Hydroxycut

Hydroxycut is sold at conventional retailers, online retailers, 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.{{cite web|last=Frank|first=Hoffman|title=Sean Lowe is Hydroxycut Hardcore's New Dancing Star|work=MuscleMag |url=http://www.musclemag.com/blog/sean-lowe-is-hydroxycut-hardcores-new-dancing-star/|publisher=Muscle Maf|access-date=30 April 2013}} In the same month, IndyCar racer Tony Kanaan announced he will pilot the No. 11 Hydroxycut IndyCar at the Indianapolis 500 along with 8 other events at the 2013 IndyCar Championship.{{cite web|title=Hydroxycut supports Tony Kanaan|url=http://www.nationalspeedsportnews.com/indy/izod-indycar/hydroxycut-supports-tony-kanaan/|publisher=Nationalspeed Sports News|access-date=14 May 2013}}{{cite news|title=KV Racing signs sponsor in time for season opener |url=http://aol.sportingnews.com/nascar/story/2013-03-21/kv-racing-signs-sponsor-in-time-for-season-opener |archive-url=https://archive.today/20130630085328/http://aol.sportingnews.com/nascar/story/2013-03-21/kv-racing-signs-sponsor-in-time-for-season-opener |url-status=dead |archive-date=30 June 2013 |newspaper=Washington Post |access-date=14 May 2013 }} 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.{{cite news |publisher=ABC News |title=I'm Not a Doctor, but... |first=Peggy |last=Peck |date=May 9, 2009 |access-date= March 11, 2013 |url=https://abcnews.go.com/Health/WellnessNews/story?id=7542510}}

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 Carhart [http://www.millerthomson.com/assets/files/article_attachments/Reflections_on_the_Muscletech_Case.PDF "Reflections on the MuscleTech Case"] Annual Review of Insolvency Law. March 4, 2009, pp. 499–516{{rp|499}} 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.{{rp|503}} 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.{{rp|503–504}} MuscleTech filed for bankruptcy in June 2005{{rp|499}}{{cite web|title=rown Rudnick Prevails on Behalf of Creditors in Metabolife Chapter 11 Bankruptcy Proceedings|url=http://www.businesswire.com/news/home/20061113005229/en/Brown-Rudnick-Prevails-Behalf-Creditors-Metabolife-Chapter|publisher=Business Wire|access-date=October 27, 2015|date=November 13, 2006}} and the claims of litigants against MuscleTech were resolved by 2007.{{rp|515}} Since then, MuscleTech has become a brand of Iovate, under which Hydroxycut products are sold.[http://www.linkedin.com/company/iovate-health-sciences Iovate's Linked-in page]

Iovate is now owned by Xiwang Foodstuffs Company Ltd.{{Cite news|date=2016-06-13|title=Xiwang Agrees to Acquire Canada's Iovate Health for $730 Million|language=en|work=Bloomberg.com|url=https://www.bloomberg.com/news/articles/2016-06-13/xiwang-agrees-to-acquire-canada-s-iovate-health-for-730-million|access-date=2021-05-05}} and has been since 2016.

Prior to 2004, some formulations of Hydroxycut contained ephedra.{{cite news |title=Studies of Dietary Supplements Come Under Growing Scrutiny |work=The New York Times|url=https://www.nytimes.com/2003/06/23/us/studies-of-dietary-supplements-come-under-growing-scrutiny.html?pagewanted=all&src=pm |date=June 23, 2003 |access-date=2009-05-02 |first=Ford |last=Fessenden}} 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.{{cite journal |vauthors=Kockler DR, McCarthy MW, Lawson CL |title=Seizure activity and unresponsiveness after hydroxycut ingestion. |year=2001 |journal=Pharmacotherapy |volume=21 |issue=5 |pages=647–51 |pmid=11349754 |doi=10.1592/phco.21.6.647.34542|s2cid=40396092 }}

