BY: TED BARNABY
If you live in the U.S., you’ve probably felt the pressure of a system where money is more than just a means to an end—it’s also the currency of many moral, political and even legal issues.
So it’s no surprise that, for decades, the dietary supplement industry has been releasing “health” and “weight loss” products that—despite the encouraging packages—do literally nothing at all to supplement your diet, or help you lose weight.
Occasionally, taking these supplements has even resulted in widespread adverse events, including death, as was the case with Ephedra, a weight-loss supplement claiming hundreds of lives including Major League Baseball pitcher, Steve Bechler.
In fact, a Canadian research team DNA-tested 44 bottles of popular supplements from 12 different companies to discover that one in three supplements did not even contain the plant advertised on the label, but instead, were filled with a number of unlisted ingredients.
Think about that for a moment. It’s like coming home from the grocery store with a one in three chance that your bread will be made out of Play-Doh, with the occasional chance of your “100% orange juice” being horse urine (or with the luck of Steve Bechler, hydrogen cyanide). Needless to say, you would probably take up vegetable gardening.
Perhaps you’ve heard of the Food and Drug Administration (FDA), a regulatory body, which was put in place to prevent fraudulent, misleading or harmful food and drug products from reaching the market. You can review their policies here.
However, the FDA somehow intends to do this under an umbrella of curiously apathetic guidelines that serve as the political equivalent of putting your fingers in your ears, shutting your eyes and yelling “La la la la la I can’t hear you!”
According to the FDA, “Although dietary supplement manufacturers must register their facilities with FDA, they are not required to get FDA approval before producing or selling dietary supplements.”
Hold on now, there has to be SOME guidelines to labeling?
Again: sort of.
If (and only if) you wish to make a structure/function claim, you cannot claim that your product cures diseases or otherwise acts as a drug, as stipulated by question 44 of the Dietary Supplement Labeling Guide: Chapter VI. Claims:
However you may notice that their regulation policies are about as meticulous as their spell checking for the question proposing, “What types of structure/functure claims may be made under section 403(r)(6) of the act?”
More troubling than their spelling, however, is the shocking leniency of this clause. Let’s use the example of a fake product I just created right now, Miracle Power 9000 (containing only a half milligram of lonicera flower, iron, calcium and vitamin c), to demonstrate how you could legally market a worthless product:
“Miracle Power 9000 contains iron, calcium and vitamin C. These essential nutrients will prevent you from a number of crippling diseases like anemia, rickets, osteomalacia and scurvy—which affect thousands of Americans each year. Miracle Power 9000 also contains Lonicera Flower, an antibiotic, which remedies colds, flu, and sore throat. Miracle Power 9000 contains the ingredients which are essential to healthy bodily functioning, and that promote a general sense of wellbeing.”
Notice how nothing in my example actually states the benefits of Miracle Power 9000, but rather talks about the impact of the ingredients—even though there is not enough of each ingredient to actually provide any benefits.
Also, keep in mind that the FDA only needs to be notified if the label intends on making a structure/function claim, and this notification still only needs to be sent in up to 30 days after the product has already gone to market.
Furthermore, the FDA still lacks the authority to actually investigate the accuracy or relevancy of these claims, instead their duty is merely “to determine if the claims appear to be disease claims…” according to Constance J. Hardy, R.D., M.S., from the FDA’s Office of Nutrition, Labeling and Dietary Supplements.
According to Hardy, “Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to the FDA.”
This basically means: The companies that manufacture and distribute these products must have evidence supporting their claims; they just don’t have to show anybody.
This relates back to the clause, “Manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading… these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.”
Meaning: The people who make and sell these products are responsible for regulating themselves.
But how does this make sense?
Quite simply, it doesn’t; it’s equivalent to an imagined world where we don’t have police, but rather the government expected citizens to arrest themselves when they break the law.
Not quite: A BRIEF HISTORY OF LOBBYING
It all started when Senators Orrin Hatch and Tom Harkin co-sponsored the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act eliminated the FDA’s power to ban “unapproved food additives”, instead allowing companies to send products to market without FDA testing and approval.
