weight loss
Weight loss, in the context of medicine, health, or physical fitness, refers to a reduction of the total body mass, by a mean loss of fluid, body fat ( adipose tissue), or lean mass (namely bone mineral deposits, muscle, tendon, and other co ...
aid. Hydroxycut was originally developed and manufactured by
MuscleTech
MuscleTech is a brand of dietary supplements, marketed by Iovate Health Sciences Inc., which includes Hydroxycut. It was owned by Canadian company Kerr Holdings which was acquired by the Xiwang Foodstuffs Company, a Chinese company, for $584 mil ...
Research and Development; MuscleTech was sold to Iovate Health Sciences in 2003–2004 and declared bankruptcy in 2005; Iovate continues to use MuscleTech as a brand to market Hydroxycut.
Since 2013, the primary ingredients in the product line include
caffeine
Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class. It is mainly used recreationally as a cognitive enhancer, increasing alertness and attentional performance. Caffeine acts by blocking binding of adenosine to ...
, lady's mantle extract (''
Alchemilla vulgaris
''Alchemilla vulgaris'', common name Lady's mantle, is an herbaceous perennial plant in Europe and Greenland. These perennial wildflowers, members of the rose family, are sometimes grown in gardens - mainly for their leaves, which collect spark ...
Mentha longifolia
''Mentha longifolia'' (also known as horse mint, fillymint or St. John's horsemint; syn. ''M. spicata'' var. ''longifolia'' L., ''M. sylvestris'' L., ''M. tomentosa'' D'Urv, ''M. incana'' Willd.) is a species in the genus ''Mentha'' (mint) nati ...
''), and, in some products, green coffee bean extract (''
Coffea canephora
''Coffea canephora'' ( syn. ''Coffea robusta'', commonly known as ''robusta coffee'') is a species of coffee that has its origins in central and western sub-Saharan Africa. It is a species of flowering plant in the family Rubiaceae. Though wid ...
'').
Before the 2004 reformulation, formulations contained
ephedra Ephedra may refer to:
* Ephedra (medicine), a medicinal preparation from the plant ''Ephedra sinica''
* ''Ephedra'' (plant), genus of gymnosperm shrubs
See also
* Ephedrine
Ephedrine is a central nervous system (CNS) stimulant that is of ...
, a supplement banned by the FDA in 2004. Before the 2009 reformulation, formulations contained several substances with potential to harm the liver. After a series of reports in the medical literature of serious liver problems, including one death, the FDA warned consumers to stop using Hydroxycut, and Iovate agreed to voluntarily recall the products.
The harm caused by Hydroxycut products has led to calls for stricter regulation of the dietary supplement industry and to calls within the industry for more rigorous safety testing.
Marketing and sales
Hydroxycut is sold at conventional retailers,
online retailers
Online shopping is a form of electronic commerce which allows consumers to directly buy goods or services from a seller over the Internet using a web browser or a mobile app. Consumers find a product of interest by visiting the website of the ...
, and through direct television marketing. Like many dietary supplements, published studies demonstrating scientific evidence of its effectiveness and safety is lacking.
In March 2013, Sean Lowe became the brand ambassador for Hydroxycut Hardcore. In the same month, IndyCar racer
Tony Kanaan
Antoine Rizkallah "Tony" Kanaan Filho (born 31 December 1974), nicknamed TK, is a Brazilian racing driver. He currently competes full-time in the Brazilian Stock Car Pro Series, driving the No. 6 Toyota Corolla E210 for Full Time Bassani a ...
announced he will pilot the No. 11 Hydroxycut IndyCar at the
Indianapolis 500
The Indianapolis 500, formally known as the Indianapolis 500-Mile Race, and commonly called the Indy 500, is an annual automobile race held at Indianapolis Motor Speedway (IMS) in Speedway, Indiana, United States, an enclave suburb of Indi ...
along with 8 other events at the 2013 IndyCar Championship. Hydroxycut has been promoted as being created and endorsed by doctors. Television advertisements for Hydroxycut featured a medical resident, although reporters were unable to locate him after Hydroxycut was removed from the market in 2009.