In 2003, Missouri Attorney General Jay Nixon filed a lawsuit in St. Louis 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."{{cite news |work=St. Louis Business Journal |title=Nixon sues maker of Hydroxycut |url=http://www.bizjournals.com/stlouis/stories/2003/03/24/daily68.html |date=March 27, 2003 |access-date= April 18, 2012}}{{cite news |work=20/20 |publisher=ABC News |title='20/20' Investigates Diet Pill Ads |url=https://abcnews.go.com/2020/story?id=124290 |access-date=April 18, 2012}} MuscleTech paid $100,000 to settle the case and agreed to cease marketing ephedra-containing products in Missouri and to refund customers' money.{{cite news |work=St. Louis Business Journal |title=Hydroxycut distributor to pay Missouri $100K to settle suit |url=http://www.bizjournals.com/stlouis/stories/2004/05/03/daily33.html |date=May 4, 2004 |access-date=April 18, 2012}}

The New York Times 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 and stroke were attributed to ephedra, including the death of Baltimore Orioles pitcher Steve Bechler. It was the first banning of a dietary supplement by the FDA.{{cite web |url=http://health.howstuffworks.com/wellness/diet-fitness/diets/hydroxycut.htm |title=Hydroxycut: What You Need to Know |work=Sarah Siddons |date=15 May 2009 |publisher=How Stuff Work |access-date=29 March 2013}}[https://books.google.com/books?id=5C9t6NlWEbYC&dq=%22Steve+Bechler%22&pg=PA64 Death at the ballpark: a comprehensive study of game-related fatalities of …] By Robert M. Gorman, David Weeks. McFarland Press. p. 64.

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.{{cite journal|author=Ano Lobb |pmc=2668789 |title=Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance|pmid=19360927 |journal=World J Gastroenterol |date=2009-04-14|volume=15|issue=14|pages=1786–7 |doi=10.3748/wjg.15.1786 |doi-access=free }}

However, Hydroxycut formulations contained several substances with potential to harm the liver such as hydroxycitric acid.{{cite journal |vauthors=Dara L, Hewett J, Lim JK |year=2008 |title=Hydroxycut hepatotoxicity: a case series and review of liver toxicity from herbal weight loss supplements |journal=World J Gastroenterol |volume=14 |issue=45 |pages=6999–7004 |pmid=19058338 |pmc=2773866 |doi=10.3748/wjg.14.6999 |doi-access=free }}

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.{{cite news |work=Reuters |title=Hydroxycut products recalled after one death |access-date=March 11, 2013 |date=May 1, 2009 |url=https://www.reuters.com/article/us-supplements-hydroxycut-idUSTRE5404NW20090501 |first=Lias |last=Richwine}}{{cite journal |vauthors=Dehoney S, Wellein M |title =Rhabdomyolysis associated with the nutritional supplement Hydroxycut. |year=2009 |journal=Am J Health Syst Pharm |volume=66 |issue=2 |pages=142–8 |doi=10.2146/ajhp070640 |pmid=19139478}}{{cite journal|last1=Fong|first1=TL|last2=Klontz|first2=KC|last3=Canas-Coto|first3=A|last4=Casper|first4=SJ|last5=Durazo|first5=FA|last6=Davern Tj|first6=2nd|last7=Hayashi|first7=P|last8=Lee|first8=WM|last9=Seeff|first9=LB|title=Hepatotoxicity due to hydroxycut: a case series|journal=The American Journal of Gastroenterology|volume=105|issue=7|pages=1561–6|year=2010|pmid=20104221|doi=10.1038/ajg.2010.5|pmc=3825455}}{{cite news |last=Norton |first=Amy |title=Hydroxycut linked to other cases of liver damage |newspaper=Reuters Health |location=New York |publisher=Reuters |date=February 12, 2010 |url=https://www.reuters.com/article/idUSTRE61B4P720100212 |access-date=December 9, 2010}}{{cite journal |vauthors=Rashid NN, Grant J |title =Hydroxycut hepatotoxicity. |year=2010 |journal=Med. J. Aust. |volume=192 |issue=3 |pages=173–4 |doi =10.5694/j.1326-5377.2010.tb03464.x |pmid=20121691|s2cid =42661917 }}{{cite journal |last1=Sharma |first1=T. |last2=Wong |first2=L. |last3=Tsai |first3=N. |last4=Wong |first4=R. D. |year=2010 |title=Hydroxycut® (herbal weight loss supplement) Induced Hepatotoxicity: A Case Report and Review of Literature |journal=Hawaii Medical Journal |volume=69 |issue=8|pages=188–190 |pmid=20845283 |pmc=3118021}}

