Berryland Canning Company Ltd. (Plaintiff)
v.
The Queen (Defendant)
Trial Division (T-1472-71), Heald' J.—Ottawa,
December 10, 11, 12, 13, 14 and 17, 1973;
January 2, 1974.
Constitutional law—Food and Drugs—Adulteration by
cyclamates—Whether law and Regulations are intra vires—
Whether exercise of criminal law powers Damages sus
tained by cannery because of lack of notice—Food and
Drugs Act, R.S.C. 1970, c. F-27, ss. 4(d), 25(1Xa)—Food
and Drug Regulations, P.C. 1970-645 and 1970-1314.
Section 4 of the Food and Drugs Act prohibits the sale of
food articles possessing certain characteristics and para
graph (d) thereof prohibits the sale of food articles that are
adulterated. Section 26 provides for penalties for a violation
of the provisions. It is clear that one of the main purposes of
the Act was with the view to a public purpose—the protec
tion of the health of all Canadians and can be supported as
being in relation to criminal law. Regulations made under
section 25(1)(a) regarding the prohibition of the use of
cyclamates are intra vires of the Parliament of Canada under
its jurisdiction to legislate in respect to the criminal law.
Standard Sausage Co. v. Lee [1933] 4 D.L.R. 501 and
[1934] 1 D.L.R. 706, followed.
The addition of cyclamates to canned fruit results in the
fruit being "adulterated" within the meaning of the Food
and Drugs Act and in reading the regulation-making section
and the impugned regulation, the Governor in Council was
acting within its powers in defining "adulterated" for the
purposes of the Act. Deputy Minister of National Revenue v.
Saint John Shipbuilding and Dry Dock Co. [1966] S.C.R.
196; M.N.R. v. Creative Shoes [1972] F.C. 993, followed.
The officials of the Food and Drug Directorate acted at all
times in a responsible and reasonable manner; there was no
evidence of anything false or misleading or careless in their
actions. The plaintiff's allegations of impropriety in the
actions of the Food and Drug Directorate are rejected.
ACTION.
COUNSEL:
G. Henderson, Q.C. and G. Fisk for
plaintiff.
I. G. Whitehall and P. Betournay for
defendant.
SOLICITORS:
Gowling and Henderson, Ottawa, for
plaintiff.
Deputy Attorney General of Canada for
defendant.
HEALD J.—The plaintiff is a private corpora
tion duly incorporated in 1961 under the laws of
British Columbia and carries on business at
Maple Ridge, British Columbia, as a canner of
fruits produced mainly in the Province of Brit-
ish Columbia and marketed throughout Canada.
The plaintiff has twenty to twenty-five per
manent employees, which figure increases to
some two or three hundred during the canning
season. Since the early 1950's, it has been cus
tomary to can diet fruits using cyclamates (salts
of cyclohexylsulphamic acid) as artificial sweet
eners. Prior to that time, diet fruits were canned
in what is described as a "water-pack", that is
fruit packed in water with no sweetener added.
Said "water-pack" was not too palatable, thus
once the industry discovered that it was possi
ble to use artificial sweeteners, the market
increased considerably. The market is described
as consisting of diabetics who must have a
restricted sugar diet and also those who wish to
control their weight through adoption of a low
calorie diet. From and after the early 1950's in
Canada, there developed a substantial and
expanding market for diet foods, sweetened
with cyclamates. During its first two years of
operation, the plaintiff . canned only fruits with
sugar. However, in 1963, the plaintiff began to
produce canned fruits with cyclamates, thus
moving into the Canadian diet food market. By
1969, plaintiff was producing approximately
35,000 to 40,000 cases of canned diet fruit
annually. The plaintiff's President, William S.
Deacon, testified that this branch of business
was producing about 1/5 of the company's total
annual profit by 1969.
Plaintiff's packing season for diet fruit in a
normal year commences on about June 15 with
the strawberry crop and ends approximately
October 15 with the Bartlett pear crop. In 1969,
the plaintiff's entire inventory for its 1970 busi
ness in diet foods had been packed prior to
October 21, 1969.
