Update: Four Probiotic Natural Health Products May Pose Serious Health Risks to Canadians with Milk or Soy Allergies

Advisory
2010-232
December 24, 2010
For immediate release

Note that one additional product has been added to this advisory as of December 24, 2010.

The issue

Consumers with milk or soy allergies are advised that four probiotic natural health products (listed below) are being voluntarily recalled from the market because they are labelled as not containing dairy (milk) and/or soy but may contain trace amounts of milk or soy protein from ingredients used in the production process.

People with allergies to milk or soy can experience a range of mild to severe symptoms when exposed to even small amounts of milk or soy proteins. These symptoms may include breathing difficulties that, in some cases, can be life threatening. It is important to note that no adverse reactions involving these products have been reported to Health Canada.

Who is affected

Canadians with milk or soy allergies who have purchased or used any of the four products listed below.

What Health Canada is doing

Health Canada will monitor the company recalls and work with the companies to ensure these products are appropriately labelled.

Background

Live microorganisms, including probiotics, that are included in 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. Because culture media is removed, it is not considered to be a non-medicinal ingredient and is not required to be listed on product labels. However, traces of milk, soy or any other priority allergen included in culture media that was removed can remain in the product in quantities sufficient to provoke an allergic reaction in highly sensitive individuals.

Products that have been assessed by Health Canada for safety, effectiveness and quality 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. The products being recalled have NPNs, as indicated below.

Products recalled/affected:

The four products are promoted as natural health products that contain live bacteria (probiotics) for therapeutic purposes:

Product	Company	Description	Reason for Recall	Product Photo
Saccharomyces Boulardii (NPN 80013551)	Advanced Orthomolecular Research Inc. (AOR)	Oral capsule	Product claims to not contain soy but has come into contact with soy during manufacturing
Herbasaurs Bifidophilus for Kids (NPN 80015508)	Nature's Sunshine Products of Canada Ltd.	Oral capsule	Product claims to not contain dairy but has come into contact with dairy during manufacturing
Acidophilus Bifidobacterium (NPN 80015336)	Nature's Sunshine Products of Canada Ltd.	Oral capsule	Product claims to be dairy free but has come into contact with dairy during manufacturing
Cultures de Yogourt 2 Milliards (NPN 80013273	Bio-Dis Inc.	Oral capsule	Product claims to be dairy free but has come into contact with dairy during manufacturing

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 problems with consumer 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 and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

Related Health Canada Web content:

• Advisory (December 6, 2010) - "Probiophilus" and "Cultures de Yogourt 5 Milliards" May Pose Serious Health Risks to Canadians with Milk Allergies
• Warning (July 24, 2009) - Milk Allergy Risk Identified in the Natural Health Product: Dophilus Chewable Tablets
  

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