Transition of Caffeinated Energy Drinks from NHPs to Food Using Temporary Market Authorization Letters (TMAL)
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Table of Contents
Caffeinated energy drinks (CEDs) are pre-packaged, ready-to-consume water-based beverages with a high caffeine content. They generally feature health claims related to their capacity to restore energy and alertness in the individual consuming the product. There is no standard for CEDs in the Food and Drug Regulations (FDR), however; in general they contain caffeine in combination with other ingredients such as taurine, glucuronolactone, B vitamins, minerals, various herbal ingredients and other bioactive ingredients.
Food additive provisions and associated Marketing Authorizations (MA) allow for the use of caffeine and caffeine citrate in colas and non-cola carbonated soft drinks. The FDR upper limit on caffeine as an additive in cola type beverages is 200 ppm, and for non-alcoholic carbonated water-based flavoured and sweetened beverages it is 150 ppmFootnote 1.
Health Canada can issue Test Market Authorization Letters (TMAL) to permit the use of food additive caffeine in non-alcoholic beverages other than carbonated soft drinks, such as CEDs. Sources of food additive caffeine include synthetic caffeine (or synthetic caffeine citrate), pure caffeine isolated from natural sources, and caffeine-containing extracts with concentrated levels of caffeine. Examples of extracts that could contain concentrated levels of caffeine include guarana, coffee, and tea extracts. In the case of CEDs, extracts are considered as food additive caffeine when they contain or provide a high amount (200-400 ppm) of caffeine to the food.
Note: Some ingredients containing caffeine may be used for flavouring purposes, such as guarana, crude extractives or natural flavours. The caffeine content is not considered as food additive caffeine when the ingredients are added to foods and the caffeine is present in an amount consistent with the reported flavour uses.
Historically, specific provisions in the FDR limiting the addition of caffeine, vitamins, mineral nutrients and amino acids to foods led to manufacturers and distributors of CEDs gaining market access through Health Canada's natural health products (NHP) approval process.
However, the scope of the Natural Health Product Regulations does not include food products. Given this, Health Canada reconsidered the status of CEDs as NHPs and determined that CEDs are packaged, perceived and consumed as foodFootnote 2. In October 2011, the Minister of Health announced that CEDs would be regulated as food, thus transferring the responsibility for compliance and enforcement of these products to the CFIA.
The transition of CEDs to the food regulatory regime is part of a larger Health Canada initiative to transition all products regulated as NHPs that are packaged, perceived and consumed as foodsFootnote 3.
Process for Transition of Caffeinated Energy Drinks from NHPs to Food
In order to minimize market disturbance, CEDs deemed by Health Canada to present no immediate safety concerns, but found to be in contravention of the FDR with regard to caffeine levels, vitamin and mineral fortification, novel ingredients, labels or claims, were transitioned from NHPs to food through the use of a Temporary Marketing Authorization (TMA). Health Canada developed eligibility criteriaFootnote 4 as the basis for granting the TMA. Some companies were required to re-formulate their CED products in order to meet the eligibility criteria before the TMA would be granted.
The purpose of a TMA is to allow eligible products to be marketed subject to specific conditions while industry collects and provides data to Health Canada. Health Canada will use this data in order to finalize the regulatory amendments required for the safe marketing of these products under the FDR.
The company must sign a Letter of Agreement with Health Canada to demonstrate that they have agreed to the terms and conditions in the TMA under which the product may be marketed. This also includes agreeing to conduct research to fill data gaps identified by Health Canada, to report any consumption-related incidents, and to withdraw the product if requested by Health Canada. Once the Letter of Agreement is signed, Health Canada issues the Temporary Marketing Authorization Letter (TMAL). TMALs for CEDs are valid for 5 years after the date of issuance.
Note: A TMAL is issued for a specific product and formulation. If a company wants to modify anything related to the conditions in the TMAL, they must re-negotiate the TMA with Health Canada before the modified product can appear in the marketplace. In this case the previous TMAL is retracted by Health Canada and a new version is issued and signed.
Current Status of CEDs
As of January 2, 2013, Health Canada has completed the transition process and all CEDs are now considered to be food, require a TMA to be in the marketplace, and are subject to enforcement by the CFIA.
