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How do we know that supplements are safe and effective?

30 June 2009 1,604 views No Comment


• Professor of medicine, Emory University School of Medicine, and director of the Emory Clinical Biomarkers Laboratory.
Supplements that claim to help maintain healthy memory, alertness, immune function, protection from infection, healthy joints, youthful vigor, etc., offer many options for consumers to help manage their own health. They also raise questions about effectiveness and possible side effects.
Some history: The Dietary Supplement Health and Education Act, enacted by Congress in 1994, defined “dietary supplement” and allowed manufacturers to make claims about a product’s ability to affect the structure or function of the body or a person’s general well being.
It also put the burden of proof on the Food and Drug Administration to remove unsafe products. This differs from food additives and therapeutic drugs, where the burden of proof is on the manufacturer. This legislation allowed a dramatic increase in the availability of supplements and the claims they make for improved health.
Researchers are providing more data everyday that shows appropriate supplements can enhance individual health and provide a useful complement to usual medical care.  Many advances have been made in understanding how differences in genetics, lifestyle, diet and environmental exposures affect an individual’s health.
New technologies promise more systematic ways to predict individual needs and possible benefits. These methods will make it easier to assess whether certain amino acids, higher doses of vitamins or phytochemical supplements are likely to improve specific aspects of an individual’s health.
Meanwhile, a few straightforward principles can help guide our decision-making about the role of these supplements in managing our health.
• Don’t confuse dietary supplements with medical care. Dietary supplements are not intended to treat disease and cannot replace regular medical checkups and appropriate medical treatments for disease.
• Be wary of supplements that sound like inexpensive “natural” forms of drugs. Even though supplements are not regulated like drugs, they can still have drug-like effects or toxic side effects. Many of the therapeutic drugs in use today were derived from natural products, and natural products do provide “natural” remedies. However, therapeutic drug development focuses on improving effectiveness, removing toxic substances and providing a preparation that can be administered in safe and effective doses. Supplements are not required to go through the same procedures and are not necessarily administered under appropriate medical supervision.
• Always consider the source of a supplement. Reputable manufacturers will make every effort to avoid marketing toxic products simply because of the liability, and this is perhaps the most important assurance of safety.
• Knowledge of personal health habits and exposures, characteristics of skin, gastrointestinal irregularities and intestinal flora, and responses to specific supplements, can provide a better basis to evaluate the use of supplements. Public health recommendations already suggest the benefit of supplements for different groups. For instance, individuals likely to have low vitamin D levels due to dark skin color or little exposure to sunlight are advised to take vitamin D supplements.
Everyone has a personal responsibility for managing his or her health, but we must do so knowledgeably and responsibly. Use of available products to improve health, including supplements, can be an important part of the solution to the national healthcare crisis. This is a relatively new aspect of health management that is still developing and maturing. Consulting with individuals knowledgeable about the effects of supplements, and library and Internet searches can also help avoid undesired or toxic responses.
But even with such caution, and with the FDA’s responsibility to remove unsafe products from the market, we can expect that individuals will differ in responses, that manufacturing errors will occur and that there will be a small risk from even the best and most reliable products. Just as therapeutic drugs are not always effective, supplements with intended outcomes are not always effective. There are risks with some products, but these can be reasonably managed.
For more on science at Emory visit www.whsc.emory.edu/soundscience; for more about medical advances visit www.emoryhealthcare.org/medicaladvances/index.html.

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