Archived – Important Labelling Information for Iron-Containing Products

Starting date:

June 10, 2009

Posting date:

June 10, 2009

Type of communication:

Information Update

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Dosage

Audience:

General Public

Identification number:

RA-110003481

• Media enquiries
• Public enquiries

Health Canada is advising Canadians to carefully read the labelling of iron supplement products as there is potential for confusion about dosage. Products currently on the Canadian market display the dose in different ways on the product label and consumers may misinterpret the amount of iron in the product and potentially take an incorrect dose. The potential for harm from consuming too much iron includes adverse effects such as constipation, nausea, vomiting and diarrhea. At very high doses, iron may cause serious harm. Children may be particularly at risk for overdose.

This update comes in light of Health Canada's action to update how information is presented on labels so that consumers can easily compare the iron content of different products and make informed choices with confidence. As of January 1, 2010, all products containing iron on the Canadian market will be required to have consistent labelling information with respect to daily dosage. Until January 1, 2010, it is possible that consumers may find similar products on the market that have different labelling and as such, Health Canada will continue to work with industry to ensure there is consistent labelling of iron products.

In 2004, the Natural Health Products Regulations came into force requiring all natural health products, including those containing iron, to have consistent labelling with respect to dosage information. Prior to the Regulations coming into effect, single ingredient iron products were authorized as drugs and identified the quantity of the source of the iron (iron salt) on the front label e.g., ferrous gluconate 300 mg; this may also apply to other iron salts such as ferrous sulphate or ferrous fumarate. Details about how much elemental iron this quantity of the iron salt provides (for the example above, 37.5 mg of iron) are generally found on the side or back panels of the label. A review of currently marketed products shows that the placement and arrangement of the information on the labels varies.

With all authorized iron supplements currently on the market, the information necessary for the safe and appropriate use of the product is present on one or more panels of the label. Consumers should carefully read the labelling of these products and consult with their health care practitioner if they still have any questions or concerns.

Health Canada would also like to remind Canadians that the maximum daily dosage for elemental iron is 45 mg per day for adults and youths between the ages 14 –18 years and 40 mg per day for children between the ages of 0 – 13, unless a health care practitioner advises otherwise.

Please visit Health Canada's website for more information on Health Canada's Iron Monograph.

Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at 613-957-2991, or call toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this website.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709