As a result of the transition:
- All CEDs sold in Canada must immediately comply with a limit on caffeine of:
- no less than 200 ppm (mg/L) and no more than 400 ppm, and
- no more than 180 mg/servingFootnote 5).
- CEDs cannot contain alcohol.
- CEDs may contain various vitamins, minerals and amino acids at specified levels (i.e. in accordance with the TMA).
- The addition of folic acid and vitamin A are not permitted.
- Effective immediately, companies cannot market or provide samples of CEDs to children.
- CED labels must be in full compliance with the Food and Drugs Act and FDR by the date indicated in the TMALFootnote 6. This includes:
- a Nutrition Facts Table, ingredient listing and allergen information;
- cautionary statements advising not to mix the product with alcohol, and that the product is not recommended for children, pregnant/breastfeeding women and individuals sensitive to caffeine;
- a "High Caffeine Content" statement;
- quantitative declaration of caffeine content from all sourcesFootnote 7 in the product;
- maximum daily intake statement; and
- quantitative declaration of level of select bioactive ingredients per serving size if the ingredient does not have an accepted food purpose (e.g., ginseng, ginko biloba, etc.). More details on this requirement can be found in Section 3.3.4 of Health Canada's Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks.
A list of CEDs that have been granted TMALs is available. This list provides details on the product name, company name, TMAL number, TMAL issuance date, and TMAL expiration date. In addition, the CFIA's Consumer Protection Division (CPD) maintains a reference document containing copies of all TMALs issued for energy drinks which outline all conditions set out in each individual TMA. (This document is intended for internal use. CFIA staff can access this document using RDIMS number 3218587.)
Regulatory Requirements for Transitioned (New/Re-Formulated/As-is) CEDs
The regulatory requirements for CEDs are no different than for any other food marketed under a TMA. In general, all requirements for labelling and advertising for food in the Food and Drugs Act (FDA), Part B of the Food and Drug Regulations (FDR) and in the Consumer Packaging and Labelling Act and Regulations (CPLAR) apply, other than the aspects that are the subject of the TMA. In other words, a CED must comply with the conditions stated in the TMAL as well as all other regulatory requirements not covered by the TMAL.
CFIA Oversight of Caffeinated Energy Drinks
At this time, the Imported and Manufactured Food Division (IMFD) does not intend to develop inspection work plans specific to CEDs. Rather, the CFIA will deal with CEDs on a complaint-driven basis using existing risk-based compliance and enforcement processes.
Inspectors should refer to the Imported and Manufactured Food Program's Memo to Inspectors – Caffeinated Energy Drinks for current compliance and enforcement information.
- CEDs that do not have a TMAL and do not comply in full with food regulations: These should be treated as any other non-compliant food, subject to appropriate enforcement action by the CFIA (e.g., detention or re-exportation to the country of origin until the company seeks and obtains a valid TMAL from Health Canada).
- CEDs with a TMAL: CFIA oversight should focus on verifying that the TMAL is valid (refer to the list of CEDs that have received TMALS) and that the conditions of the individual TMAL are being met. If the TMAL is not valid, or if the conditions are not being met, inspectors should advise their Area Specialist. Area Specialists will work with IMFD/CPD to notify Health Canada. Health Canada has the authority to revoke the product's TMAL and to require the company to withdraw the product. CFIA has no jurisdiction over the issuance or revocation of TMALs. If the TMAL is revoked, the product becomes a non-compliant food and is subject to enforcement action by CFIA. Health Canada will notify the CFIA and this will be reflected in the TMAL listing appearing on Health Canada's website and in the document maintained by CPD.
Questions related to this file can be forwarded to CFIA's Area and Regional Offices.
Questions and Answers
What is a Temporary Marketing Authorization (TMA) and a Temporary Marketing Authorization Letter (TMAL)?
A Temporary Marketing Authorization (TMA), granted by Health Canada, authorizes the sale of a food that does not meet one or more of the compositional, packaging, labelling or advertising requirements under the Food and Drugs Act and Regulations. A TMA does not exempt foods from the requirements under the Consumer Packaging and Labelling Act and Regulations. Its purpose is to generate information to support an amendment to the Food and Drug Regulations (FDR) (see Sections B.01.054 and B.01.055 of the FDR).
