Exemption numbers are provided 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.
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 Almost 50% of these applications have been rejected or withdrawn.
Rodger Rohde Jr., Triarco President, said: “Triarco’s commitment to ingredient quality includes giving manufacturers the tools they need to successfully get their products to market, and now we are proud to say that includes the Canadian natural products market.
US growth
Speaking with NutraIngredients-USA, Rohde said that the ingredient was going from strength to strength in the US.
Rohde added that online retailing giant BodyBuilding.com recently included the ingredient into a product at a level of 50 mg per gram of protein - the highest levels used in the industry to date.
“It’s a strong product with good science and with good safety data,” he said.
The ingredient is already found in select protein powders and supplements from companies such as Optimum Nutrition, GNC, Herbalife, and Amway, he added.
The ingredient
Aminogen is described as a patented blend of digestive proteases from Aspergillus niger and Aspergillus oryzae. The ingredient is Certified Kosher, Halal, and is self-affirmed GRAS.
Safety data on the ingredient was published at the end of last year in the journal Food Digestion. Authored by Triarco Industries’ director of R&D, Mark Anderson, the paper reports that data from 40 healthy, resistance-trained men randomized to receive two 40-g doses of whey protein per day (Avonlac 180, Glanbia Nutritionals) with or without Aminogen for four weeks.
“The addition of Aminogen to whey protein resulted in no adverse events and did not cause any measurable negative changes in various markers of clinical health,” concluded Dr Anderson.
The ingredient's efficacy was reported in a paper published in the Journal of the International Society of Sports Nutrition (2008, 5:10 doi:10.1186/1550-2783-5-10) which concluded that the patented blend of digestive proteases could triple the rate of protein absorption, increase free amino acid levels by 100%, key amino acid levels by 250%, and nitrogen retention by 32%.
Beyond sports nutrition, Aminogen is now going into a wider field of usage, said Rohde. As the American population ages, opportunities are developing to counter the increase in issues like muscle wasting. The ingredient is being used in medical foods for use in institutions and hospitals.
“It’s taken us 15 to 20 years to be an overnight success,” he said.