On May 1, 2009, the U.S. Food and Drug Administration (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.{{cite web |url=https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm152152.htm |archive-url=https://web.archive.org/web/20090603052906/http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm152152.htm |url-status=dead |archive-date=June 3, 2009 |title=FDA Warns Consumers to Stop Using Hydroxycut Products |publisher=U.S. Food and Drug Administration}}{{cite news |agency=Associated Press |title=FDA warns dieters: Stop Hydroxycut use now |url=http://www.nbcnews.com/id/30518843 |archive-url=https://web.archive.org/web/20151005035159/http://www.nbcnews.com/id/30518843 |url-status=dead |archive-date=October 5, 2015 |publisher=NBC News |date=May 1, 2009 |access-date=2009-05-02}} 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."{{cite web|title=FDA Safety Recall|url=https://www.fda.gov/Safety/recalls/ucm145164.htm|archive-url=https://web.archive.org/web/20090603160822/http://www.fda.gov/Safety/Recalls/ucm145164.htm|url-status=dead|archive-date=June 3, 2009|publisher=FDA|access-date=16 May 2013}} Following the FDA warning, the manufacturer then agreed to voluntarily recall the products.

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.{{cite news |publisher=CBS News |title=How Hydroxycut Stays in Business Despite Deaths, Recalls and a Class-Action Suit |first=Jim |last=Edwards |access-date=March 11, 2013 |url=https://www.cbsnews.com/news/how-hydroxycut-stays-in-business-despite-deaths-recalls-and-a-class-action-suit/}}Lorraine Heller for NutraIngredients-USA.com, September 8, 2009. [http://www.nutraingredients-usa.com/Industry/Reformulated-Hydroxycut-back-on-shelves Reformulated Hydroxycut back on shelves]

As of 2013, its primary ingredients include caffeine,{{cite news |title=How Hydroxycut Stays in Business Despite Deaths, Recalls and a Class-Action Suit |url=https://www.cbsnews.com/news/how-hydroxycut-stays-in-business-despite-deaths-recalls-and-a-class-action-suit/ |access-date=20 February 2019 |work=www.cbsnews.com}} Lady's mantle extract (Alchemilla vulgaris), Wild olive extract (Olea europaea), Cumin extract (Cuminum cyminum), Wild mint extract (Mentha longifolia) and, in some Hydroxycut products, Green coffee bean extract (Coffea canephora robusta).{{cite web|url=http://www.webmd.com/diet/hydroxycitric-acid-hydroxycut |title=Hydroxycut: Uses, Side Effects, and Risks |author=Smith, Michael W. |website=WebMD |date=28 February 2013 |access-date=21 March 2013}}

Following the reformulation, case reports 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{{cite journal |vauthors=Karth A, Holoshitz N, Kavinsky CJ, Trohman R, McBride BF |year=2010 |title=A case report of atrial fibrillation potentially induced by hydroxycut: a multicomponent dietary weight loss supplement devoid of sympathomimetic amines |journal=J Pharm Pract |volume=23 |issue=3 |pages=245–9 |doi=10.1177/0897190010362104 |pmid=21507821|s2cid=6496079 }} in Hydroxycut Green Tea, a product that as of 2012 is no longer marketed.[https://www.diethealthmag.com/hydroxycut/ DietHealthMag Hydroxycut Pro Clinical Review]{{Dead link|date=June 2022 |bot=InternetArchiveBot |fix-attempted=yes }}. Accessed March 30, 2013 Another case published in 2013 reported on a patient who developed ulcerative colitis due to Hydroxycut Hardcore.{{cite journal |vauthors=Sivarajah V, Abdul Q, Pardoe H, Lunniss P |year=2013 |title=Ulcerative colitis associated with the herbal weight loss supplement Hydroxycut |journal=BMJ Case Rep |volume=2013 |pages=bcr2012007509 |doi=10.1136/bcr-2012-007509 |pmid=23291814 |pmc=3603930}}

