The FDA, the Law, and Weight Loss Supplements

A “travesty of a mockery of a sham,” or just government staying out of the way of the multi-billion-dollar weight loss supplement industry? At the expense of your health. Maybe even your life.

Who Regulates Diet Pills?

Data from 2013-14 shows more than half of all American adults (20+ yrs) take a dietary supplement; one-third of that figure take just a vitamin or mineral supplement. The other two-thirds, however, have gone far beyond a gummy multi-vitamin. [1]

With more than two-thirds of all Americans overweight or obese, and half of those trying to lose weight, the U. S. Centers for Disease Control (CDC) say a great number have turned to supplements—or if you prefer, diet pills. The latter term is closer to the facts.

The CDC says more than 15 percent of adults in the United States have taken weight loss capsules, tablets, or similar. And spend billions of dollars every year on those pills and powders. [2]

The industry is a behemoth and the marketing is savvy; manufacturers convincingly claim everything from appetite reduction to thermogenesis on good old TV and streaming devices, in magazines and newspapers, on billboards and the sides of buses, and of course globally via the internet. With promises that are often not backed up—or if they are, the evidence is flimsy—weight loss supplements can contain a cornucopia of ingredients, some as many as seventy-five, and often include caffeine and herbal stimulants.

There are two issues; one a question and the other a concern. First, as the U.S. General Accounting Office declared:

…little is known about whether weight loss supplements are effective, but some supplements have been associated with the potential for physical harm. [3]

And second—and for multitudes, most importantly—who is checking to make sure these supplements are safe?

(Hint: look in the mirror.)

Diet Supplement Horror Stories

In 2000, staff at a weight loss clinic in Europe gave clients an herbal supplement which people took for over a year. Tragically, and reportedly unknown to the staff, the supplement contained a Chinese herb linked to kidney failure and which may also cause cancer. Eighteen people using the diet concoction ended up with cancers of the urinary system. Dozens more, who had used the herb and were being treated for kidney diseases, were offered removal of kidneys and uterus to mitigate the potential for developing the cancer; most agreed. Kidney failure in people using the herb for weight loss across Europe and the U.S. was reported. An advisory went out to physicians. Too late for many. [4]

A nonherbal but still organic compound, 2,4-Dinitrophenol (DNP), promised rapid weight loss. And reportedly delivered on that claim. But it, too, claimed lives: more than 60. DNP has perilous side effects, outlined in a study published in the September 2011 Journal of Medical Toxicology:

[The] classic symptom complex associated with toxicity of phenol-based products such as DNP is a combination of hyperthermia, tachycardia, diaphoresis and tachypnoea, eventually leading to death. Fatalities related to exposure to DNP have been reported since the turn of the twentieth century. To date, there have been 62 published deaths in the medical literature attributed to DNP. [5] (emphasis added)

In layman’s English, those symptoms translate to a dangerously over-heated body, a frighteningly rapid heart rate, extreme and unhealthy sweating, and abnormally accelerated breathing. Any or all of which can become deadly. DNP was banned in the United States in 1938. [5]

But it’s back. And thanks to a convicted con man and former body builder, Dr. Huge—yes, Dr. Huge—based in California, DNP is being sold online and the hucksters behind it even boast that death is at the door while taking the deadly compound—but insist that the fat loss and muscle-build are worth the risk. They admit it’s “the world’s most deadly fat burner” even as they praise and promote DNP. (The YouTube links I had for Dr. Huge’s infomercials have since been removed due to the termination of the account.)

Recently, a global law enforcement task force worked to shut down thousands of websites selling DNP and similar dangerous weight loss supplements. It took the death of a Rhode Island man to bring the wide distribution of the so-called supplement back into the spotlight. [6]

Perhaps the most familiar case of a dietary supplement producing horror stories is the tale of ephedra. Sixteen thousand reports of adverse effects weren’t enough for the U. S. Food and Drug Administration (FDA) to step in. It took the gruesome details of the sudden death of a hopeful 23-year-old looking to pitch for the Baltimore Orioles—his body temperature was 108 degrees when he collapsed during a training drill in Florida—for the FDA to ban ephedrine alkaloids. [7]

And yet they also still pop up from time to time, in various “extracts” and variations. Colloquially known as ephedra, the alkaloids are compounds found in some varieties of an herb used for centuries in traditional Chinese medicine. But in the West—used as a weight loss and sports performance-enhancing supplement—ephedra-based supplements can reasonably be described as similar to amphetamines, with all the same side effects and potential for abuse. Ephedra marked the first time the FDA as an agency banned a so-called dietary supplement. [8] [9]

Dietary Supplement Regulations, or the Lack Thereof

In countless consumer reviews of myriad weight loss supplements, people who have suffered adverse health effects often ask:

  • How are they even allowed to sell this product?
  • Why doesn’t the government do something about it?

The answer is at once simple and mind-boggling: the government acts only after the fact when it comes to supplements.

