Food & Drug Update

Health Canada to Prescribe Use and Content of Precautionary Labelling For Allergens

By Lynne Weagle

People who suffer from food allergies and intolerances face the daily challenge of determining what products are free of the foods that make them ill. Allergic reactions may be as mild as a skin rash or as severe as anaphylactic shock and death. Researchers at Health Canada believe that up to 2% of the adult population and about 6% of children suffer from food allergies. The majority of food reactions in Canada are caused by the following common allergens and their derivatives, along with gluten and sulphites: peanuts, tree nuts, sesame seeds, milk, eggs, seafood, wheat and soy.

The only way that food allergies and intolerances can be successfully “treated” is for susceptible individuals to stringently avoid the foods to which they are sensitive. In addition to avoiding foods that list allergens in the ingredients, sensitive individuals must also be alerted to the potential presence of undeclared allergens in food products that are either components of other ingredients or the result of cross-contamination of the food at some point during the manufacturing or packaging process.

Current Labelling of Precautionary Statements
Under the Food and Drug Regulations (the Regulations), the ingredients of most food products must be listed on the product labels; however, there is no requirement to declare allergens that may be present inadvertently. This can result from cross-contamination during the manufacturing or packaging process or from the disclosure in the ingredient list of certain ingredients that are not required but which may contain allergens (e.g., “seasoning”).

Although Health Canada and the Canadian Food Inspection Agency (the CFIA) have encouraged manufacturers in the past to include precautionary statements on labels of pre-packaged foods alerting consumers to the potential inadvertent presence of allergens, currently the use of these precautionary statements is voluntary and goes beyond the requirements for labelling found in the Regulations. The only guidance that Health Canada has previously given about these statements is that they be true, clear and unambiguous, and that they not replace good manufacturing processes (such as the proper cleaning of food production lines).

This lack of consistency can lead to confusion for consumers and inadvertent consumption by sensitive individuals of foods to which they are allergic or intolerant. Health Canada and the CFIA have noted that while the use of voluntary precautionary statements on labels has increased since the mid-1990s, the wording of the statements is inconsistent and doesn’t provide consumers with meaningful information about the presence of allergens.

According to Health Canada’s policy, precautionary statements are not to be used when one of the common allergens is deliberately added as an ingredient to a product; rather, they are only supposed to be used where, despite the manufacturer’s use of all reasonable measures, the potential presence of an allergen in a food product is unavoidable. Further, such statements should not be added to labels as “blanket coverage” where there is no possible presence of an allergen in particular food products. Such usage makes it more difficult, not less so, for consumers to make safe food choices.

Proposed Changes to the Use of Precautionary Statements
Recognizing that current labelling regulations and the limited guidelines for the use of precautionary statements are insufficient for people with food allergies and intolerances, and after consultation with various stakeholders and the medical community, Health Canada is revising the Regulations to enhance the labelling requirements for specific life-threatening “priority allergens” (the most common allergens as listed above, plus gluten and sulphites). Because precautionary statements may be very useful to consumers when they are used appropriately, more guidance regarding what is considered “appropriate” use is needed. As a result, Health Canada is in the process of prescribing the use and content of precautionary statements and is aiming to publish the proposed regulations by the end of December, 2007 to allow for public comment and suggestions.

Recommendations for Use of Precautionary Statements
Following a string of food recalls due to the presence of undeclared allergens, the CFIA released a bulletin entitled “Precautionary Labelling Regarding Food Allergens” on September 25, 2007 regarding the use of precautionary statements by food manufacturers and importers. Until the new regulations come into effect, Health Canada and the CFIA recommend that manufacturers begin using one of the two following different phrases for these statements: i) “may contain [X]” or ii) “not suitable for consumption by persons with an allergy to [X].” This wording will allow for greater consistency in the content of precautionary statements and prevent consumers from being confused by a wide array of different phrasings. Precautionary statements should never be used in lieu of listing the presence of allergens in the list of ingredients where it is likely that the allergen is a component of the food. Further, where suppliers have labelled raw material for the ingredients with a precautionary statement, manufacturers are advised to use the same statement on the finished product label unless they can demonstrate that the allergen in the finished product is not likely to represent a health risk.

In addition, the CFIA recommends that the food industry adopt strategies to ensure that priority allergens are properly controlled during the manufacturing and packaging process, and that they follow manufacturing procedures that minimize the risk of cross-contamination. These strategies could include the selection of more carefully-controlled raw ingredients and the use of dedicated production lines for foods that don’t contain allergens.

Finally, the CFIA notes: “Although precautionary labelling is voluntary, enforcement action will be taken when allergens are not clearly represented on pre-packaged foods and a potential health risk has been identified. Enforcement action can include product seizure, detention and recall, and may include prosecution.” Manufacturers and importers must, therefore, be vigilant regarding their use of precautionary statements and ensure that any foods potentially containing allergens are correctly labelled.

