Yl• 42: F '14965 -\`1

AMEND SECTION 402(d) OF THE FEDERAL

(WERNMFNT FOOD, DRUG, AND COSMETIC ACT

tor age

rq

CT- BEFORE A

,HEARING

AL SUBCOMMITTEE

-0 Nugs% OF THE

COMMITTEE ON

r,

BOR AND PUBLIC WELFARE

UNITED STATES SENATE

EIGHTY-NINTH CONGRESS

FIRST SESSION

ON

S. 1839 and H.R. 7042

TO AMEND SECTION 402(d) OF THE FEDERAL FOOD,

DRUG, AND COSMETIC ACT

AUGUST 24, 1965

Printed for the use of the

Committee on Labor and Public Welfare

U.S. GOVERNMENT PRINTING OFFICE

Z 2-927 WASHINGTON: 1965
4 Etc

COMMITTEE ON LABOR AND PUBLIC Wli++-A

LISTER HILL, Alabama, Chairman

PAT McNAMARA, Michigan

WAYNE MORSE, Oregon

RALPH W. YARBOROUGH, Texas

JOSEPH S. CLARK, Pennsylvania

JENNINGS RANDOLPH, West Virginia

HARRISON A. WILLIAMS, JR., New Jersey

CLAIBORNE PELL, Rhode Island

EDWARD M. KENNEDY, Massachusetts

GAYLORD NELSON, Wisconsin

ROBERT F. KENNEDY, New York

STEWART E. MCCLURE, Chief Clerk

JOHN S. FORSYTHE, General Counsel

STEPHEN KURZMAN, Minority Counsel

JACOB K. JAVITS, New York

WINSTON L. PROUTY, Vermont

PETER H. DOMINICK, Colorado

GEORGE MURPHY, California

PAUL J. FANNIN, Arizona

SPECIAL SUBCOMMITTEE ON S. 1839

HARRISON A. WILLIAMS, JR., New Jersey, Chairman

CLAIBORNE PELL, Rhode Island JACOB K. JAVITS, New York EDWARD M. KENNEDY, Massachusetts GEORGE MURPHY, California

ROBERT W. BARCLAY, Professional Staff Member

ROY H. MILLENSON, Minority Clerk

II
CON TEN

Text of— 

Page

S. 1839 - 2

H.R. 7042 

3

CHRONOLOGICAL LIST OF WITNESSES

Hon. Jacob K. Javits, a U.S. Senator from the State of New York 6

George P. Larrick, Commissioner of Food and Drugs, Department of

Health, Education, and Welfare; accompanied by Van W. Smart,

Office of Assistant Commissioner for Planning, Food and Drug Administration 

7

John W. Vassos, director of research and development of Whitman

Division, Pet Milk Co., Philadelphia, Pa.; accompanied by John H.

Nair, consultant to the food industry, Raleigh, N C 17

Ruth G. Desmond, president, Federation of Homemakers 27

Roger Folz, director and past president, National Vendors Association;

accompanied by Donald A. Mitchell, general counsel 37

STATEMENTS

Desmond, Ruth G., president, Federation of Homemakers 27

Folz, Roger, director and past president, National Vendors Association;

accompanied by Donald A. Mitchell, general counsel 37

Hartke, Hon. Vance, a U.S. Senator from the State of Indiana, prepared

statement 

5

Javits, Hon. Jacob K. a U.S. Senator from the State of New York 6

Larrick, George P., Commissioner of Food and Drugs, Department of

Health, Education, and Welfare, accompanied by Van W. Smart,

Office of Assistant Commissioner for Planning, Food and Drug Administration 

7

Nair, John H., consultant, food and chemical industries, Raleigh, N.C 23

Scott, Hon. Hugh, a U.S. Senator from the State of Pennsylvania 40

Vassos, John W. director of research and development of Whitman

Division, Pet kilk Co., Philadelphia, Pa.; accompanied by John H.

Nair, consultant to the food industry, Raleigh, N C 17

ADDITIONAL INFORMATION

Letters from—

Feighner, J. W., president, Tom Huston Peanut Co., to Senator

Williams, August 23, 1965 42

Mulcahy, T. R., director of public affairs, the Pillsbury Co., Minneapolis, Minn., to Senator Williams, August 5, 1965 42

Newman, Sarah H., general secretary, National Consumers League,

to Senator Williams, August 31, 1965 41

Randolph, Hon. Jennings, to Senator Williams of New Jersey,

August 24, 1965 

5

Table 1.—Tables of expectancy of life insurance companies 36.

III

AMEND SECTION 402(d) OF THE FEDERAL FOOD,

DRUG, AND COSMETIC ACT

TUESDAY, AUGUST 24, 1965

U.S. SENATE,

SPECIAL SUBCOMMITTEE OF THE

COMMITTEE ON LABOR AND PUBLIC WELFARE,

Washington, D.C.

The special subcommittee met, pursuant to notice, in room 4221,

New Senate Office Building, at 10 a.m., Senator Harrison A. Williams,

Jr., chairman of the special subcommittee, presiding.

Present: Senators Williams (presiding), and Javits.

Committee staff members present: Robert W. Barclay, professional

staff member; Frank Cummings, minority labor counsel; and Woodruff

M. Price, executive assistant to Senator Williams.

Senator WILLIAMS. The special subcommittee will now come to

order.

As you will see this morning, there is a lot of competition for the

time of our members. I think many of the subcommittees of the

Labor Committee are meeting, and members of this special subcommittee have to be many places. So, without waiting further for any

of our other members to arrive here, we will begin.

This is a hearing by a special subcommittee appointed by Chairman.

Hill consisting of, in addition to myself, Senator Kennedy of Massachusetts, and Senators Pell, Javits, and Murphy.

The responsibility of this special subcommittee is to conduct a,

hearing and submit a report to the Labor and Public Welfare Committee on H.R. 7042 and S. 1839. They are identical bills.

(The bills referred to appear on following pages.)

Senator WILLIAMS. H.R. 7042 was introduced by Representative

Torbert Macdonald of Massachusetts. It passed the House of Representatives on June 7 of this year. While no hearings were held this

year in the House on H.R. 7042, hearings were held by the House

Public Health and Safety Subcommittee of the House Interstate and

Foreign Commerce Committee last year on H.R. 4731, which was an

identical bill, and that passed the House in the last session. As the

result, the House this year passed H.R. 7042 without the necessity,

of course, of further hearings.

S. 1839 was introduced by 16 Senators, 8 of whom are members of

the Labor and Public Welfare Committee and 4 of whom are members

of this special subcommittee. Until the food additives amendment

was enacted in 1958, the Food and Drug Administration lacked

effective authority to assure the safety of the many additives used in

foods. While until 1958 the Food and Drug Administration did lack

this authority over foods in general, it has traditionally had a broad

authority over additives used by the confectionery industry.'