But doesn’t it make sense to test the safety and/or effectiveness of a supplement before going to market? Why were Harkin and Hatch so passionate about banning these regulations against the supplement industry?
Perhaps it had something to do with the fact that, in 1994 Hatch and Harkin were the two top recipients of funds from the supplement industry.
In 2010 we saw a similar pattern when Harkin submitted a bill (on behalf of himself and Hatch) ensuring that the DSHEA remained enforced and supported. Guess who the top recipients of funding from the supplement industry were again in 2010? That’s right, our boys Harkin and Hatch.
Looking to revise this, the following year Senator Dick Durbin filed an amendment called the Dietary Supplement Labeling Act, requesting that supplements carry warning labels against potentially dangerous side effects, and to “require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration [FDA].”
To no surprise, in 2012 Hatch and Harkin came forth again to prevent Durbin’s bill from getting passed (and succeeded). You can watch Hatch in action here, and Harkin’s little speech here. Not surprisingly, Harkin and Hatch were once again the top two recipients of funding from the supplement industry in 2012.
Thanks to Hatch and Harkin’s DSHEA, how are products now regulated?
According to the FDA, “After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.”
This means that the FDA evaluates a product only after it has already gone to market, and often only after the product is reported to push false or extremely misleading information, or in some cases even causes illness and/or death as we saw with the dietary supplement, Ephedra, which reportedly caused 155 deaths and 16,000 cases of adverse events.
These adverse events—despite stemming from their own policy—are outlined in an FDA video stating, “The FDA has found more than a hundred weight-loss dietary supplements that contain hidden drug ingredients. One example, the ingredient Sibutramine, which was pulled from the prescription drug market for increased risk of heart attack and stroke, has been found in weight loss products.”
The once popular product, HCG Fusion, a dietary supplement intended for quick weight loss, demonstrated one of the major problems with this system. In 2011, the FDA declared HCG products to be fraudulent and illegal, prohibiting over-the-counter and “homeopathic” distribution. However, nearly four years later, you can still buy the product online and in certain retail stores.
Hardy breaks down the iron-fisted ramifications of the FDA’s “adverse event monitoring.”
“If a firm continues to market products with unacceptable claims, then the agency may consider on a case-by-case basis, what other avenues to pursue. For example, an inspection of the firm could be conducted. Based upon the findings of that inspection, there could be a meeting with the firm. If the firm continues to sell violative products, then other courses of action could be considered, i.e., injunction, seizure, etc.”
In other words: the FDA will intervene in cases of unacceptable marketing claims…maybe…you know, if they feel like it…perhaps.
So how is all of this legal?
Like I said, money does more than afford you a home, car, or groceries in the U.S—in the land where everything is for sale, even laws come with a price tag. And when it comes to dietary supplements—an industry of false advertising and snake oil sales tactics—the price is right.
According to the New York Times, Americans spend “an estimated $5 billion a year on unproven herbal supplements”. I repeat, $5 billion dollars. We all buy useless stuff from time to time, but this is the equivalent of spending $5 billion annually on what might as well be jars of capsuled belly-button lint.
Are we naive for believing that a product will actually do what it says it’s going to do, or at the very least, contain the ingredients that it says it contains? On the other hand, have we become so desensitized by corruption that it begins to sound like conspiracy theory, and we brush it off with the same tired apathy you would extend to a city street canvasser handing out information pamphlets?
Asking ourselves this question brings an immediate answer to mind: we do it without supplements. If a product sounds too good to be true, it probably is. There is no magical weight-loss cure, or super-vitamin, or miracle health pill—and if you start to feel persuaded by that 2:00am infomercial, turn it the fuck off and go to bed. Plan a healthy diet, and make room for exercise.
But much larger than the issue of effective weight-loss, phony marketing campaigns or even illegally labeled food products is both the question of where the problem begins (what system permits these cases of pervasive corruption) as well as the more difficult question of when, and how, it will end.
The solution begins with understanding the purpose of marketing, and more importantly, understanding ourselves; we all want something for nothing… including the marketers.