It is the responsibility of the food industry to ensure that the food it sells is safe for consumers with food allergies and intolerances. The new regulations will make it easier for people with food sensitivities to make safe and nutritious food choices and to be confident that they won’t suffer the consequences of consuming foods that contain undisclosed allergens.

Recently, the CFIA released a “Questions and Answers” document regarding the labelling of food allergens. That document can be accessed by visiting their website. For additional information regarding food labelling laws and the use of precautionary statements, please visit the CFIA or Health Canada websites, or contact any member of the Osler Marketing & Distribution group.

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By Nicole J. Kutlesa

In 2004, Health Canada introduced the Natural Health Products Regulations (the Regulations) pursuant to the Food and Drugs Act (the Act). The Regulations created a new national regulatory regime for natural health products (NHPs). NHPs are products represented for use in the diagnosis, treatment, mitigation or prevention of a disease in humans, or products that otherwise restore, correct or modify organic functions in humans, and that contain certain prescribed ingredients (e.g., plant material or extracts derived from plants, vitamins, amino acids, probiotics, etc.). NHPs are available over-the-counter and do not require a prescription to be sold. Common examples of NHPs include multi-vitamins, anti-dandruff products and toothpastes with fluoride. The NHP regulatory regime is administered by the Natural Health Products Directorate (NHP Directorate) of Health Canada. Recently, the NHP Directorate released prohibitions on the use of “Rx” in product brand names and new guidance on the labelling of extremely small packages.

Use of “Rx” No Longer Permitted
The NHP Directorate will no longer permit the use of “Rx” in brand names or on labels and packages of NHPs. This prohibition follows the NHP Directorate’s determination that the international understanding of this term is that a product identified as “Rx” has prescription status. By definition, NHPs do not include substances that require a prescription to be sold. In addition, use of “Rx” in relation to products that do not actually require a prescription is considered to be misleading pursuant to the general prohibition under the Act for false and misleading claims. Accordingly, the NHP Directorate has called for the removal of “Rx” from all brand names and labels of licensed NHPs.

Reduced Labelling Requirements and New Guidelines for “Extremely Small” Packages
The Regulations set out mandatory labelling requirements for packages of NHPs, as well as reduced labelling requirements for “small packages” which are defined as NHPs whose immediate container is not large enough to accommodate all of the information required for NHP packages. Recently, the NHP Directorate decided to further reduce the labelling requirements for “extremely small” or special packages in response to industry complaints that for some packages, even the reduced labelling requirements are difficult to meet. The NHP Directorate has released additional guidelines for these “extremely small” packages, which include multi-dose packs (e.g., blisters, strips, push-through cards and ampoules attached by a plastic strip) and single-dose packs (e.g., sachets, pouch-type packs and individual dose vials of liquid).

The guidelines provide that certain information must be disclosed on the label of the immediate container (e.g., brand name, quantity and potency, lot number and expiry date) and such information must meet the requirements in the Regulations for small packages. “Outer labels” (i.e., an outer container such as a box) are still required to meet the requirements of the Regulations for outer labels of NHP products; however, where an extremely small package does not have an outer label, the guidelines stipulate that the information affixed to the immediate container must meet the requirements of the Regulations for outer labels. Finally, the guidelines require that for multi-dose packages, the information required to be included on the label should be presented in such a way that the package can still be identified after units have been removed.

For more information on labelling requirements for NHPs, please consult the Labelling Guidance Document currently available on the NHP Directorate’s website. Or, contact any member of the Osler Marketing & Distribution group. The NHP Directorate is currently in the process of updating this document; but, additional specific information on the labelling requirements for “extremely small” packages can be found here.

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By Nicole J. Kutlesa

On October 9, 2007 the Natural Health Products (NHP) Directorate at Health Canada announced that product license applications for NHPs in food formats will be reviewed on a going forward basis in consultation with Health Canada’s Food Directorate. Since the introduction of the Natural Health Products Regulations (the Regulations) in 2004, the status of ”food-like” NHPs (e.g., probiotic yogurts, juices and gum) has been uncertain. Questions have been raised over whether these products are better regulated as foods rather than NHPs. The concern is that consumers may consume these products at will without considering the recommended conditions of use and that these products contain medicinal ingredients which, if over-consumed, increase the risk of potential adverse effects. This situation raises additional health and safety concerns and may perhaps require additional labelling. Accordingly, the NHP Directorate has determined that such products would be better addressed by Health Canada’s Food Directorate, which has specific food expertise.

