November 2014

Source Nutraceutical, Inc. E-Newsletter

Welcome to our E-Newsletter, your “one-stop” for the information you need to ensure success in the Canadian market. Learn about current issues and how they may affect your business, what’s new at Source Nutraceutical, Inc., how we can help you and where you can find us.

New Options for Selling Foods in Canada

The continuing trend towards healthier lifestyles and increasing longevity means greater demand for health and wellness products including healthier foods. Lower salt, fat and calorie consumption are all on the consumer’s radar as are fortified and functional foods.

Where Canadian food regulations were once overly restrictive with regards to things such as fortification and novel fibres some flexibility has been seen lately. Particularly with regards to fortification where the government is increasingly allowing safe, but non- compliant food products to go to market under a Temporary Marketing Authorization.

Contact Source Nutraceutical, Inc. today (info@sourcenutra.ca) to learn more about how we can help you gain access to this exciting new market.

 

Temporary Marketing Authorization Letter

What is it?

A Temporary Marketing Authorization Letter (TMAL) is a formal agreement with Health Canada that allows you to market a safe, but non-compliant food under prescribed conditions including the amount, the location and the timeframe.

Are TMALs new?

No. The conditions under which Temporary Marketing Authorization may be issued are described in the Food Regulations. It is a tool that has been around for a quite awhile but until fairly recently has seen limited use. The transition of many natural health products back to the food regulatory environment has been largely facilitated by the issuance of Temporary Marketing Authorization Letters. For example, the majority of caffeinated energy drinks would not be allowed for sale under the current Food Regulations in the absence of a TMAL.

What is the purpose of a TMA?

A Temporary Marketing Authorization is used to generate market data in support of an amendment to the Food Regulations. Once a TMAL is issued companies must work with Health Canada to develop an acceptable research protocol that will help generate the required market data.

How do I know if I should apply for a TMA?

If the composition and/or labeling of your product do not comply with the current provisions of the Food Regulations and you do not wish to reformulate and/or relabel then applying for a Temporary Marketing Authorization is a possible option. However, even if your food product is safe, it will not necessarily be issued a TMAL. For example, if your food contains a non-permitted food additive (except for caffeine) or a novel food ingredient (that has not been deemed acceptable by Health Canada) it will not be issued a TMAL. The majority of TMALs that have been issued to date are for products that contain caffeine and/or non-permitted nutrients.

What is the process for obtaining a TMA?

A detailed application form must be completed and submitted to Health Canada. Information required includes contact information for the supplier, quantitative formula for the food, draft label text, evidence to support the safety of the product and the purpose of the TMA (i.e. identified differences between the product formulation / label and the current regulatory framework). For a new TMA application Health Canada’s performance standard is 190 days for review and issuance of a TMAL.

What happens after I get a TMAL?

As mentioned above the purpose of a TMA is to generate data that can only be obtained by bringing the product to market. Specific market research will need to be obtained based on a research protocol developed with the approval of Health Canada. Consumption data and adverse events will also need to be tracked and reported. Any information that changes from the original application and agreement will need to be reported to Health Canada.

What happens at the end of the TMA?

TMALs are issued for a specified period of time. At the end of the TMA there are a few options as to next steps: 1. Health Canada may extend the TMA 2. The regulations may have been amended such that your product formulation and/or label claims now comply with the regulations or 3. You will need to reformulate your product to bring it into compliance with the existing regulations.

How can Source Nutraceutical, Inc. help you?

With our extensive knowledge and hands on experience Source Nutraceutical’s regulatory experts will help you determine whether your product will qualify for a Temporary Marketing Authorization, complete the required paperwork, prepare the draft label text and interact with Health Canada to ensure the successful receipt of a TMAL that meets your market needs. We will also work with you and Health Canada to develop a practical research protocol to obtain the required market data.

And our Graphics experts are on hand to create market ready art and labels.

Contact us today (info@sourcenutra.ca) to let us help you get your product to market without unnecessary reformulation and labeling changes.

Source Nutraceutical is Expanding

Source Nutraceutical, Inc. knows that there is an increasing need for specialists whose sole job is to be on top of the ever changing regulatory world. To meet the demand we have brought on board two new senior people with knowledge and hands on experience in GMP auditing, quality assurance and food and natural health product regulations.

No regulatory challenge is too big or too small for Source Nutraceutical, Inc. to help you with.

Contact us today (regulatory@sourcenutra.ca) to let us show you how to make the regulations work for you.

Did You Know?

The U.S. market for tea has more than quadrupled during the past twenty-plus years—from just under $2 billion in 1990 to just over $10 billion last year.

In 2012, Americans consumed well over 79 billion servings of tea, or over 3.60 billion gallons. About 84% of all tea consumed was Black Tea, 15% was Green Tea, and a small remaining amount was Oolong and White Tea.

On any given day, over one half of the American population drinks tea. On a regional basis, the South and Northeast have the greatest concentration of tea drinkers. (http://www.teausa.com)

Whatever your regulatory, packaging and/or fulfillment needs are – contact Source Nutraceutical today to learn how we can help you achieve brand success and market penetration in 2014/2015 (info@sourcenutra.ca).

Source Nutraceutical, Inc. is your “one-stop-solution” for regulatory compliance, graphic design, mandatory bilingual (English & French translation) labeling and importation and fulfillment services for foods, natural health products, cosmetics, medical devices and pharmaceutical products in Canada. Contact us today to learn more about how we can help you get your products to market quickly, compliantly and cost effectively.

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