On October 21, 1969, the Minister of Nation
al Health and Welfare announced, through a
Press Release (Exhibit P-1), the Department's
decision to phase out the use of salts of
cyclohexylsulphamic acid as an artificial sweet
ening agent in certain foods. Subsequent to that
announcement, wide publicity was given to this
policy by the distribution of several Trade
Information Letters to food manufacturers in
Canada.
In its Petition of Right, the plaintiff alleges
that the aforesaid decision and announcement
were made negligently in that they were made
precipitately without independent investigation
as to the facts relating to any alleged dangers
from the use of cyclamates as an artificial
sweetening agent in foods. Additionally, the
plaintiff alleges that the said announcement was
made without any advance notice to the trade.
Plaintiff further alleges that as a direct conse
quence of the said decision and announcement,
it was unable to market its canned dietetic fruit
through normal channels, and was eventually
obliged to dispose of such products at a consid
erable loss. The Petition of Right further alleges
that section 4(d) of the Food and Drugs Act and
the Regulations purporting to be passed under
said Act by which the aforesaid cyclamate ban
was effected are ultra vires. In its prayer for
relief, the plaintiff asks for: a declaration that
section 4(d) of the Food and Drugs Act is ultra
vires the Parliament of Canada; that the Regula
tions in question as passed by P.C. 1970-645
and 1970-1314 be declared ultra vires the Gov
ernor General in Council and of no force and
effect; and finally that the plaintiff be compen
sated in damages for the losses suffered as a
direct result of the actions taken by the Minister
and by the Department of National Health and
Welfare.
Dealing firstly with the plaintiff's attack on
the constitutionality of section 4 of the Food
and Drugs Act, I have no difficulty in conclud
ing that section 4(d) of the Food and Drugs Act
is intra vires the Parliament of Canada. Section
4 reads as follows:
4. No person shall sell an article of food that
(a) has in or upon it any poisonous or harmful substance;
(b) is unfit for human consumption;
(c) consists in whole or in part of any filthy, putrid,
disgusting, rotten, decomposed or diseased animal or
vegetable substance;
(d) is adulterated; or
(e) was manufactured, prepared, preserved, packaged or
stored under unsanitary conditions.
Looking at the scheme and purpose of the
Food and Drugs Act, R.S.C. 1970, c. F-27 it is
clear that the provisions of said Act are
designed, inter alia, to protect Canadians from
hazards to health which may be present in
foods, drugs, cosmetics and devices as therein
defined. The constitutionality of a predecessor
to the present Food and Drugs Act, the 1927
Act, was considered by the British Columbia
Court of Appeal in the case of Standard Sau
sage Co. v. Lee [1933] 4 D.L.R. 501 and [1934]
1 D.L.R. 706. In that case, it was held that since
the main purposes of the Act were the protec
tion of the public against the adulteration of
foods and to suppress fraud, in its criminal
aspect, in the distribution of food products, that
the impugned sections of said Act were intra
vires the Parliament of Canada under its juris
diction to legislate in respect to the criminal law.
The Court also held that it was immaterial that
penalties were imposed for acts of adulteration
which are harmless to health. At page 505 of
that judgment, Macdonald J.A. said:
These considerations point to the conclusion that, granted
the general subject of the adulteration of food may be the
subject of legislation by the Dominion Parliament under the
heading `criminal law", it must follow, reasonably and
necessarily, that it may define precisely the ingredients that
may or may not be used. Nor is it any less a crime because it
may be shown scientifically that some of the ingredients
prescribed may not, if used in proper quantities, be deleteri
ous at all.
A comparison of the 1927 Act with the present
Act clearly shows that, while some provisions
have been added and others changed, the main
purposes of the Act have not changed over the
years. Thus, the rationale of the Standard Sau
sage case (supra) applies equally to the present
case.
