Bloomberg News reports that is required under the 815 pages of new rules recently issued by U.S. regulators.
Manufacturers of such products nationwide also must establish written procedures and keep production records for at least a year, according to documents posted today on the U.S. Food and Drug Administration's Web site.
Failure to follow the rules could result in products being pulled from the market.
The $22 billion-a-year U.S. supplement industry is exempted by law from requirements drugmakers must meet to show the FDA products are safe before going on the market. Some members of Congress sought more extensive regulation over supplements after Ephedra, a supplement now banned, was linked to hear risks and the deaths of some athletes.
The industry endorsed the new FDA rules.
"Good manufacturing practices are the first line of defense in ensuring product safety and quality," said David Seckman, executive director of the Natural Products Association, a Washington-based trade group. "This regulation is long overdue, and with heightened consumer concerns about food safety, it couldn't come too soon."
The rules are intended to prevent dietary supplements from contamination by substances such as bacteria, natural toxins or lead, and to ensure they have the correct amount of the intended ingredients.
The regulations will go into effect Aug. 24. Small businesses will have as long as three years to be in compliance.
Legislation passed in December requires that makers of supplements and over-the-counter drugs report serious side effects to the FDA after products reach the market. The reporting will take effect by the end of this year.
- Bloomberg News