1
2 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

89Trt CONGRESS

1sT SESSION S. 1839

IN THE SENATE OF THE UNITED STATES

APRIL 213, 1965

Mr. HARTKE (for himself, Mr. SCOTT, Mr. CLARK, Mr. Boccs, Mr. KENNEDY

Of Massachusetts, Mr. DIRKSEN, Mr. FANNIN, Mr. MCCARTH Y, Mr.

MURPHY, Mr. WiLmAms of New Jersey, Mr. MONDALE, Mr. HOLLAND,

Mr. PROUTY, Mr. WILLIAMS of Delaware, Mr. RANDOLPH, and Mr. JAvrrs)

introduced the following bill; which was read twice and referred to the

Committee on Labor and Public Welfare

A BILL

To amend section 402 (d) of the Federal Food, Drug, and.

Cosmetic Act.

1 Be it enacted by the Senate and House of 1?epresenta2 tives of the United States of America in Congress assembled,

3 That section 402 (d) of the Federal Food, Drug, and Cos4 metic Act, as amended, is hereby amended to read as follows:

5 "(d) If it is confectionery, and it bears or contains6 "any alcohol other than not to exceed one-half

7 of 1 per centum by volume derived solely from the

8 use of flavoring extracts."

II
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

89Til CONGRESS H R

1ST SESSION R. 7042

IN THE SENATE OF THE UNITED STATES

JUNE 8 (legislative day, JUNE 7), 1965

Read twice and referred to the Committee on Labor and Public Welfare

AN ACT

3

"To amend section 402 (d) of the Federal Food, Drug, and

Cosmetic Act.

1 Be it enacted by the Senate and House of Representa2 tires of the United States of America in Congress assembled,

3 That section 402 (d) of the Federal Food, Drug, and Cos4 metic Act, as amended, is hereby amended to read as follows:

5 "(d) If it is confectionery, and it bears or contains6 "any alcohol other than not to exceed one-half of

7 1 per centum by volume derived solely from the use of

8 flavoring extracts."

Passed the House of Representatives June 7, 1965.

Attest: RALPH R. ROBERTS,

Clerk.

I I_
4 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

First, in the Food and Drugs Act of 1906 and then later in the Federal Food, Drug, and Cosmetic Act of 1938, Congress sought to assure the wholesomeness of all additives used in confectionery by requiring that all such additives, with special statutory exceptions, should be nutritive, or have food value. When Congress in 1958 enacted the food additives amendment, in effect it obtained Federal control over all additives used in all foods with a requirement that each such additive be pretested to determine its safety before being used.

Even though Congress in 1958 enacted this broad statute covering all additives used in all foods, it failed to amend section 402(d) which pertains only to confectionery. As a result, confectionery manu- facturers not only have been subjected to the broad food additives statute assuring safety of all additives used in all foods, to which the confectionery industry is, of course, not opposed, but the confectionery industry continues to be covered by section 402(d) of the Federal Food, Drug, and Cosmetic Act.

In substance, section 402(d) pertains to three items. One is alcohol. Section 402(d) prevents the use of alcohol except not to exceed one- half of 1 percent by volume derived solely from the use of flavoring extracts. The confectionery industry is not seeking to change the provision of 402(d) as it pertains to alcohol.

The second provision of section 402(d) is that with certain excep- .

tions it prohibits the use of any additive which is not nutritive. The confectionery industry contends that it should not be subjected, as I

understand it, to a double standard to which no other industry is subjected. It maintains that if an additive is safe, it should have the right to use it just as the rest of the food industry does. It is also maintained that the FDA should be concerned solely with the safety of additives and not with their nutritive value. In other words, it is felt that the FDA is rightly concerned with protecting the public from harm, but should not attempt to write recipes. It should also be pointed out that if this bill is passed, the public will continue to be protected from excessive use of nonnutritive additives by the other adulteration provisions of section 402 of the Food and Drug Act. This is the principal issue involved. Because of the seemingly in- equitable situation, many Members of Congress including myself, have introduced this corrective legislation.

The third aspect of section 402(d) pertains to nonnutritive articles

or trinkets and their use involving confectionery, and I am sure we will have testimony on this.

I will say that I appreciate Chairman Hill's response to the sponsors of this bill in suggesting that a special committee be formed to consider it. We have not only many cosponsors but many Members who are not cosponsors but who have expressed interest in this legislation, and have appreciated the fact that we are moving quite alertly to con- sider it.

I have a letter from Senator Jennings Randolph which, without objection, I would like to include in the record at this point, in support of this legislation.

And I would also like to include in the record the statement of Senator Hartke, the principal sponsor of this legislation.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 5

(The documents referred to follow:) U.S. SENATE,

COMMITTEE ON LABOR AND PUBLIC WELFARE,

August 24, 1965.

Hon. HARRISON A. WILLIAMS, Jr.,

U.S. Senate,

Washington, D.C.

DEAR PETE: Thanks for your recent letter informing me of your plans to

conduct Senate hearings on H.R. 7042, a bill which would amend the Federal

Food, Drug, and Cosmetic Act to permit the use of safe nonnutritive additives in

the manufacture of confectionery.

As you know, I am a cosponsor of the Senate version of this measure, S. 1839,

introduced by Senator Hartke on April 28, 1965. We are also aware that a

similar bill was overwhelmingly approved in the House of Representatives during

the 88th Congress but did not come to a vote in the Senate.

Under the present provisions of the Federal Food, Drug, and Cosmetic Act,

such foodstuffs as canned goods, baby foods, baked goods, and preserves may

contain a variety of preservatives, emulsifiers, stabilizers, and other additives.

These ingredients do much to improve the texture, flavor, and other desirable

attributes of the product. Use of these safe, nonnutritive additives, however,

is denied our confectionery industry.

It would appear that some congressional action is justified to eliminate this

discrimination against reputable members of the confectionery industry, and to

permit them to employ in the manufacture of candy products the same safe,

nonnutritive additives that are used widely by other food producers.

I am hopeful that language can be worked out which will remedy this inequitable

situation, which will be acceptable to the Food and Drug Administration, and

which will offer effective safeguards for the consumer.

It would be appreciated if this letter could be made a part of the official record

of your hearings.

With appreciation and warm personal regards, I am,

Very truly, JENNINGS R,ANDOLPH.

