The modern history of dietary supplements regulation began in 1994 with the passage of the Dietary Supplement Health and Education Act. The timeline below spells out the key legislative and regulatory actions affecting dietary supplements from 1994 to the present.
Prior to DSHEA, supplements were regulated as foods under the Federal Food, Drug and Cosmetic Act of 1938. DSHEA created a separate regulatory category for supplements, established the structure/function claim mechanism and grandfathered in all existing dietary supplements ingredients. Although premarket approval was not required for supplements, the law gave the U.S. Food and Drug Administration broad regulatory powers; however, due to budget constraints and political issues surrounding the industry, many of these powers were not immediately enforced.
2004: Ephedra Ban, Anabolic Steroid Control Act
In April 2004, FDA exercised—for the first time—its power under DSHEA to ban a dietary supplement ingredient. Following the much-publicized death of major-league pitcher Steve Belcher, who had taken ephedra supplements, the agency determined that ephedra and ephedrine alkaloids could cause serious side effects. Its ban was challenged in court, but later upheld.
In fall of the same year, 26 substances were added to the 1990 list of steroids classified as schedule III controlled substances. The law put an end to the vast majority of legal steroidal dietary supplements such as androstenedione, which is known as “andro.”
2007: Adverse Events Reporting, Good Manufacturing Practices
In Dec. 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was passed, requiring that all serious adverse events linked to dietary supplements (as well as over-the-counter medications) be reported to FDA; the law took effect in 2007. Under the law, the manufacturer or distributor whose name appears on the label is required to make the report.
The year 2007 also saw the release of Current Good Manufacturing Processes for dietary supplements manufacturers. CGMPs, required under section 9 of DSHEA, took 13 years for FDA to develop and were generally welcomed by the industry. The GMP requirements affected larger companies first, but the third phase, involving manufacturers with less than 20 employees, went into effect in June 2010.
2010: Dietary Supplement Full Implementation and Enforcement Act
Introduced by Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, the stalwarts of supplements legislation, this bill, if passed, would require full FDA enforcement of current statutes under DSHEA, and set aside funds specifically for this purpose. It would also require the release of the New Dietary Ingredient guidance and double the funding for the Office of Dietary Supplements in order to expand research and consumer information.