Corporate background
MuscleTech Research and Development Inc was a Canadian company based in Toronto that operated with a group of closely related companies, and developed the Hydroxycut product line.Jeffrey Carhar "Reflections on the MuscleTech Case" ''Annual Review of Insolvency Law''. March 4, 2009, pp. 499–516 Thousands of lawsuits were filed over ephedra in the early 2000s; the first lawsuits against MuscleTech began in 2000 and by 2004 there were about 80 pending. In 2003 and 2004, most of the assets of the MuscleTech group of companies were sold off to other companies, including Iovate Health Sciences; the same person controlled MuscleTech and Iovate. MuscleTech filed for bankruptcy in June 2005 and the claims of litigants against MuscleTech were resolved by 2007. Since then, MuscleTech has become a brand of Iovate, under which Hydroxycut products are sold.
Iovate is now owned by Xiwang Foodstuffs Company Ltd. and has been since 2016.
Pre-2004 formulations
Prior to 2004, some formulations of Hydroxycut contained
ephedra Ephedra may refer to:
* Ephedra (medicine), a medicinal preparation from the plant ''Ephedra sinica''
* ''Ephedra'' (plant), genus of gymnosperm shrubs
See also
* Ephedrine
Ephedrine is a central nervous system (CNS) stimulant that is of ...
. There were reports of seizures in people who had ingested Hydroxycut, which were attributed to the ephedra and caffeine in the product. As a result, there were around 80 pending ephedra lawsuits against MuscleTech.
In 2003,
Missouri 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 Gen ...
Jay Nixon
Jeremiah Wilson "Jay" Nixon (born February 13, 1956) is an American lawyer and politician who served as the 55th Governor of Missouri from 2009 to 2017. A member of the Democratic Party, he was first elected to the governorship in 2008 and reel ...
filed a lawsuit in
St. Louis
St. Louis () is the second-largest city in Missouri, United States. It sits near the confluence of the Mississippi and the Missouri Rivers. In 2020, the city proper had a population of 301,578, while the bi-state metropolitan area, which e ...
against Hydroxycut's manufacturer, MuscleTech, stating that its marketing claims that Hydroxycut was "clinically proven" to be a "fat-burner" were false. Nixon also alleged that "MuscleTech's own consultants had serious concerns about the safety of Hydroxycut, but the company continued to market the product." MuscleTech paid $100,000 to settle the case and agreed to cease marketing ephedra-containing products in Missouri and to refund customers' money.
The ''
New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid ...
'' reported in 2003 that internal documents from MuscleTech indicated that the company had 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 a lawsuit in Oklahoma.
In 2004, the FDA banned ephedra after 155 deaths from
heart attack
A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which ma ...
and stroke were attributed to ephedra, including the death of
Baltimore Orioles
The Baltimore Orioles are an American professional baseball team based in Baltimore. The Orioles compete in Major League Baseball (MLB) as a member club of the American League (AL) East division. As one of the American League's eight charter ...
pitcher
In baseball, the pitcher is the player who throws ("pitches") the baseball from the pitcher's mound toward the catcher to begin each play, with the goal of retiring a batter, who attempts to either make contact with the pitched ball or draw ...
Steve Bechler. It was the first banning of a dietary supplement by the FDA.
Pre-2009 formulations
By 2009, about 15% of Americans had tried taking dietary supplements for weight loss, and Hydroxycut was the biggest seller, with about a million units sold each year.
However, Hydroxycut formulations contained several substances with potential to harm the liver such as
hydroxycitric acid
Hydroxycitric acid (HCA) is a derivative of citric acid that is found in a variety of tropical plants including '' Garcinia cambogia'' and ''Hibiscus sabdariffa''.
There are four isomers, (+)- and (-)-hydroxycitric acid, and (+)- and (-)-allo-hyd ...
.
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
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(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, and to destroy any product that they may possess. The warning stated ''"Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk. Consumers who have these products are urged to stop using them."'' Following the FDA warning, the manufacturer then agreed to voluntarily recall the products.
Post-2009 formulations
After the 2009 recall, Hydroxycut was reformulated and placed back on sale, and the FDA confirmed that the only ingredient left from prior formulations was caffeine.