An apt description of the criminal law power
of the Parliament of Canada is contained in the
judgment of Mr. Justice Rand in The Reference
as to the Validity of Section 5(a) of the Dairy
Industry Act [1949] S.C.R. 1 at p. 50 where he
said:
Is the prohibition then enacted with a view to a public
purpose which can support it as being in relation to criminal
law? Public peace, order, security, health, morality: these
are the ordinary though not exclusive ends served by that
law ... [Italics mine].
One of the definitive cases on the use by Parlia
ment of its power to legislate on the criminal
law is the case of Attorney General for British
Columbia v. Attorney General for Canada
[1937] A.C. 368 at p. 375 where Lord Atkin,
speaking for the Court, held that there is no
other criterion of "wrongness" than the inten
tion of Parliament in the public interest to pro
hibit the act or omission made criminal. At page
375 of the judgment, Lord Atkin said:
The only limitation on the plenary power of the Dominion to
determine what shall or shall not be criminal is the condition
that Parliament shall not in the guise of enacting criminal
legislation in truth and in substance encroach on any of the
classes of subjects enumerated in s. 92. It is no objection
that it does in fact affect them. If a genuine attempt to
amend the criminal law, it may obviously affect previously
existing civil rights.
In the case at bar, section 4 prohibits the sale of
food articles possessing certain characteristics.
Paragraph (d) thereof prohibits the sale of food
articles that are adulterated. Section 26 of the
Act provides for penalties of fines and/or
imprisonment for a violation of said section 4 or
any other of the provisions contained in the Act.
It seems clear that the Food and Drugs Act,
including section 4 thereof has been enacted
"with a view to a public purpose"—i.e.,—the
protection of the health of all Canadians and
that said legislation can be supported as being in
relation to criminal law. I am fortified in my
belief that Parliament considered it was exercis
ing its criminal law powers in enacting this
legislation by the provisions of section 29 of the
Act which effectively retains mens rea for the
purposes of a prosecution under section 4.
Defendant's counsel also submitted that the
impugned section could be further supported as
being within the legislative competence of the
Parliament of Canada under section 91(2) of the
British North America Act, 1867, that is, "The
Regulation of Trade and Commerce". In sup
port of this position, counsel cited the recent
judgment of the Federal Court of Appeal in
MacDonald v. Vapor Canada Limited [1972]
F.C. 1156 where Chief Justice Jackett said (at
page 1171):
To summarize the result of the authorities as I understand
them, there has been removed from the prima facie ambit of
the "Regulation of Trade and Commerce" entrusted to
Parliament by section 91(2)
(a) the regulation of dealings in particular commodities or
classes of commodities in local trade in a province,
(b) the regulation of the contracts of a local trade in a
province, and
(c) the regulation of the employer-employee relationships
in local trade in a province;
while, on the other hand, it would appear that what is left to
Parliament to regulate (in addition to international trade and
1 29. (1) Subject to subsection (2), in a prosecution for
the sale of any article in contravention of this Act or the
regulations, if the accused proves to the satisfaction of the
court or judge that
(a) he purchased the article from another person in pack
aged form and sold it in the same package and in the same
condition the article was in at the time he purchased it,
and
(b) that he could not with reasonable diligence have
ascertained that the sale of the article would be in contra
vention of this Act or the regulations,
the accused shall be acquitted.
(2) Subsection (1) does not apply in any prosecution
unless the accused, at least ten days before the day fixed for
the trial, has given to the prosecutor notice in writing that he
intends to avail himself of the provisions of subsection (1)
and has disclosed to the prosecutor the name and address of
the person from whom he purchased the article and the date
of purchase.
interprovincial trade), as being general regulations of trade
as a whole or regulations of general trade and commerce,
includes
(a) the creation of a national mark to be used in trade to
indicate standards, and the control of the use thereof,
(b) a system of trade marks,
(c) a system of credits to be used in lieu of bank credit,
(d) commodity standards, and
(e) statistics.
It seems to me that there is much to be said
for the argument that section 4 does in reality
set "commodity standards" with respect to food
that can be sold in Canada and thus might well
come within the Federal power to regulate
Trade and Commerce. However, in view of my
conclusion that the impugned section comes
within the criminal law power of the Parliament
of Canada, it becomes unnecessary to finally
determine the validity of this legislation under
section 91(2) of the British North America Act.
