The deal with diet pills—Weight loss supplements remain a ‘Wild West’

By Neil Murthy

Meet Whitney—a 42-year-old wife and a mother living on the North Shore.  Her favorite pastimes include performing in musical theater, actively participating in her child’s PTA, volunteering with various local charity organizations and mentoring her 7-year-old daughter’s busy round of school, homework and sports.

She is also on a decades-long quest to lose weight.

Ever since she was in the second grade, Whitney remembers having a problem with excess weight. She was a size ten by high school and her weight soared to her record of 330 pounds when she was pregnant with her daughter. Her weight challenges pushed her to the brink of despair—even to the point of battling with bulimia. For years, she battled her weight and for years, she failed in the process.

Whitney’s story is not unique. According to the Centers for Disease Control and Prevention (CDC), nearly 71 percent of adult Americans hit the scales at either overweight or obese in 2014. With excess weight rising to epidemic proportions, the ever-burgeoning weight loss industry has become a lucrative market. Like so many millions of other Americans, Whitney turned to the weight loss industry to find relief.

“I was constantly yo-yo dieting,” said Whitney. “Jenny Craig, Optifast, Weight Watchers… you name it, I’ve tried it. But they never worked.”

But one thing she firmly avoided was over-the-counter weight loss supplements. For her, the reason why is simple.

“One minute you hear the latest craze, and the next thing you know a supplement is going to kill you,” she said.

Whitney’s instincts are solid.  A study published in October in the New England Journal of Medicine found that approximately 23,000 emergency room visits across the nation per year are attributed to dietary supplements—71 percent of which are specifically linked to weight loss products. And the side effects from weight loss supplements are frightening—thousands come to emergency rooms complaining of chest pain, palpitations, and fast heart rate all triggered by over the counter weight loss supplements. In 2013, 29 people in Hawaii succumbed to severe acute hepatitis and fulminant liver failure after taking a supplement called Oxy-Elite Pro, sparking an investigation by the CDC that eventually led to that product’s recall. One patient died and two patients required liver transplants.

“Some of these supplements don’t even work. These companies just prey on people to latch on to their ideas,” said Whitney.

A quick glance at your local pharmacy or grocery shelves will show the myriad of weight loss products with nothing short of miraculous claims.  Words such as “revolutionary,” and “latest scientific discovery” are prominently emblazoned on the packaging. Manufacturers are peddling concoctions of caffeine, herbs and sometimes, in cases where there have been recalls, even banned pharmaceuticals.

“It’s a bit of a Wild West out there,” said Dr. Kimberly Anne Gudzune, assistant professor of medicine at Johns Hopkins. “People are offered whatever they want without any scientific basis.”

There is little sign that the weight loss supplement industry will slow down. A Consumer Reports survey last year found that nearly 25 percent of 3,000 Americans surveyed had tried a weight loss supplement. And as the industry continues to expand, the Wild West seems to be getting wilder. And most dietary supplements don’t require FDA approval.

Weight Loss Supplements
Dietary supplements line shelves of pharmacies, groceries and many other stores. (Neil Murthy/MEDILL)

The Beginning of the “Wild West”

It all began with a simple question—what exactly are dietary supplements?

Throughout much of the 20th century, the answer to that question has been fraught with contention. Some thought supplements were drugs. Others thought they were foods, and still others thought that they were a separate category in their own right. Throughout the 1960s and 1970s, the Food and Drug Administration (FDA) initially argued that dietary supplements were “drugs” and therefore had to be regulated as such. The administration therefore wanted to regulate the potency and the combination of the ingredients in supplements, just as they would do for other drugs.

In 1976, however, Congress passed the Proxmire Amendment to the Food, Drug and Cosmetic Act of 1938, an amendment named for   Senator William Proxmire (D-Wis.) The amendment struck down the FDA’s plan to regulate daily allowances, combinations or the potency of the ingredients in supplements. Although it was certainly a setback, the FDA regrouped and declared that supplements should fall under the category of “food additives.” That would have allowed the administration to employ stricter oversight over supplements, and declare certain supplements to be unsafe. The FDA came close to achieving a major victory when Congress passed the Nutritional Labeling and Education Act (NLEA) of 1990, which would have allowed the FDA to review and authorize the health claims made by dietary supplements.

However, before the act could be implemented, a large grass roots campaign supported by the supplement industry compelled Congress to pass the Dietary Supplement Act of 1992, placing a one-year moratorium on the provisions of NLEA. During that moratorium, Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, which remains the law of the land to this day.

