257:
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.
480:(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.
27:
206:, 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.
256:
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. Thousands of lawsuits were filed over ephedra in the early 2000s; the first lawsuits against MuscleTech began in 2000 and
472:
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,
454:
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
286:
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
450:
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
300:
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.
462:
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."
358:(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
248:. 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.
1749:
Healy, Melissa (25 May 2009). "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".
1531:
Karth A, Holoshitz N, Kavinsky CJ, Trohman R, McBride BF (2010). "A case report of atrial fibrillation potentially induced by hydroxycut: a multicomponent dietary weight loss supplement devoid of sympathomimetic amines".
441:
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.
272:. 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.
360:"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."
522:
162:
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.
634:
209:
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.
1644:
473:
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."
738:
330:
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.
370:
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.
1265:
669:
355:
496:
105:
1675:
849:
816:
1480:
1443:
642:
419:
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
455:
despite having the money to perform such studies and their self-definition as a "research-oriented" company. The editors of the nutrition
523:"Television Personality Sean Lowe is new Brand Ambassador for Hydroxycut Hardcore™ - Will Help Provide Energy for Dancing with the Stars"
746:
411:
in the medical literature have continued to link Hydroxycut to serious side effects. An article published in 2010 reported on a case of
800:
1636:
1806:
468:
1724:
716:
1822:
1026:
1468:
1216:
Fong, TL; Klontz, KC; Canas-Coto, A; Casper, SJ; Durazo, FA; Davern Tj, 2nd; Hayashi, P; Lee, WM; Seeff, LB (2010).
694:
978:
922:
400:
245:
1154:
500:
276:
1765:
1395:
544:
1827:
874:
Kockler DR, McCarthy MW, Lawson CL (2001). "Seizure activity and unresponsiveness after hydroxycut ingestion".
416:
229:
115:
1001:
1356:"Hydroxycut® (herbal weight loss supplement) Induced Hepatotoxicity: A Case Report and Review of Literature"
288:
1104:"Hydroxycut hepatotoxicity: a case series and review of liver toxicity from herbal weight loss supplements"
1667:
950:
1259:
477:
344:
305:
333:
However, Hydroxycut formulations contained several substances with potential to harm the liver such as
476:
The paper noted that at least three studies supported the safety and effectiveness for weight loss of
291:
and agreed to cease marketing ephedra-containing products in Missouri and to refund customers' money.
1181:
Dehoney S, Wellein M (2009). "Rhabdomyolysis associated with the nutritional supplement Hydroxycut".
1048:"Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance"
973:
917:
412:
340:
283:
222:
171:
37:
225:, published studies demonstrating scientific evidence of its effectiveness and safety is lacking.
1802:
1557:
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343:
of serious side effects from Hydroxycut products accumulated, including liver failure (requiring
334:
269:
203:
151:
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1549:
1377:
1328:
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1198:
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817:"rown Rudnick Prevails on Behalf of Creditors in Metabolife Chapter 11 Bankruptcy Proceedings"
769:
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313:
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1190:
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593:
362:
Following the FDA warning, the manufacturer then agreed to voluntarily recall the products.
241:
218:
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608:
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296:
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435:
382:
319:
177:
1340:
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545:"FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine"
1561:
1420:
1481:"How Hydroxycut Stays in Business Despite Deaths, Recalls and a Class-Action Suit"
1444:"How Hydroxycut Stays in Business Despite Deaths, Recalls and a Class-Action Suit"
1589:"Ulcerative colitis associated with the herbal weight loss supplement Hydroxycut"
887:
408:
237:
155:
1637:"Tekashi 6ix9ine 'hospitalised after having a diet pill and caffeine overdose'"
260:
Iovate is now owned by Xiwang Foodstuffs Company Ltd. and has been since 2016.
945:
375:
159:
1545:
598:
373:
As of 2013, its primary ingredients include caffeine, Lady's mantle extract (
1604:
1574:
1027:
Death at the ballpark: a comprehensive study of game-related fatalities of …
279:
97:
26:
1622:
1553:
1381:
1332:
1251:
1202:
1139:
1083:
895:
635:"Weight-Loss Supplement Sales Plummet Following Iovate's Hydroxycut Recall"
617:
582:"Science of weight loss supplements: Compromised by conflicts of interest?"
438:
1728:
1447:
431:
166:
1120:
1064:
232:
became the brand ambassador for Hydroxycut Hardcore. In the same month,
1233:
1194:
1159:
427:
316:
233:
1769:
1399:
351:, and at least one death, of a 19-year-old man who used the product.
