Fact 1: Dietary Supplement (DS) manufacturers must register their facilities with the FDA; however, they are not required to get FDA approval before producing or selling DS.
What does this mean? The FDA does not require manufacturers to go through the same clinical trials as prescription drugs.
Fact 2: The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
What does this mean? The FDA will only intervene if there are problems after the supplements have been sold.
Fact 3: All manufactures, packers, or distributors whose name appears on the label of the dietary supplement marketed in the United States are required to submit all serious adverse event reports associated with the use of the DS.
What does this mean? If a consumer reports a serious side effect to a DS to the manufacturer, the manufacturer must submit that claim to the FDA.
Fact 4: Manufacturers cannot promote a drug as a treatment, prevention or cure for a specific disease or condition.
What does this mean? It is illegal if the bottle claims that the DS is a treatment, prevention, or cure for any condition. Only a prescription or over-the-counter drug that has gone through clinical trials can legally claim that the product is intended to diagnose, treat, cure, or prevent a disease.
All in all, patients should evaluate information about DS before choosing to use them. Refer to the FDA website on dietary supplements for more tips for users and other regulations.