Weight-Loss Products Illegally Spiked with Prescription Drugs

Weight-Loss Products Illegally Spiked with Prescription Drugs

Public Citizen: FDA Response 'Inadequate'

At least 72 weight-loss products have been found by the Food and Drug Administration (FDA) to contain prescription drugs, including four drugs not approved by the FDA for sale in the U.S., according to Public Citizen's WorstPills.org.

This is the third time in the past six months that the FDA has announced alerts about the illegal addition of active prescription drug ingredients to otherwise ineffective weight-loss supplements.
Because the added drugs are active in the body, they can be dangerous as well. For instance, sibutramine (brand name Meridia, an appetite suppressant available by prescription only and a controlled substance) and fluoxetine (brand names Prozac and Serafem, an antidepressant available by prescription only) were among the drugs found in the supplements.

The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking voluntary recalls of the 72 products.

Based on the FDA’s inspections and the companies’ responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions or criminal charges.

“The FDA’s response has been inadequate,” said Sidney M. Wolfe, M.D., director of Public Citizen’s Health Research Group and acting Public Citizen president. “Some of the drugs found in these supplements are dangerous and are putting people at an unacceptable risk of injury. To protect citizens, the agency needs to go further and seize these products.”

The affected weight-loss products are categorized as dietary supplements by the FDA.
Due to the 1994 Dietary Supple*ment Health and Education Act (DSHEA), which clarified that dietary supplements were to be regulated essentially as foods rather than as drugs, dietary supplements are not subject to the better-controlled process for approval and manufacturing as drugs.

FULL STORY: http://www.consumeraffairs.com/news04/2009/04/pubcit_weight.html