If you know what Temporary Market Authorization (TMA) means and your company sells Caffeinated Energy Drinks in Canada, get ready to be puzzled. Maybe grab an energy drink to fuel your mind. Just make sure it has a Temporary Market Authorization Letter (TMAL).
In 2012, food-like natural health products in Canada—in queue to be licensed for market authorization—were transitioned from the Natural Health Products Directorate (i.e., the department responsible for licensing health products) to the Food Directorate. Those of you who had products, such as caffeinated energy drinks – and were suddenly redirected to this new stream will likely agree that this transition has had many of us scratching our heads. It all began in 2011 when the Health Minister at the time, Leona Aglukkaq, announced that caffeinated energy drinks would no longer be regulated as health products, but as food products. The argument was that these caffeinated energy drinks were not being consumed as health products, a subset of drugs under Canadian law, but as food products. As a health product, companies were not obliged to include a table of nutritional facts on the product label, preventing customers from making informed nutrition choices. As a food product, information such as total calorie count and amount of sugar per serving would be required on the label. Following this decision to transition energy drinks, other food-like health products, known as ‘Supplemented foods’ such as bars and shakes, quickly followed behind to become reclassified as food products.
The companies selling these supplemented food products erupted in joy. A conventional food product in Canada only requires a compliant bilingual label. There is no need for pre-market review and approval, as was the case when these caffeinated energy drinks were classified as health products. As it so often happens when dealing with regulations, however, this joy quickly evolved into disappointment. Products would now require TMAs, and go through a similar pre-market approval process as health products. The safety of each ingredient would have to be demonstrated to the Food Directorate and a product label would also be reviewed. The process was tedious and Health Canada, to this day, sets a performance target between 100 – 190 days to review and approve a TMA application, but can be much longer for those who have filed a TMA submission may know.
What’s important here is the word temporary. The Food Directorate set an expiry date on all TMAs whether they are for caffeinated energy drinks or supplemented foods and as part of the renewal process; they expect to see market data, such as consumer demographics, sales figures and consumption patterns. This is all due to the Food Directorate’s initiative to study these products and understand how Canadians are interpreting and consuming supplemented foods (including caffeinated energy drinks).
The million dollar question is, “How do companies collect this data?” What is really expected beyond number of units sold by region? The first TMAs were issued in December of 2012 for both Supplemented Foods and caffeinated energy drinks, the former are set to expire on August 31st, 2016, while the latter are valid until December 2017. It leaves us a little time to scratch our heads, but the Food Directorate has started to hint that they will expect to see market data in the interim from all TMA holders. When, exactly, this data will be due remains unclear, but it could be as soon as this year. As TMAL holders for caffeinated energy drinks have been issued the first call for data in the Letter of Agreement that your company signed in order to receive your market authorization, the Food Directorate expects you to provide 3 year’s worth of market research on your caffeinated energy drinks. If you are doing the math, this means you would need a time machine in order to provide data for products expiring next year. While the Food Directorate has not set a carved in stone deadline, TMAL holders are best to plan early, since a market authorization for a caffeinated energy drinks is valid for 5 years, and the Food Directorate would like the data to be submitted 2 years before the TMAL expires so they can assess the safety of your product to determine your pending renewal.
Some companies are turning to associations for guidance. Others are teaming up with like-product companies – collaborating together to collect data. Others are going at it alone. Dicentra has been working with many of these companies, as we have obtained hundreds of TMALs on behalf of our clients throughout the years. With this in mind, the Food Directorate has been very kind and sincere in collaborating with Dicentra and providing guidance on how market study protocols should be designed and on what data is expected from the department. Whatever your strategy may be, please consult Dicentra or have us review your plan of action.
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