Safety, Efficacy and Quality of Dietary Supplements

Today, more than 70 percent of Americans trust dietary supplements and use them as a way to complement inadequate diets and maintain a healthy lifestyle. As more consumers experience the many health benefits of dietary supplements, major research institutions are validating the benefits, efficacy and safety record of dietary supplements as compared to other commonly consumed products.

Under DSHEA, the FDA has ample authority to ensure that all dietary supplements sold are of the highest quality and safe for consumers. Should the FDA discover a supplement on the market is unsafe, it has the ability to recall the supplement immediately.

Medical professionals and researchers have confirmed that adding certain supplements to consumers' diets will produce positive effects on health:

• A recent study in the Journal of the American Medical Association reports that diets lacking in certain essential nutrients, such as folic acid, and vitamins B6 and B12, can lead to serious health problems including cardiovascular disease, which is the leading cause of death in the United States.
  
  
• Over the past few decades, several studies have indicated that most Americans do not consume the recommended daily servings of key nutrients from food intake. Using dietary supplements is an easy and effective way to guarantee that these consumers get the recommended quantities of the nutrients they need to ward off preventable diseases and stay healthy.

Under DSHEA, supplement labels may only include truthful and non-misleading claims that describe the role of a nutrient in supporting wellness (for example, calcium builds strong bones; antioxidants protect against cell damage) on labels. Manufacturers must have proof for these claims and notify the FDA. Dietary supplement labels also must list the name and quantity of each active ingredient; identify the product as a dietary supplement; and for herbal supplements, identify the part of the plant from which it is taken.

The FDA guarantees the quality of dietary supplements by enforcing Good Manufacturing Practices (GMPs). Currently, dietary supplement manufacturers must abide by food GMPs, and the FDA is working on finalizing GMPs specifically for supplements that will hold manufacturers to an even higher standard for the potency, cleanliness and stability of their products. The Coalition urges that Good Manufacturing Practices (GMP) be published immediately and recommends that the agency be provided adequate funding to implement GMPs and to enforce the statutory framework of DSHEA.