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Are Supplements Regulated?

If you listened to some media outlets, you'd think that the dietary supplement industry was unregulated. But that's not the case.

Legislation governing dietary supplements has been in place since 1994. The Dietary Supplement Health and Education Act (DSHEA) requires companies to follow guidelines and regulates how they promote their products.

The passage of DSHEA increased the enforcement powers of the U.S. Food and Drug Administration (FDA) over dietary supplements by creating new labeling and potency standards. Violations of these standards are crimes. Under DSHEA, FDA has the 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 supplement that makes false or unsubstantiated claims. A supplement maker, for example, may not claim that a product is intended to “diagnose, treat, cure, or prevent a disease.”
  • require dietary supplements to meet strict manufacturing guidelines (Good Manufacturing Practices), including potency, cleanliness, and stability.

Dietary supplements are regulated as foods, not drugs. This means FDA has the power to ensure that these products on the market are both safe and accurately labeled. Before a product can be sold, a manufacturer must first notify FDA of all intended label claims and ensure that they can be substantiated.

Supplement makers must also use safe substances. If a manufacturer wants to market a product containing an ingredient that was not used in commerce prior to the passage of DSHEA, FDA must be notified in advance and provided with safety data. At any time, FDA is fully authorized to require manufacturers to recall a product if the agency believes it presents a health risk.

 

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