Plaintiff's second attack is upon the validity
of certain Regulations passed by the Governor
in Council under the purported authority con
tained in the Food and Drugs Act. The power to
make Regulations is contained in section 25 of
the Act, the pertinent portion thereof reading as
follows:
25. (1) The Governor in Council may make regulations
for carrying the purposes and provisions of this Act into
effect, and, in particular, but not so as to restrict the
generality of the foregoing, may make regulations
(a) declaring that any food or drug or class of food or
drugs is adulterated if any prescribed substance or class
of substances is present therein or has been added thereto
or extracted or omitted therefrom;
The first relevant Regulation was promulgat
ed on September 23, 1964 [S.O.R./64-366] and
the pertinent portion thereof reads as follows:
B.01.046. A food is adulterated if any of the following
substances or classes of substances are present therein or
have been added thereto:
(c) synthetic sweetening agents other than saccharin,
cyclohexylsulphamic acid or their salts;
The effect of this Regulation was to permit the
presence of cyclamates as synthetic sweetening
agents in food.
On April 14, 1970, by Order-in-Council P.C.
1970-645, [S.O.R./70-152] Regulation B.01.046
(supra) was amended by Regulation B.01.046A
as follows:
B.01.046A. Notwithstanding the provisions of paragraph
(c) of section B.01.046
(a) beverages, beverage mixes and bases recommended
for addition to any liquid, and
(b) fruit spreads, puddings, bakery products, frozen and
other desserts, confectionery, table syrups, dressings and
toppings,
shall be deemed to be adulterated if they contain cyclohex-
ylsulfamic acid or any of its salts.
On July 22, 1970, by Order-in-Council P.C.
1970-1314 [S.O.R./70-332], the Regulations
were further amended by Schedule No. 129, the
pertinent portions whereof read as follows:
SCHEDULE NO. 129
2. Paragraph (c) of section B.01.046 of the said Regula
tions is revoked and the following substituted therefor:
"(c) synthetic sweetening agents other than saccharin or
its salts;"
3. Section B.01.046A of the said Regulations is revoked.
4. The said Regulations are further amended by adding
thereto, immediately after section B.01.046A, the following
section:
"B.01.046B. Notwithstanding paragraph (c) of section
B.01.046, dietetic canned fruits that are manufactured in or
imported into Canada on or after the coming into force of
this section shall be deemed to be adulterated if they contain
cyclohexylsulphamic acid or any of its salts."
7. Sections 1 to 3 shall come into force on September 1,
1970.
From the above, it will be seen that Order-in-
Council P.C. 1970-645 is not the material regu
lation to be considered on the facts in this case
since this plaintiff was not engaged in the manu
facture or sale of any of the diet foods specified
in said Order-in-Council. The Order-in-Council
material to the facts of this case is Order-in-
Council P.C. 1970-1314 (supra) inasmuch as it
has reference to dietetic canned fruits, which
was the plaintiff's business.
Section 2 of Schedule No. 129 thereof
amends the definition of adulterated foods to
include cyclamates and section 7 of said
Schedule No. 129 brings section 2 into force on
September 1, 1970.
In his argument, plaintiff's counsel attached
much significance to the fact that in section
25(1)(a) of the Act, the word "declare" was
used whereas, in some portions of the two
impugned Orders-in-Council, the word
"deemed" is used. His submission was that
"deem" is a much wider term than "declare",
that "declare" does not permit anything but a
declaration of a fact whereas "deem" used in
this context is wide enough to include some
thing as being deemed adulterated which is not
in fact adulterated. Accordingly, he submits,
that, on the factual situation in the case at bar,
since there was no evidence that cyclamates are
adulterated in fact, the power to "declare" con
tained in section 25(1)(a) is not wide enough to
cover the "deeming" provisions of the
impugned Regulations by which cyclamates are
"deemed" to be adulterated.