Spearheaded by Republican Senator Orrin Hatch of Utah and Democratic Senator Tom Harkin of Iowa, DSHEA (pronounced “duh-shay”) declared that dietary supplements were a separate category in its own right, although it fell under the larger umbrella of “food.” As a separate category, dietary supplements did not have to abide by the regulatory requirements of other foods and drugs. Any dietary supplement that was already on the market by 1994 did not need FDA approval before marketing and did not need to be proven safe or efficacious prior to sale. For newly discovered dietary ingredients, manufacturers have to prove the product’s safety to the FDA, but do not have to prove the product’s efficacy. Essentially, the FDA has little to no oversight over any of the health claims being made, so long as the supplement manufacturer does not claim that the product cures a disease.

“The challenge is that, since 1994, companies can make claims—such as ‘increase fat metabolism’ or ‘help maintain a normal weight’—without a shred of human data to support their claims,” said Dr. Pieter Cohen, an assistant professor at Harvard Medical School. “The companies therefore have little incentive to actually test their products.”

DSHEA was a resounding success for the supplement industry. Their lobbying efforts had literally paid off. Ever since 1990, Senators Hatch and Harkin have been the supplement industry’s largest beneficiaries.  According to the Center for Responsive Politics, Hatch reportedly received $422,737 from the industry while Harkin reportedly received $311,543 in campaign contributions from PACs and individuals based on Federal Election Commission data.  In a statement published on Senator Hatch’s website, the senator states that he wants to “work with the supplement industry to ensure that Utah’s economy remains strong and is not targeted by unnecessarily burdensome regulations.”

With no oversight on claims of efficacy and restricted oversight on safety, the supplement industry grew explosively from sales of $17 billion in 2000 to approximately $34 billion in 2015. The Wild West was now here to stay.

The FDA’s “Uphill Battle”

Visit the FDA’s website and you will see that a part of the FDA’s mission is to “protect public health by assuring the safety, efficacy and security of drugs and biological products.”

But ever since the advent of DSHEA, the FDA’s ability to “assure the safety, efficacy, and security” of dietary supplements was mostly sidelined. For one, the FDA’s ability to regulate claims of efficacy was virtually relinquished. Claims of efficacy were relegated to a self-policing supplement industry.

“You do not have to prove to us that your product does what it claims to do,” said Lyndsay Meyers, an FDA spokeswoman. “The manufacturers are supposed to conduct their own research to verify that their claims are accurate, and they don’t have to submit that proof to the agency.”

Furthermore, the FDA’s ability to ensure the safety of supplements can be circumvented. Although DSHEA calls for companies to prove that new dietary ingredients are safe for human consumption, many companies bypass the process.

“Companies sometimes either skip it all together, or they come back and say, ‘no we disagree with your findings,’ and they just go to market anyways,” said Meyers.

At times, even banned pharmaceuticals, such as the appetite suppressant sibutramine (known to increase the risk of heart attacks and strokes) and the laxative phenolphthalein (linked to increased risk of cancer) have made their way into weight loss supplements. According to the FDA’s recall and market withdrawals webpage, four distinct weight loss products in the past year alone were found to have either phenolphthalein or sibutramine. All four of those products have now been recalled.

“Some people who make these supplements are not really up and up in terms of ethics,” said Meyers. “They are made in the basements in people’s homes, or made overseas and shipped in [people’s] purses. They evade our screening process.”

The supplement industry itself has acknowledged that this is a serious problem.  Douglas MacKay is the Senior Vice President of the Council for Responsible Nutrition, a trade association representing more than 150 dietary supplements that lobbies on behalf of the industry in Washington, DC.

“Adding banned substances to supplements is illegal and totally against the law,” said MacKay. “These people should go to jail. Consumer safety is our number one priority.”

The controversy has resulted in several lawsuits. In August, U.S. Attorney Walt Green indicted several Louisiana and Florida residents for including sibutramine in dietary supplements and selling the product as “all-natural.”

Despite the multiple lawsuits, MacKay defended the industry’s practices and stated that many manufacturers have responded to consumer concerns by inviting third parties—such as Underwriters Laboratories and United States Pharmacopeia—to certify product safety.

“We understand that some consumers want extra verification that someone is looking over the shoulder of a dietary supplement,” said MacKay. “There are supplement companies that have video feeds on their manufacturing line, where you can watch them make the products and see how it’s done and what goes into it. Those companies market to a clientele that demands transparency.”

MacKay said that the way to ensure product safety is not increased FDA regulation, and called that idea “ludicrous.”

“You don’t change the law because there are criminals out there,” said MacKay. “Enforcement of the law is the solution.”