To qualify for a TMA, products must be deemed to present no immediate safety concerns. The manufacturer or distributor must sign a Letter of Agreement with Health Canada to demonstrate that they have agreed to the terms and conditions in the TMA under which the product may be marketed. This also includes agreeing to conduct research to fill data gaps identified by Health Canada, to report any consumption-related incidents, and to withdraw the product if requested by Health Canada. Once the Letter of Agreement is signed, Health Canada issues the Temporary Marketing Authorization Letter (TMAL).
What is the difference between a Test Market Food and a food with a Temporary Market Authorization (TMA)?
A Temporary Marketing Authorization, granted by Health Canada, authorizes the sale of a food that does not meet one or more of the compositional, packaging, labelling or advertising requirements under the Food and Drugs Act and Regulations.
A Test Market Food is authorized by the CFIA. The food must comply with current legislation in all respects, except for the bilingual labelling requirement and standardized container sizes under the Consumer Packaging and Labelling Regulations. For a food to be granted a Test Market Food authorization letter, it must never have been sold in Canada in that form and must differ substantially from any other food sold in Canada with respect to its composition, function, state or packaging form. A Test Market Food includes food for which a manufacturer or distributor has been issued a Temporary Marketing Authorization Letter under the FDR.
Are CEDs containing alcohol allowed to be sold in Canada?
No. The TMA that permits the sale of CEDs as foods does not authorize the sale of alcoholic versions of these products and does not authorize their use as ingredients in other foods, including in alcoholic beverages.
Furthermore, the Food and Drug Regulations do not permit the addition of caffeine to any alcoholic beverage. However, some alcoholic beverages are allowed to have flavouring ingredients that naturally contain caffeine (e.g. guarana, coffee). They are also allowed to have as ingredients cola or other soft drinks that are themselves permitted to contain caffeine as a food additive.
Health Canada continues to advise consumers not to mix CEDs with alcohol and will continue to restrict their use as an ingredient in pre-mixed alcoholic beverages. In addition, Health Canada is requiring all CEDs to display the statement "Do not mix with alcohol" on the label.
[Source: Health Canada - Questions and Answers: Caffeinated energy drinks]
The transition of CEDs from Natural Health Products (NHP) to food is the first phase of a larger Health Canada initiative. How many food-like NHPs is Health Canada planning to transition?
There are approximately 50,000 NHPs in the marketplace. A very small proportion of these (2%) will be transitioned to the food regulatory framework in a phased manner.
As of April 17, 2012, Health Canada no longer accepts NHP applications for products that are represented, packaged and sold as food. NHP applications will only be accepted for products that are intended for therapeutic purposes.
Are other caffeinated products included in the transition?
Caffeinated products that are not consumed or perceived as foods are not included. For example, many products termed "Energy Shots" are distinguished from foods by their smaller volumes and product representation, and thus would not be perceived as traditional foods. These kinds of products will remain under the NHP regulatory framework.
Can new CED products be marketed under a TMAL?
Yes. Companies bringing new CEDs to the market can request a TMAL from Health Canada's Submission Management and Information Unit. Refer to Health Canada's Category Specific Guidance for Temporary Marketing Authorization: Caffeinated Energy Drinks for information on the eligibility criteria.
When do CED labels have to comply with the enhanced allergen labelling requirements that came into effect on August 4, 2012?
The individual TMAL for each product indicates when the label has to be in compliance with food labelling requirements. This would include the enhanced allergen labelling requirements.
- TMALs that were issued prior to August 4, 2012 for CEDs that were transitioned 'as is' (meaning they did not require reformulation in order to meet Health Canada's eligibility criteria) are not required to be in compliance with allergen labelling requirements until December 2013.
- New CEDs, or CEDs that were re-formulated in order to be eligible for a TMA, are required to meet the enhanced labelling requirements immediately upon being issued the TMAL.
List of Acronyms Used in this Document
- Caffeinated Energy Drink
- Consumer Packaging and Labelling Act and Regulations
- Food and Drug Regulations
- Imported and Manufactured Food Division
- Natural health product
- parts per million
- Temporary Market Authorization
- Temporary Market Authorization Letter
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