Diet supplement products have become big business in the US. In 2002, nutritional supplement sales were approximately 1.4 billion dollars; in 2004 sources had the yearly figure at 16 billion, and more recent data claims sales have now topped 23 billion annually. Nutritional supplement advocates boast many health benefits of their products, including assistance with weight loss, lowering of cholesterol, decreased blood pressure and many, many others, however these products are not drugs and in addition, have limited regulation by the FDA. What are nutritional supplements? Are their claims substantiated? Are they worth the money?
What is a Dietary Supplement
According to the FDA's website, dietary supplements are foods, not drugs. They are taken orally and contain at least 1 ingredient intended to supplement the diet. They are often manufactured in the form of tablets, capsules, liquids, powders, bars, or softgels. Supplement bars must not be labeled as a conventional food item but must be labeled as a supplement. Nutritional supplements contain at least one, or any combination of vitamins, minerals, botanicals such as herbs, amino acid, enzymes or organ/glandular tissue, or a concentrate or extract. They must be labeled as supplements - not as food or drugs. Any claim that they are a diagnosis, cure, treatment or preventative measure for a specific condition or illness makes them an illegal, unapproved drug. The Federal Trade Commission is responsible for regulating truth in advertising, not the FDA, although the 2 agencies work together.
How are Supplements Regulated?
Manufacturers are responsible for the safety of the dietary supplements they market and for the safety of their manufacturing process. Prior to 1994, dietary supplements were treated and regulated the same way as other foods, however a new law signed that year classified supplements as an entity separate from foods or drugs and created a new process for regulation. Under the current law, manufacturers must be able to provide evidence that any claims they make about their product are not false or misleading. However, there is no process or requirement that a dietary supplement be approved by the FDA prior to being marketed, and the evidence manufacturers are required to have - they are NOT required to present to the FDA. Manufacturers also do not need to register with the FDA, and only need to inform them of their intent to market a new supplement if the supplement contains a 'new' ingredient that is not currently available and accepted in the food supply in other forms. If a 'new' ingredient is present, then the manufacturer must present evidence that the ingredient is "reasonably expected to be safe for use".
The Bottom Line
When supplement-related consumer complaints and public health hazards come to light, and products prove themselves to be dangerous, the FDA will stop their distribution. This is what happened to ephedra products, which were linked to serious side effects and several deaths, and banned by the FDA from sale in 2004. So in terms of the effectiveness of a particular supplement, who do you trust to determine its effectiveness? Be cautious; and check out the FDA website for recommendations on the best ways to evaluate a particular supplement - http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110567.htm.
Dr. Amir Rassoli, a long-practicing internist and emergency room physician, heads the Center for Beautiful Bodies (http://centerforbeautifulbodies.com), a premier cosmetic surgery clinic in Houston, TX.
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