The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.
The tainted weight loss products are: Fatloss Slimming, 2 Day Diet, 3x Slimming Power,
Japan Lingzhi, 24 Hours Diet, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim,
Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim
Plus, GMP, Imelda Perfect Slim, Lida DaiDaihua, Miaozi Slim Capsules,
Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal
Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrim,
Superslim,TripleSlim, Zhen de Sho and Venom Hyperdrive 3.0.
FDA analysis found that the undeclared active pharmaceutical
ingredients in some of these products include sibutramine (a controlled
substance), rimonabant (a drug not approved for marketing in the United
States), phenytoin (an anti-seizure medication), and phenolphthalein (a
solution used in chemical experiments and a suspected cancer causing
agent). Some of the amounts of active pharmaceutical ingredients far
exceeded the FDA-recommended levels, putting consumers’ health at risk.
weight loss products, some of which are marketed as "dietary
supplements," are promoted and sold on various Web sites and in some
retail stores. Some of the products claim to be "natural" or to contain
only "herbal" ingredients, but actually contain potentially harmful
ingredients not listed on the product labels or in promotional
advertisements. These products have not been approved by the FDA, are
illegal and may be potentially harmful to unsuspecting consumers.
FDA advises consumers who have used any of these products to stop
taking them and consult their healthcare professional immediately. The
FDA encourages consumers to seek guidance from a healthcare
professional before purchasing weight loss products.
health risks posed by these products can be serious; for example,
sibutramine, which was found in many of the products, can cause high
blood pressure, seizures, tachycardia, palpitations, heart attack or
stroke. This drug can also interact with other medications that
patients may be taking and increase their risk of adverse drug events.
The safety of sibutramine has also not been established in pregnant and
lactating women, or in children younger than 16 years of age.
another ingredient found in these products, was evaluated, but not
approved by the FDA for marketing in the United States. The drug, which
is approved in Europe, has been associated with increased risk of
depression and suicidal thoughts and has been linked to five deaths and
720 adverse reactions in Europe over the last two years.
care professionals and consumers should report serious adverse events
(side effects) or product quality problems to the FDA’s MedWatch
Adverse Event Reporting program either online, by regular mail, fax or
- Online: www.fda.gov/MedWatch/report.htm
Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers
Lane, Rockville, MD 20852-9787
- Fax: (800) FDA-0178
- Phone: (800) FDA-1088