafil. On April 12, Atlas Operations announced that it would expand its voluntary recall to include three more or its sexual enhancement products based on the FDA's findings, according to a press statement issued by the company at the time.

But if the hazardous substance in these "supplements" is actually a drug doctors prescribe regularly -- or a chemically similar version of it -- why does the FDA consider these products so dangerous?

There's a large potential for overdose, said Dr. Karen Boyle, urologist and specialist in fertility and sexuality, because there's no way to tell how much of the active ingredient you're getting in a cup of this coffee.

Because Magic Power Coffee is unregulated by the FDA, there is no control on how much of the sildenafil-like ingredient makes it into each cup of "passion coffee," and because no doctor's appointment or prescription is necessary to obtain the product, consumers wouldn't be warned about the dangers of overuse or possibly dangerous interactions the product could have with other medication, she said.

"Sildenafil taken at high doses can cause prolonged erection, penile scarring and in women, this could cause clitoral and vaginal engorgement and a lot of pain," Boyle said.

As with Viagra, if this substance were taken at the same time as nitroglycerine (a heart disease medicine), it could cause death due to a rapid drop in blood pressure, she said.

The "active ingredients" listed on the website -- horny goat weed, goji berry and ginseng -- are used in many supplements and have not created a problem with the FDA in the past, said Dr. Andre Guay, head of the Lahey Clinic Sexual Dysfunction Center in Peabody, Mass.

"This must be a specific sildenafil -like effect to get the FDA's dander up," he said.

Sulfoaildenafil is not listed among the ingredients on the company's website.

"I'm appalled that the company hasn't followed the FDA's suggestion to recall," Boyle said. "They're not being honest about what's in the product, which is scary."

Safe Shopping for OTC Sex Help

Given the numerous FDA recalls on products marketed as sexual enhancers, should these types of herbal supplements be avoided altogether?

Because most over-the-counter aphrodisiacs or sexual enhancers are not regulated for safety, drug purity and efficacy by the FDA, Boyle said, it's important to be cautious when using them.

"I warn my patients that with anything on the Internet making large claims of success -- these claims are probably not true, because if they were true, we'd be prescribing it," she said.

It's a "tricky business" with herbal supplements because without strict regulation, they can have potentially harmful impurities, Guay said.

While the FDA does extend some of its regulatory power over supplements, the agency uses a different set of rules with these products than it does with prescription and over-the-counter drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) maintains that a supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. In general, however, manufacturers need not register their products with FDA nor get FDA approval before producing or selling them.

"These things, even those from nature, can be bad for you," he said.

If consumers want to try something herbal for sexual dysfunction or loss of libido, Boyle said she suggests trying individual ingredients, not blends, as they tend to contain unknown amounts of many substances, some of which can be potentially harmful.

"DHEA, a precursor to testosterone, and the herb Yohimbine are not very effective but they are tested and safe, so at least they're not going to be harmful. Beyond that, I don't really suggest herbal supplements for this," Boyle said.

Though Magic Power Coffee will remain on the market for the time being, its alleged sexual buzz is not be worth the risk, she said.