Hydroxycut
Encyclopedia
Hydroxycut is the brand name of a series of dietary supplement
s marketed as an aid to weight loss
. According to a 2009 paper in the World Journal of Gastroenterology
, Hydroxycut is the most popular brand of weight-loss supplement, selling approximately 1 million units per year. On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a warning after some Hydroxycut products were linked to liver damage, rhabdomyolysis
, and at least one death. The manufacturer then recalled the products. Shortly after the recall, Hydroxycut was "reformulated" with reportedly some different ingredients and placed back for sale.
, Gymnema sylvestre
, chromium polynicotinate
, caffeine
, and green tea
. Like many nutraceutical
s, according to the New York Times, its efficacy has been questioned and not well-supported by research
.
Hydroxycut was promoted as being created and endorsed by doctors
. Television
advertisements
for Hydroxycut featured Jon Marshall, a graduate of Midwestern University
's osteopathic medical school, and still in residency
. Hydroxycut was also endorsed by its formulator, Marvin Heuer, Associate Clinical Professor in the Department of Family Medicine and Community Health at the University of Florida
, and Former Chief Scientific Officer of Iovate Health Sciences, the company that markets the product.
The New York Times reported in 2003 that internal documents from the manufacturer of Hydroxycut indicated that the company buried studies showing that Hydroxycut was ineffective, covered up evidence of cardiac side effects, and even tampered with the documents it submitted as evidence in the lawsuit. An accurate assessment of the safety of dietary supplements in the United States, including Hydroxycut and other weight loss supplements, is hampered by a lack of oversight and regulation of the supplement industry.
Ultimately, scientific evidence of serious side effects from Hydroxycut products accumulated, including liver failure (requiring liver transplantation
in some cases), rhabdomyolysis
, and at least one death, of a 19-year-old man who used the product. On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a warning to consumers to stop using Hydroxycut immediately because of the risk of serious side effects or death. The manufacturer then recalled the products, although a new formulation of Hydroxycut weight loss products has been
created and is being sold.
Jay Nixon
filed a lawsuit in St. Louis
against Hydroxycut's manufacturer MuscleTech Research and Development, Inc
stating that claims Hydroxycut was "clinically proven" to be a "fat-burner" were false, specifically:
Nixon also alleged that the "before" and "after" photographs were misleading, and that one woman's "before" photo was deceptive because she was recently pregnant. MuscleTech paid $100,000 to settle the case while denying any wrongdoing.
In one study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study. Looking at factors like patients' risk factors for liver disease and the timing of their Hydroxycut use, the researchers found that for eight of the liver-damage cases, there was a greater than 95 percent likelihood that the weight-loss aid was to blame.
While some industry sources defended the safety of Hydroxycut and believed the media "over-hyped" the FDA withdrawal, others questioned why Iovate had not published long term safety or efficacy studies on the final Hydroxycut products despite having the money to perform such studies and the self-promoted reputation as being "research-oriented." The editors of the nutrition trade journal
Nutrition Business Journal noted that this recall "will ultimately be a good thing for the dietary supplement industry if it encourages weight-loss supplement manufacturers to care as much about their products' safety and efficacy as they do about expanding and protecting their bottom lines."
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
s marketed as an aid to weight loss
Weight loss
Weight loss, in the context of medicine, health or physical fitness, is a reduction of the total body mass, due to a mean loss of fluid, body fat or adipose tissue and/or lean mass, namely bone mineral deposits, muscle, tendon and other connective tissue...
. According to a 2009 paper in the World Journal of Gastroenterology
World Journal of Gastroenterology
World Journal of Gastroenterology is an online peer-reviewed open access medical journal that covers research in gastroenterology. It is published by Baishideng Publishing Group. The editor-in-chief is Ferruccio Bonino ....