STATEMENT OF HON. VANCE HARTKE, A U.S. SENATOR FROM THE

STATE OF INDIANA

Senator HARTKE. Mr. Chairman, I am happy to present a statement in support of H.R. 7042, a companion bill to S. 1839, which I

introduced in the Senate on April 28. I would like to note that the

Senate bill was cosponsored by 15 other Senators from both sides of

the aisle. They are Senators Scott, Clark, Boggs, Kennedy of

Massachusetts, Dirksen, Fannin

'

McCarthy, Murphy, Williams of

New Jersey, Mondale, Holland, Prouty, Williams of Delaware,

Randolph, and Javits.

I am happy that the House has again passed this bill, as it did also

last year on August 12. I sincerely hope that the Senate will give

it favorable consideration in committee and on the floor so that this

year will see its enactment.

This bill will allow the use of nonnutritive substances in the manufacture of candy, according them the same treatment now extended

to their use in all other foods, provided their safety for human consumption has been established. There is no logical reason for permitting a variety of emulsifiers, stabilizers, preservatives, and additives which improve the desirability of the product in canned foods,

baked foods, even baby foods, and denying the candy industry the

right to employ them.

It is true that the prohibition had a historical justification. The

Food and Drug Act of 1906 was in part brought about by the adulteration of candy which some unscrupulous makers had employed around

52-927-65-2
6 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

the 

being 

turn 

added 

of the 

to 

century. 

increase 

Substances such as terra alba and talc were

reason other than, to be 

bulk and weight, without regard to any

greater profit. The language 

blunt, cheating the buyer and making a

additives used in confectionery 

of the 1906 act, specifying that all

forward in succeeding must be nutritional, was carried laws.

there 

But 

have 

as scientific 

been 

advancement has taken place in the food industry,

do not adulterate 

developed 

foods 

numerous nonnutritive additives which

otherwise to the advantage 

but enhance them in appearance, taste, and

of it. The Food 

of the product and the public's enjoyment

all such materials 

Additives 

before 

Amendment of 1958 requires pretesting of

language forbidding nonnutritive 

they may be used in food. But the old

This bill is one which 

additives to candy is still there.

same rights to candy makers 

will give, without any danger whatsoever, the

for the use of safe 

as those enjoyed by other food processors

ministration. additives, approved by the Food and Drug Adspecial 

The case 

prohibition 

is really 

of 

very 

nonnutritive 

simple and entirely logical. Any need for the

moved since enactment 

additives for candy has been reprovisions instead of being 

of the 1958 law, if candy is brought under its flatly excluded.

support 

As author 

the enactment 

of the Senate bill to achieve the same purpose, I strongly

public, since it extends 

of this measure. It cannot harm the consuming

At the same time, it 

the same protection now given to other foods.

most modern and useful 

can 

techniques 

assist the candy industry to employ the

the subcommittee will 

for enhancing its product. I trust

needless restriction in existence 

see fit to recommend its passage, and that the may be removed. Senator WILLIAMS. Senator Javits?

STATEMENT OF SENATOR JACOB K. JAVITS, U.S. SENATOR FROM THE STATE OF NEW YORK

consulted 

Senator 

about 

JAVITS. 

the 

Mr. 

matter 

Chairman, I just wish to state that, when first

of my support that I would 

by the industry, I made it a sine qua non

this measure would not only 

have to be absolutely convinced that

would be of a positive and 

not be a disadvantage to consumers but

Chairman, consumers and 

affirmative advantage to consumers. Mr.

that, if we have any 

their representatives should be reassured

protect against that doubt 

doubt about its effect upon consumers, we will

lation, notwithstanding the fact 

even to the extent of rejecting the legis- •

I that I am a sponsor.

science 

wish 

I feel 

to pledge 

that this 

myself 

is 

to the consumers that, if in the best coninterest, I will be the 

something that should not be done in their

personally. embarrassing. 

first 

The 

to stand against it; whether or not it is

lation will be meaningless. 

fact that I am a sponsor of the legisto test out whether 

The purpose of these hearings is precisely

insignificant as it may 

there is even any fair doubt—small, modest,

So far, I think 

be—if there is any real doubt at all.

self and, I believe 

that 

in all 

has 

fairness, 

been the standard that I have set for mydelighted to have heard what 

that of my colleagues; and I am

out the dynamics and 

the Chair just said which, in spelling

that conclusion. details of the questions, comes precisely to
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 7

Senator WILLIAMS. I certainly appreciate that.

Senator JAVITS. Thank you, Mr. Chairman.

Senator WILLIAMS. We will proceed with our first witness, Mr.

George P. LaiTick, Commissioner of the Food and Drug Administration; accompanied by Mr. Van W. Smart, Office of Assistant

Commissioner for Planning, Food and Drug Administration.

Mr. Larrick, you are a welcomed, regular visitor before the

various Senate committees, and now before this special subcommittee,

and we certainly appreciate your continuing assistance. I believe

we will have you back shortly on another bill of mine dealing with

premarket testing of therapeutic devices. We do not have a schedule

of hearings on that, but you have been most helpful in dissolving

that legislation in the interest of consumers who are, too often, being

duped by false devices, and false claims for devices.

STATEMENT OF GEORGE P. LARRICK, COMMISSIONER OF FOOD

AND DRUGS, DEPARTMENT OF HEALTH, EDUCATION, AND

WELFARE; ACCOMPANIED BY VAN W. SMART, OFFICE OF

ASSISTANT COMMISSIONER FOR PLANNING, FOOD AND DRUG

ADMINISTRATION

Mr. LARRICK. Right. I certainly hope that there will be time for

Congress to consider your bill this session before it adjourns for the

holiday.

Thank you again for this opportunity to discuss S. 1839 and H.R.

7042, which, as you have pointed out, are bills to amend section 402(d)

of the Federal Food, Drug, and Cosmetic Act.

The provision of the present law now declares confectionery to be

adulterated if it contains any alcohol or any nonnutritive substances

other than coloring, harmless flavoring, harmless resinous glaze,

natural gum, or pectin. Small amounts of alcohol are permitted as

constituents of flavoring extracts, and chewing gum may contain

harmless nonnutritive masticatory substances. The bills would

change this to permit the use of nonnutritive substances.

The Department for whom I speak is opposed to the passage of this

legislation in its present form, Mr. Chairman, because it would roll

back certain public health and consumer protection features of the

national pure food law. We have suggested, in our report, substitute

language which would allow the confectionery industry to use nonnutritive substances which perform a functional purpose, such as

mineral oil as a slab grease in candy making, upon compliance with

the preclearance procedures of the food additives amendment, and

the Department has proposed clarifying language which would plainly

outlaw the commingling of unwrapped metallic and plastic trinkets

with confectionery. The amendments we have suggested would, in

our judgment, meet the stated objectives of the confectionery industry

without weakening existing law.

