Dietary Supplements
 
Help or Hype?
Many people take dietary supplements (vitamins, minerals, herbs, amino acids, fatty acids, enzymes, prohormones, etc.). And, more and more supplements are being added to food and beverage products as well. Grocery store shelves are stocked with everything from protein bars packed with creatine (purported to help bulk you up) to juices spiked with ginkgo biloba (purported to boost your memory).

Students may choose to take supplements for many reasons: to help meet their nutrient needs, achieve their fitness goals, promote optimal physical health, or improve their emotional well-being There is accumulating scientific evidence that many supplements do, in fact, offer these benefits. However, there is also a lot of evidence that many supplements do not. Effective or not, most dietary supplements are safe when taken in the recommended dose (meaning they will not harm you). But, some supplements carry significant health risks of which you might not be aware.

Read on to learn…
  • What you ABSOLUTELY must know before you buy any supplement.
  • Whether or not you need to take a multivitamin and mineral supplement.
  • The truth about fat burners and muscle builders.
  • Whether or not nutrition/sport bars are worth your money.
Regulation of Dietary Supplements
What you absolutely need to know!

Unlike pharmaceutical drugs and food additives, dietary supplements are largely unregulated by the FDA (Food and Drug Administration) for consumer protection. This is largely due to heavy lobbying by the health food store industry, which led to the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. Read on to learn how this act made the following legal…
  • Supplements do not have to prove they work to be sold.
  • Supplements do not have to prove they are safe to be sold.
  • Supplement manufacturers can put “structure-function claims” on their labels, so long as they don’t claim to “prevent” or “treat” a specific disease.
  • Supplements do not have to be manufactured according to any standards.
Supplements do not have to prove they work to be sold.
Before drugs or food additives go on the market, hundreds of research studies must be submitted to the FDA for review of the product’s efficacy. In fact, the average evaluation of a new drug may take 15 years and cost $500 million! With dietary supplements, manufacturers are simply required to notify the FDA (as a courtesy) within 30 days of marketing their product. The FDA does not evaluate the research to make sure that the product does what the manufacturer claims it does. 

Supplements do not have to prove they are safe to be sold.
Before new drugs or food additives go on the market, extensive research proving safety must be conducted by the manufacturer and then submitted to the FDA for evaluation and approval. In other words, the "burden of proof" that a product is safe is placed on the manufacturer. 

With a new dietary supplement, however, manufacturers simply need to submit safety data to the FDA 75 days before marketing it. The data need not be evaluated or approved by the FDA, so the quality of research may be questionable. If the FDA suspects that a product is unsafe and wants to take a product off the market, the FDA has to prove it is unsafe. In other words, the "burden of proof" that a product is unsafe is placed on the FDA. 

Given the huge number of new dietary supplements added to the market each year and the FDA’s limited resources, it is impossible for the FDA to finance and conduct safety studies for all of these products. As a result, many potentially dangerous products are sold over-the-counter to unsuspecting consumers.

Examples:
  • Ephedra or Ma huang, a popular herbal supplement added to many weight loss formulas for its stimulant and appetite-suppressing effects, was linked with 2200 reports of adverse effects and numerous deaths before the FDA was able to officially ban it in 2004.
  • Many herbs can have dangerous interactions with drugs or other supplements. But because their use is usually not supervised by a health professional, consumers are not aware of these interactions. For instance, St. John’s Wort, a popular (and potentially helpful) herbal supplement for mild depression, can interfere with the action of HIV medications and birth control pills.
Supplement manufacturers can put “structure-function claims” on their labels, so long as they don’t claim to “prevent” or “treat” a specific disease.
Structure-function claims can often be misleading. For example, carnitine is added to many weight loss products with the claim: "promotes fat burning." This claim is perfectly legal and somewhat true since it describes the function of carnitine in the human body. Carnitine plays an essential role in transporting fatty acids into the part of the cell responsible for producing energy. This implies that carnitine's function is to “support or promote” fat burning. 

