Enzyte
Encyclopedia
Enzyte is a herbal nutritional supplement originally manufactured by Berkeley Premium Nutraceuticals (now Vianda, LLC) of Cincinnati, Ohio
Cincinnati, Ohio
Cincinnati is a city in the U.S. state of Ohio. Cincinnati is the county seat of Hamilton County. Settled in 1788, the city is located to north of the Ohio River at the Ohio-Kentucky border, near Indiana. The population within city limits is 296,943 according to the 2010 census, making it Ohio's...

. The manufacturer has claimed Enzyte promotes "natural male enhancement", which is suggestive of a euphemism
Euphemism
A euphemism is the substitution of a mild, inoffensive, relatively uncontroversial phrase for another more frank expression that might offend or otherwise suggest something unpleasant to the audience...

 for penile enlargement. However, its effectiveness has been called into doubt and the claims of the manufacturer have been under scrutiny from various state and federal organizations. Kenneth Goldberg, M.D., medical director of the Male Health Center at Baylor University, says, "It makes no sense medically. There's no way that increasing blood flow to the penis, as Enzyte claims to do, will actually increase its size."

In March 2006, following thousands of consumer complaints to the Better Business Bureau
Better Business Bureau
The Better Business Bureau , founded in 1912, is a corporation consisting of several private business franchises of local BBB organizations based in the United States and Canada, which work through their parent corporation, the Council of Better Business Bureaus .The Better Business Bureau, through...

, Federal agents raided Berkeley facilities, gathering material that resulted in a 112-count criminal indictment
Indictment
An indictment , in the common-law legal system, is a formal accusation that a person has committed a crime. In jurisdictions that maintain the concept of felonies, the serious criminal offence is a felony; jurisdictions that lack the concept of felonies often use that of an indictable offence—an...

. The company's founder and CEO, Steve Warshak, and his mother, Harriet Warshak, were found guilty of conspiracy
Conspiracy (crime)
In the criminal law, a conspiracy is an agreement between two or more persons to break the law at some time in the future, and, in some cases, with at least one overt act in furtherance of that agreement...

 to commit mail fraud, bank fraud
Bank fraud
Bank fraud is the use of fraudulent means to obtain money, assets, or other property owned or held by a financial institution, or to obtain money from depositors by fraudulently representing to be a bank or financial institution. In many instances, bank fraud is a criminal offense...

, and money laundering
Money laundering
Money laundering is the process of disguising illegal sources of money so that it looks like it came from legal sources. The methods by which money may be laundered are varied and can range in sophistication. Many regulatory and governmental authorities quote estimates each year for the amount...

, and in September 2008 were sentenced to prison and ordered to forfeit $500 million in assets. The convictions and fines forced the company into bankruptcy
Bankruptcy
Bankruptcy is a legal status of an insolvent person or an organisation, that is, one that cannot repay the debts owed to creditors. In most jurisdictions bankruptcy is imposed by a court order, often initiated by the debtor....

, and in December 2008 its assets were sold for $2.75 million to investment company Pristine Bay, which continued operations.

By 2009, marketing was oriented to erectile dysfunction
Erectile dysfunction
Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance....

 and attracting more naive purchasers seeking permanent enlargement of the penis. Enzyte is widely advertised on US television as "the once daily tablet for natural male enhancement". The commercials feature a character known as "Smilin' Bob", who always wears a smile that is implied to be caused by the enhancing effects of Enzyte; these advertisements feature double entendre
Double entendre
A double entendre or adianoeta is a figure of speech in which a spoken phrase is devised to be understood in either of two ways. Often the first meaning is straightforward, while the second meaning is less so: often risqué or ironic....

s. Some commercials feature an equally smiling "Mrs. Bob".

Because Enzyte is an herbal product, no testing is required by the U.S. Food and Drug Administration. An official of the Federal Trade Commission
Federal Trade Commission
The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...

 division that monitors advertising says the lack of scientific testing is "a red flag right away. There's no science behind these claims." The company has conceded that it has no scientific studies that substantiate any of its Enzyte claims.

Dr. Ira Sharlip, a spokesman for the American Urological Association
American Urological Association
The American Urological Association is a professional association in the United States for urology professionals.-Awards:*Hugh Hampton Young Award. Presented annually to an individual for outstanding contributions to the study of genitourinary tract disease. This award is sponsored by Karl Storz...

