Performance targets for TMAs has been released. Caffeinated Energy Drinks receive TMA in 100 days if in compliance with new guidance document.

Health Canada’s Timelines for Receiving Temporary Marketing Authorisation Letters (TMALs), Health Canada’s Food Directorate has released the Guidance for the Management of Temporary Marketing Authorization Submissions for Foods which will be publicly posted at a later date by the Food Directorate. This guidance document includes clear information on TMA Performance standards to provide the industry with an explanation of the TMA process and how long you can expect to wait to receive your marketing authorization.

This guidance document indicates that TMA submissions and Amendments will be streamed into 3 categories, as below:

Stream 1: Performance target to receive TMAL = 31 days.

This stream is for administrative changes to existing TMALs (including changes that do not require scientific review).

Stream 2: Performance target to receive TMAL = 100 days.

This stream is for TMAs which are compliant with the category specific guidance documents (e.g. Caffeinated Energy Drinks guidance document) or are extensions of existing TMALs (e.g. new flavors, new product sizes).

Stream 3: Performance target to receive TMAL = 190 days.

This stream is for all other applications that fall outside of the scope of stream 2 (new products), or do not meet the scope of products covered in the Category Specific Guidance for Temporary Marketing Authorization – Caffeinated Energy Drinks.

Revised Guidance Document for TMAs for Caffeinated Energy Drinks

The Food Directorate has also released a revised Guidance document for Caffeinated Energy Drinks. It is important to note that the updated Guidance document is effective immediately and replaces the previous ‘Category Specific Guidance for Temporary Marketing Authorization – Caffeinated Energy Drinks’ dated March 2012.

As with the previous version of this guidance document, this applies to all Caffeinated Energy Drinks providing caffeine from all sources between 200 and 400 ppm, for pre-packaged, ready-to-consume and/or predominantly water-based products.

Some of the Revisions to the Guidance document have been highlighted here:

• Eligibility  – additional details with respect to the criteria that must be met to qualify for a Caffeinated Energy Drinks TMA, as indicated in section 3.0 of the guidance document.
• There have been some changes in the maximum upper limits (ULs) of some ingredients:
  • The maximum level for niacinamide has been revised to 126 mg  (previously up to 450 mg was acceptable).
  • The maximum level for pantothenic acid has also been revised to 100 mg/day.
•  Further guidance on the following ingredients has also  been provided
  • Daily maximum level for the following vitamins or minerals: vitamin B6, vitamin C, vitamin E, calcium and phosphorus, riboflavin, thiamine, and vitamin B12.
  • Maximum intake levels for magnesium and potassium.
• The age of child has been defined as  12 years of age or less (important for marketing purposes)
• More detailed information is provided for Advertising of Caffeinated Energy Drinks including recommended wording for advertising information to the consumer and clarification on disclosures for broadcast and print advertisements.

The Food Directorate has also repealed the section of the guidance document relating to the NHP-food transition as this process was completed in December 2012.  As such, for any new Caffeinated Energy Drinks, the applicant must apply to the Food Directorate and receive a TMAL prior to going to market. Additionally, the product must not contain any novel ingredients or unapproved food additives at the time of submission –  this was previously acceptable during the transition period for food-like NHPs.

Dicentra can assist you with reviewing your food products to ensure they are compliant with respect to their formulation and labelling and advise if a TMA is required. NHP Consultant and FDA Consultant dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.

References

Category Specific Guidance for Temporary Marketing Authorization – Caffeinated Energy Drinks. December, 2013. Food Directorate, Health Canada.

Guidance for the Management of Temporary Marketing Authorization Submissions for Foods. September, 2013.  Food Directorate, Health Canada.