But taking carnitine supplements does not speed up the fat burning process and it does not cause weight loss. The healthy body knows how to synthesize carnitine and already has all the carnitine it can use. 

The manufacturer can make this misleading claim by including a simple disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” In other words, the supplement can't claim to "prevent" or "treat" obesity (a disease)--that would imply that the supplement has drug-like actions. But, it can claim to "support" or "promote" fat burning.

In 1999, due to complaints from the supplement industry and consumers, the FDA relaxed its definition of what constitutes a “disease.” Now manufacturers can make claims about “common conditions associated with the passage of life” such as pregnancy, menopause, adolescence, and aging. This means supplements can claim to improve mild memory loss associated with aging, but can't claim to treat real dementia or Alzheimer’s disease. They can claim to ease the mood swings associated with PMS, but not treat clinical depression. Clearly this is a very fine line! 

Supplements do not have to be manufactured according to any standards.
Regardless of whether or not a supplement actually does what it claims to do, you might not be getting what you think you are. Products may or may not contain the right amount of the active ingredient that was used in research studies showing a positive effect. And, even if the product label states that it has the right amount, it may actually contain much less or none at all! Contaminants that are not listed on the label may also be present.

Several independent labs are testing products' contents and finding that several don’t contain what is stated on the label. One company, ConsumerLab.com , analyzes several brands of supplements for quality and purity and reports its findings on its web site. For instance, in October and November 2000, ConsumerLab.com purchased and tested 21 leading brands of St. John’s Wort and found that 1/3 either did NOT contain the stated amount of the active ingredients or were contaminated with unacceptable levels of cadmium (a toxic heavy metal).

When herbs and other supplements are added to foods and beverages, it’s even less likely that the right amount of the active ingredient is present. For example, to get one herbal dose of Siberian ginseng from Sobe Green Tea, you would have to drink 13-20 bottles. Ginseng is expensive, so many manufacturers may not add a therapeutic dose to their products.

What's a person to do?
Given the limitations described above, it’s hard for consumers to know what (if anything) to take. If you do decide to take supplements, be smart about it.
  • Consult with a qualified health provider to determine if a product is safe and effective for you.
  • Choose a product that is manufactured by a major company that also produces pharmaceutical drugs (and/or sells directly to health professionals). It is more likely that these companies have existing good manufacturing practices (GMPs) in place to ensure top quality products.
  • Visit ConsumerLab.com and select one of the brands that passed its independent lab tests. Alternatively, look for products with a “USP” (United States Pharmacopeia) or “NSF” quality seal.
  • Check out the recommended books and web links on dietary supplements for more advice on what and how much to take.
Vitamins & Minerals
Click on the link above to learn…
  • If taking supplemental vitamins and minerals will boost your energy.
  • From A to Zinc: What does each vitamin and mineral do for your body.
  • Best food sources to get the levels you need.
  • Whether or not you need a multivitamin and mineral supplement.
  • Tips for choosing a quality product.
Muscle Builders
Click on the link above to learn…
  • How much protein and amino acids you really need to build muscle.
  • If creatine is the magic bullet it is claimed to be.
  • Whether or not andro and other pro-hormone supplements offer safe and effective alternatives to anabolic steroids.
  • What are the keys to achieving optimal muscle strength and mass?
  • Is there a genetic limit to how much muscle you can gain?
Fat Burners
Click on the link above to learn…
  • Whether the active ingredients in fat burner products are effective and safe.
  • Are the new “ephedra-free” products really better and safer alternatives?
  • What are the keys to losing body fat and keeping it off for good?
  • Is there a genetic limit to how lean and shredded you can get?
Nutrition/Sport Bars
Click on the link above to learn…
  • Whether nutrition bars are superior to regular whole foods.
  • If there are hidden dangers in some of these bars.
  • How to include nutrition bars in your eating plan.

Sheri Barke, MPH, RD
COC, Student Health & Wellness Center
Rev. 2005