Archived – Sixty-Eight Weight Loss Products

Starting date:

March 5, 2009

Posting date:

March 5, 2009

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-120001047

• Media enquiries
• Public enquiries

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

U.S. Food and Drug Administration (FDA)

Product name

1. 2 Day Diet
2. 2 Day Diet Slim Advance
3. 2x Powerful Slimming
4. 3 Day Diet
5. 3 Days Fit
6. 3x Slimming Power
7. 5x Imelda Perfect Slimming
8. 7 Day Herbal Slim
9. 7 Days Diet
10. 7 Diet
11. 7 Diet Day/Night Formula
12. 8 Factor Diet
13. Eight Factor Diet
14. 21 Double Slim
15. 24 Hours Diet
16. BioEmagrecim
17. Body Creator
18. Body Shaping
19. Body Slimming
20. Cosmo Slim
21. Extrim Plus
22. Extrim Plus 24 Hour Reburn
23. Fasting Diet
24. Fatloss Slimming
25. GMP
26. Imelda Fat Reducer
27. Imelda Perfect Slim
28. JM Fat Reducer
29. Lida DaiDaihua
30. Meili
31. Meizitang
32. Miaozi MeiMiaoQianZiJiaoNang
33. Miaozi Slim Capsules
34. Natural Model
35. Perfect Slim
36. Perfect Slim 5x
37. Perfect Slim Up
38. Phyto Shape
39. Powerful Slim
40. ProSlim Plus
41. Reduce Weight
42. Royal Slimming Formula
43. Sana Plus
44. Slim 3 in 1
45. Slim 3 in 1 Extra Slim Formula
46. Slim 3 in 1 Extra Slim Waist Formula
47. Slim 3 in 1 M18 Royal Diet
48. Slim 3 in 1 Slim Formula
49. Slim Burn
50. Slim Express 4 in 1
51. Slim Express 360
52. Slim Fast
53. Slim Tech
54. Slim Up
55. Slim Waist Formula
56. Slim Waistline
57. Sliminate
58. Slimming Formula
59. Somotrim
60. Starcaps
61. Super Fat Burner
62. Superslim
63. Super Slimming
64. Trim 2 Plus
65. Triple Slim
66. Venom Hyperdrive 3.0
67. Waist Strength Formula
68. Zhen de Shou

Manufacturer / Place of origin

According to the FDA alert, most of the products appear to have been manufactured in China.

Product description

The 68 products listed above are promoted as "natural" or "herbal" dietary supplements used for weight loss. Health Canada has previously issued Public Advisories for the products Lida DaiDaihua and Miaoza Slimming Capsules, and a Foreign Product Alert for Slim 3 in 1.

Reason for warning

The FDA warned consumers not to buy or use the 68 products listed above after they were found to contain the undeclared pharmaceutical ingredients sibutramine, phenytoin, bumetanide, rimonabant, and/or phenolphthalein, as follows:

• Sibutramine was found in all products except Phyto Shape and Starcaps
• Phenytoin was found in 3x Slimming Power and Extrim Plus
• Bumetanide was found in Starcaps
• Rimonabant was found in Phyto Shape
• Phenolphthalein was found in eight products: 5x Imelda Perfect Slimming, 8 Factor Diet, 24 Hours Diet, Fatloss Slimming, 
  Perfect Slim 5x, Royal Slimming Formula, Superslim, and Zhen de Shou.

Sibutramine is used to treat obesity, while phenytoin is used to treat seizures. Bumetanide is a diuretic (water pill) used to remove excess fluid from the body. All three are prescription drugs and should only be taken under the supervision of a health care practitioner.

Rimonabant, used to treat obesity, is not authorized for sale in Canada.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer. The FDA has initiated product recalls in the U.S. and may take additional enforcement measures if necessary.

Possible side effects

• Side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.
• Side effects associated with phenytoin include problems with speech, vision and coordination, as well as confusion, dizziness, and bone and blood abnormalities.
• Side effects associated with bumetanide include muscle cramps, dizziness, low blood pressure, headache and nausea.
• Side effects associated with rimonabant include an increased risk of depression and suicidal thoughts, anxiety, insomnia, aggressiveness, memory loss, dizziness, nausea and fatigue.
• In addition to an increased risk of cancer, side effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709