As of 2013, its primary ingredients include caffeine, Lady's mantle extract (''
Alchemilla
''Alchemilla'' is a genus of herbaceous perennial plants in the family Rosaceae, with the common name lady's mantle applied generically as well as specifically to ''Alchemilla mollis'' when referred to as a garden plant. The plant used as a herb ...
Mentha longifolia
''Mentha longifolia'' (also known as horse mint, fillymint or St. John's horsemint; syn. ''M. spicata'' var. ''longifolia'' L., ''M. sylvestris'' L., ''M. tomentosa'' D'Urv, ''M. incana'' Willd.) is a species in the genus ''Mentha'' (mint) nati ...
'') and, in some Hydroxycut products, Green coffee bean extract ('' Coffea canephora robusta'').
Following the reformulation,
case report In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrenc ...
s in the medical literature have continued to link Hydroxycut to serious side effects. An article published in 2010 reported on a case of atrial fibrillation that the author suspected was due to
epigallocatechin gallate
Epigallocatechin gallate (EGCG), also known as epigallocatechin-3-gallate, is the ester of epigallocatechin and gallic acid, and is a type of catechin.
EGCG – the most abundant catechin in tea – is a polyphenol under basic research for its ...
in Hydroxycut Green Tea, a product that as of 2012 is no longer marketed. Another case published in 2013 reported on a patient who developed
ulcerative colitis
Ulcerative colitis (UC) is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary symptoms of active disease are abdominal pain and diarrhea mixed with blood (hematochezia). Weight loss, fever, and ...
due to Hydroxycut Hardcore.
In October 2020, 6ix9ine was reportedly hospitalized after having an
overdose
A drug overdose (overdose or OD) is the ingestion or application of a drug or other substance in quantities much greater than are recommended.
from mixing two Hydroxycut diet pills with a
McDonald's
McDonald's Corporation is an American multinational fast food chain, founded in 1940 as a restaurant operated by Richard and Maurice McDonald, in San Bernardino, California, United States. They rechristened their business as a hambur ...
McCafé
McCafé is a coffee-house-style food and beverage chain, owned by McDonald's. Conceptualised and launched in Melbourne, Australia, in 1993, and introduced to the public with help from McDonald's CEO Charlie Bell and then-chairman and future ...
coffee. He has claimed that he came to weigh more than 200 lbs after leaving prison but has said that using the medication had helped him shed 30 lbs since he was released. His lawyer denies the overdose claim.
Reactions
The Hydroxycut case has been cited as emblematic of the weak regulation of dietary supplements in the U.S. Defenders of the nutritional supplements industry said that the recall demonstrated that the FDA has the power to protect consumers from toxic products, while critics cited it as evidence that the FDA's powers over dietary supplements need to be expanded.
While some diet supplement executives 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, and used weak trial duration and sample sizes. This is despite having the money to perform such studies and their self-definition as a "research-oriented" company. The editors of the nutrition
trade journal
A trade magazine, also called a trade journal or trade paper (colloquially or disparagingly a trade rag), is a magazine or newspaper whose target audience is people who work in a particular trade or industry. The collective term for this ...
''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."
In a paper published in the ''
World Journal of Gastroenterology
''World Journal of Gastroenterology'' is a weekly peer-reviewed open access medical journal that covers research in gastroenterology. It was established in 1995 and is published by Baishideng Publishing Group, which was included on Beall's list of ...
'' in October 2010, Hydroxycut was cited as an example of "current and former weight loss products backed by potentially conflicted or low quality research." It noted that "Marketing materials for Hydroxycut cited two published studies asserting product effectiveness that were small, of short duration, reported no serious side effects, and did not disclose relationships between authors and the product manufacturer or that funding was received from the product manufacturer."
The paper noted that at least three studies supported the safety and effectiveness for weight loss of
Cissus quadrangularis
Cissus quadrangularis is a perennial plant of the grape family. It is commonly known as veldt grape, winged treebine or adamant creeper. The species is native to tropical Asia, the Arabian Peninsula and much of Africa.
Description
''Cissus ...
(CQ), which is an ingredient used in one of the reformulated Hydroxycut products, but "lack financial disclosures or funding sources, beyond mentioning that the CQ being tested was provided by" General Health Alliances, an herbal products manufacturer. The studies did not disclose that one of its authors was a chief scientific officer for GHA that holds a patent on a CQ product.
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...