Triarco Industries’ Aminogen® has received an exemption number from Health Canada, allowing the patented enzyme matrix to be legally sold in Canada. Exemption numbers are issued to products that have undergone an initial assessment and have met specific criteria including data supporting safety, quality and efficacy. Health Canada provides exemption numbers so that products with submitted license applications that meet these standards can be sold while awaiting further review and license approval. It is the first step to becoming a licensed product under Canada’s Natural Health Products Regulations.
“Triarco’s commitment to ingredient quality includes giving manufacturers the tools they need to successfully get their products to market,” said Triarco President Rodger Rohde Jr. “And now we are proud to say that includes the Canadian natural products market. “
“This also reflects well on Aminogen in other international markets,” Rohde added. “People are paying attention to which products are approved for sale under the new Canadian regulations.”
Triarco conducted unpublished pre-clinical studies over a decade ago in order to establish basic safety and toxicity guidelines for the enzyme. A clinical study recently published in Food Digestion found Aminogen had no effect on measures of clinical safety, and no adverse events were reported.
Earlier this year, another published clinical study on Aminogen was cited by Health Canada’s Natural Health Products Dictorate as one of only two studies available to support fungal proteolytic enzyme dosing guidelines. That study, published in the Journal of the International Society of Sports Nutrition, found that adding Aminogen to whey tripled the rate of protein absorption, increased free amino acid levels by 100 percent, key amino acid levels by 250 percent, and nitrogen retention by 32 percent.
American manufacturers entering Canada’s $2.75 billion retail supplement market are required to have a product license number or exemption number for each product and to provide that number on their product label. Since implementing a new licensing and approval process in 2004, Health Canada has received some 43,000 product applications. Almost half of these applications have been rejected or withdrawn.
Aminogen is certified kosher, halal, and is self-affirmed GRAS. Currently, Aminogen is found in select protein powders and supplements.