Section 7 of the Federal Food and Drugs Act of 1906 was the

predecessor of section 402(d) of the present law. That provision

aimed primarily at preventing economic adulteration of confectionery,

but it also embodied other features, such as the ban on adding alcohol

to confectionery.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

and 

Between 

plastic 

1906 

trinkets 

and 

in 

1938 some manufacturers began mixing metallic

hearings and debates on 

candy 

the 

and in candy containers. During the

Federal Food, Drug, and 

various bills which led to enactment of the

opinion clearly stated its 

Cosmetic Act of 1938, Congress in our

- Senate report on one of these 

concern about these trinkets in candy. The bills stated:

This provision will also ban such practices as embedding metallic trinkets in 'confectionery, which often result in the aspiration and lodgment of the trinket In the windpipes of children.

given 

Thus, 

by 

section 

section 7 

402(d) of the 1938 law, broadened the protection

of trinkets in candy. 

of the Wiley law of 1906 to prohibit the concealing

forbade the indiscriminate 

We thought that the language of the 1938 law

and other containers. We 

mixing of trinkets with candy in packages

courts. In 1951 the U.S. 

were unable to sustain this position in the

held that inedible plastic 

Court of Appeals for the Fourth Circuit

chewing gum in vending machines 

and metal trinkets admixed with candy and

and chewing gum (as required 

were not "contained" in the candy

along with it.

by sec. 402(d)) but were merely sold

the 

The 

candy. 

district 

An 

court 

expert 

had held that the trinkets were "contained" in

trial of that case about the 

witness for the Government testified at the

candy and gum. This 

dangers inherent in mixing trinkets with

for on August 21, 

witness' testimony proved all too accurate,

choked to death on a 

1953, an 8-year-old boy in Long Island, N.Y.,

machine. When 

plastic trinket he got with gum from a vending

take regulatory action. 

these facts 

However, 

came to our attention, we attempted to

a case on the basis of the 

the U.S. attorney declined to file

we have been unable 

court's decision in the earlier case. Thus,

despite the 

to deal with trinkets mixed with confectionery, known dangers.

Association 

We recently 

for 

solicited 

Thoracic 

the views of the members of the American

from the biting, 

Surgery about injuries to children resulting

confectionery. 

swallowing, or aspirating of trinkets accompanying

association. Two 

Questionnaires 

hundred 

were sent to the 600 surgeons in the

number, 22 reported 34 documented 

and fifty-three responded, and of this

also mentioned 78 

cases of injury. The responses

documented. 

additional cases, but these were inadequately

principle, trinkets 

Ten 

mixed 

surgeons reporting no injuries stated that, in

children. with confectionery present a hazard to

of 

Mr. 

a 2-year

Chairman, 

-old child 

I have here a print of an X-ray taken of the chest

machine. The surgeon 

that obtained a toy Pegasus from a vending

child's chest had to be opened 

who reported this case to us stated that the

esophagus repaired. Fortunately, 

so the trinket could be removed and the

The this child recovered.

addition 

only 

to confectionery 

specific prohibition in these two bills, would be on the

This would not 

of alcohol in excess of one-half of 1 percent.

would thus perpetuate 

reach the problem of trinkets admixed with candy and

permit the old practice 

the loophole in present law. It would also

Department's suggested 

of concealing trinkets to be revived. Our

prohibition on concealed 

amendment would make clear that the present

the indiscriminate trinkets is continued and would also prohibit mixing of trinkets with confectionery.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 9

Senator JAVITS. Mr. Chairman, may I interrupt the witness for a

minute?

Would the witness inform us, what is the pertinence to H.R. 7042

of the testimony which he is now giving about trinkets? What is the

germaneness to this bill? We are not talking about trinkets.

Mr. LARRICK. Yes, you are, Senator.

Senator JAVITS. We are?

Mr. LARRICK. You are repealing a basic public health protection

provided by the present law and you are failing to correct a definite

loophole in the present law. I have just testified about a survey that

we made of all members of the thoracic surgeons' association in the

United States who reported complicated cases where children

aspirated trinkets and where surgery or other drastic measures had to

be taken.

Senator JAVITS. What do you wish us to do then? Not confine

ourselves to this bill? You want us to plug up another loophole in

another respect that you find in the law; is that right?

Mr. LARRICK. Yes.

Senator JAVITS. There is nothing against this bill. It is just that

you want us to do something else?

Mr. LARRICK. Well, that is not true.

Senator JAVITS. Well, that is what we are trying to find out.

Mr. LARRICK. The Department of Health, Education, and Welfare

finds two health problems in these bills.

Senator JAVITS. Yes.

Mr. LARRICK. One is a repealer of a part of the present statute

which prohibits imbedding foreign objects, metallic objects, and toys

in candy.

Now, that is clearly prohibited by the present statute. If you

enact this bill, you repeal it.

Senator JAVITS. I see. So, you wish to save that section; is that

right?

Mr. LARRICK. I am asking you to save that section.

Senator JAVITS. Right.

Mr. LARRICK. And I am asking you to overcome an adverse

circuit court of appeals decision which we think is notSenator JAVITS. Now, are these two questions severable?

In other words, is it physically possible to write a law which will

not repeal the trinket section while legislating into law what we wish

to do about additives or preservatives, or call it what you will?

Mr. LARRICK. Yes.

Senator JAVITS. That is possible?

Mr. LARRICK. That is quite possible.

Senator JAVITS. Will you show us how to do it?

Mr. LARRICK. I am not personally a draftsman

Senator JAVITS. You will show us how to do it?

Mr. LARRICK. We will be glad to show you.

Senator JAVITS. That is all I was trying to get at. Thank you

very much.

Mr. LARRICK. Under the heading of economic adulteration, the bills

will roll back present law designed to protect consumers against economic adulteration. Before the enactment of the Federal Food and

Drugs Act of 1906, candy and other confectionery was often debased

with cheap fillers such as white clay, talc, and barytes. These sub-
10 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

stances were used as a less expensive substitute for nutritive ingre- dients. It was this type of debasement that section 7 of the 1906 law sought to prohibit by deeming confectionery to be adulterated:

If it contains terra alba, barytes, talc, chrome yellow, or other mineral sub- stance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt or spiritous liquor or compound or narcotic drug.

Thus, the use of the named substances in confectionery to increase bulk, at the expense of quality, was effectively banned. When the Federal Food, Drug, and Cosmetic Act of 1938 was passed, the old section 7 was broadened to prohibit all nonnutritive substances and articles except harmless coloring, harmless flavoring, glaze, and natural gum and pectin. In 1960 the words "harmless coloring" were changed to read "authorized coloring." Other than this, the law has remained unchanged since 1938. Today it still prohibits adulteration of confectionery by nonnutritive substances and by embedding trinkets in the candy.

