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{{short description|American multi-level marketing company}}
 
'''Protandim''' is a herbal [[dietary supplement]] marketed with unsupported claims that it can treat a number of medical conditions. The product is a [[patent medicine|patented]]<ref name=Patent1 /> mix of five herbal ingredients and sold by LifeVantage Corporation (formerly LifeLine Therapeutics, Lifeline Nutraceuticals, and Yaak River Resources, Inc), a [[Utah]]-based [[multi-level marketing]] company.<ref name="LifeVantage">LifeVantage Corporation{{cite web | url=http://www.lifevantage.com/faqs/ | title=FAQs – LifeVantage | access-date=4 July 2014 }}</ref> The manufacturers of Protandim claimmake no claims that it can prevent or cure a wide variety ofany medical conditions.<ref name="sbm2017">{{cite web |url=https://sciencebasedmedicine.org/protandim-update-new-studies-and-an-fda-warning-letter/ |publisher=Science-Based Medicine |author=Hall H |author-link=Harriet A. Hall |title=Protandim Update: New Studies and an FDA Warning Letter |date=9 May 2017}}</ref> In 2017, LifeVantage was issued a [[FDA warning letter|warning letter]] by the [[U.S. Food and Drug Administration]] (FDA) regarding illegal advertising claims on the company's websites suggesting that Protandim can help to cure various ailments, including cancer and diabetes.<ref name="SLT_042617" /><ref name="SBN">{{cite news|last1=Montgomery|first1=Matt|title=FDA warns RSL kit sponsor LifeVantage over cancer treatment claims|url=http://www.rslsoapbox.com/2017/4/26/15436756/rsl-kit-sponsor-lifevantage-cancer-treatment-claims-fda-warning|access-date=April 27, 2017|publisher=[[SB Nation]]|date=April 26, 2017}}</ref><ref name="fda0417">{{Cite web|url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554234.htm|title=2017 – Lifevantage Corp 4/17/17|website=www.fda.gov|language=en|access-date=2017-04-25}}</ref>
 
== History ==
 
In 2003, Lifeline Therapeutics, a privately held Denver-based [[nutraceutical]] licensing and marketing company, entered into an agreement with Massachusetts biotechnology company CereMedix for the rights to market CMX-1152, an experimental [[peptide]]-based [[chemical compound|compound]], under the brand name "Protandim" (also sometimes referred to at that time as "Rholen," "Rejuven8r" and "ependymin").<ref name="NutraceuticalsWorld">{{cite news|title=Lifeline Nutraceuticals, CereMedix sign agreement|url=http://www.highbeam.com/doc/1G1-112356866.html|archive-url=https://web.archive.org/web/20160413142849/https://www.highbeam.com/doc/1G1-112356866.html|url-status=dead|archive-date=April 13, 2016|access-date=2012-08-19|newspaper=Nutraceuticals World|date=December 1, 2003}}</ref><ref name=BetterhumansPR>{{cite news|title=The Uncertain Antiaging Pill (press release)|url=http://www.prweb.com/releases/2004/12/prweb183718.htm|archive-url=https://web.archive.org/web/20050125045232/http://www.prweb.com/releases/2004/12/prweb183718.htm|url-status=dead|archive-date=January 25, 2005|access-date=2012-08-19|newspaper=Betterhumans|date=December 1, 2004}}</ref><ref name="McCook">{{cite journal |author=Alison McCook|title=Your Money for Your Life |journal=The Scientist|volume=20 |issue=3 |pages=33 |date=February 2006 |url=http://www.the-scientist.com/article/display/23192/#ixzz1DA5Ng18E}}</ref><ref name=PR101603>{{cite news|title=LifeLine Therapeutics press release|url=http://www.cryonics.org/immortalist/january04/lifeline.htm|access-date=2012-08-19|date=October 16, 2003|url-status=dead|archive-url=https://archive.today/20130414193633/http://www.cryonics.org/immortalist/january04/lifeline.htm|archive-date=April 14, 2013}}</ref><ref name=Betterhumans>{{cite news|last=Bailey |first=Patrick |title=The Uncertain Antiaging Pill |url=http://www.betterhumans.com/Features/Reports/report.aspx?articleID=2004-11-29-1 |access-date=2004-11-29 |newspaper=Betterhumans |url-status=unfit |archive-url=https://web.archive.org/web/20041204092646/http://www.betterhumans.com/Features/Reports/report.aspx?articleID=2004-11-29-1 |archive-date=December 4, 2004 }}</ref><ref name=Scotsman>{{cite news|title=Scientist returns to build long-life pill plant|url=http://www.scotsman.com/news/scientist-returns-to-build-long-life-pill-plant-1-894387|access-date=2012-08-20|newspaper=[[The Scotsman]]|date=November 17, 2003}}</ref><ref name=DenverPost>{{cite news|last=Austin|first=Marsha|title=Denver Businessmen Gamble on Selling Fountain of Youth in Pill Form|url=http://business.highbeam.com/3563/article-1G1-111038316/denver-businessmen-gamble-selling-fountain-youth-pill|archive-url=https://web.archive.org/web/20130610042619/http://business.highbeam.com/3563/article-1G1-111038316/denver-businessmen-gamble-selling-fountain-youth-pill|url-status=dead|archive-date=June 10, 2013|access-date=2012-08-20|newspaper=[[Denver Post]]|date=December 8, 2003}}</ref> CereMedix was a ten percent owner of Lifeline and members of the CereMedix management board served on Lifeline's board of directors. CMX-1152 was claimed to upregulate the production of the endogenous antioxidant enzymes [[superoxide dismutase]], [[catalase]], and [[glutathione peroxidase]], and to offset the aging process.<ref name=Scotsman />
 