, has said, "There is no such thing as a penis pill that works. These are all things that are sold for profit. There's no science or substance behind them."

Ingredients

Despite being a mixture of herbs, minerals, and vitamin
Vitamin
A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...

s, Enzyte formerly promoted itself under a seemingly scientific name of Suffragium asotas. While Enzyte's manufacturer claims this phrase translates as "better sex," this is incorrect; suffragium in Latin means vote, and asotas is not a Latin word at all. Harvard teaching fellow Rhett Martin says that the phrase might be an error for suffragor asotis, meaning "refuge for the dissipated."

Enzyte is said to contain:
  • Tribulus terrestris
    Tribulus terrestris
    Tribulus terrestris is a flowering plant in the family Zygophyllaceae, native to warm temperate and tropical regions of the Old World in southern Europe, southern Asia, throughout Africa, and Australia. It can thrive even in desert climates and poor soil...

    (puncture vine)
  • Niacin
    Niacin
    "Niacin" redirects here. For the neo-fusion band, see Niacin .Niacin is an organic compound with the formula and, depending on the definition used, one of the forty to eighty essential human nutrients.Niacin is one of five vitamins associated with a pandemic deficiency disease: niacin deficiency...

  • Panax ginseng
    Ginseng
    Ginseng is any one of eleven species of slow-growing perennial plants with fleshy roots, belonging to the genus Panax of the family Araliaceae....

  • Epimedium
    Epimedium
    Epimedium, also known as Rowdy Lamb Herb, Barrenwort, Bishop's Hat, Fairy Wings, Horny Goat Weed, or Yin Yang Huo , is a genus of about 60 or more species of herbaceous flowering plants in the family Berberidaceae...

  • Avena sativa
    Oat
    The common oat is a species of cereal grain grown for its seed, which is known by the same name . While oats are suitable for human consumption as oatmeal and rolled oats, one of the most common uses is as livestock feed...

    (oat)
  • Zinc oxide
    Zinc oxide
    Zinc oxide is an inorganic compound with the formula ZnO. It is a white powder that is insoluble in water. The powder is widely used as an additive into numerous materials and products including plastics, ceramics, glass, cement, rubber , lubricants, paints, ointments, adhesives, sealants,...

  • Lepidium meyenii
    Lepidium meyenii
    Lepidium meyenii, known commonly as maca, is an herbaceous biennial plant or annual plant native to the high Andes of Peru and Bolivia. It is grown for its fleshy hypocotyl , which is used as a root vegetable and a medicinal herb...

    (maca)
  • Muira puama
  • Ginkgo biloba
  • L-Arginine
    Arginine
    Arginine is an α-amino acid. The L-form is one of the 20 most common natural amino acids. At the level of molecular genetics, in the structure of the messenger ribonucleic acid mRNA, CGU, CGC, CGA, CGG, AGA, and AGG, are the triplets of nucleotide bases or codons that codify for arginine during...

  • Saw palmetto
  • Other ingredients: gelatin
    Gelatin
    Gelatin is a translucent, colorless, brittle , flavorless solid substance, derived from the collagen inside animals' skin and bones. It is commonly used as a gelling agent in food, pharmaceuticals, photography, and cosmetic manufacturing. Substances containing gelatin or functioning in a similar...

    , cellulose
    Cellulose
    Cellulose is an organic compound with the formula , a polysaccharide consisting of a linear chain of several hundred to over ten thousand β linked D-glucose units....

    , rice bran, oat fiber, magnesium stearate
    Magnesium stearate
    Magnesium stearate, also called octadecanoic acid, magnesium salt, is a white substance which is solid at room temperature. It has the chemical formula . It is a salt containing two equivalents of stearate and one magnesium cation...

    , silicon dioxide
    Silicon dioxide
    The chemical compound silicon dioxide, also known as silica , is an oxide of silicon with the chemical formula '. It has been known for its hardness since antiquity...

    , dicalcium phosphate
    Dicalcium phosphate
    Dicalcium phosphate, also known as calcium monohydrogen phosphate, is a dibasic calcium phosphate. It is usually found as the dihydrate, with the chemical formula of CaHPO4 • 2H2O, but it can be thermally converted to the anhydrous form. It is practically insoluble in water, with a solubility of...