My first comment in respect of this argument
is that the word "deem" is not used anywhere in
those portions of the Regulations applying to
the facts in the case at bar.
Impugned Order-in-Council, P.C. 1970-645
uses the word "deemed" but, as indicated ear
lier, said Order-in-Council does not apply to this
case. Similarly, the word "deemed" is used in
Order-in-Council P.C. 1970-1314, but, as
indicated earlier, not in the portion thereof
applying to the case at bar. The Regulations
applying here are the original Regulation
B.01.046 (September 23, 1964) as amended by
section 2 of Schedule No. 129 (July 22, 1970).
Thus, for the purposes of deciding this case, the
Regulation reads as follows:
B.01.046. A food is adulterated if any of the following
substances or classes of substances are present therein or
have been added thereto:
(c) synthetic sweetening agents other than saccharin or its
salts.
Thus, it is seen that the word "deemed" is not
present in that portion of the Regulations ma
terial to the case at bar.
Having so found, it is perhaps unnecessary to
determine whether "declared" in section
25(1)(a) is wide enough to include "deemed" as
used in some of the Regulations purported to be
passed thereunder. However, I have no hesita
tion in expressing the view that "declared" as
used in section 25(1)(a) is wide enough to
include "deemed".
One of the definitions of "deem" given in the
Shorter Oxford English Dictionary is: "To pro
nounce; to tell, say, declare" (italics mine). This
seems to indicate that in some contexts at least
the words "deem" and "declare" are used inter
changeably. Roget's Thesaurus suggests that
"declare" is synonymous with "proclaim" and
"decree" and, in this context, would be synony
mous with "deem" in the sense that section
25(1)(a) empowers the Governor in Council to
"decree" or "declare" or "deem" a certain sub
stance adulterated, having regard to the purpose
of the statute and the necessity of ensuring that
it be served. Here we have a statute, the pur
pose of which is to protect the health of the
populace from harm or possible harm as a result
of the addition of substances to food or drugs.
Parliament clearly intended to delegate to the
Governor in Council the power to "deem" or
"declare" what those substances might be.
Plaintiff's counsel's further attack on the
validity of subject Regulation centres around
the meaning of the word "adulterated" as that
word is used in sections 4(d) and 25(1)(a) of the
Food and Drugs Act. His submission is that on
the evidence adduced in this case, there was
absolutely no scientific evidence to show that
cyclamates have caused cancer or any other
harmful effects in humans. Relying on the dic
tionary meaning of "adulterate" as "To debase
or deteriorate by an admixture of foreign or
baser materials " (see: The Living Webster-16)
he submits that the "adulteration" prohibited
under section 4 is a question of fact and that the
Regulation granting power under section 25 is
restricted to those substances which have, in
fact, been proven to be base or harmful and that
since there is no proof here of any harmful
effect on humans by the use of cyclamates, that
any Regulation which "deems" cyclamates to be
an adulterated substance is ultra vires the
powers given to the Governor in Council under
section 25.
With deference, I am not able to agree with
this submission. Cockburn C.J., decided in the
case of Francis v. Maas (1877-78) 3 Q.B.D. 341
that "adulteration" means the infusion of some
foreign substance. It seems to me that a
"foreign substance" would be wide enough to
include any substance that one would not nor
mally expect to be present in a food. In the
context of the facts of this case, surely artificial
sweeteners can be considered a "foreign sub
stance" because in a can of peaches, for exam
ple, you would not normally expect to find an
artificial chemically produced sweetener. In my
view, the word "adulterated" cannot be restrict
ed to only those substances which have been
proven to be harmful. I consider the ordinary
meaning of the word to be wide enough to
encompass all foreign substances, harmful or
otherwise. Thus, I have the view that the addi
tion of cyclamates to canned fruit results in the
fruit being "adulterated" within the meaning of
the Food and Drugs Act.
