The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined a dietary supplement as a “product taken by mouth that includes a dietary ingredient.”
The dietary ingredient may be a vitamin, mineral, herb or other botanical, an amino acid or substances such as enzymes, organ tissues, glandulars and metabolites.
Dietary supplements are readily available in health food stores, supermarkets and at pharmacies. whether as pills, capsules, tablets, powders, liquids, sprays or creams, dietary supplements can contain a single herb or mineral, a combination of vitamins and herbs or any other mix of dietary ingredients.
Dietary Supplements and the FDA
Dietary ingredients are considered foods rather than drugs, and the Food and Drug Administration has no authority over their manufacture.
Unless a firm adds a new dietary ingredient that has never before been marketed in the United States, no approval is necessary. The individual firm or manufacturer is solely responsible for the safety and quality of its products.
The FDA must monitor the safety of dietary supplements once they are on the market and does investigate if it has reason to believe that illegal or banned substances are used in a particular dietary supplement.
If the FDA finds a product to be unsafe, it can issue a warning and require that the manufacturer or distributor remove the product.
Here are some of the dangers inherent in dietary supplements:
Dietary supplements have been found to contain heavy metals such as lead or poisonous substance such as arsenic. Depending on where they are grown, herbal supplements may also contain heavy metals.
Contaminants can range from fungal toxins and waterborne parasites to deliberate substitution of a less effective or even dangerous product in place of a higher-priced item.
2. Efficacy and Potency
Just because a supplement contains a “natural” product or “extra” vitamins does not mean it is effective.
A supplement may contain less of an ingredient than is stated on the label. Some tests have shown that as many as 75% of some supplements have less of an ingredient than the manufacturer claims.
Even a mineral or vitamin pill can have too much or too little of a particular substance. Many dietary supplements make vague claims or have never been subjected to rigorous testing.
3. Side effects
Side effects are reactions that occur in addition to or instead of the desired action of a medication, herb or supplement. High doses of vitamin C can cause an upset stomach and magnesium can cause diarrhea.
Yohimbe, an African tree bark in some herbal sex pills, can cause heart rhythm problems or high blood pressure. Ephedra, used in diet pills, was banned by the FDA in 2004 after it caused heart problems, seizures and some deaths.
Willow bark, used as a tea for conditions such as arthritis, can irritate the stomach and cause gastrointestinal bleeding.
4. Drug interactions
Herbal preparations in particular can interact with both over-the-counter and prescription medications.
St. John’s wort can make birth control pills less effective. Alfalfa pills, which are high in Vitamin K, can make anticoagulants less effective.
Fish oil can cause bleeding if taken in high doses or with anticoagulants.
An overdose of a dietary supplement can be accidental, deliberate or the result of incorrect formulations or inaccurate labeling.
Selenium is a trace mineral that is essential for good health; a supplement that contained 200 times what was noted on the product label caused illness in over 200 people in 2008, according to ConsumerLab.com.
Foxglove, the original source of the cardiac drug digitalis, can cause heart rhythm disturbances in high doses.
Resources to Help Determine Supplement Safety
How can you determine if a product is safe, free of contaminants and actually does what the label says it will? Most importantly, you need to be an informed consumer.
Read labels and do the research on claims made for any product. Take all supplements according to directions.
- ConsumerLab.com is an independent testing company that buys supplements off the shelf just like any consumer, then subjects them to rigorous quality testing and publishes reports on their findings that are available by subscription.
- “Tips For The Savvy Supplement User: Making Informed Decisions and Evaluating Information” is an FDA publication that includes information on how to evaluate research findings and health information on-line.
- The FDA also publishes “Claims That Can Be Made for Conventional Foods and Dietary Supplements” to help consumers sort through the advertising claims for dietary supplements.
- The Office of Dietary Supplements provides dietary supplement fact sheets that include current data on recommended doses, efficacy and potential side effects for a number of minerals, vitamins and botanical supplements.
Staying informed is the best way to be aware of what dietary supplements are safe for you, and what ones are not. Always do your research before adding a new supplement to your diet.
Our author Brittany A. is a health consultant dedicated to helping other with weight loss. When writing online, she can be found working as a tour guide with her husband’s heli-tour company.
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