Senator WILLIAMS. And the confectionery section is a separate section, and the limitation on nonnutritive substances is a lot broader than the sections dealing with food, generally; is that right?

Mr. LARRICK. That is quite correct, Senator Williams.

In the past 22 years we have detained about 140 lots of imported. confectionery containing nonnutritive substances. These cases in- volved the presence of such things as talc, clay, silver, and mineral oil. The utilization of section 402(b) (4), the so-called economic adultera- tion provision, to prevent debasement of confectionery with cheap fillers would be extremely difficult to say the least. For example, a

U.S. court of appeals, in a leading case, has said that in determining

whether a product is adulterated because it has been made to appear better than it is, the standard to be applied is whether the adulterated product has been made to appear to be a defined superior product.

The reaction of the ordinary consumer who exercises a normal measure

of the layman's commonsense and knowledge is the test as to what the product appears to be.

I have given the citation to that case in the footnote, which is United States v. 88 Cases (187 F. 2d 967 (3d Cir. 1951); cert. den. 342

U.S. 861 (1951)).

Children, important purchasers of confectionery, could hardly be expected to measure up to this standard.

Confectionery comes in so many different forms that more often

than not there is no defined superior article which the adulterated food simulates. Thus, it is no answer to say that we can proceed against

the debased candy under the general adulteration provisions of the

law. Nor does the standard making authority provide the answer

because it is impractical to establish standards for all confectionery

products. The food additives amendment will not take care of the debasement because many of the adulterants would be safe.

If either of these bills is passed in its present form, the pre-1906 practices of adding cheap filler substances in small amounts may again

be possible; also the pre-1938 practice of concealing trinkets in candy

can be claimed, perhaps successfully, to be allowable.

The Federal Food, Drug, and Cosmetic Act is designed to protect

consumers generally, but section 402(d) is particularly concerned with

the protection of children—the young and unsophisticated buyer.

Thus, the argument for equality of treatment of candy with other foods
AMEND THE FEDERAL FOOD, DRUG, AN

is not really relevant, in our judgment, si

present law seeks to protect children partic

history of being debased with economic ad

problem of trinkets, this country's confectio

wholesome. We do, however, point to the pa

of adulterants found in imported candy in recent

adulterants in domestic candy before 1906.

The President's Consumer Advisory Council, in May of last year,

adopted a resolution unequivocally opposing the passage of H.R.

4731 in the last Congress.

We understand that the confectionery industry merely seeks the

right to use safe nonnutritive substances in manufacturing processes

when such substances serve a useful technological purpose. We

would not object to an amendment to section 402(d) which would

allow industry to use safe nonnutritive substances having a technological value in the production of confectionery. The Department's

report of August 18, 1965, encloses suggested language to accomplish

this. Thank you very much.

Senator WILLIAMS. Commissioner Larrick, up above you say it is

impractical to establish standards for all confectionery products.

And now down here, you suggest that it would be all right for nonnutritive substances having a technological value to be used in the

production of confectionery.

Well, this would put you right in the position of having to establish

standards for all confectionery products, would it not?

Mr. LARRICK. Not at all, Senator. It would simply put us in the

position of having the manufacturer convince us that the additive

did serve some useful purpose in the candy. It would parallel 

Senator WILLIAMS. Let us be absolutely clear as to what we are

talking about here. We are only talking about a change in law that

would permit the use of safe nonnutritive substances, are we not?

Mr. LARRICK. And our counsel believes that that would permit

safe, economic adulterants.

Senator WILLIAMS. We are only talking about safe substances.

We are not talking about anything harmful?

Mr. LARRICK. I would not agree with that, Senator. I would think

in the case of trinkets, you are talking about something that is harmful.

Senator WILLIAMS. Well, now, that comes back to Senator Javits'

observation on the trinket that is imbedded and the trinket that is

Commingled. And you have suggested that you can help us find a way

to make the trinket issue divisible between imbedded and commingled.

Mr. LARRICK. Right. And that is the most important 

Senator WILLIAMS. We have been working on language that would

clearly prohibit the imbedding of any article in confectionery.

Mr. LARRICK. You would still leave the health hazard of trinkets

mixed with confectionery and the trinkets in the vending machine.

Senator WILLIAMS. Well, again, I agree with Senator Javits.

We are opening an entirely new area of discussion here.

Mr. LARRICK. You are amending an important 

Senator WILLIAMS. Do you not find that there are a lot of nonconfectionery foods that package with trinkets commingled?

Mr. LARRICK. There have been some breakfast foods that have

been packaged with trinkets.

11

the

long

the

e and

e types

e types of
12 AMEND THE^ ERAL FOOD, DRUG, AND COSMETIC ACT

Senator WILLIAMS. T4 re still are, and I think that maybe you have 'something to, dilt ss here, but it is a lot broader than confeiilnery. •

Mr. LARRICK. Our jeyerience has been that the principal public health 114106-d-4e nfirmed by the 600 thoracic surgeons that we have coma ' Jiatst importantly in candy.

Senator JAVITS. Mr. Chairman, would the Chair yield for a moment? Senator WILLIAMS. Yes.

Senator JAVITS. Commissioner Larrick, we are not in adversary proceedings here, are we?

Mr. LARRICK. Not at all. I deem it my duty, Senator, to speak

very forthrightly, and when we get through anything you decide we will accept graciously and do our best to carry it into effect. Senator JAvirrs. That was not quite my point. I did not mean that

you are adverse to us. I inquired whether you are adverse to the mdustry.

Mr. LARRICK. The industry has been very cooperative. We think

very highly of this industry. We reserve the right to have differences with them. They are both officially and personally good friends of the Food and Drug Administration and some of us in it.

Senator JAVITS. Well, yes. Rather than to try and develop and settle this problem at arms' length, might it be conceivable, as this is an industry problem, that coupling a suitable amendment to the law with some ethical declaration on the part of industry to which perhaps

even other Government agencies might be a party, this problem could be settled, and that it might be worthwhile under our auspices to get

you and the industry together to see if there can be an agreed solution to these problems?

Mr. LARRICK. Senator, if that can be done, it would be a very happy day. We would welcome an opportunity to try. I should

say that we have tried several times without success, but I think it is always worthwhile trying again.

Senator JAVITS. To try to do that, yes. Because, it seems to

me, you are dealing with a mixed problem of law and business practice; and the trinket ramification, it seems to me, does raise that question

very sharply. I would agree with my chairman that, on the face of it, the mere fact that you sell a jack and a ball of gum—and, of course,

you know I have kids, too, and I know precisely what this is—does not necessarily make it a hazard, but it may be a hazard in practice because the thing is small enough to swallow, and these kids, you know, kind of take a handful of anything they see and swallow it. Mr. LARRICK. They eat or chew the gum, and the rest of the ma- terial goes in their mouth.

