Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products
FDA has developed these questions and answers (Q & A’s) to help consumers, health care practitioners, and the general public understand FDA’s actions regarding weight loss products contaminated with various prescription drugs and chemicals. Many of these products are marketed as dietary supplements. Unfortunately, FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety. Enforcement actions and consumer advisories for unapproved products only cover a small fraction of the potentially hazardous weight loss products marketed to consumers on the internet and at some retail establishments.
1. What undeclared drugs and/or chemicals are contained in the weight loss products associated with this action?
FDA laboratory tests have revealed the presence of sibutramine, fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat, and phenolphthalein in weight loss products being sold over-the-counter. The tainted products are listed below in alphabetical order along with the undeclared drug and/or chemical ingredient.
|1. 2 Day Diet - sibutramine|
2. 2 Day Diet Slim Advance - sibutramine
3. 2x Powerful Slimming - sibutramine
4. 3 Day Diet - sibutramine
5. 3 Days Fit - sibutramine
6. 3x Slimming Power – sibutramine, phenytoin
7. 5x Imelda Perfect Slimming - sibutramine
8. 7 Day Herbal Slim - sibutramine
9. 7 Days Diet - sibutramine
10. 7 Diet - sibutramine
11. 7 Diet Day/Night Formula - sibutramine
12. 8 Factor Diet – sibutramine, phenolphthalein
13. Eight Factor Diet - sibutramine
14. 21 Double Slim - sibutramine
15. 24 Hours Diet – sibutramine, phenolphthalein
16. 999 Fitness Essence - sibutramine
17. BioEmagrecim, sample 1 – fenproporex
BioEmagrecim, sample 2 – fluoxetine, furosemide
18. Body Creator – sibutramine
19. Body Shaping - sibutramine
20. Body Slimming - sibutramine
21. Cosmo Slim - sibutramine
22. Extrim Plus – sibutramine, phenytoin
23. Extrim Plus 24 Hour Reburn - sibutramine
24. Fasting Diet - sibutramine
25. Fatloss Slimming – sibutramine, phenolphthalein
26. GMP – sibutramine
27. Herbal Xenicol - cetilistat
28. Imelda Fat Reducer - sibutramine
29. Imelda Perfect Slim – sibutramine, phenolphthalein
30. JM Fat Reducer - sibutramine
31. Lida DaiDaihua - sibutramine
32. Meili - sibutramine
33. Meizitang - sibutramine
34. Miaozi MeiMiaoQianZiJiaoNang - sibutramine
35. Miaozi Slim Capsules - sibutramine
36. Natural Model - sibutramine
37. Perfect Slim - sibutramine
38. Perfect Slim 5x – sibutramine, phenolphthalein
39. Perfect Slim Up – sibutramine
40. Phyto Shape - rimonabant
41. Powerful Slim - sibutramine
42. ProSlim Plus - sibutramine
43. Reduce Weihgt - sibutramine
44. Royal Slimming Formula – sibutramine, phenolphthalein
45. Sana Plus - sibutramine
46. Slim 3 in 1 - sibutramine
47. Slim 3 in 1 Extra Slim Formula - sibutramine
48. Slim 3 in 1 Extra Slim Waist Formula - sibutramine
49. Slim 3 in 1 M18 Royal Diet - sibutramine
50. Slim 3 in 1 Slim Formula - sibutramine
51. Slim Burn - sibutramine
52. Slim Express 4 in 1 - sibutramine
53. Slim Express 360 - sibutramine
54. *Slim Fast - sibutramine
55. Slim Tech - sibutramine
56. Slim Up - sibutramine
57. Slim Waist Formula - sibutramine
58. Slim Waistline – sibutramine
59. Slimbionic- sibutramine
60. Sliminate - sibutramine
61. Slimming Formula - sibutramine
62. Somotrim – sibutramine
63. Starcaps - bumetanide
64. Super Fat Burner - sibutramine
65. Superslim – sibutramine, phenolphthalein
66. Super Slimming - sibutramine
67. Trim 2 Plus - sibutramine
68. Triple Slim - sibutramine
69. Venom Hyperdrive 3.0 - sibutramine
70. Waist Strength Formula – sibutramine
71. Xsvelten - sibutramine
72. Zhen de Shou – sibutramine, phenolphthalein
* This product should not be confused with the line of meal replacement and related products marketed as conventional foods under the brand name “Slim-Fast®”. The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products.
2. What action is FDA taking regarding these tainted weight loss products?
FDA is taking action to help ensure that these products and other products containing undeclared prescription ingredients are removed from the marketplace. FDA has inspected a number of firms associated with the sale of these products and is currently seeking recalls of these products. FDA may take additional enforcement steps to include warning letters, seizure, injunction, or criminal charges.
3. What is bumetanide and what are the associated risks?
Bumetanide is the active pharmaceutical ingredient in Bumex, a prescription diuretic. Bumex carries a Boxed Warning because the drug may lead to serious and significant fluid and electrolyte loss. Another potential risk associated with the use of bumetanide is elevation in uric acid concentrations. Consumers should not take bumetanide if they are allergic to sulfonamides. Significant drug interactions, such as taking bumetanide with digoxin and lithium, may lead to an increased risk of toxicity. Consumers may also be at an increased risk of hypotension (low blood pressure), fainting, and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication. The risk of toxic reactions to the drug may be greater in elderly consumers or consumers with impaired kidney function.
