April 30, 2009
72 Weight-Loss Products Illegally Spiked With Prescription Drugs
FDA Response “Inadequate,” Public Citizen Says
WASHINGTON, D.C. – 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., Public Citizen writes in a Worst Pills, Best Pills News article released today on WorstPills.org, the organization’s drug safety Web site.
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 Supplement 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.
Thus, the manufacturers of dietary supplements are not required to submit proof that their products are safe and effective, or that the amount of a substance claimed to be in a supplement is actually in the supplement, or that contaminants or active drugs are not present. Moreover, on the rare occasions on which dietary supplements have been subjected to the same rigorous, controlled trials as drugs, the majority of supplements have been found to be ineffective.
Dietary supplement manufacturers sometimes seek to gain a competitive advantage by clandestinely adding prescription drugs to a largely inactive dietary supplement. Unfortunately for the companies, this has the side effect of converting these products from dietary supplements into prescription drugs. To sell prescription drugs without FDA approval is illegal, providing the basis for the FDA’s possible actions.
“Most dietary supplements do not fall under the jurisdiction of the FDA, but this is one case where all of these products are clearly in violation of the laws that govern drugs,” Wolfe said. “The FDA has not exercised its legal authority to seize all of these products and take them off the market, and anything short of that simply is not good enough.”
WorstPills.org includes the full list of 72 implicated weight-loss products, as well as the nine drugs they may contain. These include, in addition to Meridia and Prozac/Serafem, fenproporex (a stimulant drug not approved for marketing in the U.S.); bumetanide (brand name Bumex, a potent diuretic available by prescription only); furosemide (brand name Lasix, a potent diuretic available by prescription only); rimonabant (brand name Zimulti, an appetite suppressant not approved for marketing in the U.S.); cetilistat (an experimental obesity drug not approved for marketing in the U.S.); phenytoin (brand name Dilantin, an anti-seizure medication available by prescription only); and phenolphthalein (a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States).
Some of the affected weight-loss products include Slimtech, 2 Day Diet and Miaozi Slim Capsules. A full list of these products is available on WorstPills.org.
Worst Pills, Best Pills News is a monthly newsletter available in print and electronic formats through Public Citizen’s subscription Web site, www.WorstPills.org. The article about weight-loss products illegally spiked with prescription drugs will be available free for the next seven days. The site has other searchable information about the uses, risks and side effects associated with prescription medications.
WorstPills.org is an unbiased analysis of information compiled from well-regarded medical journals and unpublished data obtained from the FDA, that allows Public Citizen to sound the alarm about potentially dangerous drugs long before they are banned by the federal government, and to recommend safer drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid years before they were pulled from the market.