FAQs on Dietary Supplements & DSHEA

What is a dietary supplement?

Are dietary supplements regulated by the government?

What are the benefits of dietary supplements?

Are dietary supplements safe?

What does DHSEA stand for?

Why did DSHEA generate such strong Congressional support when it was passed in 1994?

Under DSHEA, which government agencies have the authority to ensure the safety of dietary supplements?

What is a dietary supplement?

According to DSHEA, a dietary supplement is any product that contains one or more dietary ingredients such as a vitamin, mineral, herb or other botanical, amino acid or other ingredient used to supplement the diet. Dietary supplements are not food additives (such as saccharin) or drugs.

Are dietary supplements regulated by the government?

Yes. Dietary supplements are regulated, although not in the way prescription or over-the-counter drugs are, because dietary supplements are foods - not drugs. The FDA has the power to ensure the safety of all dietary supplements on the market while assuring consumers' accessibility to the supplements that they have come to use and trust.

Unfortunately, some journalists have incorrectly reported that the supplement industry is unregulated, which is absolutely false. All supplements, including vitamins, minerals, herbs and specialty products, must conform to federal regulations that control manufacturing, labeling and advertising practices.

What are the benefits of dietary supplements?

There are many compelling reasons to consider dietary supplements as a complement to health care. While a good diet is the foundation for better health, research shows that most adults and children don't eat the way that they should. Supplements are easy to add to the daily diet, and this is often the first step that people take toward greater nutritional awareness and the adoption of other healthy lifestyle choices. Whether taking a multivitamin, herb or specialty product, people can and do live healthier lives by supplementing their diets.

Are dietary supplements safe?

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 and more consumers experience the health benefits of dietary supplements, major research institutions are validating their experience and the efficacy and safety of these products.

These scientific studies serve to substantiate the fact that dietary supplements have an enviable safety record when compared to other commonly consumed products.

DSHEA gives the FDA ample authority to ensure the safety of all dietary supplements sold to consumers and manufacturers' compliance with good manufacturing practices. Additionally, the law empowers the FDA to immediately remove any supplement from the market it deems unsafe. The real question for policymakers today is not whether the FDA has sufficient authority to protect consumers from unsafe practices, but whether the FDA is adequately enforcing the law.

What does DSHEA stand for?

DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994, legislation that regulates dietary supplements. DSHEA was passed overwhelmingly by Congress in October 1994 and was signed into law (PL 103-417) on October 25, 1994.

Why did DSHEA generate such strong Congressional support when it was passed in 1994?

At a time when the FDA was proposing to restrict access to dietary supplements, consumers became alarmed and urged Congressional action to recognize the value of supplements and the role they can play in promoting health and preventing disease. Congress wanted a new system that would guarantee consumer access to safe products and provide consumers with more information about the benefits of health supplements. Pleas from hundreds of thousands of health-conscious Americans prompted Congress to take much-needed action.

Under DSHEA, which government agencies have authority to ensure the safety of dietary supplements?

DSHEA increased the FDA's ability to preserve consumer safety, ensure product labels are informative and truthful, and set higher manufacturing standards. Additionally, the Federal Trade Commission has regulatory authority over claims supplement manufacturers make about their products in advertising, including the Internet. The dietary supplement industry also takes responsible action to implement rigorous standards for self-regulation including regular, independent laboratory testing of products for safety and authenticity.