, Hydroxycut is the most popular brand of weight-loss supplement, selling approximately 1 million units per year. On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a warning after some Hydroxycut products were linked to liver damage, rhabdomyolysis
Rhabdomyolysis
Rhabdomyolysis is a condition in which damaged skeletal muscle tissue breaks down rapidly. Breakdown products of damaged muscle cells are released into the bloodstream; some of these, such as the protein myoglobin, are harmful to the kidneys and may lead to kidney failure...
, and at least one death. The manufacturer then recalled the products. Shortly after the recall, Hydroxycut was "reformulated" with reportedly some different ingredients and placed back for sale.
Background
Hydroxycut is sold at conventional retailers, online retailers, and through direct television marketing. Prior to May 2009, its primary ingredients included Garcinia cambogiaGambooge
Garcinia gummi-gutta is a subtropical species of Garcinia native to Indonesia also commonly known as gambooge,ಕಾಚುಪುಳಿ brindleberry, brindall berry, Malabar tamarind, kodumpuli , or goraka...
, Gymnema sylvestre
Gymnema sylvestre
Gymnema sylvestre is a herb native to the tropical forests of southern and central India where it has been used as a natural treatment for diabetes for nearly two millennia.-Description:...
, chromium polynicotinate
Chromium polynicotinate
Chromium polynicotinate is an ionic substance used in some nutritional supplement products. It appears in products that are referred to as a medical food used for nutritional support for conditions associated with diabetes mellitus type 2. The product is also known as niacin-bound chromium, as...
, caffeine
Caffeine
Caffeine is a bitter, white crystalline xanthine alkaloid that acts as a stimulant drug. Caffeine is found in varying quantities in the seeds, leaves, and fruit of some plants, where it acts as a natural pesticide that paralyzes and kills certain insects feeding on the plants...
, and green tea
Green tea
Green tea is made solely from the leaves of Camellia sinensis that have undergone minimal oxidation during processing. Green tea originates from China and has become associated with many cultures throughout Asia. It has recently become more widespread in the West, where black tea is traditionally...
. Like many nutraceutical
Nutraceutical
Nutraceutical, a portmanteau of the words “nutrition” and “pharmaceutical”, is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease. Health Canada defines the term as "a product isolated or purified from foods that is...
s, according to the New York Times, its efficacy has been questioned and not well-supported by research
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
.
Hydroxycut was promoted as being created and endorsed by doctors
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...
. Television
Television
Television is a telecommunication medium for transmitting and receiving moving images that can be monochrome or colored, with accompanying sound...
advertisements
Advertising
Advertising is a form of communication used to persuade an audience to take some action with respect to products, ideas, or services. Most commonly, the desired result is to drive consumer behavior with respect to a commercial offering, although political and ideological advertising is also common...
for Hydroxycut featured Jon Marshall, a graduate of Midwestern University
Midwestern University
Midwestern University is a graduate degree-granting institution specializing in the health sciences with eight colleges and two campuses....
's osteopathic medical school, and still in residency
Residency (medicine)
Residency is a stage of graduate medical training. A resident physician or resident is a person who has received a medical degree , Podiatric degree , Dental Degree and who practices...
. Hydroxycut was also endorsed by its formulator, Marvin Heuer, Associate Clinical Professor in the Department of Family Medicine and Community Health at the University of Florida
University of Florida
The University of Florida is an American public land-grant, sea-grant, and space-grant research university located on a campus in Gainesville, Florida. The university traces its historical origins to 1853, and has operated continuously on its present Gainesville campus since September 1906...
, and Former Chief Scientific Officer of Iovate Health Sciences, the company that markets the product.
The New York Times reported in 2003 that internal documents from the manufacturer of Hydroxycut indicated that the company buried studies showing that Hydroxycut was ineffective, covered up evidence of cardiac side effects, and even tampered with the documents it submitted as evidence in the lawsuit. An accurate assessment of the safety of dietary supplements in the United States, including Hydroxycut and other weight loss supplements, is hampered by a lack of oversight and regulation of the supplement industry.
