Update: Additional Probiotic Natural Health Products May Pose Serious Health Risks to Canadians with Milk Allergies

Starting date:

April 5, 2011

Posting date:

April 5, 2011

Type of communication:

Advisory

Subcategory:

Allergen - Milk, Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Allergy Information

Audience:

General Public

Identification number:

RA-110004940

• Issue
• What you should do
• Who is affected
• Background
• Affected products
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

Following our previous communications regarding Probiotic Natural Health Products, Health Canada is updating Canadians on two additional probiotic natural health products (listed below) found on the Canadian market that are labelled as vegan or not containing dairy (milk) but that may contain trace amounts of milk from ingredients used in the production process.

People with milk allergies can experience a range of mild to severe symptoms when exposed to even small amounts of milk proteins. Symptoms may include breathing difficulties that, in some cases, can be life threatening. To date, Health Canada has not received any reports of adverse reactions related to the use of Friendly Flora or Healthy Skin with Greens+.

What you should do

• Speak to your healthcare practitioner with any questions or concerns regarding further use of these products.
• Report any adverse reaction potentially related to these products to Health Canada (see below).
• Contact the company (listed below) concerning their product.

Who is affected

Canadians with milk allergies who have purchased or used Friendly Flora or Healthy Skin with Greens+.

Background

Live microorganisms, including probiotics, which are included in some natural health products are grown in nutrient solutions called culture media. The culture media used to produce probiotics include a source of protein, which is frequently but not always derived from milk or soy, which are both priority allergens in Canada.

For products that are formulated as pills or dry powders, the culture media is mostly removed before freeze-drying. However, traces of milk, soy or any other priority allergen included can remain in the product in quantities sufficient to provoke an allergic reaction in highly sensitive individuals.

Affected products

Report health or safety concerns

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

• Facsimile: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

Related AWRs

Media enquiries

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

Public enquiries

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.

What Health Canada is doing

Friendly Flora is distributed by Avena Originals while Healthy Skin with Greens+ is distributed by Genuine Health. The products are being removed from the Canadian market by the companies; Health Canada will continue to work with Avena Originals and Genuine Health to help ensure that their products are appropriately labelled.

Should any new information be identified, Health Canada will continue to provide an update to Canadians.

Images

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