FWD 2 Dr. Oz's Miracle Herbal Weight-Loss Products

HerbalEGram: Volume 11, Issue 7, July 2014

Dr. Oz's "Miracle" Herbal Weight-Loss Products:
The Senate Hearing, Advertising Regulations, and Science Behind the Claims


Introduction

Mehmet Oz, MD, a Harvard-trained cardiologist and surgeon, has been disseminating his unique brand of enthusiastic and entertaining medical advice to audiences of “The Dr. Oz Show” since 2009.1 In more than 750 episodes of his popular daytime talk show, Dr. Oz has addressed a diverse range of health-related questions and concerns from the common (“Could You Have a Hidden Food Allergy?” and “The Truth About Antidepressants”) to the curious (“How You Can Use Angels to Heal” and “Is Your Poo and Pee Normal?”).2 But it was one of his most frequently covered topics — weight loss — that made him the focus of a recent US Senate hearing on illegal advertisements for weight-loss products.3

Senator Claire McCaskill (D-MO), chair of the Senate Subcommittee on Consumer Protection, Product Safety, and Insurance, which held the hearing on June 17, 2014, criticized Dr. Oz for his endorsements of “miraculous” weight-loss supplements with unproven health claims, which unscrupulous companies later used to sell products.3 In addition to Dr. Oz, witnesses included the Federal Trade Commission’s (FTC) Mary Engle, the associate director of its Division of Advertising Practices (DAP); natural products industry representatives Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), and Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN); and others.3

The Senate hearing focused largely on Dr. Oz — dubbed “America’s Doctor” by Oprah Winfrey after his 2004 appearance on her talk show4 — but he and other witnesses were in agreement that federal authorities have the appropriate tools to curb deceptive or false weight-loss product ads. 5-8 CRN, in its testimony, recommended increasing and prioritizing federal enforcement of existing regulations; expanding consumer education efforts; and encouraging volunteer, self-regulatory programs for industry members, retailers, and advertisers as potential measures to counter the continued prevalence of misleading weight-loss product ads.8

Engle attributed the problem to a strong, widespread consumer desire for easy and effective weight-loss solutions. 6 The potential market for such products is huge; according to the Center for Disease Control’s most recent statistics, roughly 70 percent of Americans are overweight, and more than 35 percent are considered obese.6

However, Sen. McCaskill suggested that Dr. Oz did his audience a disservice by using hyperbolic and overblown language to promote weight-loss products with unproven benefits — in particular, Garcinia cambogia, green coffee bean (Coffea arabica) extract, and raspberry (Rubus idaeus) ketones.3

“The scientific community is almost monolithic against you in terms of the efficacy of those three products you called miracles,” she said.3 “I don’t get why you need to say this stuff because you know it’s not true.… So why, when you have this amazing megaphone, do you cheapen your show like that?”3


FTC Actions: Past and Present

Since 1927, the FTC has filed “hundreds of cases challenging false and unproven weight-loss claims” and 82 in the past decade alone, according to Engle.6 An FTC survey from 2011 found that “more consumers were victims of fraudulent weight-loss products” than any other category of fraud, which included scams related to credit repair, debt relief, unauthorized billing, and others.6

In January 2014, the Commission launched “Operation Waistline,” a new regulatory initiative targeting misleading weight-loss claims. Since that time — citing a lack of substantiating evidence for product claims in each case — the FTC has filed suit against Sensa Products for alleging that its supplement can helping users “lose 30, 40, 90 pounds or more without dieting or exercise;” L’Occitane for claiming its almond creams had “body slimming capabilities that could trim inches in months;” and HCG Diet Direct for suggesting its homeopathic drops could help consumers “lose up to one pound a day.”6

Most recently, in May 2014, the FTC sued Florida-based Pure Green Coffee for fabricating news websites and using clips without permission from “The Dr. Oz Show” to sell its green coffee bean extract.9 The company — which charged $50 for a one-month supply of the product — was charged with “false and unsupported advertising claims,” such as their assertion that “studies prove Pure Green Coffee use can result in average weight loss of 17 pounds in 12 weeks.”9