Additionally, I have the view that, for a
proper consideration of this matter, the Regula
tion making section of the Act (section 25) must
be read in conjunction with the impugned Regu
lation. A similar situation was dealt with in the
Supreme Court case of Deputy Minister of
National Revenue v. Saint John Shipbuilding
and Dry Dock Co. [1966] S.C.R. 196 at pages
202 and 204. In that case, the Act (section 6(10)
of the Customs Tariff Act) referred to "substan-
tial quantities of goods of a class or kind made
in Canada" and empowered the Governor in
Council to define such "substantial quantities"
by Regulation. Pursuant to said authority, the
Governor in Council passed a Regulation so
defining the term as being a quantity sufficient
to supply 10% of the normal Canadian con
sumption of the article. Cartwright J. (as he then
was) at page 204 of the judgment held that the
effect of the section of the Act was to enable
the Governor in Council to define the expres
sion "substantial quantities" as used in section
6(10). The learned Justice then went on to read
the subsection of the statute together with the
Regulation and then proceeded to consider the
combined effect of the two. It seems to me that
such an interpretation is proper and should be
applied to the situation at bar. Subject statute
has as its main purpose the protection of public
health by controlling what can be added to food
and drugs. The statute delegates to the Gover
nor in Council the power to regulate pursuant to
that broad purpose. Thus, the meaning of "adul-
terated" as used in section 4 of the Act and
elsewhere is the meaning ascribed to it by the
Governor in Council. Thus, it follows that the
Governor in Council was acting within its
powers in defining "adulterated" for the pur
poses of the Food and Drugs Act.
To give the word "adulterated" the meaning
ascribed to it by the plaintiff would result in the
Governor in Council having to act on a judicial
or a quasi-judicial basis, that is, before declaring
a substance to be adulterated, the Executive
Branch of Government would be required to
make a finding of fact that the particular sub
stance was, or was not, harmful to humans. I do
not so construe section 25. Said section confers
on the Governor in Council the power to
declare, which seems to be apt wording to
confer a power to legislate "for carrying the
purposes and provisions of this Act into effect".
(For a similar view see: M.N.R. v. Creative
Shoes [1972] F.C. 993 at page 1000.) I cannot
conceive that Parliament intended to so restrict
the Executive Branch of Government as to limit
them in the administration of the Act to banning
only those substances which had been proven to
be harmful to humans. There are many cases
where definitive conclusions have not been
reached, where the results are inconclusive. I
am satisfied that section 25(1)(a) is wide enough
to cover this category and to permit the Gover
nor in Council to ban substances in this catego
ry in the public interest.
I have accordingly concluded that the Regula
tions here impugned are intra vires the Gover
nor in Council.
Plaintiff's final submission was to the effect
that, where there is an absence of good faith
and illegality (i.e.—ultra vires Regulations or
sections of the statute) then, since a regulating
authority has a duty to those being regulated,
there has been a breach of that duty which falls
under the general heading of negligence and that
any one such as the plaintiff suffering damages
as a result of that negligence, is entitled to be
compensated for its loss.
For the reasons above stated, I have found
against the plaintiff on the question of illegality.
However, even assuming for the sake of argu
ment that the subject Regulations were ultra
vires, this proven circumstance would not, by
itself, entitle the plaintiff to be compensated in
damages. In the case of Welbridge Holdings
Ltd. v. The Metropolitan Corporation of Greater
Winnipeg [1971] S.C.R. 957, the plaintiff leased
certain lands in the City of Winnipeg intending
to construct thereon a multi-storey apartment
building, and relying on the validity of an
amending zoning law which was eventually
declared invalid by the Supreme Court of
Canada (Wiswell case). A building permit was
obtained, a building contract was executed and
construction was commenced. When the trial
judge in the Wiswell case found the by-law
invalid, the building permit was revoked and
work on the apartment project stopped. Plain
tiff's action was for damages founded on
negligence.