But because DSHEA has placed such a high burden of proof on the FDA, enforcement of DSHEA would not prevent dangerous supplements from hitting the market. According to DSHEA, if the FDA has a concern with a certain product, the agency has to scientifically prove in a court of law that the product is unsafe. By the time the FDA compiles its scientific argument, the supplement in question has already hit the market and could theoretically harm countless consumers even before the FDA had a chance to step in.

What the FDA is allowed to do, according to DSHEA, is to conduct post-market surveillance of products. But according to a report from the Office of the Inspector General, only 1 percent of all adverse events from supplements are actually reported to the FDA. Although the FDA encourages the public to report any side effects to the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), a large number of adverse events simply go undetected.

Funding remains another challenge for the FDA. According to Meyers, the team at the FDA that is responsible for overseeing the supplement industry consists of only 24 people and has a budget of less than $5 million annually. It is this team that has the gargantuan task to monitor a supplement industry worth an estimated $34 billion dollars in annual sales.

“The FDA doesn’t have the bandwidth to control all of [the supplement industry]. It does not have the people power to catch all the bad guys,” said Dr. David Katz, president of the American College of Lifestyle Medicine.

“We’re fighting an uphill battle here,” Meyers conceded.

The Skinny on Weight Loss Supplements

Behind all of the packaging, behind the fantastical claims, what exactly are inside weight loss supplements? What are their most common ingredients?

Many of the supplements on the pharmacy shelves contain an amalgamation of a variety of ingredients allowed under the Proxmire Amendment. Most commonly, these supplements consist of green tea, caffeine from coffee beans, and a dried powdered fruit called garcinia cambogia, which multiple studies have shown has little to no anti-obesogenic effect compared to placebo.

“The evidence that these supplements actually work is quite weak,” said Anne Till, a registered dietician from Chapel Hill, NC. “Sometimes supplements haven’t even gone through human studies. Lots of supplements come on the market with claims that are often unsubstantiated.”

Till goes on to describe how a team of researchers from the Weight Control at Diabetes Research Center at Brown University in Providence, Rhode Island developed the National Weight Control Registry which evaluates the diets and habits of individuals who have successfully lost and kept off at least 30 pounds of excess weight for at least one year.

“Weight loss supplements don’t even really appear in this registry,” said Till. “No supplement can produce sustained weight loss.”

Furthermore, it is very difficult to assess how pure these substances are.

“There are no laws that say you have to use high-quality materials,” said Cohen. “Manufacturers can buy very cheap stuff and put it into pills and sell it. The millions of dollars spent by lobbyists ensure that you can do this.”

Given these factors, Dr. Scott Kahan, Director of the National Center for Weight and Wellness in Washington, D.C., warns consumers to not rely too heavily on weight loss supplements.

“[They] say you can lose 40 pounds in a month or 20 pounds in a week,” said Kahan. “That’s nonsense. I would run.”


A Safer Alternative

Three Steps
Data from the World Health Organization. Graphic by Neil Murthy/MEDILL

But where do we run to?

“The answer to sustained weight loss is lifestyle modification with diet with exercise,” said Till. “People are always looking for a quick fix, but there is no quick fix.”

“Most things in life take time and effort and most people want neither,” said Katz. “This is definitely a case of the tortoise and the hare – slow and steady wins the race.”

It’s no surprise that the medical community has touted the benefits of diet and exercise for years.  To address the burgeoning obesity epidemic, the American Board of Obesity Medicine was founded in 2011, and there are now 1,182 certified obesity medicine specialists practicing in the United States. Physicians must undergo extensive training where they learn how to help patients lose weight based on scientific principles. Five of these specialists practice in Chicago.

Dr. Lisa Oldson is an obesity medicine specialist in Evanston who provides scientifically-grounded weight loss strategies to her patients.

“I follow guidelines that are evidence-based,” said Oldson. “I go to their homes, open cabinets and read labels. I take them to grocery stores and help them with their shopping carts. I can get a patient to a much healthier place with the scientific tools we have today.”

One of the patients Oldson counsels is Whitney, who began working with the doctor a year and a half ago. Since starting her sessions with Oldson, Whitney said that she harbors a holistic approach to the process of weight loss—emphasizing the small everyday victories of lifestyle modification, rather than obsessing over the numbers on the weight scale.

“I feel hopeful with Dr. Oldson. She makes me feel accountable. She has completely reshaped my thinking,” she said.

Whitney takes great pride in never having tried a weight loss supplement and admits that she never will.

“For me, supplements feed into disordered thinking,” said Whitney. “I am not in it for the short term. I’m a mom, a wife and I’m active and I want to stay that way. For me, being healthy is a lifestyle.”

Photo at top: Over the counter weight loss supplements line the shelves at pharmacies, grocieries and many other stores. (Neil Murthy/MEDILL)