Herbal Supplements Essay, Research Paper
Jeff Reese was a bright, energetic scholar-athlete at the University of Michigan when he died suddenly on December 9, 1997. His death came as a total shock because, as a wrestler, Reese was a fit young man without any known medical conditions. The autopsy said the cause of death was “rhabdomyolysis,” a cellular breakdown of skeletal muscle. His family, friends, doctors, and the NCAA all think Reese’s death was caused by the supplement creatine Reese was taking to improve his wrestling skills.
This unfortunate story highlights a growing problem in America today, namely the use of supplements. The September 22, 1998 New York Times states that supplements can be broadly defined to include herbs, amino acids, botanical extracts, quasi-vitamins as well as real vitamins and minerals. According to the September 8, 1998 Los Angeles Times, the supplements business is becoming big business, grossing $18 million dollars in annual sales. The April 30, 1998 USA Today reports that more than 130 million Americans regularly use supplements. Unfortunately, there are number of problems related to supplements that pose a number of critical dangers to consumers. The majority of these dangers can be linked to one single problem overall, the lack of adequate labeling.
Today we will explore one of the most troubling problems in society today, that being supplement labeling. We will begin by first, exploring the dangers associated with supplement labeling. Second, we will identify why these dangers exist. And finally, we will examine what steps we can take to protect ourselves when taking supplements
Ira Flatow in NPR’s September 25, 1998 edition of Talk of the Nation points out that there are over 20,000 supplements on the market today. Unfortunately, there are a number of dangers associated with these supplements because of their labeling. Those dangers include misleading labels, poor FDA regulation, and the lack proper medical research on supplements.
The first danger associated with supplements labeling is that current labels mislead the public. The August 28, 1998 Regulatory Intelligence Data Agency states that the DSHEA or the Dietary Supplement Health and Education Act of 1994 allows dietary supplements to make claims that a product MAY affect the structure or functioning of the body – but CANNOT make claims that they can treat, diagnose, cure or prevent a disease.
In addition, supplements labels are not always clear about what they may or may not do, thus confusing consumers about the supplements different uses. For example, the February 1998 Scientific American states that manufacturers have interpreted the law very liberally, making package statements like “Clinically Proven to Improve Memory and Concentration.” To the uninformed consumer, this statement implies legitimacy to supplements when that legitimacy really has not been established.
A second danger stems from the lack of adequate FDA regulation regarding supplements. According to the September 1, 1998 FDA Consumer, the DSHEA expanded the types of products that could be marketed as “supplements” beyond essential nutrients to include vitamins, minerals, herbs or other botanicals, amino acids, and any concentrate, metabolite, constituent, extract, or any combination of such ingredients. This means ANYTHING could be considered an essential nutrient and thus be marketed as a supplement.
A third danger centers on the lack of proper research on supplements and their effectiveness. The New York Times of September 17, 1998 reports that unlike drugs, dietary supplements do not have to be proven safe and effective before they are put on the market. Bruce Silverglade, legal affairs director for The Center for Science in the Public Interest , said in the August 7, 1998 Biloxi Sun Herald that Congress and the DSHEA has handcuffed the FDA by “allowing dietary supplement companies to make claims without first proving they’re true.” Dr. Marcia Angell, executive director of the New England Journal of Medicine, states that if supplements were held to the same standards as drugs, the “onus would be on the manufacturers to prove safety and efficacy, and I think most of them would shut down.” Because supplements are not tested, consumers are putting themselves at risk when they use them.
Now that we are more familiar with the dangers that exist, we can now turn our attention to why these dangers will continue to exist in the future. To do this, we will turn our attention to the new FDA supplement law and explore why this new law will not address current labeling problems.
According to the January/February 1998 FDA Consumer, new labeling rules will take place next month. These news labels will contain information about appropriate servings, how supplements should be referred to on a label and when products can use the terms “high potency” and “antioxidants.”