Senator JAVITS. Yes. I just wonder, Mr. Chairman, based upon

your testimony as well as the testimony of the industry, whether it might in this case be fruitful to bring the parties together under our auspices in an effort to see if some agreed businesslike solution could not be arrived at.

Mr. LARRICK. That, we would welcome.

Senator JAVITS. Thank you very much.

Senator WILLIAMS. I am not sure I follow this dialog. What is the fear that you have that would require some understanding with the industry?

Again, I come back to the fact that we are only talking about those substances that you have found to be safe in food. Confec-
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 13

tionery, while separately dealt with under the law, has nutritive

value. It is like a food, is it not?

Mr. LARRICK. Well, maybe I have an extreme view, but I hate to

see the pure food and drug law weakened, and there is no question

but that this does weaken the pure food and drug law.

Senator WILLIAMS. I do not know. It seems to .me that if we can

solve the imbedded question, and I am sure we can solve it, that what

this bill does is extend the same kind of opportunity, and I would put

this in terms of inequity to the confectionery people, that your law

that you are so proud of extends to food. I hate to disappoint my

confectionery friends, and I am sure some of them are here in the

audience today, but I have a few kids, too. And I will tell you, they

are doing a lot of buying of cookies and cakes, and they are buying

their own cereals these days. They are a little off candy and on food.

Mr. LARRICK. Four- and five-year-old children are?

Senator WILLIAMS. Yes.

Mr. LARRICK. Well, my experience has been that the children buy

candy a lot more than they buy other things that children need.

Senator WILLIAMS. I was rudely awakened up in the country

yesterday morning by my 10-year-old boy saying, "Hey, pop, where

is the money? I want to get some flakes."

Mr. LARRICK. Some what?

Senator WILLIAMS. Flakes.

Mr. LARRICK. Oh, I see. How old was the child?

Senator WILLIAMS. This was the 10-year-old.

Mr. LARRICK. We are also concerned about 10 year olds. These

children that have these things are mostly very young children.

Senator WILLIAMS. Well, now, again, we are coming back to the

commingling and that is really not the issue before this subcommittee.

Mr. LARRICK. Well, you are amending the basic section of the pure

food and drug law that was originally construed to deal with both

problems.

Senator WILLIAMS. Is that what the circuit court of appeals said?

Mr. LARRICK. The circuit court of appeals decided that it did not

cover it, but it certainly was intended to cover it. At least, I testified

personally at these hearings when it was put in the law.

Senator WILLIAMS. You know that the best evidence of what

Congress really intended is what the court says it intended. We cannot argue with that.

Mr. LARRICK. That is the law of the land.

Senator WILLIAMS. That is. Our intention is defined in the circuit

courts and ultimately the Supreme Court.

Mr. LARRICK. This did not go the Supreme Court. It stopped at

the fourth circuit, as I recall.

Senator WILLIAMS. Did you ask for a writ of certiorari from the

Supreme Court?

Mr. LARRICK. I do not recall.

Mr. SMART. No,I do not see certiorari denied.

Mr. LARRICK. We could supply that for the record. Maybe

John Mackey knows. He has studied these cases. Maybe he

knows.

Senator WILLIAMS. Well, I would say the industry folks would

not have asked certiorari, because they won.

52-927--65-8
14 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

Mr. LARRICK. NO, that is right.

Senator WILLIAMS. It would be your Department.

looked 

Mr. LARRICK. 

it up 

That is right, and I just did not happen to have

the decision, 

to see whether the certiorari was sought. We accepted

another case 

and the U. S. attorney subsequently declined to file

that came 

even after the child had died. That was a trinket

Senator 

out of a vending machine. I take a very serious view 

Mr. LARRICK. 

WILLIAMS. Well, I do not want this record to be confused. Of this being a hazard to children.

reading 

Senator WILLIAMS. The Members of the Senate will be carefully

this legislation 

this record, and I think that it should be crystal clear that

the law 

we are dealing with has not a thing to do with changing

Mr. 

with respect to the commingling of trinkets in candy. LARRICK. Well, do not forget 

question 

Senator 

on 

WILLIAMS. 

a rollback 

This repealer might present, as it is, some

and 

which would allow the possibility of imbedding,

have 

believe 

already 

me, 

indicated.

we will take care of that, and with your help, as you

very 

Mr. 

clear 

LARRICK. 

that we 

We will give it to you, but I think I should make it

problem, 

are dealing with a real problem, not a theoretical

cited in my 

when 

testimony 

we are dealing with trinkets in vending machines. I

1953, choked 

that a child of 8 years of age who, on August 21,

vending machine. 

to death on a plastic trinket he got with gum from a

duty of the Department 

And under those circumstances, I think it is the of Health to emphatically urge 

ment 

Senator 

drawn 

WILLIAMS. Well, have you presented—has your Departfoods and in candy 

legislation that would deal with commingling both in and brought it up here Mr. LARRICK. Yes, sir, and sent it to the committee. Senator WILLIAMS. Oh, you have?

Mr. LARRICK. We have; yes, sir.

little 

Senator 

thing 

WILLIAMS. No, no, before this came on. This is a simple that we are dealing with here.

long 

Mr. 

time.

LARRICK. Yes, we have had this bill before the Congress for a

Senator WILLIAMS. The commingling in food and candy?

bill—but 

Mr. LARRICK. 

my 

My recollection is—I did not personally handle the

several 

recollection is that we sent up alternative language times.

Senator WILLIAMS. Has it ever been heard by this committee?

recall 

Mr. 

hearings 

LARRICK. Not by this committee, but in the House. I do not in the Senate previously.

mittee, 

Senator WILLIAMS. Well, Senator Hill is the chairman of this comthat 

and there are not many things that are presented in substance

tive forum.

he does not feel the responsibility to consider carefully in legislaMr. LARRICK. I have talked to Senator Hill numerous times.

deal 

Senator 

with 

WILLIAMS. And you have drafted legislation that would commingling in food and in confectionery?

that. 

Mr. LARRICK. That is my impression. I would have to check

But the 

I do not think it was presented to the Senate until this year. previous years 

number 

Senator WILLIAMS. Well, I have not seen any bill. What is the of the bill?
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 15

Mr. LARRICK. It is not a bill—this is a committee of the Congress I

understand that is dealing with an amendment to the basic section

of the statute.

Senator WILLIAMS. We are not even talking about that part of the

bill. You feel this is very important, this commingling. Have you

proposed specific legislation dealing with this problem?