Mr. Justice Laskin, in delivering the judgment
of the Court, analyzes the functions of the
defendant corporation. He observes that it is a
municipal corporation with some legislative,
some quasi-judicial and some administrative or
ministerial or business powers. At pages 968
and 969 he said:
The defendant is a municipal corporation with a variety of
functions, some legislative, some with also a quasi-judicial
component (as the Wiswell case determined) and some
administrative or ministerial, or perhaps better categorized
as business powers. In exercising the latter, the defendant
may undoubtedly (subject to statutory qualification) incur
liabilities in contract and in tort, including liability in negli
gence. There may, therefore, be an individualization of
responsibility for negligence in the exercise of business
powers which does not exist when the defendant acts in a
legislative capacity or performs a quasi-judicial duty.
Its public character, involving its political and social re
sponsibility to all those who live and work within its territo
rial limits, distinguishes it, even as respects its exercise of
any quasi-judicial function, from the position of a voluntary
or statutory body such as a trade union or trade association
which may have quasi-judicial and contractual obligations in
dealing with its members: cf. Abbott v. Sullivan ([1952] 1
All E.R. 226); Orchard v. Tunney ([1957] S.C.R. 436). A
municipality at what may be called the operating level is
different in kind from the same municipality at the legisla
tive or quasi-judicial level where it is exercising discretion
ary statutory authority. In exercising such authority, a
municipality (no less than a provincial Legislature or the
Parliament of Canada) may act beyond its powers in the
ultimate view of a Court, albeit it acted on the advice of
counsel. It would be incredible to say in such circumstances
that it owed a duty of care giving rise to liability in damages
for its breach. "Invalidity is not the test of fault and it
should not be the test of liability": see Davis, 3 Administra
tive Law Treatise, 1958, at p. 487.
In my view, this decision is a complete
answer to the plaintiff's submission that illegal
ity, even where it is proven, would give rise to
liability in damages.
Coming now to the question of good faith, I
am satisfied, on all of the evidence adduced,
that the officials of the Food and Drug Director
ate acted at all times in a responsible and
reasonable manner. There was no evidence of
anything false, or misleading or careless in their
actions.
Dr. Ross Chapman, who was Director Gener
al of the Food and Drug Directorate at all rele
vant times, gave lengthy and detailed evidence
at the trial. He explained that one of the respon
sibilities of the Food and Drug Directorate was
the administration of the Food and Drugs Act,
and, incidental thereto, the obligation to make
recommendations to their responsible Minister,
the Minister of National Health and Welfare,
when, in their judgment, the Regulations under
the Food and Drugs Act required amendment.
Attached to the Food and Drug Directorate is
a Research laboratory which continuously car
ries on research to enable the Directorate to
administer the Food and Drugs Act. Additional
ly, there was an Advisory Group to the Direc
torate whose function it was to evaluate the
various information available on food additives.
Both of these bodies continually surveyed the
rather large volume of literature and informa
tion available in this field. Dr. Chapman estimat
ed that, as of the year 1969, there were prob
ably several thousand papers and studies on
cyclamates as a food additive, and that said
material was being continually assessed and
considered by the Directorate.
I heard detailed evidence on a number of
studies and experiments conducted using rats
and mice to test the effect on them of cycla-
mates. The position up to 1968 may be general
ly summarized by saying that up to that point in
time, the research and studies had not estab
lished any relationship between the ingestion of
cyclamates and the incidence of carcinoma
(cancer).
However, the situation began to change some
what in 1968 and 1969. On October 12, 1968,
the results of a study by B. Oser, S. Carson, E.
Wagin and R. Saunders was released which
indicated that conversion of cyclamate to
cyclohexylamine (H.C.A.) occurred when cycla-
mates were given to rats. At about this same
time, two Japanese scientists, Messrs. S.