    , titanium dioxide
    Titanium dioxide
    Titanium dioxide, also known as titanium oxide or titania, is the naturally occurring oxide of titanium, chemical formula . When used as a pigment, it is called titanium white, Pigment White 6, or CI 77891. Generally it comes in two different forms, rutile and anatase. It has a wide range of...

     and propylene glycol
    Propylene glycol
    Propylene glycol, also called 1,2-propanediol or propane-1,2-diol, is an organic compound with formula C3H8O2 or HO-CH2-CHOH-CH3...

    .


Most of the above ingredients are commonly available as over the counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...

 herbal or dietary supplements, and most have anecdotal reports, but marginal or unproven scientific evidence, of efficacy on various systems in the human body. Several of the herbal ingredients are included in only very low quantities.

One notable ingredient, Yohimbe, was included in the original formulation of Enzyte, produced until at least 2004, however as Yohimbe's legal status in Canada is unclear, Enzyte produced after 2004 no longer contains Yohimbe extract.

Additionally, zinc is an ingredient in Enzyte. Some men who have low zinc levels in their body have had success using zinc supplements to treat erection problems. Overdosage of zinc is a hazard to health. Zinc supplements are available without prescription at significantly lower prices than Enzyte.

Effectiveness

Currently, the effectiveness of Enzyte is unproven. The Center for Science in the Public Interest
Center for Science in the Public Interest
Center for Science in the Public Interest is a Washington, D.C.-based non-profit watchdog and consumer advocacy group focusing on nutritional education and awareness.-History and funding:...

 has urged the Federal Trade Commission
Federal Trade Commission
The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...

 (which has power under federal law
Federal law
Federal law is the body of law created by the federal government of a country. A federal government is formed when a group of political units, such as states or provinces join together in a federation, surrendering their individual sovereignty and many powers to the central government while...

 to regulate advertising) to disallow further television advertising for Enzyte, because of a lack of proper clinical trials. The company has agreed to pay $2.5 million to settle allegations of deceptive sales practices made by the Attorneys General of various states, and have altered their advertising in a more truthful fashion.

Enzyte originally advertised that use of the Enzyte product would promote permanent physical penile growth, or the company would return purchasers double their cost. Those who attempted to collect this refund claim they either received a partial refund or were duped into signing away the right to a refund. Enzyte advertising was changed to state that the product is intended to create a firmer erection by temporarily increasing blood flow to the penis. The advertising change was made after lawsuits against the company and its rebate policies began to surface. No evidence exists that proves Enzyte to be effective in any of its claims. The product advertising states in small print that it "is not intended or promoted to diagnose, or treat any disease" and since erectile dysfunction is a recognized disease, the advertising is considered legal.

A civil lawsuit alleged Enzyte does not work as advertised. Despite manufacturer claims that Enzyte will increase penis size, girth, firmness, and improve sexual performance, there exists no scientific evidence that Enzyte is capable of these claims. In fact, Enzyte has never been scientifically tested by the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

, or other independent third party. Accordingly, Enzyte is required by current US law to be marketed as an herbal supplement, and may not legally be called a drug. In keeping with FTC rulings, Enzyte is not allowed to claim these benefits in its advertising. However, as of June 2010, TV commercials for the product still use the phrase "natural male enhancement."

Federal indictment and trial

Thousands of consumer complaints were made to the Better Business Bureau about the company's business practices, especially the "autoship" program that repeatedly charged their credit cards for refills even after they canceled their orders. Federal agents raided Berkeley facilities in March 2005, gathering material that led to criminal charges.
On September 21, 2006, Berkeley Premium Nutraceuticals, its owner and president, Steven Warshak, and five other individuals were indicted by the United States, Southern District of Ohio, U.S. Attorney Greg Lockhart, on charges of conspiracy
Conspiracy (crime)
In the criminal law, a conspiracy is an agreement between two or more persons to break the law at some time in the future, and, in some cases, with at least one overt act in furtherance of that agreement...