Dr. Oz, who emphasized in the hearing that he does not endorse or receive money from manufacturers of products mentioned on his show, called these deceptive practices “a large scale orchestrated criminal fraud … and a grave threat to the health of any person buying and ingesting products from a dishonest seller.”5

Such misleading product advertisements have the potential to harm not only consumers, but members of the industry as well. As CRN’s Mister noted in his testimony: “Responsible firms…suffer along with consumers as legal, reasonable and defensible advertising for weight management gets dwarfed by outlandish claims that violate the law and deceive consumers.”8

FTC Regulations and Required Evidence

The Senate hearing specifically addressed the deceptive advertising of weight-loss products, which includes herbal and dietary supplements. The US Food and Drug Administration’s (FDA) Dietary Supplement Health and Education Act of 1994 (DHSEA) is concerned primarily with the labeling of such products but also addresses certain product health claims.10

“Marketers of dietary supplements should be familiar with the requirements under both DSHEA and the FTC Act that labeling and advertising claims be truthful, not misleading and substantiated,” the FTC explains in its Dietary Supplements: An Advertising Guide for Industry.10 For these claims, the FTC requires “competent and reliable scientific evidence,” which they define broadly as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."10

Although the FTC does not specify what it considers acceptable scientific studies, it notes a number of factors that can “enhance the validity of the test results,” such as the use of a control, double blinding, and increased study durations. Further, the Commission stresses the importance of statistically significant results and, “in most situations,” research quality over quantity. 10

Such ambiguous regulatory language, the Commission notes in its industry guide for dietary supplements advertising, is intended to benefit consumers. “The FTC's standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of science.”10

In her testimony, Engle described weight-loss product study requirements in slightly more detail. “[I]f a company had one good study showing weight loss, FTC wouldn’t necessarily consider it unsubstantiated,” she wrote, “but in cases where a company has violated the FTC Act and is under order, the agency has determined two studies are needed going forward.”6

This statement is reflected in FTC’s recent settlements with Sensa Products, L’Occitane, and HCG Diet Direct, in which the Commission specifically prohibits the companies from making any further weight-loss claims “unless the claim is backed by two adequate and well-controlled human clinical studies.”6


The Science Behind Dr. Oz’s “Magic” Weight-Loss Supplements

Perhaps the most tangible benefit from Dr. Oz’s frequent discussions of weight loss —despite his endorsements of products with limited, if any, scientific evidence to support their claims — is simply an increased awareness of the issue. With approximately three million viewers per episode,1 it is clear that his enthusiastic and unusual approach to medicine resonates with some Americans.

The often-sensational language he uses on the show — including references to “miracle” or “magic” weight-loss solutions — Dr. Oz added, is part of his role as a motivational daytime talk-show host. “When we write a script, we need to generate enthusiasm and engage the viewer. Viewers do not watch our show because they are seeking our dry clinical language.”5

According to Dr. Oz, his enthusiastic recommendations for various products are meant to help inspire his audience to make meaningful changes — such as losing weight — in their lives. “[W]e actively research new and emerging products and trends and news about products found in the average health food store,” he noted.5 “We look to published research, expert guests, our own testing that we do with third party laboratories and anecdotal testimony from audience members about people’s experience with the various products with the goal of providing useful information.”5

But as Michael Spector wrote in his 2013 New Yorker profile of Dr. Oz: “Oz has been criticized by scientists for relying on flimsy or incomplete data, distorting the results, and wielding his vast influence in ways that threaten the health of anyone who watches the show.”4

Acknowledging the limited scientific research supporting his claims for products such as the three previously mentioned herbal products, Dr. Oz said: “I actually do personally believe in the items I talk about in the show.... I recognize oftentimes they don't have the scientific muster to present as fact, but nevertheless, I would give my audience the advice I give my family.”5