Going forward, all food-like NHP license applications will be reviewed by the NHP Directorate in consultation with the Food Directorate. The two Directorates will collaborate to assess the safety and efficacy evidence submitted in support of NHP product license applications. Such evidence shall include reference to relevant NHP Directorate guidance documents as well as the Interim Guidance Document for Preparing a Submission for Foods with Health Claims (the Interim Guidance Document). This Interim Guidance Document was prepared to provide guidance on the principles and criteria by which health claims for foods would be evaluated by Health Canada. It includes details on the types of information to be submitted for health claim approvals (i.e., in the areas of product safety, claim validation and quality assurance).

The NHP Directorate has been reviewing the issue of food-like NHPs this past year and has proposed that amendments to the Regulations to exclude food-like NHPs be initiated. This regulatory amendment would make it clear that these products are not regulated as NHPs. It is expected that Health Canada will consider the merits of an amendment to the Regulations. The Food Directorate is currently developing a framework for managing health claims, although it is not anticipated that consultations on this health claim framework will completely resolve the food/NHP interface. The two Directorates intend to hold targeted consultations to resolve any outstanding issues not addressed by the exclusion of food-like NHPs from the Regulations or their inclusion under the food framework.

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By Nicole J. Kutlesa

On September 26 to 28, 2007 the International Cooperation on Cosmetic Regulation (ICCR) held its inaugural meeting in Brussels, Belgium. The ICCR is a voluntary international group made up of cosmetics regulatory authorities from Canada, the US, Japan and the EU. As the successor to the Cosmetics Harmonization and International Cooperation (CHIC) which was created in 1999, the organization’s mandate is to identify ways to remove regulatory obstacles among the regions while maintaining the highest level of global consumer protection. Topics previously canvassed by the CHIC include UV filters (sunscreens), preservatives, ingredient nomenclature and animal testing.

All decisions and subsequent actions of the ICCR are to be decided on consensus by the regulatory representatives. Members have committed to taking appropriate steps within their respective regulatory jurisdiction to implement those items agreed to by consensus, including the promotion of any related documents of the ICCR and the convergence of regulatory policies and practices. The ICCR will solicit the input of industry by inviting the cosmetics trade associations of each region to suggest items for priority actions to be considered by ICCR members.

The inaugural meeting was attended by representatives of Health Canada, the U.S. FDA, Japan’s Ministry of Health, Labour and Welfare, the EU Commission, DG Enterprise and various cosmetics industry trade associations. It focused on six key areas of discussion: good manufacturing practices, INCI labelling, nanotechnology, market surveillance, ingredient safety and animal testing.

The meeting resulted in the ICCR acknowledging certain key issues in the cosmetics industry and offering its direction in these areas. The ICCR has committed to taking into consideration ISO standard 22716 – Guidelines for the Production, Control, Storage and Shipment of Cosmetic Products. To this end, Health Canada will create Good Manufacturing Practices guidelines based on this ISO standard. The other regions will either adopt or update current standards to reflect ISO 22716. In the area of market surveillance, the ICCR acknowledged the need to maintain effective communication among the regions about product safety issues.

In addition to these acknowledgements, the ICCR has laid the foundation for further cooperation with the cosmetics industry by inviting submissions from industry in a number of areas that can be expected to shape the future direction of the ICCR. The ICCR recognizes that a common definition of “nanotechnology” for cosmetics is required. While nanoparticles are currently used in cosmetics such as sunscreens and anti-aging products, their safety has been questioned. The ICCR will be gathering information on applications of nanotechnology currently used in the cosmetics industry to assess its future response in this area.

In addition to further recent efforts around regulatory harmonization of cosmetics ingredients labelling, the ICCR will evaluate data submitted by industry associations substantiating the claim that U.S. consumers understand the meaning of trivial names. In Canada, the Cosmetics Regulations list 57 commonly understood “trivial names” of cosmetics ingredients that are permitted to be used in ingredient lists in place of the International Nomenclature of Cosmetic Ingredients (INCI) names that are otherwise required. A trivial name is the Latin version of the INCI name assigned to certain ingredients (e.g., acetum/vinegar/vinaigre). The ICCR has recommended that consumer groups be involved in the development of the survey protocol, which the ICCR will review. The ICCR has also invited industry to submit proposals on the possible role of the ICCR in the global harmonization of ingredient safety and risk assessment.

Finally, the ICCR recognized the importance of reducing, refining and replacing animal testing. The ICCR recognized the industry’s collaborative and intensive efforts in phasing out animal testing but called for further strengthening of collaboration and communication in the design, execution and peer review of validation studies. In particular, the ICCR has invited representatives from the Government of Canada, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and similar agencies in the EU (ECVAM) and Japan (JaCVAM) to propose options to ensure collaboration on this issue.

The next ICCR meeting is expected to take place in the United States in 2008.

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