, money laundering
Money laundering
Money laundering is the process of disguising illegal sources of money so that it looks like it came from legal sources. The methods by which money may be laundered are varied and can range in sophistication. Many regulatory and governmental authorities quote estimates each year for the amount...

; and mail, wire and bank fraud. The indictment alleged that the company defrauded consumers and banks of US$
United States dollar
The United States dollar , also referred to as the American dollar, is the official currency of the United States of America. It is divided into 100 smaller units called cents or pennies....

100 million. The United States Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

, Internal Revenue Service
Internal Revenue Service
The Internal Revenue Service is the revenue service of the United States federal government. The agency is a bureau of the Department of the Treasury, and is under the immediate direction of the Commissioner of Internal Revenue...

, United States Postal Inspection Service
United States Postal Inspection Service
The United States Postal Inspection Service is the law enforcement arm of the United States Postal Service. Its jurisdiction is defined as "crimes that may adversely affect or fraudulently use the U.S...

 and other agencies participated in the investigation. The federal fraud trial began on January 8, 2008.

In testimony during the trial, a former executive with Berkeley testified that the enhancements that the company claimed were given by use of Enzyte were fabricated, and the company defrauded customers by continuing to charge them for additional shipments of the supplement. He further testified that company employees were instructed to make it as difficult as possible for unhappy customers to receive refunds.

Conviction and sentencing

On February 22, 2008, Steven Warshak was found guilty of 93 counts of conspiracy, fraud and money laundering. On August 27, 2008 he was sentenced by U.S. District Judge Arthur Spiegel to 25 years in prison and ordered to pay $93,000 in fines. His company, Berkeley Premium Nutraceuticals, along with other defendants, was ordered to forfeit $500 million. His 75-year-old mother, Harriet Warshak, was sentenced to two years in prison but released on bond pending appeal after turning over her house, bank accounts and other assets related to her crimes.

Both Steven and Harriet Warshak appealed their convictions. The United States Court of Appeals for the Sixth Circuit in United States v. Warshak
United States v. Warshak
United States v. Warshak is a criminal case decided by the United States Court of Appeals for the Sixth Circuit holding that government agents violated the defendant's Fourth Amendment rights by compelling his Internet Service Provider to turn over his emails without first obtaining a search...

upheld Steven Warshak's convictions, and upheld all convictions against Harriet Warshak's except for money laundering, and vacated their sentences, remanding the sentencing to the lower court once more.

Continued company operation

The Warshaks' convictions and fines forced the company into bankruptcy
Bankruptcy
Bankruptcy is a legal status of an insolvent person or an organisation, that is, one that cannot repay the debts owed to creditors. In most jurisdictions bankruptcy is imposed by a court order, often initiated by the debtor....

. In December 2008 its assets were acquired from bankruptcy court for $2.75 million by investment company Pristine Bay, affiliated with Cincinnati developer Chuck Kubicki. Kubicki said he wanted to save the jobs of the company's 200 employees and retain a major tenant in one of his properties in suburban Cincinnati at Forest Park, Ohio
Forest Park, Ohio
As of the census of 2000, there were 19,463 people, 7,505 households, and 5,238 families residing in the city. The population density was 2,990.4 people per square mile . There were 7,748 housing units at an average density of 1,190.4 per square mile...

. He said he would change the company name but would keep the brand.

On June 26, 2009, the company name was changed to Vianda LLC. In a press release, the company announced plans to expand, hiring as many as 400 additional workers.

See also

  • Erectile dysfunction
    Erectile dysfunction
    Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance....

  • ExtenZe
    ExtenZe
    ExtenZe is a herbal nutritional supplement claiming to promote "natural male enhancement", which suggests a euphemism for penis enlargement. However, television commercials make few definitive claims, employing suggestion and euphemism or promising a "better" or "more fun" sexual experience...

  • Penis enlargement
    Penis enlargement
    Penis enlargement procedures are techniques alleged to make the human penis increase in girth, length, or hardness. Often, in the course of advertising fraudulent products, the distinction between temporary enlargement, i.e...

  • Patent medicine
    Patent medicine
    Patent medicine refers to medical compounds of questionable effectiveness sold under a variety of names and labels. The term "patent medicine" is somewhat of a misnomer because, in most cases, although many of the products were trademarked, they were never patented...


External links

The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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