Dr. Oz has described modern medicine as a “challenging orthodoxy”11 in which scientific validation is inherently more difficult for products and ideas not rooted in the Western medical tradition. “[T]his is one of the fundamental disconnects between Western medicine and what people often refer to as complementary medicine,” he noted in the New Yorker. “Not everything adds up. It’s about making people more comfortable.”4

However, some remain convinced that Dr. Oz is doing more harm than good.4 In Dr. Oz’s 2013 profile, Eric Rose, MD — a professor of cardiology and a former colleague of Dr. Oz — offered both compliments and criticisms of “America’s doctor.”4

“In many respects, Mehmet is now an entertainer. And he’s great at it. People learn a lot, and it can be meaningful in their lives. But that is a different job,” said Dr. Rose.4 “In medicine, your baseline need has to be for a level of evidence that can lead to your conclusions.”

Garcinia Cambogia

In November 2012, Dr. Oz unveiled the exotic-sounding fruit Garcinia cambogia as the “newest, fastest fat-buster,” which he claimed “may be the simple solution you’ve been looking for to bust your body fat for good.”12

Of the three main herbal products criticized by Sen. McCaskill, Garcinia cambogia has the most human clinical research data. According to Dr. Oz’s website, hydroxycitric acid (HCA) isolated from the rind of fruits of this Garcinia species “aids in weight loss by doing two things: It helps to block fat, and it suppresses your appetite.”12

The most recent meta-analysis of the anti-obesity effects of Garcinia extracts was published in 2013 by Chuah et al in Evidence-Based Complementary and Alternative Medicine.13 Analyzing 17 randomized, controlled trials (RCTs) with supplements containing varying levels of HCA, the authors concluded that, despite several statistically significant weight-loss results, the total body of evidence suggested that “G. cambogia extract possessed limited or no effects on weight loss in human subjects.”13

Green Coffee Bean Extract

In April 2012, Dr. Oz included green coffee bean extract as one of his “[five] fastest fat burners.” In hyping the supplement, Dr. Oz said, “You may think magic is make believe but this little bean has scientists saying they’ve found the magic weight loss cure for every body type — it’s green coffee extract.”14 These alleged actions are thought to stem from a compound known as chlorogenic acid (CGA), which “slows absorption of fat from food intake and also activates metabolism of extra fat,” according to a fact sheet posted on “The Dr. Oz Show” website.15

In the segment, Dr. Oz discussed the product’s weight-loss properties with nutrition advocate and entrepreneur Lindsey Duncan, a frequent guest on “The Dr. Oz Show.” Dr. Oz, however, failed to disclose that Duncan is the CEO of Pure Genesis, a supplement company that sells green coffee bean extract, among other products.16 His failure to acknowledge conflicts of interest in scientific research is apparently not uncommon.

The latest literature review of “green coffee extract” studies for weight loss was published by Onakpoya et al in Gastroenterology Research and Practice in 2011.17 Out of the five relevant human clinical trials on green coffee bean and weight loss identified, three met the authors’ inclusion criteria. However, as two trials were funded by extract manufacturers, Onakpova et al concluded that their results — which suggested potential weight-loss benefits — should be interpreted with caution.17

The most recent published results of a human clinical trial of green coffee bean extract appeared one year later in the journal Diabetes, Metabolic Syndrome, and Obesity: Targets and Therapy.18 In their 2012 randomized, placebo-controlled study, Vinson et al examined the effects of green coffee bean extract on overweight subjects. Results from 16 participants indicated significant reductions in weight, body mass index, and body fat percentage after 22 weeks. 18 Sen. McCaskill, however, took issue with the relatively small study, which she noted was funded by a manufacturer of green coffee bean extract (Applied Food Sciences, Inc., as reported by the Los Angeles Times).3,19  

In September 2012, frustrated with increased criticism of the science supporting green coffee bean claims, Dr. Oz dedicated an entire episode to an in-house, placebo-controlled study he refers to as “The Green Coffee Bean Project.”14 “The Dr. Oz Show” medical unit enrolled 100 overweight women between 35 and 49 years old. After two weeks, the women taking green coffee bean extract lost an average of two pounds, while the women taking a placebo lost one pound. Dr. Oz remarked that, according to his study, “taking green coffee bean extract doubles your weight loss,” but the statistical significance of the results was not reported.14