What is alarming about this new law is that it does not address the fundamental problems linked to supplements. The first reason why this new law will be ineffective is because these new labels still will not protect consumers from supplements or warn them of side effects. Prevention’s Guide to Healing Herbs from September 29, 1998 states that manufacturers are prohibited from labeling herb products to specify possible side effects. That’s because the FDA views posting this information as making medicinal claims. What that means to us is that we cannot be really sure what is in a supplement because of incomplete labeling.
A second reason this new law will not work is because the FDA does not check supplement labeling to ensure they contain the correct ingredient contents. The New York Times reminds us that “There are currently no federal regulations that establish scientific criteria for purity, identification, and manufacturing procedures of dietary supplements,” which means “producers can put in just about anything they want, including no active ingredient at all, and there is still no guarantee that what is says on the label is what is in the bottle.”
And that is exactly what supplement producers do. The June 22, 1998 Business Week reports that a Mississippi watchdog group checked 107 products to check their label accuracy. It found that over one-half deviated in ingredient content by 20% or more. Despite this, the new law still will not require the FDA to check products to make sure labels accurately list dosage amounts.
Finally, without any type of proper research on supplements, no amount of rules regulating the supplements will help us the consumer determine if they are safe or not. Manufacturers are not required by the FDA to test their products, so most do not. Prevention’s Guide points out that herb marketers are unwilling to shell out the $200+ million dollars it would take to get a medicinal claim on a herb, one because of the cost, and two, because marketers cannot patent the benefits of a plant. So herbs remain classified as herbs. And we, as the consumer, may not really know what we are taking or in what amounts.
It is clear that there are a lot of danger associated with supplement labeling, and that the new law taking effect next month won’t solve those problems. But there are steps we can take as consumers to protect ourselves from supplements.
First, we need to remember that supplements are indeed drugs. The September 6, 1998 Chicago Tribune states that people simply don’t view the increasingly popular ‘natural supplements’ as drugs because they way the products are described on their labels. But supplements are drugs, and caution should be exercised when taking them.
Second, look at your supplement’s label closely. The May 1, 1998 Medical Education and Research Foundation suggests that you buy products with an U.S.P. label, indicating that the supplement meets dissolution standards created by the US Pharmacopoeia. If the product doesn’t have a U.S.P label, consider purchasing a different one.
Third, keep on the lookout for fraudulent products. These products may have written on their labels questionable statements like “laboratory-tested” and “quality and potency guaranteed.” Or supplements may use pseudomedical jargon like “detoxify,” “purify,” or “energize” to describe a product’s effects, jargon that is really vague and hard to measure. Also be wary of products that claim to be a “secret cure” or use such terms like “breakthrough,” “magical,” “miracle cure,” or “new discovery.” The only discovery you might make is how much you are spending on worthless products.
Fourth, always check with your doctor before taking supplements, especially if you are taking prescription medicine. The September 22, 1998 New York Times states that most people who take over-the-counter dietary supplements never report that fact to their physicians. For example, those who take the medicine Prozac are told not to take St. John’s Wort as a supplement. Combining the two could cause adverse reactions and decrease the effectiveness of the prozac. Also, if you are hospitalized for any reason, make sure your doctor knows of all drugs you are taking, including supplements. By informing your doctor, he or she may be better able to diagnose your problems as well as make sure you don’t take any drugs that might adversely react with the supplements.
Finally, if you continue to take supplements, take them with meals, when everything is passing through the digestive tract at a slower rate and the pill is therefore more likely to dissolve properly. This will help in preventing any unwanted problems, medical or otherwise.
Today we have looked at the problem of supplements labeling, the causes of the problem, and what we can do to protect ourselves from supplements. We found that the FDA is not doing enough to inform or warn consumers about supplements, despite new rules increasing the amount of information on supplement labels. Until the rules change, it’s up to us to make sure we are protecting ourselves from potential dangerous supplements.
So, as you cruise the aisle of your local health food store or WalMart, and are tempted to reach for a bottle of Gingkoba or Ginseng, look before purchasing. Remember Jeff Reese’s death, a death that could have been prevented. Supplements may sound good, but until the FDA tightens up its labeling requirements and consumers know what they are taking, you might be better off avoiding natural supplements altogether.