Mr. LARRICK. I have proposed legislation to the Department, but

I think the Department's view was that since there were bills pending

before the Congress where the Department's point of view could be

dealt with and could be expressed completely in response to the cornmittee's request for comments on their bill, that they felt that that

was sufficient, and that they did endorse the recommendations that

we made and that legislation be had to protect children in this area.

Senator WILLIAMS. Well, I will report what you say to Senator

Hill and get his understanding of what has been 

Mr. LARRICK. Well, I think it is my duty, Senator, to point out

what our view is.

Senator WILLIAMS. Well, the only point is that I have never seen

one of those bills come up here.

Mr. LARRICK. We have never sent up a bill.

Senator WILLIAMS. Oh, than my recollection is right.

Mr. LARRICK. We sent letters to the chairman of the Insterstate

and Foreign Commerce Committee in response to their request, and

it covered the subject matter that would have been the Department

bill presumably if we had been asked to 

Senator WILLIAMS. Normally, if the downtown departments want

something, they know how to get a bill drafted and how to find

someone to introduce it, and then we are in a legislative situation.

Mr. LARRICK. That is right.

Senator WILLIAMS. Mr. Price?

Mr. PRICE. Commissioner, if this bill were passed, would you

outline—and I know you touched on this in your statement—what

ways you would have to protect the consumer from adulterated or

dangerous candy.

Mr. LARRICK. We would not abandon an attempt to prevent the

sale of any article broadly within our jurisdiction that is dangerous or

that is economically adulterated. There would be sections of our

statute that we would bring to bear. Our lawyers, upon whom I

must rely, tell me that if this bill passes we have substantially lessened

the chance that we can win those cases against either economic

adulteration or against the imbedded trinkets.

Senator WILLIAMS. Well, now, we are going to work that one out,

that imbedded issue.

Mr. LARRICK. I understand that, but I want the record 

Senator WILLIAMS. Let's forget about imbedded, because we categorically promised that those imbedded possibilities will be absolutely

prohibited and no absolutely unsafe substance will be permitted.

Mr. LARRICK. Well, I thank you very much, Senator.

Senator WILLIAMS. That is a categorical promise.

Mr. PRICE. Commissioner, in earlier discussions on this bill at a

staff level, we covered a lot of hypotheticals. We raised the point

then that if our bill passed and the candy industry went beserk and

started making candy that was 50 percent talc, or whatever, and 50

percent candy, then you would be able to proceed then, would you not?
16 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

try 

Mr. 

would 

LARRICK. I just would not suppose that the whole candy indus- go beserk.

they 

Senator 

did that 

WILLIAMS. 

with 

Well, they would then certainly go beserk if

not in business 

talc. Talc costs more than corn sirup. They are

is 8 cents a 

to lose money. Corn sirup is 6 cents a pound. Talc pound.

Mr. 

Mr. 

PRICE. But you would be able to proceed, if there were?

would prevail. 

LARRICK. With 50 percent adulterant, I would think we

chances of winning 

As you get down the line, I think you lessen our with this bill.

adulterated, 

Mr. PRICE. Where do you draw the line? If it was 25 percent you would still be able to proceed.

in 

Mr. 

the area.

LARRICK. I gave you citations to the leading court decision

that 

Senator 

mean? 

WILLIAMS. 

We 

Now, when we talk of adulteration, what does

because 

are not even talking about anything that is unsafe, anything unsafe is absolutely prohibited; right? Mr. LARRICK. Yes.

stances. 

Senator 

It 

WILLIAMS. So adulteration does not mean unsafe subMr. 

means something else. It is what you call economic.

tory' definition.

LARRICK. Well, it means both in the statute. It has a statuprohibited, 

Senator WILLIAMS. Well, anything that is unsafe absolutely is

then you have 

and you can move in and send people to jail. And

do with health. 

the economic adulteration which has not anything to

right?

It is like the fellow that is overpuffuig his goods;

have 

Mr. 

very 

LARRICK. 

much 

Well, it hurts your pocketbook when you do not in your pocket.

is 

Senator 

what it 

WILLIAMS. That is what I am saying, overpuffing. That amounts to.

candy 

Mr. 

has 

PRICE. I think what is difficult for people to understand is why

to deal with 

to be superprotected, as it were. The laws you have now

goes 

any other food would apply then to candy if this repealer through.

they 

Mr. 

wrote 

LARRICK. That was the view of the Congress in 1906 when

bought 

the law originally, that candy was a special substance

was 

and consumed very largely by children. This whole question gone into very thoroughly during the 5 years of our legislative efforts 

question 

to amend the law which was passed in 1938. This same

opinion arose, 

was gone over in great length. The same differences of

be treated 

but Congress in its wisdom decided that candy should separately.

mothers 

Senator WILLIAMS. I think you are protecting mothers and grandMother's 

more 

Day.

than children. You know, the biggest candy dealer is

Mr. LARRICK. Well, you are interested in old people, too.

are 

Senator 

so 

WILLIAMS. Yes. I just cannot see why food and candy inequitably considered, so differently considered. Mr. LARRICK. Well, I have tried to explain 

can 

Senator 

use 

WILLIAMS. And we are just trying to say for candy that they the same substance that all those food folks are using.

the 

Mr. LARRICK. I said in my concluding remarks that we thought stated objectives of the industry could be met without weakening the pure food and drug law.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 17

Senator WILLIAMS. Well, I am not sure I understood all of the

import of Senator Javits' suggestions and observations. I will say that

nobody has mastered better than he the business of consensus and

legislation. Nobody surpasses Senator Javits on that. I will have to

discuss this further with him. I think it would be wise to go on with

the rest of the hearing, and then we will see where we stand.

Mr. LARRICK. We will be at your disposal, on call.

Senator WILLIAMS. All right. Fine. Thank you very much.

Mr. LARRICK. Thank you very much, and it is always a pleasure

to try to help in any way we can.

Senator WILLIAMS. If I seemed a little strident at times, it is only

because I have lived with this provision, and, of course, I have been

given the responsibility of the committee. I have talked to many

Members of the Senate who are sponsors—I have to convince them

and convince myself.

Mr. LARRICK. Thank you very much. The hearing has been a

very pleasant one.

Senator WILLIAMS. Our next witness, Mr. John W. Vassos, comes

to us from Philadelphia, from the Whitman Division of the Pet

Milk Co., and Dr. John H. Nair, consultant, with a very distinguished

background here.

Would you come up here, Mr. Nair, too?

First, we will hear from Mr. Vassos, and then from Mr. Nair.

STATEMENT OF JOHN W. VASSOS, DIRECTOR OF RESEARCH AND

DEVELOPMENT OF WHITMAN DIVISION, PET MILK CO., PHILADELPHIA, PA.; ACCOMPANIED BY JOHN H. NAIR, CONSULTANT

TO THE FOOD INDUSTRY, RALEIGH, N.C.

