Final FDA rule lists good manufacturing practices for dietary supplements

Loren Israelsen, executive director of the United Natural Products Alliance, gave the report thumbs up.

In an article in Functional Foods and Nutraceuticals, he said its negative tone had changed dramatically since the last draft in 2003, when the FDA received about 400 comments from the dietary supplements industry and others.

The final rule requires establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products. It also includes requirements for recordkeeping and handling consumer complaints.

The FDA believes the rule will prevent supplements from containing the wrong type or amount of ingredients, and prevent contamination by bacteria, pesticides, glass, and heavy metals. The good manufacturing practices should also help ensure that products are properly labeled and packaged.

The regulations do not include raw ingredient suppliers.

7/11/07 23:14 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at, a complementary and alternative medicine website.