In October 2020, 6ix9ine was reportedly hospitalized after having an overdose from mixing two Hydroxycut diet pills with a McDonald's McCafé 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.{{Cite web|title=Tekashi 6ix9ine 'hospitalised after having a diet pill and caffeine overdose'|url=https://www.mirror.co.uk/3am/celebrity-news/tekashi-6ix9ine-hospitalised-after-having-22779111.amp|access-date=October 2, 2020|website=Mirror|date=October 2, 2020|language=en|archive-date=October 7, 2020|archive-url=https://web.archive.org/web/20201007151141/https://www.mirror.co.uk/3am/celebrity-news/tekashi-6ix9ine-hospitalised-after-having-22779111.amp|url-status=live}} His lawyer denies the overdose claim.{{Cite web|last=Curto|first=Justin|date=October 2, 2020|title=Tekashi 6ix9ine's Lawyer Denies Diet Pill-Coffee Overdose Report|url=https://www.vulture.com/2020/10/tekashi-69-in-hospital-no-overdose.html|access-date=October 4, 2020|website=Vulture|language=en-us|archive-date=October 5, 2020|archive-url=https://web.archive.org/web/20201005164324/https://www.vulture.com/2020/10/tekashi-69-in-hospital-no-overdose.html|url-status=live}}

The Hydroxycut case has been cited as emblematic of the weak regulation of dietary supplements in the U.S.{{cite web |work=MedPage Today |title=Groups Call for Review of DSHEA in Light of Hydroxycut |url=http://www.medpagetoday.com/PrimaryCare/DietNutrition/14074 |first=Kristina |last=Fiore |date=May 7, 2009 |access-date=March 11, 2013}}{{cite news |publisher=CBS News |title=Why Hydroxycut Had to Kill Someone Before the FDA Could Act |url=https://www.cbsnews.com/news/why-hydroxycut-had-to-kill-someone-before-the-fda-could-act/ |date=May 4, 2009 |first=Jim |last=Edwards |access-date=March 11, 2013}} 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.{{cite news|last=Healy|first=Melissa|title=Sizing up safety; If a bestselling weight-loss aid is recalled, does that mean oversight of the supplement industry is working? For consumers with few options, that's a tough call to make|newspaper=Los Angeles Times|date=25 May 2009}}

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.{{cite web|title=Hydroxycut and PhenqAvis Phentermine|url=http://phenq-avis.com/en/about-us/|date=3 March 2015|access-date=11 May 2016|archive-date=4 June 2016|archive-url=https://web.archive.org/web/20160604011403/http://phenq-avis.com/en/about-us/|url-status=dead}} 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 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."{{cite web|url=http://newhope360.com/supplements/weight-loss-supplement-sales-plummet-following-iovates-hydroxycut-recall|title=Weight-Loss Supplement Sales Plummet Following Iovate's Hydroxycut Recall|work=Nutrition Business Journal|access-date=2013-03-30|archive-date=2015-10-03|archive-url=https://web.archive.org/web/20151003215245/http://newhope360.com/supplements/weight-loss-supplement-sales-plummet-following-iovates-hydroxycut-recall|url-status=dead}}

In a paper published in the World Journal of Gastroenterology 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."{{cite journal|last=Lobb|first=Anno|title=Science of weight loss supplements: Compromised by conflicts of interest?|journal=World Journal of Gastroenterology|date=14 October 2010|volume=16|issue=38|pages=4880–4882|doi=10.3748/wjg.v16.i38.4880|pmid=20939120|pmc=2955261 |doi-access=free }}

The paper noted that at least three studies supported the safety and effectiveness for weight loss of Cissus quadrangularis (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.

{{Reflist|2}}

• {{official website|http://www.hydroxycut.com/}}
• [https://web.archive.org/web/20090605155729/http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm155683.htm FDA Letter to Iovate Health Sciences re: Hydroxycut]. U.S. Food and Drug Administration, 30 April 2009.

Category:Dietary supplements

Category:Product recalls