Raspberry Ketones

Also in 2012, Dr. Oz introduced — with “weight-loss expert” Lisa Lynn — the promising effects of raspberry ketones, which he referred to as “the No. 1 miracle in a bottle to burn your fat.” Lynn touted the supplement’s ability to “slice [fat] up inside the cell so it burns fat easier.” “And we all want easier,” she added.20

No human clinical trials have been published on raspberry ketones for use in weight loss (at least insofar as a search on the National Library of Medicine’s PubMed database on July 2, 2014), and Dr. Oz, in his online factsheet for the supplement, mentions only a single rodent study that found raspberry ketones reduced abdominal fat in mice when compared to control animals.21


The “Dr. Oz Effect”

The power and influence Dr. Oz has over consumers is undeniable. After he discussed neti pots on his show, retail sales increased exponentially and Internet searches for the term shot up a remarkable 42,000 percent, according to Forbes.22 The impact Dr. Oz can have on product sales is so well established there is even a term for it: the “Dr. Oz effect.” In large part, this influence is why he was called to testify at the June Senate hearing.

“You are being made an example of today because of the power you have in this space,” said Sen. McCaskill.3 “We didn’t call this hearing to beat up on you. We called it to talk about a real crisis in consumer protection.”

The hearing received extensive coverage in the American news media, most of which focused on Dr. Oz and his testimony.23-26 Comedian John Oliver — in a 16-minute segment that aired on HBO’s “Last Week Tonight with John Oliver” on June 22, 2014 — was decidedly blunt in his criticisms of Dr. Oz.27 He referred to Dr. Oz as a “shameless panderer” and compared him to an “Old West traveling salesman” for endorsing products such as “miracle flowers.” (“Name me one case where a man named Oz claimed mystical powers and led people astray,” Oliver joked.27)

Oliver, however, did not place blame squarely on Dr. Oz. “The problem is this Senate hearing is going to achieve nothing for a very chilling reason,” he said.27 He continued with the unfortunately inaccurate theme all-too-often repeated by serious members of the American media: “Dr. Oz is just a symptom of the problem. The disease is the fact that dietary supplements in the US are shockingly unregulated.”


Conclusion

Regardless of whether or not the hearing will bring about any meaningful change, it highlighted the new and ongoing efforts of the FTC and the responsible elements in the natural products industry and partner organizations to reduce the impact of unscrupulous advertisers preying on a growing consumer market.

In his written testimony, CRN’s Mister noted that such irresponsible companies that violate existing federal regulations damage the industry’s reputation as a whole.8 “[T]hat is the reality of the current weight loss market,” he wrote. “[I]t is a tale of two industries — with legitimate manufacturers who responsibly produce products that work and make claims for their products within the bounds of the law, and unscrupulous players who prey on desperation and the insatiable desire to be thin, and will say almost anything to make a quick profit.”8

NPA’s Fabricant, who previously served as the director of FDA’s Division of Dietary Supplement Programs, expressed his organization’s willingness to work with federal officials to help protect consumers from deceptive weight-loss products.7 “[W]e view our role as playing a strong partnership with regulatory officials, since we share their goals and objectives,” NPA’s Fabricant wrote.7 “But we do depend on federal authorities to provide that enforcement action to make all of this a reality.”

