As we approach the end of the year, New Year’s Resolutions will lead many individuals both into the gym and into nutrition center and online supplement vendors in attempts to lose weight. Although gym membership soar between January and February so does the supplement sales. Supplements are a $22 billion industry. In the United States alone, it is estimated that 73% of adults have used some type of dietary supplement, vitamins and minerals most commonly. An individual hoping to improve some physical aspect of him/herself will find shelf after shelf filled with bottles touting the properties of the products contained within, whether it claims to help one burn fat, add muscle mass, improve hair, skin or nails, increase libido, or prevent the onset of any number of diseases or conditions. However, the majority of individuals shopping for these products are unaware that the market for supplements/ergogenic aids is essentially “buyer beware.” All effects of the products are implied with no success guarantees. Unbiased scientific research does not often support the use of supplements as limited or equivocal confirmations of claims have been found.

The regulation known as DSHEA, or the Dietary Supplement Health and Education Act of 1994, defines a dietary supplement as a product “intended to supplement the diet; (it may contain) vitamins, minerals; herbs or other botanicals; amino acids; or any combination of . . .ingredients.” DSHEA allows the Food and Drug Administration (FDA) to remove dietary supplements from the shelf if they are shown to have adverse or detrimental effects on humans but does not give the FDA any power to regulate or otherwise limit the sale of supplements before their claims are proven. This is critical to understand because it ultimately means that anything can be sold for any price with any purported benefits under these terms, so long as it has not already been banned, regulated or illegalized.

DSHEA requires the manufacturers of supplements to make sure their products are safe and effective before they are distributed for sale. Additionally, manufacturers must identify the composition of the product on the label, as well as the strength and purity of their ingredients. However, few benchmarks exist to allow consumers to compare the potential efficacy from one product to the next, as there is no standardized range of consumption of any of the hundreds of products available. Research conducted on 880 products containing one of ten herbs, including many of the most popular options such as echinacea, St. John’s Wort and ginseng, found not only a wide range of recommended daily dosages, but 37% of the products neither met a benchmark of ingredients nor listed sufficient information on the label informing consumers of the contents. Price per dose appeared to be the best predictor of consistency, with the higher-priced options adhering more closely to the benchmark established by the manufacturers.

Unlike prescription and over-the-counter drugs, which must be registered with the FDA and undergo a rigorous examination of their safety and efficacy before they can be sold, supplement manufacturers do not have to register their supplements with the FDA or get approval to sell them on the open market. Also unlike prescription and over-the-counter (OTC) drugs, supplement manufacturers are not required to inform the FDA of any problems that result from an individual’s use of a product, and it is believed that the FDA receives information regarding less than 1% of all adverse events. This voluntary reporting system effectively limits the FDA’s ability to keep track of potential hazards.

The most egregious example of such dangers of dietary supplements is the ephedra scare leading to the ban in 2004. Consumption of ephedra and ephedrine, purported to aid in short-term weight loss and increased energy, was linked to several strokes, seizures, and deaths, including those of a 23-year-old baseball player and a 16-year-old high school athlete. In response, the FDA forced manufacturers to pull their ephedra-based products from shelves. However, while dozens of studies have attempted to clearly establish the harmful effects of ephedra and ephedrine, researchers have been unable to settle on an appropriate dose, and in 2005 the federal ban was ruled unconstitutional by a federal judge in Utah.

Some products containing ephedra remain on the market despite a 2006 ruling overturning the Utah court’s decision. While the Utah judge felt it was unconstitutional for the FDA to pull a supplement because it could not determine a safe level of consumption, the appeals court felt differently. The back-and-forth nature of the controversy illustrates the need for broader and clearer dissemination of information so consumers can make informed decisions until tighter regulations can be put into place.

The media targeted ephedra because it was linked to identifiable deaths, but other popular supplements may not be as safe as manufacturers would like consumers to believe. Kava, commonly purported to help relieve stress and anxiety, and comfrey, generally used topically to help heal minor skin injuries, have both been linked to adverse effects including liver damage. St. John’s wort, purported to relieve symptoms of depression, has been lately reported to adversely interact with other common prescription drugs such as warfarin. Because herbal substances are marketed as natural, many individuals tend to think of them as essentially harmless and may use them as a first resort, a last resort, or on a whim, without being aware of potential consequences and interactions with current medications or their own body chemistry. A simple introductory class in pharmacology would teach you that biochemistry becomes very complicated and that predicting results of the interactions of multiple mixed drugs is increasingly difficult, but the average consumer does not take classes in pharmacology.

Additionally, the use of supplements in traditional schools of medicine such as the Ayurvedic and Chinese systems have raised questions. Ephedra has been used in Chinese medicine for thousands of years to provide temporary relief from symptoms of asthma, but its uses in the States differs markedly, as do the doses. FDA examination of one Chinese manufacturer found that the company sent the higher-dose products to the United States. A recent study of the presence of heavy metals in herbal supplements prescribed in the Ayurvedic School of Medicine found that 20 percent of the products tested exceeded acceptable levels of daily intake. While Ayurvedic principles incorporate the use of several heavy metals into their tinctures, it is clear that individuals should be schooled in the use of such supplements and inform their physicians of any supplement they are using.

One study published in 2003 found that 273 out of 338 retail sites made at least one health claim promising to treat, prevent, diagnose or cure a specific disease, but more than half of the sites making such a claim did not have the required FDA disclaimer. Retail sites were also less likely than non-retail sites to provide links to the research used to back up their claims. A later study found that while all 32 sites reviewed did list the FDA disclaimer, very few listed potential hazards or interactions with prescription or OTC drugs, and while most listed the active ingredients, most did not include the strength of the active ingredient or a listing of the inactive ingredients. All of these criteria are required by the FDA, leading the researchers of both studies to conclude that not only might consumers be misled by information available to them on websites, but that physicians need to be aware of the amount of information available online and have open discussions with their patients about the use of supplements. More effective regulations on the manufacturing and marketing of supplements is one possible way to control the flow of misinformation on the Internet.

Supplementation is not inherently dangerous. Prescription drugs aren’t either, so long as their mechanisms are clearly understood and they are used within certain limits and for appropriate reasons. Many of the supplements on the shelves are likely safe and possibly effective. However, problems arise when individuals lack all the information necessary to make informed decisions or are led to believe that all supplements are proven safe and effective simply because they are on a shelf in the United States. Allowing manufacturers to make claims that their products are inherently harmless because of their “natural” origins puts individuals in a dangerously ignorant position. Honest information can be difficult to come by, and the FDA is hampered in its ability to protect consumers. Therefore, although creating tighter regulations on the use of supplements might affect the profit sheets of manufacturers, it could reduce the number of adverse health effects that right now must be documented before the safety of a product can be confirmed.