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SIMPLYTHICK ADVISORY INFORMATION

 

Advisory To Our Customers, Medical Professionals and Medical and Healthcare Facilities In Canada

 SimplyThick is notifying our customers and medical professionals in Canada and the United States to follow the Health Canada’s and FDA’s warning that SimplyThick® brand thickener not be used with or given to premature babies pending the results of our, Canada’s and the FDA’s investigations.

Date: May 20, 2011

SimplyThick is aware of communications from certain neonatal intensive care unit physicians and staff members in the United States questioning a potential relationship between the use of Simply Thick with infants born before 37 weeks and late onset necrotizing enterocolitis. Simply Thick is currently conducting our own investigation into those issues in cooperation with the FDA and were are also cooperating with the Canadian Food Inspection Agency.

For your information, we have attached a copy of the CFIA and FDA advisory warnings.  Click to download: [CFIA advisory]  [FDA Advisory

SimplyThick is notifying our customers and medical professionals in Canada and in the United States to follow the CFIA’s and FDA’s warning that SimplyThick® brand thickener not be used with or given to premature babies pending the results of our, the CFIA’s and the FDA’s investigations.

As you are aware, possible necrotizing enterocolitis is NOT a medical concern in any other population group (such as children, adults, or older adults) and our warning and the CFIA’s and the FDA’s advisory warning is limited to babies who were born before 37 weeks.

Simply Thick is aware of no other toxicity complaints in regard to any other population group (such as children, adults, or older adults) in either Canada or the United States and again the CFIA’s and the FDA’s advisory warnings are limited to babies who were born before 37 weeks.

The President of Simply Thick, John Holahan, is personally spearheading the company’s investigation team and is in close communication with the FDA’s investigation team and the CFIA.

Please also be aware that neither the CFIA nor the FDA have issued a recall notice regarding Simply Thick; these agencies have issued targeted advisory warnings for infants born before 37 weeks.

We hope that this notice does not cause any inconvenience to medical professionals or our customers in Canada but, as you can understand, Simply Thick wants to proceed with all due caution until the investigations are concluded.

SimplyThick will strive to keep you advised as developments occur. If you would like additional information or have any questions in the meantime, please call (800-205-7115) or email (latestInfo@simplythick.com).