Date: 19990323 Docket: T-2107-97
BETWEEN:
WRIGLEY CANADA
Plaintiff
- and -
HER MAJESTY THE QUEEN
Defendant
REASONS FOR ORDER
RICHARD A.C.J.:
NATURE OF THE PROCEEDING
[1] This is a motion for summary judgment brought by the plaintiff for judgment in the nature of a declaration.
[2] Essentially, the plaintiff seeks a declaration that its product, "EXTRA Sugarfree Gum", is a food and not a drug as defined in the Food and Drugs Act, R.S.C. 1985, c. F-27 (the Act), even if its use is represented to prevent dental cavities.
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[3] The parties agree that there are no factual issues which require a trial and that the only question to be resolved is a question of law.
BACKGROUND
[4] At various times since July 1986, Wrigley Canada has been attempting to advertise EXTRA Sugarfree Gum as having cavity fighting properties.
[5] The Canadian Radio-Television and Telecommunications Commission rejected a "cavity fighting" script for EXTRA Sugarfree Gum in 1986 indicating that the cavity fighting claim was such that EXTRA Sugarfree Gum was being represented as a drug.
[6] In a letter dated February 23, 1987, the initial position taken by then Assistant
Director of the Drug Evaluation Division, Bureau of Non-prescription Drugs, Health
Canada, was that:
"Extra" is not a drug and does not contain any active ingredient. It is regulated as a "food" and any discussions as to the claims which may or may not be made for this product should be addressed to the Food Directorate of the Health Protection Branch.
[7] Meetings and discussions with Health Canadaculminated in a script which was
aired on television on or about October 26, 1987 containing the wording:
new dental studies prove chewing Sugar Free Extra after a sugary snack can actually reduce the acids that can cause cavities.
[8] By letter dated October 30, 1987, the then Assistant Deputy Minister of Health
Canada referred to the above-noted claim and indicated:
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Although this claim was decided upon after discussion with officials of the Health Protection Branch and the Department of Consumer and Corporate Affairs, a trade complaint has now caused us to reexamine the claim. It is now our opinion that the last phrase of this claim i.e. "that can cause cavities" is a "drug" claim and therefore not acceptable for a food.
[9] After further discussions with Health Canada, Dr. Liston stated by letter dated
November 18, 1987 that "It is the policy of this Branch that any reference to the
prevention of a disease is considered a drug claim". The letter cited the definition of a
"drug" in the Food and Drugs Act. It also added:
In the interim, your clients may wish to prepare alternative wording, which is acceptable to them, for their advertisements, should they wish to continue promoting Extra Sugar Free Gum as a food.
[10] It has been Wrigley Canada's position that "salivary action", that is, the creation of saliva in the mouth through the combined effect of a chewing action with flavour, reduces the plaque acids which cause cavities and therefore chewing sugar-free gum actually fights cavities.
[11] None of the decisions made by the CRTC or Health Canada concerning this chewing gum were challenged by way of judicial review and I am not called upon to judicially review any such decisions.
[12] EXTRA Sugarfree Gum is currently packaged, labelled and sold as food.
[13] The plaintiff's current packaging states: "Won't Cause Cavities". The plaintiff seeks to use the claim: "Prevents Tooth Decay".
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ISSUE
[14] The issue before the Court is whether the plaintiff's "EXTRA Sugarfree Gum" falls within the Act's definition of "food" or, if its use is represented to prevent dental cavities, within the Act's definition of "drug".
STATUTORY PROVISIONS
[15] The definitions from section 2 of the Act that are particularly relevant are set out
below:
"drug" « drogue » « drogue » "drug"
"drug" includes any substance or mixture « drogue » Sont compris parmi les
of substances manufactured, sold or drogues les substances ou mélanges de represented for use in substances fabriqués, vendus ou présentés comme pouvant servir
(a) the diagnosis, treatment, mitigation a) au diagnostic, au traitement, à
or prevention of a disease, disorder or l'atténuation ou à la prévention d'une
abnormal physical state, or its maladie, d'un désordre, d'un état symptoms, in human beings or animals, physique anormal ou de leurs symptômes, chez l'être humain ou les animaux;
(b) restoring, correcting or modifying organic functions in human beings or animals, or
b) à la restauration, à la correction ou à la modification des fonctions organiques chez l'être humain ou les animaux;
(c) disinfection in premises in which food is manufactured, prepared or kept;
c) à la désinfection des locaux où des aliments sont gardés.
"food" « aliment))
"food" includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that
« aliment » "food"
« aliment » Notamment tout article fabriqué, vendu ou présenté comme pouvant servir de nourriture ou de boisson à l'être humain, la gomme à mâcher ainsi que tout ingrédient pouvant
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may be mixed with food for any purpose être mélangé avec un aliment à quelque
whatever; fin que ce soit.
[16] ANALYSIS
[17] Food and drugs are regulated differently under the Food and Drugs Act and Food and Drug Regulations. Generally speaking, no license is required to manufacture, import or sell food. The ingredients have to be "food grade" and the food should be manufactured in accordance with Good Manufacturing Practices for food.
[18] Schedule B to the Food and Drug Regulations sets out the regulatory scheme governing the manufacture and sale of food. No license or licensing fee is required to manufacture a food.
[19] Schedule C to the Food and Drug Regulations sets out the regulatory scheme governing the manufacture and sale of a drug. There are other provisions dealing with controlled drugs which are not relevant to this proceeding.
