FDA regulations for nutritional supplements differ in important ways from those for prescription or over-the-counter drugs. For one thing, pharmaceutical companies have to gather data showing that a new drug is safe and effective in order to get the FDA's approval to market the drug. Makers of dietary supplements don't have to show that sort of proof. Be sure to let your doctor know about any nutritional supplement you plan on taking so you can discuss whether it's right for you and the appropriate dose.
The guidelines also establish ranges (called acceptable macronutrient distribution ranges or AMDR) for fat, carbohydrates and protein, instead of exact percentages of calories or numbers of grams. The report maintains that since all three categories serve as sources of energy, they can, to some extent, substitute for one another in providing calories.
SOURCES: Institute of Medicine Food and Nutrition Board, Dietary Reference Intakes: "Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride." National Academy Press, Washington, D.C., 1999. Journal of Nutrition, October 2005. Position paper of the American Dietetic Association on Food Fortification and Supplementation, Journal of the American Dietetic Association, August 2005. Michael Holick, MD, PhD, professor of medicine, physiology, and biophysics, Boston University Medical Center. Andrew Shoa, PhD, vice president for regulatory affairs, Council for Responsible Nutrition. Alice Lichtenstein, DSc, director and senior scientist, Cardiovascular Nutrition Laboratory, Human Nutrition Research Center on Aging, Tufts University. Dave Grotto, RD, spokesman, American Dietetic Association; author, 101 Foods That Could Save Your Life. Eduardo Baetti, MD, rheumatologist; Kaiser Permanente. Patrick Rea, editorial director, Nutrition Business Journal. Kristine Clark, PhD, RD, director of sports nutrition, Penn State University. Vasilios Frankos, PhD, Division of Dietary Supplement Programs, FDA. Sarubin, A. The Health Professionals Guide to Popular Dietary Supplements, American Dietetic Association, Chicago, IL, 2000. FDA. WebMD Weight Loss Clinic Feature: "Are You Getting Enough Vitamin D?" National Center for Complementary and Alternative Medicine: "Questions and Answers About Homeopathy."
Improving public information about use of dietary supplements involves investments in professional training programs, further studies of population and nutrient needs, expanding the database information, enhancing collaborations between governments and universities, and translating dietary supplement research into useful information for consumers, health professionals, scientists, and policymakers. Future demonstration of efficacy from use of dietary supplements requires high-quality clinical research using rigorously-qualified products and compliance with established guidelines for reporting of clinical trial results (e.g., CONSORT guidelines).
Before you take any supplements for disease prevention, it's important to know whether the potential benefits outweigh the risks. To make that conclusion, you need to look at the results of well-designed studies. A recent randomized trial in men suggested multivitamins have possible benefits for cancer prevention. For many of the other popular supplements, including vitamin D and omega-3 fatty acids, results from randomized controlled trials should be available within the next five years, according to Dr. Manson.
Healthy young people normally make sufficient amounts of conditionally essential molecules in the body, although the levels are not always optimal. With inadequate levels of minerals or vitamins, key enzymes in biochemical pathways may not function optimally. Due to genetic mutations, some enzymes may have increased needs for certain cofactors (vitamins), which can prevent them from functioning optimally. Some enzymes only function normally when supplied with cofactors in greater amounts than normally required. If supplements of essential nutrients prove insufficient for optimal enzyme function, "conditionally essential" nutrients may be added as part of a comprehensive, therapeutic program.
"These products provide a subtle, incremental effect. You can't use a sports supplement for a week and expect to gain pounds of muscle, but if used properly, research shows they can provide a slight, not overwhelming, edge," says Andrew Shoa, PhD, vice president for regulatory affairs for the Council for Responsible Nutrition, a trade association for the dietary supplement industry.
If you suspect that you have had a serious reaction from a dietary supplement, let your health care provider know. He or she may report your experience to the FDA. You may also submit a report to the FDA by calling 800-FDA-1088 or completing a form online. In addition, report your reaction to the dietary supplement company by using the contact information on the product label.