309:
55:
850:"Xiwang Agrees to Acquire Canada's Iovate Health for $ 730 Million"
1668:"Tekashi 6ix9ine's Lawyer Denies Diet Pill-Coffee Overdose Report"
1467:
Lorraine Heller for NutraIngredients-USA.com, September 8, 2009.
165:
Since 2013, the primary ingredients in the product line include
451:
the FDA's powers over dietary supplements need to be expanded.
398:) and, in some Hydroxycut products, Green coffee bean extract (
322:. It was the first banning of a dietary supplement by the FDA.
974:"Hydroxycut distributor to pay Missouri $ 100K to settle suit"
1795:
1725:"Why Hydroxycut Had to Kill Someone Before the FDA Could Act"
240:
announced he will pilot the No. 11 Hydroxycut IndyCar at the
158:
aid. Hydroxycut was originally developed and manufactured by
670:"Studies of Dietary Supplements Come Under Growing Scrutiny"
1398:. NBC News. Associated Press. May 1, 2009. Archived from
1029:
By Robert M. Gorman, David Weeks. McFarland Press. p. 64.
268:
Prior to 2004, some formulations of Hydroxycut contained
136:
1699:"Groups Call for Review of DSHEA in Light of Hydroxycut"
1311:
Rashid NN, Grant J (2010). "Hydroxycut hepatotoxicity".
562:"FDA Warns Consumers to Stop Using Hydroxycut Products"
304:
In 2004, the FDA banned ephedra after 155 deaths from
202:
Before the 2004 reformulation, formulations contained
695:"Sean Lowe is Hydroxycut Hardcore's New Dancing Star"
221:, and through direct television marketing. Like many
193:), and, in some products, green coffee bean extract (
1354:
Sharma, T.; Wong, L.; Tsai, N.; Wong, R. D. (2010).
1803:
FDA Letter to Iovate Health Sciences re: Hydroxycut
739:"KV Racing signs sponsor in time for season opener"
312:were attributed to ephedra, including the death of
131:
121:
111:
95:
87:
77:
69:
61:
51:
43:
33:
1587:Sivarajah V, Abdul Q, Pardoe H, Lunniss P (2013).
1286:"Hydroxycut linked to other cases of liver damage"
1218:"Hepatotoxicity due to hydroxycut: a case series"
1155:"Hydroxycut products recalled after one death"
217:Hydroxycut is sold at conventional retailers,
1279:
1277:
1275:
556:
554:
434:from mixing two Hydroxycut diet pills with a
73:Recalled 2009 (placed back on market in 2010)
8:
1575:DietHealthMag Hydroxycut Pro Clinical Review
1396:"FDA warns dieters: Stop Hydroxycut use now"
430:was reportedly hospitalized after having an
19:
1507:"Hydroxycut: Uses, Side Effects, and Risks"
1264:: CS1 maint: numeric names: authors list (
795:
793:
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659:
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1371:
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1222:The American Journal of Gastroenterology
1469:Reformulated Hydroxycut back on shelves
1097:
1095:
1093:
1041:
1039:
1037:
1035:
575:
573:
571:
488:
287:product." MuscleTech paid $ 100,000 to
1766:"Hydroxycut and PhenqAvis Phentermine"
1505:Smith, Michael W. (28 February 2013).
1257:
629:
627:
415:that the author suspected was due to
7:
1678:from the original on October 5, 2020
1647:from the original on October 7, 2020
946:"'20/20' Investigates Diet Pill Ads"
801:"Reflections on the MuscleTech Case"
564:. U.S. Food and Drug Administration.
1002:"Hydroxycut: What You Need to Know"
1325:10.5694/j.1326-5377.2010.tb03464.x
819:. Business Wire. November 13, 2006
14:
1807:U.S. Food and Drug Administration
1666:Curto, Justin (October 2, 2020).
1284:Norton, Amy (February 12, 2010).
1102:Dara L, Hewett J, Lim JK (2008).
717:"Hydroxycut supports Tony Kanaan"
668:Fessenden, Ford (June 23, 2003).
586:World Journal of Gastroenterology
469:World Journal of Gastroenterology
356:U.S. Food and Drug Administration
244:along with 8 other events at the
918:"Nixon sues maker of Hydroxycut"
25:
1697:Fiore, Kristina (May 7, 2009).