CMX-1152 was due to be marketed as an [[over the counter]] [[anti-aging]] pill in June 2004 after completing human clinical trials. However, plans to market the CMX-1152 version of Protandim fell through and in April 2004 Lifeline Therapeutics announced that it would instead be marketing a different (non-peptide) [[dietary supplement]] under the name "Protandim CF" (to distinguish it from the peptide version initially developed by Cermedix). The new version of Protandim, a combination of five common [[herbal]] ingredients including [[turmeric]] and [[green tea]] was invented following "months of extensive research and development" by Lifeline employees Paul Myhill and William Driscoll (a former oil company executive), who together hold the patent on the product,<ref name="Patent1">{{Cite patent | inventor1-last=Myhill | inventor1-first=Paul R. | inventor2-last=Driscoll | inventor2-first=William J. | issue-date=10 July 2007 | patent-number=7241461 | title=Composition for alleviating inflammation and oxidative stress in a mammal. | postscript=<!--None--> | country-code=US }}</ref> and it was launched in February 2005. Myhill and Driscoll resigned from the company later that year.<ref name="DenverPost" /><ref name="Footnoted">{{cite news|title=Some days it's just hard to believe|url=http://www.footnoted.com/uncategorized/some-days-its-just-hard-to-believe/|access-date=2012-08-19|newspaper=Footnoted|date=November 17, 2005}}</ref><ref name="DBJ">{{cite news|title=Lifeline Therapeutics CEO resigns|url=http://www.bizjournals.com/denver/stories/2005/07/04/daily12.html|access-date=2012-08-20|newspaper=[[Denver Business Journal]]|date=July 5, 2005}}</ref><ref name="Myhill8K">{{cite news|title=Paul R. Myhill. RE: Resignation from the Board of Directors and Executive Committee of Lifeline Therapeutics, Inc (Form 8-K)|url=https://www.sec.gov/Archives/edgar/data/849146/000102189005000208/lifeline1111058kex991.htm|access-date=2012-08-20|newspaper=[[United States Securities and Exchange Commission]]|date=November 11, 2005}}</ref>
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Beginning in 2005, Protandim was produced under a manufacturing agreement with [[Chemins|The Chemins Company]] of Colorado Springs, Colorado.<ref name="LIFEVANTAGE-CORP-Jan-2006-10KSB/A">{{cite web|url=http://edgar.secdatabase.com/135/102189006000015/filing-main.htm |title=LIFEVANTAGE CORP, Form 10KSB/A, Filing Date Jan 26, 2006 |publisher=secdatabase.com |access-date =May 15, 2018}}</ref> In July 2008, LifeVantage entered into a new manufacturing agreement with Cornerstone Research & Development to produce Protandim, and with Wasatch Product Development to produce a Protandim-based skin cream (''TrueScience'').<ref name="LIFEVANTAGE-CORP-Sep-2011-10-K">{{cite web|url=http://pdf.secdatabase.com/988/0001193125-11-258536.pdf |title=LIFEVANTAGE CORP, Form 10-K, Annual Report, Filing Date Sep 28, 2011 |publisher=secdatabase.com |access-date =May 15, 2018}}</ref>
 
