The Dietary Supplement Industry and the FDA

Kylie Flanagan

Legislation

1938: Federal Food, Drug, and Cosmetic Act

1938

The Act requires new drugs to be shown safe before marketing, starting a new system of drug regulation.

1962: Kefauver-Harris Drug Amendments

1962

Drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them.

1972: Over-the-Counter Drug Review

1972

Review is created to enhance the safety, effectiveness, and appropriate labeling of drugs sold without prescriptions

1994: Dietary Supplement Health and Education Act

October 25, 1994

Dietary supplements are now considered a food; they no longer have to meet the rigorous drug safety and efficacy requirements of the FD&C Act

2006: Dietary Supplement and Nonprescription Drug Consumer Protection Act

December 22, 2006

Manufacturers are required to report to the FDA any serious adverse effects linked to their dietary supplement.

2007: FDA implements current good manufacturing practices "final rule"

June 25, 2007

Manufacturers of dietary supplements are required to test the safety and efficacy of their product before it hits the market.

Ephedra

1994: First death linked to ephedra

1994

The FDA receives its first, but certainly not last, report of a death linked to a dietary supplement containing ephedra.

2004: Ephedra is banned

April 12, 2004

After 150 reported deaths and 800 reported serious adverse effects, the FDA finally gathers sufficient evidence to prove that it presented an unreasonable health risk