Regulation of Dietary Supplements

Dietary supplements are food supplements, not drugs, and are strictly regulated by the U.S. Food and Drug Administration (FDA). Furthermore, makers of dietary supplements must derive their products from substances that are considered safe. If a manufacturer wants to market a product containing an ingredient that was not used in commerce prior to the passage of DSHEA, the FDA must be notified in advance and provided with safety data. At any time, the FDA is fully authorized to request manufacturers to recall a product if the agency believes it presents a health risk.

Under DSHEA, makers of dietary supplements are limited as to the type of claims they can make about their products. "Statements of nutritional support," commonly referred to as "structure/function" claims, are restricted to explaining how a particular product or ingredient affects the structure or function of the body. A supplement maker may not claim that a product is intended to "diagnose, treat, cure or prevent a disease." The manufacturer must have proof that the statement is truthful and not misleading and must notify the FDA within 30 days after first using the claim in the marketplace.

DSHEA gives the FDA power to:

• Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary;
  
  
• Seize dietary supplements that pose an "unreasonable or significant risk of illness or injury;"
  
  
• Stop a new dietary ingredient from being marketed if the FDA does not receive enough safety data in advance;
  
  
• Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard;
  
  
• Obtain an injunction against the sale of a dietary supplement for using false or unsubstantiated claims;
  
  
• Require dietary supplements to meet strict manufacturing guidelines (Good Manufacturing Practices), including potency, cleanliness, and stability; and
  
  
• Sue any company making a claim that a product cures or treats a disease.