Tuesday, June 1, 2010

Regulatory News: Health Canada Raids BC Health Retailer

Recently, Health Canada has focused its NHP enforcement efforts on border control and at the manufacturer or supplier level. Are we facing a return to the 'bad old days' when health retailers were routinely raided for stocking carnitine? Was this raid motivated by complaints from consumers who experienced adverse effects from the seized products? Or, was this just the result of predatory trolling by government bureaucrats?

Unauthorized Health Products Seized at YVS (Your Vitamin Store) in Burnaby, B.C.

Advisory
2010-84
May 26, 2010
For immediate release

The issue

Unauthorized health products that may pose a serious health risk were seized by Health Canada at YVS (Your Vitamin Store) in Metrotown, Burnaby, British Columbia. The labels indicate the products contain ingredients that legally require the products to be sold by prescription or with specific controls because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner.

Who is affected

Canadians who have purchased DHEA, Free Form Carnitine, Acetyl-L-Carnitine, Hydro Lean, Xtra Lean, Yohimbe Extract, Hemo Rage Black, Lipo 6 Black, Lipo 6 Hers Black or Red Rockets sold at the YVS (Your Vitamin Store) in Metrotown, Burnaby, including over the Internet.

What consumers should do

  • Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
  • Read the labelling of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
  • Report any adverse reaction potentially related to these products to Health Canada (see below).
What Health Canada is Doing

Health Canada is working with the Canada Border Services Agency to help stop the future importation of these unauthorized health products into Canada. Health Canada has been advised that these unauthorized products will no longer be sold from the YVS (Your Vitamin Store) in Metrotown, Burnaby.

Background

These products contain ingredients that can cause serious health problems. Ephedrine and caffeine, when combined together, may cause serious and possibly fatal adverse effects. Canadians suffering from heart conditions, high blood pressure and diabetes are among those particularly at risk. Side-effects associated with L-Carnitine include nausea, vomiting, abdominal

cramps, diarrhea and seizures. Side-effects associated with yohimbine include anxiety and increased urinary frequency, dizziness, stomach problems, headache, sweating, sleeplessness, tremors, palpitations of the heart and severe high blood pressure.

Canadians who have taken products containing these ingredients without the supervision of a health care practitioner or without a prescription may face additional risks. You may be misdiagnosed, the treatment might not be appropriate to treat your illness and you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

Regulations administered by Health Canada require that health products containing certain medicinal ingredients be subject to specific controls and/or be prescribed by a health care practitioner because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner.

Specific drug ingredients may be subject to additional restrictions as outlined in the Food and Drugs Act and the Controlled Drugs and Substances Act. This may include the need for a prescription from a health care practitioner, the application of specific controls to allow for professional direction and supervision in their use, or the application of additional controls on the sale and storage of the product.

Products affected

  1. Hemo Rage Black manufactured by Nutrex, contains Yohimbine HCl.
  2. Lipo 6 Black (UPC label 853237001230) manufactured by Nutrex Research, contains 11-hydroxy-yohimbine, alpha yohimbine, yohimbine HCl (4.5mg).
  3. Lipo 6 Hers Black (UPC Label 853237001261) manufactured by Nutrex Research, contains 11-hydroxy-yohimbine, alpha yohimbine, yohimbine HCl (4.5mg).
  4. Yohimbe Extract (UPC label 833343000167) manufactured by West Pharm, contains Yohimbe (Standardized for 9mg Yohimbine).
  5. Free form Carnitine manufactured by Bio Advanced, contains L-Carnitine.
  6. Acetyl-L-Carnitine manufactured by Bio Advanced, contains Acetyl-L-Carnitine.
  7. DHEA (UPC label 622615103237), manufactured by Bio Advanced, contains Dehydroepiandrosterone.
  8. Red Rockets (UPC label 624340042652) manufactured by Integrity Labs, contains Ephedra (8% Ephedrine) and Kola-nut (standardized 75% caffeine).
  9. Hydro Lean (UPC label 833343000020) manufactured by West Pharm, contains L-Carnitine, MaHuang Extract (Standardized to 8% Ephedrine) and Guarana Extract (standardized 22% caffeine).
  10. Xtra Lean (UPC label 833343000013) manufactured by West Pharm, contains Acetyl L-Carnitine, Deanol, MaHuang (Standardized to 20 mg Ephedrine) and Guarana Extract (standardized 200 mg caffeine).
For more information

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

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