Kojima and H. Ichibagase reported that cycla-
mates were metabolized by some humans to
cyclohexylamine. Dr. Chapman explained that
the combined results of these studies caused the
Directorate to revise its thinking on cyclamates
because H.C.A. was an amine and a number of
amines had been proven to be potent carcino
gens. Then, early in 1969, the Directorate
became aware of a study by Drs. Bryan and
Erturk at the University of Wisconsin in which
sodium cyclamate was surgically implanted in
the bladders of mice. In duplicate experiments,
incidences of mouse bladder carcinomas were
significantly greater in the mice in which the
sodium cyclamate had been implanted than in
those in which no sodium cyclamate had been
implanted. Thus, the official position of the
Food and Drug Directorate, prior to October 18,
1969 was that, on the basis of all the scientific
information available to them, cyclamates when
used in normal or reasonable amounts were not
hazardous to health. However, in the light of the
experiments in 1968 and 1969 above referred
to, the Directorate was becoming to some extent
suspicious of cyclamates as a food additive and
was watching the situation very closely. Dr.
Chapman testified that the Directorate had
indicated to the industry their concern and that
they were reviewing the situation very carefully.
The Directorate was monitoring consumption
levels, the types of foods and the number of
foods to which cyclamates were being added.
On October 18, 19 and 20, 1969, Dr. Chap-
man attended a White House Conference on
Food Safety at Washington, D.C. At that Con
ference, he was made aware of a study conduct
ed by Dr. Bernard Oser, a noted scientist and
the Director of the U.S. Food and Drug
Research Laboratories at Maspeth, New York.
He discussed the results of this study with Dr.
Oser. The study (Exhibit P7-A) showed that at
high levels of cyclamate ingestion, over a two
year period, a number of the rats used in the
experiment developed carcinomas in the urinary
bladder. Dr. Chapman considered the Oser
experiment to be a very significant experiment
in so far as the safety of cyclamates in food was
concerned. He immediately contacted his
associates in the Directorate in Ottawa and, as a
result, two of the Directorate scientists went, on
October 20, 1969, to Chicago there to examine
the slides and other scientific material from the
Oser experiment, the object of said trip being to
verify the results of the experiment. On the
morning of October 21, 1969, Dr. Chapman
convened a meeting in Ottawa of all the senior
officials and the scientists of the Directorate,
including the two scientists who had been to
Chicago the day before. As a result of this
meeting, the Directorate, after fully reviewing
the results of the Oser experiment, recommend
ed to the Minister of National Health and Wel
fare a ban on cyclamates which resulted in the
Minister's Press Conference and Press Release
of October 21, 1969 (Exhibit P-1). Said Press
Release announced a phasing out of cyclamates
commencing with dietetic soft drinks and mixes
on November 30, 1969 and concluding with
dietetic canned fruits on September 1, 1970.
The reasons for the different phasing out dates
for different products are explained in detail in
Exhibit P-1 and I do not propose to repeat them
here. Suffice it to say that in my respectful
opinion, Exhibit P-1 represents a logical and
prudent decision, in the light of the changing
scientific situation hereinbefore described. It is
not without significance that a ban on cycla-
mates in food in the United States was
announced on October 18, 1969. Dr. Chapman
further testified that in December of 1969, the
Directorate became aware of a further experi
ment with rats which showed the incidence of
carcinomas in the urinary bladders at a lower
dosage level than that given in the Oser experi
ment. Dr. Chapman said that the results of this
experiment served to confirm the wisdom of
their earlier decision.
The position of the Department is best sum
marized by the concluding paragraph of the
Press Release (Exhibit P-1) which reads as
follows:
It is obvious, therefore, that the danger to humans from
cyclamates is undoubtedly very small. Nevertheless, as I
have said, we are acting to phase out the use of cyclamates
since I feel it essential that we follow a course of action that
affords the greatest protection to the health of the Canadian
public.
Considering all of the evidence adduced, I am
satisfied that the officials of the Food and Drug
Directorate acted prudently, expeditiously and
reasonably in the public interest. To have acted
otherwise, in the circumstances herein related,
might well have exposed them to a charge of
negligence or a breach of duty. In addition to
the United States and Canada, some thirty other
countries have likewise announced a ban on the
use of cyclamates as a food additive. Accord
ingly, I have no hesitation in rejecting the plain
tiff's allegations of impropriety in the actions of
the Food and Drug Directorate.
For the above reasons, the plaintiff's action is
dismissed with costs.
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