Dietary Supplement Health and Education Act (DSHEA)
What is the DSHEA?
The Dietary Supplement Health and Education Act of 1994 was enacted to prohibit dietary supplement manufacturers and distributors from making false claims, such as "natural" and "therapeutic," on supplement labels. The law also prohibits the manufacture and sale of adulterated dietary supplements.
Are dietary supplements approved by the FDA?
Dietary supplements, such as herbal remedies and vitamins, are sold by various U.S. merchants. Many people assume that these products have been thoroughly tested and approved by the U.S. Food and Drug Administration (FDA) for safety and effectiveness before they are available for purchase; however, this is not true. The law does not require that dietary supplements undergo rigorous FDA testing and approval.
What does the DSHEA ensure?
The DSHEA aims to make dietary supplements safer by forbidding manufacturers and distributors from producing and selling mislabeled or adulterated products. The DSHEA requires that the manufacturer of the dietary supplement ensures their product meets DSHEA and FDA regulations. The FDA can take action against any dietary supplement that is mislabeled or adulterated only after it hits the market. Manufacturers must alert the FDA of any serious issues (i.e., adverse events associated with their product) that occur.
Under the DSHEA, supplements with established ingredients (those that were sold in the United States before 1994) can be sold with no evidence of safety or effectiveness. Although dietary supplements made after 1994 are also not approved by the FDA, if a manufacturer produces a dietary supplement with a new ingredient, they must disclose it to the FDA. The FDA then reviews the ingredient; it does not approve it.
Dietary supplements vs. prescription and over-the-counter medication
In contrast to dietary supplements, prescription and over-the-counter medication cannot be sold in the U.S. without solid evidence that they are safe and effective, and they must meet the strict specifications made by the FDA. Yet, Americans spend more than 25 billion dollars per year on dietary supplements because many people believe that they are safer than prescription medications and don't produce any side effects. Dietary supplements, such as herbal remedies and vitamins, are not automatically safer than prescription or over-the-counter medications and are not tested by the FDA (insert link to article on Supplements and Safety); individuals should keep this in mind before purchasing or taking any supplements. Talking with a medical professional about dietary supplements before taking them is essential.