Patent/Regulatory Status

PATENT STATUS:

A provisional patent application “Compositions for prevention and/or treatment of gastrointestinal imbalances in digestive disorders” was filed at the United States Patent and Trademark Office on April 11, 2013. A corresponding PCT application (PCT/CA2014/000344) has been filed on April 11, 2014.

On October 16, 2014 the above mentioned PCT patent application was published under the number WO 2014/165975 along with amended claims.

 

REGULATORY STATUS:

The formulation identified as a “powder for solution” was issued a product license (NPN 80044580) by the Natural Health Products Directorate of Health Canada (HC) on September 6, 2013. The following labeling instructions were approved by HC:

Recommended dose (adults):            Take 1 sachet 1 time per day. Add contents of one sachet (14 grams) to 4-5 oz (120-150 mL) water with stirring and drink immediately. Repeat if necessary or as directed by a health care practitioner.

Recommended duration of use:         For use beyond 12 weeks consult a health care practitioner.

Recommended use or purpose:         Helps to restore and maintain the numbers of beneficial bacteria in the GI tract. Source of dietary fiber to help support and maintain a healthy digestive system. Source of antioxidant for the maintenance of good health.

Risk Information:

Cautions and Warnings:  Consult a health care practitioner prior to use if you are pregnant or breast feeding or if you have a liver disease or develop symptoms of liver trouble.

Contra-Indications:          Do not use if you have an allergy to green tea or dietary fiber.

Known Adverse Reactions:         May cause mild gastrointestinal discomfort (such as gas, bloating, cramps)

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