[20] Unlike food, each individual drug must go through an application process with a prescribed fee and be assigned an identification number before it can be sold. Any variation to the formula of the drug requires a new application, a new fee and a new identification number. The facilities used for fabricating, packaging, labelling, testing, distributing, wholesaling or importing a drug must also go through licensing procedure.
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[21] As a result, drugs are more stringently regulated than foods. Clearly, the line between the regulation of foods and the regulation of drugs has been drawn so as to promote the protection of the public interest by ensuring that products claiming to have health benefits as described in paragraphs a), b) and c) are safe and effective. Parliament has legislated that persons suffering from particular ailments and relying on particular products to alleviate those ailments must be assured that their reliance is not misplaced. For such products, the regulatory regime relating to foods is clearly insufficient to protect that public interest.
[22] The plaintiff submits that Parliament has determined chewing gum to be a food in clear and unambiguous language in section 2 of the Act.
[23] The plaintiff claims that EXTRA Sugarfree Gum is a food and not a drug and therefore is not subject to the Drug Regulations. However, the plaintiff insists that consuming public is nevertheless protected by the provisions of consumer protection legislation. The plaintiff will be required to ensure that the claims made in relation to EXTRA Sugarfree Gum are not deceptive or misleading and are based on adequate and proper testing which support such claim.
[24] The defendant asserts that where, as here, a product's advertising states "Won't Cause Cavities", it is appropriately regulated as a food. However, when any chewing gum manufacturer chooses to go further and advertise that its gum "prevents tooth decay", the
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product is within the meaning of section 2 of the Act and must be properly regulated as a drug.
FINDINGS
[25] The plaintiff's product is a chewing gum.
[26] The plaintiff's product is included in the definition of "food" in section 2 of the Food and Drugs Act by reason of the words "chewing gum" which appear in that definition.
[27] I find that the product in issue, EXTRA Sugarfree Gum, is a substance or mixture of substances as contemplated by the definition of a "drug" in section 2 of the Food and Drugs Act.
[28] 1 also find that the proposed claim for the product, "Prevents Tooth Decay", is a representation that promotes the product for the treatment, mitigation or prevention of a disease or disorder.
[29] EXTRA Sugarfree Gum is a drug within the meaning of section 2 of the Food and Drugs Act.
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CONCLUSION
[30] Chewing gum, which is clearly a substance or mixture of substances, does not lose its potential to be a "drug" under the appropriate conditions merely by its inclusion in the definition of "food". A particular product might be regulated as either a food or a drug, depending on the purpose for which it is manufactured, sold, or represented by the particular manufacturer or vendor.
[31] As was stated in a decision involving the interpretation of the same defined terms
La Cour en arrive donc à la conclusion que, contrairement à ce qu'affirme le juge de première instance, un article qui constitue un aliment peut également constituer une substance susceptible d'être considérée comme une drogue en vertu de la loi. La distinction essentielle entre les deux termes est le fait qu'une substance constituera une drogue aux fins de la loi si elle est vendue ou présentée comme pouvant servir à l'une des fins décrites aux sous-paragraphes a), b) ou c) de la définition. Cette interprétation est certes conforme aux objectifs de la loi qui visent à protéger le consommateur tant en matière d'aliment que de drogue. Une personne ne peut représenter qu'une substance peut être utilisée pour traiter une maladie qu'à la condition de se soumettre aux exigences de la loi et des règlements en matière de drogue. Une personne ne peut vendre un article qu'elle représente comme étant un aliment qu'à la condition de se soumettre aux exigences de la Loi en matière d'aliments. Un article vendu comme aliment deviendra, pour les fins de la loi, une drogue si l'aliment est vendu comme pouvant servir au traitement d'une maladie. C'est au juge qu'il appartient de déterminer suivant la preuve si l'objet visé est une substance vendue dans les conditions prévues aux sousparagraphes a), b) ou c) de la définition du terme "drogue"'.
R. v. Gilbert Blondin, Pierre-André Gaulin, Compagnie Easy-Ac Product & Service Ltd. (unreported, June 7, 1992, Cour Supérieure (Chambre Criminelle) Province de Québec, District de Hull) at pp. 9-10.
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[32] It is not in dispute that the plaintiff wishes to promote the use of EXTRA Sugarfree Gum in preventing dental cavities, and that by doing so the plaintiff would be selling it, or representing it for use in, the mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms.
[33] I conclude that EXTRA Sugarfree Gum, if so represented and promoted, would be required to be classified as a drug, in the Act, even though it is also defined as a food in the Act.
DISPOSITION
[34] This Court declares that "EXTRA Sugarfree Gum" falls within the Food and Drugs Act definition of a drug, when and if its use is represented to prevent dental cavities.
[35] The plaintiff's motion for summary judgment is dismissed with costs.
J. Richard
Associate Chief Justice
Ottawa, Ontario March 23, 1999
FEDERAL COURT OF CANADA TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS ON THE RECORD
COURT FILE NO.: T-2107-97
STYLE OF CAUSE: WRIGLEY CANADA
Plaintiff
AND
HER MAJESTY THE QUEEN
Defendant
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: March 16, 1999
REASONS FOR ORDER OF THE ASSOCIATE CHIEF JUSTICE, RICHARD DATED: March 23, 1999
APPEARANCES:
Mr. Gordon B. Greenwood for the Plaintiff
Mr. Frederick Woyiwada for the Defendant
SOLICITORS OF RECORD:
Mr. Gordon B. Greenwood for the Plaintiff Maclaren Corlett
Ottawa, Ontario
Mr. Morris Rosenberg for the Defendant Deputy Attorney General of Canada
Ottawa, Ontario
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