—Tyler Smith

References

  1. Press. “The Dr. Oz Show” website. Available here. Accessed June 24, 2014.
  2. All episodes. “The Dr. Oz Show” website. Available here. Accessed June 24, 2014.
  3. June 17, 2014. Protecting consumers from false and deceptive weight-loss advertisements [video]. US Senate Committee on Commerce, Science, & Transportation website. Available here. Accessed June 27, 2014.
  4. Spector M. The operator. The New Yorker. February 4, 2013. Available here. Accessed June 27, 2014.
  5. Written testimony of Dr. Mehmet Oz, MD. “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products.” Senate Committee on Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Insurance. Washington, DC: United States Senate; June 17, 2014. Available here. Accessed June 27, 2014.
  6. Prepared statement of Mary Koelbel Engle. “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products.” Senate Committee on Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Insurance. Washington, DC: United States Senate; June 17, 2014. Available here. Accessed June 17, 2014.
  7. Natural Products Association Testimony to the Senate Commerce Committee. “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products.” Senate Committee On Commerce, Science, And Transportation Subcommittee On Consumer Protection, Product Safety, And Insurance. Washington, DC: United States Senate; June 17, 2014. Available here. Accessed June 17, 2014.
  8. Written testimony of Steve Mister. “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products.” Senate Committee on Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Insurance. Washington, DC: United States Senate; June 17, 2014. Available here. Accessed June 27, 2014.
  9. FTC Charges Green Coffee Bean Sellers with Deceiving Consumers through Fake News Sites and Bogus Weight Loss Claims. Washington, DC: Federal Trade Commission; May 19, 2014. Available here. Accessed June 27, 2014.
  10. Dietary Supplements: An Advertising Guide for Industry. Washington, DC: Federal Trade Commission; April 2001. Available here. Accessed June 25, 2014.
  11. Abcarian R. Dr. Oz doubles down on bogus weight loss products at Senate hearing.Los Angeles Times. June 18, 2014. Available here. Accessed June 24, 2014.
  12. Garcinia cambogia. “The Dr. Oz Show” website. Available here. Accessed June 24, 2014.
  13. Chuah LO, Ho WY, Beh BK, Yeap SK. Updates on Antiobesity Effect of Garcinia Origin (−)-HCA.Evid Based Complement Alternat Med. 2013. doi: 10.1155/2013/751658.
  14. The green coffee bean extract. “The Dr. Oz Show” website. Available here. Accessed June 27, 2014.
  15. Fact sheet: green coffee bean. “The Dr. Oz Show” website. Available here. Accessed June 24, 2014.
  16. Lindsey’s philosophy. Genesis Pure website. Available here. Accessed June 24 2014.
  17. Onakpoya I, Terry R, Ernst E. The Use of Green Coffee Extract as a Weight Loss Supplement: A Systematic Review and Meta-Analysis of Randomised Clinical Trials. Gastroenterology Research and Practice. 2011. doi: 10.1155/2011/382852.
  18. Vinson JA, Burnham BR, Nagendran MV. Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects. Diabetes, Metabolic Syndrome, and Obesity: Targets and Therapy. 2012;5:21–27. doi: 10.2147/DMSO.S27665.
  19. Healy M. Green coffee beans show potential for weight loss. Los Angeles Times; March 27, 2012. Available here. Accessed July 1, 2014.
  20. Raspberry ketone: fat-burner in a bottle. “The Dr. Oz Show” website. Available here. Accessed June 27, 2014.
  21. Raspberry ketone: What science says. “The Dr. Oz Show” website. Available here. Accessed June 27, 2014.
  22. Walton AG. The Oz effect: medicine or marketing?Forbes. June 6, 2011 Available here. Accessed July 1, 2014.
  23. Mutnick A. Senators scold Dr. Oz for weight-loss scams.USA Today. June 18, 2014. Available here. Accessed July 2, 2014.
  24. Deng B. Sen Claire McCaskill dissects Dr. Oz.Slate.June 17, 2014. Available here. Accessed July 2, 2014.
  25. Hamblin J. Senators to Dr. Oz: Stop promising weight-loss miracles.The Atlantic.June 18, 2014. Available here. Accessed July 2, 2014.
  26. Stanek B. Lawmakers caution Dr. Oz on weight-loss tips.Time.June 17, 2014. Available here. Accessed July 2, 2014.
  27. Weber P. John Oliver steps on Dr. Oz to savagely trample the dietary supplements industry. The Week. June 23, 2014. Available here. Accessed July 1, 2013.