804:Annual Review of Insolvency Law
1768:. 3 March 2015. Archived from
1153:Richwine, Lias (May 1, 2009).
580:Lobb, Anno (14 October 2010).
1:
1008:. How Stuff Work. 15 May 2009
407:Following the reformulation,
1723:Edwards, Jim (May 4, 2009).
806:. March 4, 2009, pp. 499–516
499:. Ostrofflaw. Archived from
466:In a paper published in the
423:due to Hydroxycut Hardcore.
16:Brand of dietary supplements
888:10.1592/phco.21.6.647.34542
768:Peck, Peggy (May 9, 2009).
719:. Nationalspeed Sports News
81:
47:Iovate Health Sciences Inc.
1844:
979:St. Louis Business Journal
923:St. Louis Business Journal
770:"I'm Not a Doctor, but..."
639:Nutrition Business Journal
460:Nutrition Business Journal
1577:. Accessed March 30, 2013
277:Missouri Attorney General
246:2013 IndyCar Championship
169:, lady's mantle extract (
24:
1546:10.1177/0897190010362104
599:10.3748/wjg.v16.i38.4880
525:. Cision. March 12, 2013
417:epigallocatechin gallate
401:Coffea canephora robusta
1605:10.1136/bcr-2012-007509
1046:Ano Lobb (2009-04-14).
838:Iovate's Linked-in page
547:. FDA. 6 February 2004.
380:), Wild olive extract (
175:), wild olive extract (
1360:Hawaii Medical Journal
1183:Am J Health Syst Pharm
392:), Wild mint extract (
366:Post-2009 formulations
187:), wild mint extract (
154:that is marketed as a
1108:World J Gastroenterol
1052:World J Gastroenterol
478:Cissus quadrangularis
345:liver transplantation
326:Pre-2009 formulations
264:Pre-2004 formulations
126:Lose Weight Your Way.
354:On May 1, 2009, the
252:Corporate background
1823:Dietary supplements
1643:. October 2, 2020.
1421:"FDA Safety Recall"
1292:. New York: Reuters
1121:10.3748/wjg.14.6999
1065:10.3748/wjg.15.1786
503:on 12 November 2011
413:atrial fibrillation
341:Scientific evidence
282:filed a lawsuit in
223:dietary supplements
213:Marketing and sales
172:Alchemilla vulgaris
152:dietary supplements
82:List of brand names
38:Dietary supplements
21:
1402:on October 5, 2015
1234:10.1038/ajg.2010.5
1195:10.2146/ajhp070640
674:The New York Times
497:"About Hydroxycut"
421:ulcerative colitis
386:), Cumin extract (
335:hydroxycitric acid
181:), cumin extract (
1752:Los Angeles Times
1599:: bcr2012007509.
1114:(45): 6999–7004.
592:(38): 4880–4882.
426:In October 2020,
395:Mentha longifolia
314:Baltimore Orioles
190:Mentha longifolia
145:
144:
103:September 1, 2010
1835:
1809:, 30 April 2009.
1799:
1798:
1796:Official website
1782:
1781:
1779:
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926:. March 27, 2003
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799:Jeffrey Carhart
797:
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777:
765:
759:
758:
756:
754:
745:. Archived from
735:
729:
728:
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706:
704:
702:
693:Frank, Hoffman.
690:
684:
683:
681:
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653:
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641:. Archived from
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541:
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532:
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513:
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347:in some cases),
242:Indianapolis 500
219:online retailers
196:Coffea canephora
141:
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96:Registered as a
29:
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1842:
1838:
1837:
1836:
1834:
1833:
1832:
1828:Product recalls
1813:
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1790:
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1773:
1764:
1763:
1759:
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1485:www.cbsnews.com
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1478:
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749:on 30 June 2013
743:Washington Post
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736:
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495:
494:
490:
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389:Cuminum cyminum
368:
328:
289:settle the case
266:
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228:In March 2013,
215:
184:Cuminum cyminum
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17:
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1789:
1788:External links
1786:
1784:
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1772:on 4 June 2016
1757:
1741:
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1658:
1628:
1579:
1567:
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1497:
1472:
1460:
1442:Edwards, Jim.
1434:
1412:
1387:
1366:(8): 188–190.
1346:
1303:
1290:Reuters Health
1271:
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1058:(14): 1786–7.
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349:rhabdomyolysis
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297:New York Times
265:
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253:
250:
214:
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150:is a brand of
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78:Related brands
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1703:MedPage Today
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1534:J Pharm Pract
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