“Since there is virtually no control over the quality of these products, it is not unusual not to know what is actually in herbal preparations and dietary supplements.” [4]

This from former FDA commissioner David Kessler, the man who was actually at the helm of the FDA when the Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed after months of hearings by federal legislators. And passed is a good word to use, as it effectively describes what some critics—including Kessler in 2000—say the FDA is doing: giving supplement manufacturers a pass.

The law says:

[The] dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed… (and the) FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with [the] FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. [10] (emphasis added)

A presidential commission was established and, after presenting its 122-page report, “strongly recommended” that in the case of dietary supplements containing herbs, there be an FDA expert “review panel” for these ingredients. [11]

Critics of the DSHEA say the law, arguably written to be deliberately vague, followed a campaign by the supplement industry to lobby lawmakers (Senator Orrin Hatch of Utah—home to many supplement companies—was accused of having “midwifed” the legislation through), and ended up being a boon for manufacturers. [12]

“Sell whatever you want, just don’t let us catch you,” internist and teaching physician Peter Lipson says is a better translation of the law. “What’s more frightening than this inexcusable lack of oversight is that many of the products marketed under DSHEA aren’t just vitamins and such, but products that claim to do the same things as real medicines. How do they get away with that?” [13]

Still, others—especially the nutrition industry—see DSHEA as a valuable tool for informing good supplement manufacturing practices without being overly restrictive. They claim it’s only a few unscrupulous companies making trouble for the entire industry:

The dietary supplement industry has been battered by the news media. It is unfortunate that a few bad apples have overshadowed more positive discussions about healthful products that are designed to help people support a healthy lifestyle. Unscrupulous companies selling low-quality products drag down the reputation of the industry and the responsible companies that offer safe, scientifically backed supplements. Wild claims lacking scientific backing ultimately hurt the whole industry and increases consumer skepticism in dietary supplements and functional foods and beverages. Wild claims combined with negative media coverage have made many consumers wary. Unfortunately, because of the few companies that continue to put marketing before research, the industry is coming under growing scrutiny by [the] FDA, FTC and Congress.[14]

But the consumer is the one that matters, not Congress or dietary supplement makers. Bad apples or not, it turns out American consumers want to know what they are taking is safe and that protections are in place. But it appears few consumers understand how the process works.

All About Dietary Supplements

According to the FDA:

The law defines dietary supplements in part as products taken by mouth that contain a “dietary ingredient.” Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet. … Federal law does not require dietary supplements to be proven safe to FDA’s satisfaction before they are marketed. … For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA’s satisfaction that the claim is accurate or truthful before it appears on the product. … In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace. [15] (emphasis added)

The FDA says dietary supplements are neither drugs which must be approved nor conventional foods which must be labeled. A dietary supplement is supposed to add nutritional value, but not replace nutrition. A dietary supplement can contain:

  • Vitamins
  • Minerals
  • Plant-based ingredients like herbs and other botanicals
  • Amino acids
  • Enzymes
  • Whey or soy protein
  • Creatine
  • Weight loss compounds, concentrates, extracts or metabolites
  • And can come in the form of capsules, tablets, liquids, or powders. [15]

And like food, but unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer checks the safety of dietary supplements but the government does not.

But if a manufacturer wants to market its product with a claim of nutritional value—or that it can cure or treat disease—they do have to demonstrate that beforehand and receive FDA approval.

Ironically, it appears the FDA waffles on that rule right out of the gate:

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord. [15]

Confused? You are not alone; countless legions of people are, too: a dietary supplement may not claim to treat disease, but the agency itself uses that as an example in its own definition. Regardless, (and to help clarify) the rule is that dietary supplements cannot say they treat or cure a disease without being approved by the FDA and labeled a drug, or—like most seem to do—hiring a clever copywriter.

Take Their Word for It

If you have used any weight loss product or even a multi-vitamin, you’ve likely come across the fine print which advises the product is “not intended to diagnose, treat, cure or prevent…disease.” [16]

But dietary supplement labels can make health claims, the FDA says, like, “…a dietary supplement addresses a nutrient deficiency, supports better health, or is linked to a particular body function (like immunity or heart health)…” as long as the ubiquitous warning follows. [17] (emphasis added)

But it’s the manufacturer who judges whether what they claim is even true, and that’s the issue for many critics.

As long as supplement makers avoid claims their product will…

  • Diagnose
  • Treat
  • Prevent
  • Cure
  • Mitigate

…they’re safe. And care must be taken to state things like a supplement can “restore” or “correct” a body malfunction if that abnormality suggests some disease is present or imminent. But even that’s confusing.

Semantically speaking, the FDA looks at it this way:

No specific adjectives constitute a disease claim. Therefore, words such as ‘restore,’ ‘support,’ ‘maintain,’ ‘raise,’ ‘lower,’ ‘promote,’ ‘regulate,’ or ‘stimulate’ might create an implied disease claim if, in the context they are used, they imply an effect on disease. Similarly, words like ‘prevent,’ ‘mitigate,’ ‘diagnose,’ ‘cure,’ or ‘treat’ would be disease claims if the context of their use implied an effect on a disease. [18]

Clear as mud.

But It’s What’s Inside that Counts

On the theory that if it walks like a duck and quacks like a duck then it’s probably a duck, we’ll call weight loss supplements by their colloquial name: diet pills. That sounds bad, but worse is the question of what’s in them.