In 2006, biochemist [[Joe&nbsp;M. McCord]] joined the LifeVantage board of directors as the company's Directordirector of Sciencescience.<ref>{{Cite web |url=http://www.allbusiness.com/company-activities-management/board-management/5376294-1.html |title=Dr. Joe M. Mccord Joins Lifeline Therapeutics, Inc. Board of Directors. &#124; Business News and Press Releases from AllBusiness.com |access-date=2014-09-22 |archive-date=2011-08-24 |archive-url=https://web.archive.org/web/20110824163520/http://www.allbusiness.com/company-activities-management/board-management/5376294-1.html |url-status=dead }}</ref> McCord, who is listed by the [[U.S. Securities and Exchange Commission]] as a LifeVantage [[Insider trading|insider shareholder]],<ref name="secwatch.com">{{cite web |url=http://secwatch.com/mccord-joe-m |title=MCCORD JOE M ALL SEC FILINGS - SEC Watch |access-date=2011-02-16 |url-status=dead |archive-url=https://web.archive.org/web/20110304012432/http://secwatch.com/mccord-joe-m |archive-date=2011-03-04 }}</ref> served as a spokesperson for Protandim and was responsible for distributor training and product research.<ref name="secwatch.com" /> Under the terms of his 2011 employment agreement, McCord received $529,994 in direct compensation as well as a 50-cent commission on every bottle of Protandim sold.<ref name="10K2011">{{cite web|title=LifeVantage Corp 10-K 2011|url=https://www.sec.gov/Archives/edgar/data/849146/000119312511258536/d225491d10k.htm|publisher=sec.edgar-online.com|access-date=September 5, 2015}}</ref><ref name="McCordcontract">{{cite web|title=Employment agreement with Dr. Joe McCord|url=https://www.sec.gov/Archives/edgar/data/849146/000119312511258536/d225491dex1031.htm|publisher=[[U.S. Securities and Exchange Commission]]|access-date=2014-09-21|date=April 1, 2011}}</ref> McCord served as LifeVantage's Chief Scientific Officer from June 2011 until September 2012, and then became a member of its science advisory board. LifeVantage announced McCord's retirement in June 2013.<ref name="retire1">{{Cite web |url=http://globenewswire.com/news-release/2013/06/25/556132/10037495/en/Dr-Joe-McCord-LifeVantage-Corporation-s-First-Chief-Science-Officer-Retires-From-Company.html |title=Dr. Joe McCord, LifeVantage Corporation's First Chief Science Officer, Retires from Company Nasdaq:LFVN |access-date=2014-09-22 |archive-date=2015-02-21 |archive-url=https://web.archive.org/web/20150221091151/http://globenewswire.com/news-release/2013/06/25/556132/10037495/en/Dr-Joe-McCord-LifeVantage-Corporation-s-First-Chief-Science-Officer-Retires-From-Company.html |url-status=dead }}</ref><ref name="8Kretire2">{{cite news|title=Form 8-K for LifeVantage Corp|url=http://biz.yahoo.com/e/130625/lfvn8-k.html|access-date=10 November 2013|newspaper=Yahoo.com|date=June 25, 2013}}</ref> Under the terms of the separation agreement, McCord was to receive a payment of $1.7{{nbsp}}million from the company.<ref name="8Kretire2" />
 
