2 probiotic products may pose health risks to Canadians with milk allergies

2 probiotic products may pose health risks to Canadians with milk allergies

Health Canada is updating Canadians on two additional probiotic natural health products found on the Canadian market that are labeled as vegan or not containing dairy (milk), but that may contain trace amounts of milk from ingredients used in the production process.

The issue:

Following our previous communications regarding Probiotic Natural Health Products (www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_232-eng.php),  Health Canada is updating Canadians on two additional probiotic natural health products (listed below) found on the Canadian market that are labeled 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+".

Who is affected:

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

What consumers 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.

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 labeled.

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

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 Friendly Florabut 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.

Products affected:

1.  "Friendly Flora"
2.  "Healthy Skin with Greens+"
   

Product              Company               Description            Company contact info

"Friendly Flora"  Avena Originals   360 mg Capsules  (in     1-800-207-2239
                                                          60, 120 and 240
                                                          count bottles)

"Healthy Skin      Genuine Health   Powder (156g and        1-877-500-7888
with Greens+"                                  469g containers)

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.

How to report side effects to health products:

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 (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) and send to us using one of these methods:

Fax: 1-866-678-6789
www.healthcanada.gc.ca/medeffect

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