Ultimately, scientific evidence of serious side effects from Hydroxycut products accumulated, including liver failure (requiring liver transplantation
Liver transplantation
Liver transplantation or hepatic transplantation is the replacement of a diseased liver with a healthy liver allograft. The most commonly used technique is orthotopic transplantation, in which the native liver is removed and replaced by the donor organ in the same anatomic location as the original...
in some cases), rhabdomyolysis
Rhabdomyolysis
Rhabdomyolysis is a condition in which damaged skeletal muscle tissue breaks down rapidly. Breakdown products of damaged muscle cells are released into the bloodstream; some of these, such as the protein myoglobin, are harmful to the kidneys and may lead to kidney failure...
, and at least one death, of a 19-year-old man who used the product. On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a warning to consumers to stop using Hydroxycut immediately because of the risk of serious side effects or death. The manufacturer then recalled the products, although a new formulation of Hydroxycut weight loss products has been
created and is being sold.
2003 lawsuit for false advertising
On March 27, 2003, Missouri Attorney GeneralMissouri Attorney General
The Office of the Missouri Attorney General was created in 1806 when Missouri was part of the Louisiana Territory. Missouri's first Constitution in 1820 provided for an appointed Attorney General, but since the 1865 Constitution, the Attorney General has been elected...
Jay Nixon
Jay Nixon
Jeremiah Wilson "Jay" Nixon, Sr. is the 55th and current Governor of the U.S. state of Missouri. A member of the Democratic Party, he previously served as Missouri's Attorney General before his election in 2008.-Political career:...
filed a lawsuit in St. Louis
St. Louis, Missouri
St. Louis is an independent city on the eastern border of Missouri, United States. With a population of 319,294, it was the 58th-largest U.S. city at the 2010 U.S. Census. The Greater St...
against Hydroxycut's manufacturer MuscleTech Research and Development, Inc
MuscleTech
MuscleTech is a brand of sports nutrition supplements marketed by Iovate Health Sciences Inc.- History :Some products bearing the MuscleTech brand name include Anator P70, Anabolic Halo, Gakic Hardcore, Leukic Hardcore, Vitakic, supplements containing creatine and protein supplements .The brand...
stating that claims Hydroxycut was "clinically proven" to be a "fat-burner" were false, specifically:
- "The product is not "clinically proven" to be a "fat-burner," as MuscleTech claims. MuscleTech's own study showed that Hydroxycut has no efficacy as compared to placebo with the possible exception of an appetite-suppressing effect. Moreover, the serious adverse health risks of Hydroxycut with ephedra – including death – were not adequately described or disclosed in marketing and labelling of the product."
Nixon also alleged that the "before" and "after" photographs were misleading, and that one woman's "before" photo was deceptive because she was recently pregnant. MuscleTech paid $100,000 to settle the case while denying any wrongdoing.
FDA warning and subsequent recall
On May 1, 2009, the FDA issued a warning to consumers to stop using Hydroxycut products, due to 23 reports of serious health problems associated with the use of Hydroxycut, and at least one death.In one study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study. Looking at factors like patients' risk factors for liver disease and the timing of their Hydroxycut use, the researchers found that for eight of the liver-damage cases, there was a greater than 95 percent likelihood that the weight-loss aid was to blame.
While some industry sources defended the safety of Hydroxycut and believed the media "over-hyped" the FDA withdrawal, others questioned why Iovate had not published long term safety or efficacy studies on the final Hydroxycut products despite having the money to perform such studies and the self-promoted reputation as being "research-oriented." The editors of the nutrition trade journal
Trade journal
A trade magazine, also called a professional magazine, is a magazine published with the intention of target marketing to a specific industry or type of trade. The collective term for this area of publishing is the trade press....
Nutrition Business Journal noted that this recall "will ultimately be a good thing for the dietary supplement industry if it encourages weight-loss supplement manufacturers to care as much about their products' safety and efficacy as they do about expanding and protecting their bottom lines."
External links
- Official site
- FDA Letter to Iovate Health Sciences re: Hydroxycut. U.S. Food and Drug Administration, 30 April 2009.
- Questions and answers: Hydroxycut, from the U.S. Food and Drug Administration