In January 2014, McCord was replaced by Shawn Talbott (developer of [[CortiSlim]]),<ref name="TalbottFTC">{{cite web|title=Three Cortislim Defendants to Give up $4.5 Million in Cash and Other Assets|url=https://www.ftc.gov/news-events/press-releases/2005/09/three-cortislim-defendants-give-45-million-cash-and-other-assets|publisher=[[Federal Trade Commission]]|access-date=July 14, 2016|date=September 21, 2005}}</ref> who served as the company's Chiefchief Sciencescience Officerofficer<ref name="Talbott">{{cite web|title=LifeVantage Corporation Appoints Shawn Talbott Ph.D. as New Global Chief Science Officer|url=https://globenewswire.com/news-release/2014/01/07/600765/10063209/en/LifeVantage-Corporation-Appoints-Shawn-Talbott-Ph-D-as-New-Global-Chief-Science-Officer.html|publisher=LifeVantage, Inc.|access-date=July 14, 2016|date=January 7, 2014}}</ref> until being relieved of his duties in June 2015<ref name="TalbottBlog">{{cite web|author1=Shawn M. Talbott|title=My New Gig?|url=https://bestfutureyou.com/2015/07/13/my-new-gig/|website=Shawn M. Talbott Personal Blog|access-date=July 14, 2016|date=July 13, 2015}}</ref> and replaced in August 2015 by Natalie Chevreau, who was hired as the company's Seniorsenior Vicevice Presidentpresident of Researchresearch and Developmentdevelopment and is credited with the invention of the company's TruScience skin care product.<ref name="ChevreauPatent">{{cite web|title=Patent WO 2015164504 A1: Topical compositions and methods for reducing oxidative stress|url=httphttps://wwwpatents.google.com/patentspatent/WO2015164504A1?cl=/en|access-date=July 14, 2016|date=October 29, 2015}}</ref>
 
=== Product invention ===
 
As recently as July 21, 2011, LifeVantage credited McCord as the creator of Protandim on its website.<ref name="InventControversy2">{{cite web |url= http://www.lifevantage.com/products-breakthrough.aspx |title= Scientific Breakthrough. [Filed 21 July 2011] |url-status= bot: unknown |archive-url= https://web.archive.org/web/20110721233521/http://www.lifevantage.com/products-breakthrough.aspx |archive-date= 21 July 2011 }}</ref> At a 2011 conference for LifeVantage distributors, McCord stated, "I was presented with a list of 41 potential ingredients for a product they wanted to call Protandim, and I went through the list and penciled out, rapidly, about 36 of those ingredients," leaving the 5 ingredients in the current formulation of Protandim.<ref name="InventControversy3">{{cite web |url= http://youtube.googleapis.com/v/C5vli73g_CA&start=2303%26start%3D2303 |title= The History of Free Radical Biology, Dr. Joe McCord [Filed 17 August 2011] |access-date= 2012-08-13 |archive-date= 2013-09-27 |archive-url= https://web.archive.org/web/20130927231208/https://youtube.googleapis.com/v/C5vli73g_CA%26start=2303 |url-status= dead }}</ref> In March 2009, former LifeLine Therapeutics executive, Paul Myhill stated, "We initially decided to hide that fact [that Myhill derived the core composition for Protandim] for marketing purposes and instead rely on the impeccable background of Dr. McCord."<ref name="InventControversy1">{{cite web|url= http://www.blogtalkradio.com/lifevantage/blog/2009/03/09/inside-protandim-the-paul-myhill-interview |title= Inside Protandim: The Paul Myhill Interview [Filed 09 March 2009]|access-date=2012-08-13}}</ref> In April, 2005, Myhill produced a signed letter from McCord in which McCord stated, "I do not honestly feel that I have made contributions to the intellectual property, up to this point, that would qualify me as an inventor...I must congratulate you and Paul for having framed the concept of Protandim so close to its final embodiment, prior to the beginnings of our association."<ref name="InventControversy4">{{cite web|url= http://static.protandimscams.com/images/mccord-didnt-invent-protandim.jpg |title= McCord Rejects Credit for Inventing Protandim [Filed 29 March 2005]|access-date=2012-08-13|publisher=Joe McCord}}</ref>
 
== Composition ==
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Marketing claims that Protadim can prevent or treat [[cancer]] are unproven and have been deemed [[fraudulent]] by the FDA.<ref name="fda2017">{{cite web |publisher=FDA |title=Illegal Cancer Treatments: FDA Warning – Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure |date=25 April 2017 |archive-url=https://web.archive.org/web/20180424192807/https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554777.htm |archive-date=24 April 2018 |url=https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554777.htm}}</ref> Research into use as a treatment for [[amyotrophic lateral sclerosis]] is of poor quality, casting doubt on its usefulness for drawing any conclusions about efficacy.<ref>{{cite journal| author=ALSUntangled Group| title=ALSUntangled No. 31: Protandim. | journal=Amyotroph Lateral Scler Frontotemporal Degener | year= 2015 | volume= 17 | issue= 1–2 | pages= 154–6 | pmid=26414415 | doi=10.3109/21678421.2015.1088707 | s2cid=207664215 |type=Review| doi-access=free }}</ref>
 