Approximately 50 individual supplemental products and hundreds of combination products are promoted for weight loss. As a result, much confusion exists among health care professionals regarding the efficacy and safety of these products. Results for conjugated linoleic acid were positive in three clinical studies, with few adverse effects. Ephedra has been shown to be effective in promoting weight loss, especially when combined with caffeine, but it has a high adverse effect risk profile. The data regarding ephedra and ephedra combinations are conflicting, and many of the studies were poorly designed. Garcinia [cambogia] and chitosan have not shown much promise for weight loss, but little research has been done. Pyruvate has consistently shown positive weight loss effects. [19]

According to the FDA’s Office of Dietary Supplements (ODS):

Weight-loss dietary supplements contain a wide variety of ingredients. Not surprisingly, the amount of scientific information available on these ingredients varies considerably. In some cases, evidence of their purported benefits consists of limited data from animal and laboratory studies, rather than data from human clinical trials. In other cases, studies supporting a given ingredient’s use are small, of short duration, and/or of poor quality, limiting the strength of the findings. In almost all cases, additional research is needed to fully understand the safety and/or efficacy of a particular ingredient. [20]

(Having written scores and scores of reviews on weight loss supplements, it’s clear that this is not only true, but the rule. I have seen perhaps one or two supplements with data from clinical trials performed with real people.)

The report continues:

Complicating the interpretation of many study results is the fact that most weight-loss dietary supplements contain multiple ingredients, making it difficult to isolate the effects of each ingredient and predict the effects of the combination. Evidence may exist for just one of the ingredients in a finished product, and no evidence may be available for an ingredient when it is combined with other ingredients. Furthermore, dosages and amounts of active components vary widely among weight-loss supplements, and a product’s composition is not always fully described in published studies. Studies might also use different and sometimes inappropriate assessment techniques to measure the effectiveness of a given treatment. All of these factors can make it difficult to compare the results of one study with those of another.” [20] (emphasis added)

In other words, a scientific comparative analysis is complicated at best and impossible at worst.

If you have taken an over-the-counter diet pill you’ve likely taken or encountered these common ingredients: caffeine, hoodia, yohimbine, garcinia cambogia, glucomannan, and bitter orange, among many others. What you may not have come across are the warnings about these plant-based stimulants.

Let’s take glucomannan, for example, a high-fiber supplement ingredient made from the konjac plant, which is alleged to expand in your stomach and keep you feeling full without extra calories. The ODS says that not only does this ingredient have no effect on body weight, it’s really dangerous:

Significant safety concerns reported for tablet forms, which might cause esophageal obstructions… [20]

Glucomannan has been the culprit in reported choking incidents and choking deaths. [21]

Or how about caffeine? Anhydrous (lab-created concentrated) caffeine is often stated plainly on a supplement label, but rarely is it stated when it comes from guarana or kola nut, also really common in diet supplements and natural sources of substantial caffeine. In doses of more than 400 milligrams, caffeine can result in serious and significant cardiac effects.

And how do we know this? Not from regulators looking to make sure it is safe. It’s known because it was reported by people who suffered the side effects, or their physicians, not because of regulation beforehand. [20]

The Bottom Line for Consumers

It’s probably safe to say that the supplement that you’re taking (or thinking about taking) may not be safe. And, the FDA has essentially left it all up to consumers to figure that out.

[The] FDA does not approve dietary supplement products before they are sold to the public. Therefore, it is particularly important for consumers, health professionals, and industry members to report serious health-related reactions or illnesses (also known as adverse events) to [the] FDA, so we can take action to protect the public from unsafe products. [3]

And there you have it. If you have taken a supplement—be it a multivitamin or an expensive weight loss aid packed with ingredients you never heard of—and suffered any side effect or reaction, you are expected to report it. [22]

And the U. S. Department of Health and Human Services (HHS) is talking about an array of side effects it wants to know about: rashes, itching, swelling or wheezing; low blood pressure, fainting, chest pain, shortness of breath, palpitations, or irregular heartbeat; repeated nausea, vomiting, diarrhea, or stomach ache; urinary problems; tiredness; loss of appetite; dark urine; joint and/or muscle pain; signs of stroke like slurred speech or one-sided weakness; unusual bleeding or blood in your urine, stool, or vomit; and any changes in mood, behavior, or cognition. [23]

This is not a full list—so you should report any effects that are concerning, the government says. Otherwise, how will officials know to warn others?

And that’s not acceptable, say critics of the FDA’s policy for dietary supplements.

Dr. Pieter Cohen, assistant professor at Harvard Medical School and an expert on the dietary supplement industry, says the industry has prospered without the constraint to actually prove supplements are safe or effective—or fess up about adverse or potentially dangerous effects:

DSHEA creates perverse incentives for unscrupulous manufacturers to out-compete legitimate companies by adding undeclared, illegal ingredients including prescription medications, banned drugs and even entirely novel chemical compounds. [24]

Until the FDA or Congress decides to properly regulate dietary supplements, consumers are left to fend for themselves.

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