Americans spent close to $24 billion on dietary supplements in the in 2007, about $1.7 billion went for weight-loss pills, according to Nutrition Business Journal. The FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. 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 FDA nor get FDA approval before producing or selling dietary supplements. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising. Dietary supplement manufacturers 'release' themselves of any liability by putting this statement on their products: "This product is not intended to diagnose, treat, cure or prevent any disease."
Snake Oil or Potent Drugs?
The FDA's stance is appropriate for vitamins and minerals, but other 'natural' substances (i.e. concentrated plant and herb extracts) can have powerful drug-like effects in our bodies. For example ephedra sinica, a species of ephedral (ma huang), contains the alkaloids ephedrine and pseudoephedrine, which have been found to induce central nervous system stimulation, bronchodilation, and vasoconstriction.
On February 6, 2004 the FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury AFTER it had been on the market for years as a weight-loss supplement.
Companies that sold ephedra-containing substances could have just claimed ignorance of ephedra's potent effect on the cardiovascular system. Though, other supplement companies are just blatantly fraudulent. For example, the Los Angeles Times reported that the FDA has issued a serious warning urging consumers to steer clear of bodybuilding supplements advertised as containing steroid-like substances. That is right, the supplements were laced with illegal, anabolic steroids, known to cause kidney failure, major liver damage, and a positive drug screen for unknowing athletes. Although, they were marketed as legal, natural steroid-like compounds (Mark McGwire had these in his locker in 1997).
“A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all,” said Michael Levy, the director of the F.D.A.’s division of New Drugs and Labeling Compliance. “We don’t think consumers should be using these products.”
Recently, there was an uproar in the fitness blogs after a report in Consumer Reports showed high levels of toxic, heavy metals in some popular protein shakes and meal replacement supplements.
Here are two examples:
EAS Myoplex: 16.9 micrograms of Arsenic per three servings (max <15 micrograms per day).
Muscle Milk: 13.5 micrograms of Lead per three servings (max <10 micrograms per day).
Pipe Dreams and The Supplement Mentality
So many people are looking for a boost or a short-cut to help improve their body fat, strength, and health. Their deep, intense desire to improve their bodies leaves them vulnerable to the outragious claims made by supplement manufacturers and marketers. Why do so many people, even before they get started on a training program and improve their diet, start taking supplements? They want to believe that the supplement will help them, inspite so much of the research showing a slight or no effect. Why do people continue to buy and take these substances? Is it a placebo or Hawthorne effect (change in a behavior because they believe the supplement is helping them)?
I don't recommend taking any supplements unless your physician has found you are deficient in a nutrient (ie iron for anemia). That way you can verify what you need and have follow-up blood tests to measure levels. Taking extra doses or supra-performance supplements (fat burners & muscle builders) are a waste of money and a risk to your health. I don't recommend them to any clients, even if they did actually work or are from a well-known supplement company and endorsed by professional athletes. You can accomplish all of your health and fitness goals with a sound training program, an appropriate diet, motivation, focus, and time management.
Am I just a cynical trainer just blowing these concerns out of proportion? Not at all. I have first -hand seen people have adverse effects to some of these supplements. In fact, just yesterday I had to help a client keep consciousness after an adverse reaction to a fat burner/appetite suppressant she took prior to her workout (that she took without asking me or her doctor). In what brought back memories of working with critically-Ill cardiac patients, I had to help my client to the floor, keep her from hyper-ventilating, and make sure she stayed conscious, as she became diaphoretic, pallor, clammy, and light-headed after doing only two, easy sets of strength training. After, 15 minutes of providing fluids, checking her pulse and blood pressure, she started to feel better. Thirty minutes later she had a blood pressure of 150/100, very high blood pressure. She agreed to throw that supplement away and never take it again. I think I will remain cynical of any unregulated dietary supplement.