In 2011, [[Harriet&nbsp;A. Hall]] wrote for ''[[Science-Based Medicine (website)|Science-Based Medicine]]'' that, "Wewe simply don't know enough at this point to recommend Protandim for treatment or prevention of any disease, for anti-aging, for making people feel healthier or more energetic, or for anything else.".<ref>{{cite web|last=Hall|first=Harriet|title=Pursued by Protandim Proselytizers|date=11 October 2011|url=http://www.sciencebasedmedicine.org/index.php/pursued-by-protandim-proselytizers/|publisher=[[Science-Based Medicine (website)|Science-Based Medicine]]|access-date=12 November 2011}}</ref>
 
== Side effects ==
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=== FDA Warning for illegal marketing ===
 
On April 17, 2017, LifeVantage was issued a [[FDA warning letter|warning letter]] by the U.S. Food and Drug Administration (FDA) regarding illegal advertising claims on the company's websites suggesting that Protandim can play a role in helping to cure various ailments, including cancer and diabetes. The claims were deemed to be in violation of Section 201(g)(1)(B) of the [[Federal Food, Drug, and Cosmetic Act]] (the Act) [21 U.S.C. §&nbsp;321(g)(1)(B)].<ref name="SLT_042617">{{cite news|last1=Kamrani|first1=Christopher|title=Real Salt Lake: RSL jersey sponsor LifeVantage in hot water with FDA over supplement's treatment claims|url=http://www.sltrib.com/home/5221187-155/real-salt-lake-rsl-jersey-sponsor|access-date=April 26, 2017|publisher=[[Salt Lake Tribune]]|date=April 26, 2017}}</ref><ref name="SBN" /><ref name=fda0417 />
 
=== Other ===
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In September 2016, a class action lawsuit was filed against LifeVantage in Utah alleging that the company and its executive Darren Jensen and Mark Jaggi made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the case alleged that the defendants made false and/or misleading statements and/or failed to disclose that: (i) LifeVantage lacked effective internal financial controls; (ii) as a result, the Company had improperly accounted for sales in certain international markets, along with associated revenue and income tax accruals; and (iii) as a result of the foregoing, LifeVantage's public statements were materially false and misleading at all relevant times.<ref name="Rosen091616">{{cite web|author1=Rosen Law Firm|title=Rosen Law Firm Announces Filing of Securities Class Action Lawsuit Against LifeVantage Corporation – LFVN|url=https://www.rosenlegal.com/cases-952.html|access-date=April 27, 2018|date=September 16, 2016}}</ref><ref name="Zhang1">{{cite web|title=Zhang v LifeVantage et al: Case 2:16-cv-00965-BCW|url=http://securities.stanford.edu/filings-documents/1059/LC00_02/2016915_f01c_16CV00965.pdf|access-date=April 27, 2018|date=September 15, 2018}}</ref> The case was dismissed in June 2017.<ref name="LFVN102317">{{cite web|title=LifeVantage Announces Dismissal of Class Action Lawsuit|url=https://globenewswire.com/news-release/2017/10/23/1151587/0/en/LifeVantage-Announces-Dismissal-of-Class-Action-Lawsuit.html|publisher=Lifevantage|access-date=April 27, 2018|date=October 10, 2017}}</ref><ref name="Zhang2">{{cite web|title=Zhang v Lifevantage et al: Memorandum decision and order granting defendants' motion to dismiss.|url=https://ecf.utd.uscourts.gov/cgi-bin/show_public_doc?216cv0965-51|access-date=April 27, 2018|date=June 15, 2017}}</ref>
 
In January 2018, a class action lawsuit was filed against LifeVantage in Connecticut alleging that the company and its Chiefchief Executiveexecutive Officerofficer Darren Jensen, Chiefchief Salessales Officerofficer Justin Rose, and Chiefchief Marketingmarketing Officerofficer Ryan Goodwin were operating an illegal [[pyramid scheme]] in violation of the [[RICO Act]], federal securities laws, and the Connecticut Unfair Trade Practices Act.<ref name="BW042718">{{cite web|title=Sommers Schwartz, P.C. Announces the Filing of a Securities Class Action Claims Against LifeVantage Corp. and Certain of its Executives|url=https://www.businesswire.com/news/home/20180219005625/en/Sommers-Schwartz-P.C.-Announces-Filing-Securities-Class|website=Business Wire|access-date=April 27, 2018|date=February 19, 2018}}</ref>
 
== Promotional sponsorship ==