Advisory - "Vine Essence" Poses Risks for Children, Pregnant and Breastfeeding Women

OTTAWA, July 19, 2012 /CNW/ -

For chinese version click here: http://files.newswire.ca/1043/Chinese.pdf

The issue:

"Vine Essence" has been recalled after testing by Health Canada identified a quantity of lead that exceeds Departmental acceptable limits and low levels of undeclared acetaminophen. Infants, young children, pregnant women and breastfeeding women are particularly at risk. Short-term exposure to lead may lead to vomiting, diarrhea, convulsions, coma or even death. While the low quantity of acetaminophen found does not represent a risk to health for the general population, it may present a risk to those sensitive to acetaminophen.

"Vine Essence" is an unauthorized natural health product promoted to support the health and well-being of bones, muscles and tendons, and the circulatory, respiratory and nervous systems.

Who is affected:

Canadians using "Vine Essence," especially infants, young children, pregnant women and breastfeeding women.

"Vine Essence" was distributed by the company United Wings Enterprise Inc., in Richmond Hill, Ont. As of July 10, 2012, Health Canada had received no adverse reactions report associated with the use of this product.

What consumers should do:
  • Speak to your healthcare practitioner about any questions or concerns regarding this product.
  • Contact the company, United Wings Enterprise Inc., at 1-877-882-1083 for information on the recall of this product.
  • Report any adverse reaction you suspect may be related to this product to Health Canada (see below).
  • Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality.

What Health Canada is doing:

Health Canada is monitoring the voluntary recall by United Wings Enterprise Inc.

Health Canada would like to remind Canadian retailers that the sale of health products is governed by the Food and Drugs Act and its Regulations, and that selling unauthorized products is against the law. Retailers found selling unapproved products may have them seized by Health Canada or by various law enforcement authorities.

Background:

Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.

Health Canada's acceptable limit for exposure to lead in a finished natural health product is 0.29 micrograms per kilogram of body weight per day. Samples of Vine Essence tested by Health Canada contained 1.76 micrograms per tablet. As such, if consumers were to take the maximum recommended dose indicated on the product label (12 tablets per day), this would represent a daily intake of 21.12 micrograms of lead. This level of lead poses a risk to health for infants, young children, pregnant women and breastfeeding women.

Health Canada identified acetaminophen at a concentration of 2.7 milligrams (mg) per tablet in the Vine Essence pill. At the maximum dose suggested on the package, the daily exposure to acetaminophen from these pills would be 32.4 mg per day, well below Health Canada's recommended maximum daily dose of 4000 mg for adults and children (12 years and older).

While the low quantity of acetaminophen found does not represent a risk to health for the general population, it may present a risk to those hypersensitive to acetaminophen.  Rarely, hypersensitivity reactions to acetaminophen may manifest as rash, itching, wheezing, swelling, difficulty breathing, or severe allergic reaction (anaphylaxis).

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 Health Canada:

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

Related Health Canada Web content:

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

Également disponible en français

 

PDF available at: http://stream1.newswire.ca/media/2012/07/19/20120719_C9438_DOC_EN_16343.pdf

PDF available at: http://stream1.newswire.ca/media/2012/07/19/20120719_C9438_DOC_EN_16345.pdf

SOURCE Health Canada

For further information:

Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709


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