NEW YORK (Reuters) - ``Be the biggest man your lover has ever had!'' urges the animated Web site for an herbal pill called LONGitude, created by a ``former Viagra pharmacist'' to increase penis size, or your money back, guaranteed.

But companies selling herbal pills for enhanced sexual performance may soon be facing the wrath of US regulators, as well as possible legal action from the legitimate maker of Viagra, the world's largest drug maker, Pfizer Inc.

``We have arrested and charged people claiming a new product will change the structure or function of your body in a way that only approved drugs can,'' said Laura Bradbard of the US Food and Drug Administration (FDA).

The Internet pitch artists are taking aim at the anti-impotence drug Viagra's nearly $2 billion annual sales, making dubious claims that their drug is safer than Viagra and even adds an extra dimension.

The Web site for LONGitude, which is registered to Scottsdale, Arizona-based company CP Nutritionals Direct, tells visitors that 67% of women are unhappy with their partner's penis size--a problem for which they claim to have a remedy.

Wild claims are nothing new with herbal medicines. They are regulated less strictly than drugs in the United States and are allowed to go to market without FDA approval as long as they carry a disclaimer on their label that reads: ``This product is not intended to diagnose, treat, cure or prevent any disease.''

But in recent years, the FDA has stepped up investigations of the mushrooming number of herbal medicines being marketed online and recommends that consumers avoid doing business with Web sites that offer no access to a registered pharmacist to answer questions.

With no pharmacist contact number on its site and no prescription required, LONGitude is nonetheless billed as ''clinically analyzed.'' It is offered with a 30-day money-back guarantee that two pills a day for 3 to 4 months will increase the size of a user's penis by 26%, according to the Web site.

Made from a blend of ingredients including zinc, pumpkin seed and oat straw, LONGitude also includes the more exotic muira pauma, yohimbine, nettle leaf, and oyster meat, the Web site states.

Before the introduction of Viagra, the root extract yohimbine, which acts as a stimulant, was among the few FDA-approved medications for treating impotence.

Between March and July 1998, a total of 69 people in the US died after having taken Viagra. Of these, the cause of death was unmentioned or unknown for 21, two patients had strokes, and 46 suffered cardiac arrest. Yohimbine, though herbal, can be equally dangerous if taken in high enough doses, experts say.

``These companies are playing on the fear of cardiac arrest that scared Viagra patients for a time. But those fears have been disproved time and again and these companies are going to sell their herbal pills, take your money, then close up shop.'' said Dr. Andrew McCullough, director of Male Sexual Health & Fertility at the New York University Department of Urology.

``This stuff is bogus. There is no scientific evidence that it works,'' McCullough said.

CP Nutritionals was not available by telephone for comment.

Another herbal anti-impotence pill, Biogen 14 from Cincinnati-based Lifekey, offers a 100% money-back guarantee if for $49.95 it fails to ``enhance your sex drive, give you stronger erections and increase your semen output by 581%,'' a company saleswoman who declined to be named said in a telephone interview.

The company is currently offering two bottles for free for each customer who buys three.

Pfizer said it will vigorously defend the use of its trademarked brand on the LONGitude Web site and will look into CP Nutritional's claim that LONGitude was created by a pharmacist who had worked on Viagra. Consumers, in the meantime, should think twice before buying herbal alternatives, said Pfizer spokesman Geoffrey Cook.

``It's a situation of 'buyer beware,' and the best route has always been to see your physician,'' Cook said, adding that Viagra costs about $9 for an effect that lasts about 4 to 6 hours.

``Folks who are going to look for pharmaceutical products on the Internet need to make sure that the pharmacy they're going to is a licensed pharmacy in their state,'' Cook said.

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