Has your worst nightmare become real, or is this the start of sanity for the Dietary Supplement Health and Education Act of 1994 (DSHEA)?

It’s not necessary to comment on this. More importantly…

The FDA has announced a final rule establishing current good manufacturing practice requirements for dietary supplements. In addition, by the end of the year, the industry will have to report all serious adverse events associated with the use of dietary supplements to the FDA.

The final rule aims to ensure that dietary supplements don’t have:

  • Wrong ingredients
  • Too much or too little of a dietary ingredient
  • Improper packaging
  • Improper labeling
  • Contamination

The Washington Post reports, “If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient, or revise its label. In more serious cases, it could seize the product, file a lawsuit, or even seek criminal charges.”

The new rule goes into effect on August 24, 2007, and has a 3-year phase-in period.

To understand why this is important to consumers who depend on DSHEA, go to ConsumerLab.com and read the reviews of supplements. Or, read here, here, here, and here.

6/25/07 21:23 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 www.Vicus.com, a complementary and alternative medicine website.