4. What is cetilistat and what are the associated risks?
Cetilistat is an experimental obesity drug and is currently the subject of clinical trials in the U.S., Japan, and Europe. Because cetilistat is in clinical trials, there is no safety or efficacy profile for this drug. Consumers in certain populations, however, could face serious health risks if taking cetilistat. For example, transplant patients taking anti-rejection drugs could suffer organ rejection. Cetilistat is also contraindicated with warfarin and levothyroxine as this could cause increased risk of bleeding and hypothyroidism. The majority of adverse events associated with ingestion of cetilistat are gastrointestinal in nature; e.g., fecal incontinence, rectal discharge, and defecation urgency. Because cetilistat decreases the absorption of fat, this may result in fatty or oily stool which could lead to malabsorption of nutrients and vitamin deficiency. Other adverse events include skin and subcutaneous tissue disorders. Cetilstat may reduce serum concentrations of vitamin E, vitamin D, and beta-carotene. Other safety concerns include the development of gallstones and kidney stones.
5. What is fenproporex and what are the associated risks?
Fenproporex is a stimulant not approved for marketing in the United States. Fenproporex, an amphetamine derivative, is a schedule IV controlled substance and could show up positive for amphetamines in a urinalysis. Serious adverse effects of stimulants include headache, tachycardia, increased breathing rate, increased blood pressure, fever, sweating, diarrhea, constipation, blurred vision, impaired speech, dizziness, uncontrollable movements or shaking, insomnia, numbness, palpitations, arrhythmia and possible sudden death.
6. What is fluoxetine and what are the associated risks?
Fluoxetine is the active pharmaceutical ingredient in Prozac, a prescription antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Prozac carries a Boxed Warning because it and other antidepressants increase the risk of suicidal thinking and suicide in children, adolescents, and young adults. Additional potential risks from exposure to this drug include rashes, hives, and the potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome, which is characterized by changes in mental status, pulse, blood pressure, body temperature, and muscle control. Fluoxetine is also associated with nausea, diarrhea, headache, insomnia and anxiety.
7. What is furosemide and what are the associated risks?
Furosemide is the active pharmaceutical ingredient in Lasix, a potent diuretic which is available only through prescription for use in the treatment of congestive heart failure, high blood pressure, and edema. It can cause profound dehydration and electrolyte imbalance, with loss of potassium, calcium, sodium, and magnesium. Patients allergic to sulfonamides may also be allergic to furosemide. Serious adverse effects from overdose may lead to dehydration, seizures, GI problems, kidney damage, lethargy, collapse, and coma.
8. What is phenolphthalein and what are the associated risks?
Phenolphthalein was an ingredient in some Over-the-Counter laxative products until 1999 when the FDA reclassified the drug as “not generally recognized as safe and effective” after studies indicated that phenolphthalein presented a potential carcinogenic risk. Phenolphthalein has also been found to be genotoxic in that it can damage or cause mutations to DNA.
9. What is phenytoin and what are the associated risks?
Phenytoin is the active pharmaceutical ingredient in Dilantin, an approved anti-seizure medication. Because there were trace amounts of this drug in some of these products, the risk was not assessed. However, these products could pose a risk to consumers who are allergic or hypersensitive to phenytoin.
10. What is rimonabant and what are the associated risks?
Rimonabant is the active pharmaceutical ingredient in Zimulti which has not been approved in the United States. In Europe the drug is known as Acomplia.
In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects—seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. In June of 2008, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom linked rimonabant to 5 deaths and 720 adverse reactions over the past two years. In October, the European Medicines Agency recommended that marketing and sales of Accomplia be suspended due to safety concerns.
11. What is sibutramine and what are the associated risks?
Sibutramine is a Schedule IV controlled substance and the active pharmaceutical ingredient in Meridia, an approved prescription drug to treat obesity.
Some of the identified products recommend taking more than 3 times the recommended daily dosage of sibutramine. Because of this, even consumers without a history of health problems that take these high doses of sibutramine may suffer serious adverse effects if they take these products, such as increased blood pressure, tachycardia, palpitations, and seizure.
Populations who would be at increased risk of serious adverse health effects from consuming a standard dose of sibutramine include:
- Patients with a history of hypertension, especially those with uncontrolled or poorly controlled hypertension.
- Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
- Patients with narrow angle glaucoma.
- Patients with a history of seizure.
- Patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function.
- Patients with severe hepatic dysfunction.
- Patients concurrently taking the following medications:
- MAO inhibitors
12. Who are the manufacturers of these products?
Many of these products do not list the manufacturer on the label or in the advertisements. However, most of the products appear to have been manufactured in China. We believe that BioEmagrecim is being imported from Brazil and Phyto Shape is manufactured in Malaysia. Star Caps was encapsulated in the U.S. but the raw product was allegedly imported from Peru.
13. Does FDA regulate these products?
Although some of the identified products are marketed as “dietary supplements,” all of these products should have been submitted to the FDA for approval as a new drug prior to marketing because products which contain an FDA approved drug such as sibutramine or an ingredient that does not supplement the diet, are not dietary supplements.
Regulatory requirements for dietary supplements differ from those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that its products are safe before they are marketed. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.
14. Will there be recalls?
It is anticipated that several of these products will be recalled. Recalls, Market Withdrawals, & Safety Alerts
15. Are there more contaminated products like these on the market?
More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace. Many are labeled as dietary supplements or supplements. FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market. However, unfortunately, it is not possible for FDA to test and identify all tainted products.
16. What can consumers do to help protect themselves from harm?
Consult with your health care professional before taking dietary supplements to treat obesity or other diseases. All consumers should be familiar with the following signs of health fraud:
- Promises of an "easy" fix for problems like excess weight, hair loss, or impotency.
- Claims such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy."
- Impressive-sounding terms, such as "hunger stimulation point" and "thermogenesis" for a weight loss product.
- Claims that the product is safe because it is "natural."
- Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
- Promises of no-risk, money-back guarantees.
For more information, please see FDA News Release (12/22/2008).