GMPs for Dietary Supplements

Erik Swain

In what might signal the culmination of a long and controversial debate, FDA announced it is developing proposed regulations on good manufacturing practices (GMPs) for dietary supplements.

If proposed and approved, these would be the first significant requirements governing how dietary supplements should be packaged. Some trade associations have devised their own GMPs for members to follow in the absence of governmental regulations.

In an announcement made October 8, 2002, FDA said it has sent a draft notice of proposed rule making to the office of management and budget for its review, but it did not further specify any timetable. At press time, no such notice had been published.

The 1994 Dietary Supplement Health and Education Act gives FDA the authority to establish dietary supplement GMPs, but so far the agency, faced with budget constraints and opposition from some segments of industry, has not done so.

In that same announcement, Tommy G. Thompson, secretary of the health and human services department, which oversees FDA, said he has asked FDA to "recommend the strongest possible mandatory warning label" for products containing ephedra, an amphetamine-like stimulant that can have potentially dangerous effects on the nervous system and heart. It is already illegal to manufacture ephedra products using synthetic ingredients, and to market nonherbal ephedra products as dietary supplements.

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