Mr. VASSOS. Mr. Chairman, my name is John W. Vassos. I am

director of research and development of Whitman Division, Pet

Milk Co., confectionery manufacturers located in Philadelphia, Pa.,

and I appear as a member of the Research Committee of the National

Confectioners Association.

This association is a national trade association of confectionery

manufacturers located throughout the United States and suppliers

of goods and services to the industry. We estimate our manufacturer

members produce approximately 85 percent of the confectionery

manufactured in the United States.

This appearance is entered in support of H.R. 7042, which passed

the House of Representatives on June 7 of this year following a

unanimous report of the House Interstate and Foreign Commerce

Committee, and a companion Senate bill, S. 1839, introduced by

16 Senators, 8 of whom are members of the Labor and Public Welfare

Committee. The purpose of these bills is to let the confectionery

industry use the same safe, nonnutritive substances as may be used

by every other segment of the food industry.

Congress in 1958 enacted the food additive amendment which

requires the pretesting of all food additives used in all foods to assure

the safety of all additives to the satisfaction of the Federal Food and

Drug Administration before their use may be authorized in food

either on an unrestricted basis or for use within prescribed limits.

The Food Additives Amendment of 1958, which the confectionery

industry was pleased to support, established a new standard of pro-
18 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

tection for the American consumer to assure that every additive used in every food had been approved by the Federal Food and Drug Administration.

Section 402(d) of the Federal Food, Drug, and Cosmetic Act, with certain exceptions, requires that all additives used in confectionery be nutritive. As a result, in the case of foods other than confectionery, usage is authorized when safety has been established. In the case of the confectionery industry, after safety has been established, the additive also must be nutritive.

At the turn of the century when the Food and Drugs Act of 1906 was enacted, which provided the base for the current law, there were harmful substances being used by some manufacturers in confectionery. This was a time when there was not adequate control over the use of additives in foods in general and seemingly a requirement that addi- tives in the case of confectionery be nutritive served as a useful purpose to keep harmful substances out of confectionery. Fifty to sixty years ago this worked well for the industry, for the Government, and for the consumer. When the 1938 Federal Food, Drug, and Cosmetic Act was enacted the nonnutritive provision was carried forward which is known as section 402(d) today.

Before I go on any further, Mr. Chairman, regarding the termi- nology, quoting from Food and Drug, "nonnutritive" refers to a

substance which when ingested by man is not utilized in normal metabolism. To others, it means noncaloric. Regardless of which definition is employed our stand is the same. I am quite sure Dr. Nair will discuss this further.

With the Food Additives Amendment of 1958 having been enacted without section 402(d) having been amended, the confectionery industry has found itself in an anomalous position whereby it is treated on a basis different from every other segment of the food industry. We are very much in favor of Senate passage of H.R. 7042 for the following reasons:

(1) The industry is very desirous of having eliminated the discrimi- nation without a purpose which places the confectionery industry in a different position than the rest of the food industry. We are asking only for the same treatment as is already accorded everyone else, specifically the right to use safe additives—additives which the Fool and Drug Administration agrees to be either absolutely safe or safe for use within prescribed limits. Particularly we have reference to preservatives, emulsifiers, stabilizers, antioxidants, and release agents. The additive may keep the candy fresher longer, it may inhibit oil or other ingredient separation, it may texturize, it may prevent the candy from sticking to the slab, or it may perform one or more many other useful functions.

(2) The food business today is a highly competitive business. The human stomach holds approximately 40 ounces. There is extreme competition for space in the human stomach. If an additive imparts desirable qualities and it may be used by the bakers, the canners, the frozen food packers, the preservers, and any other food industry,

we are at a competitive disadvantage if we may not also use such additives.

(3) While we are at a competitive disadvantage today, scientific development and progress, we all know, is proceeding at an acceler- ated rate. We do not know what the future will hold. We do not
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 19

know what the scientists of tomorrow may develop which will improve

the quality and palatability of food products which by mere coincidence may not be nutritive. In the case of additives which the Food

and Drug Administration may approve for use in the future, we want

to be able to use such additives just the same as all other segments

of the food industry.

Mr. Chairman, we think we have been patient and tolerant regarding this matter. When the problem first began to confront our industry, we held initial discussions with the Food and Drug Administration in 1954 to determine if we could obtain cooperation from the

Food and Drug Administration in amending the law. Although the

law presented a hardship to our industry, we felt that they had a

sound basis at that time-1954—in not wanting to change the law,

and we accepted that position. This is in answer to Senator Javits'

comments. We did try, and we did approach Food and Drug in 1954.

At that time the Food and Drug Administration did not have the

food additive amendment and, therefore, could not assure the safety

of all additives in all foods. They do have that authority now and.,

therefore, the prohibition against the use of nonnutritive substances

in confectionery has no sound basis.

When Food and Drug first announced that it would not support

our industry position after the food additive amendment had become

law, we felt badly. We felt that they had taken a position without

good reason even though equity was completely on our side. We fully

recognize that there is a normal and natural reaction on the part of

any individual to question the wisdom of any measure involving food

additivies if opposed by the Food and Drug Administration. Nevertheless, under the circumstances we had no alternative.

The House Interstate and Foreign Commerce Committee considered the matter carefully. Last year it passed H.R. 4731 on August

12, and it reached this committee too late in the session for action.

Happily the House Interstate and Foreign Commerce Committee

•again reported a bill with the same language, H.R. 7042, this year

which has now passed the House of Representatives. We want

to invite your attention to the fact that House Report 376 was

a unanimous report of the Interstate and Foreign Commerce Committee and want to respectfully suggest that the committee would

not have taken such action had they felt that the position of the Food

and Drug Administration was not without substance. Let us make

it completely clear that we are not talking about any additives about

which there is any question of safety on the part of the Food and Drug

Administration. We are concerned only with additives which the

Food and Drug Administration itself has agreed are safe for food use.

OBJECTIONS OF THE FOOD AND DRUG ADMINISTRATION

(1) The Food and Drug Administration has commented that it

does not favor use of nonnutritive substances in confectionery because

a significant portion of confectionery is consumed by children. This

observation is so ridiculous that it is difficult to believe that the Food

and Drug Administration would advance it. We are not talking

about any additives which would be harmful to children or to anyone

else. We have reference to safe additives and only to safe additives.

We are concerned only with additives which the Food and Drug
20 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

use 

Administration 

within prescribed 

itself has certified to be safe for unrestricted use, for

future time. We 

limits, or which may be certified for use at some

but not limited 

all know children eat many other foods, including

and canned fruits 

to, baked goods, ice cream, cookies, cereals, and frozen

may be used. 

and vegetables in which safe, nonnutritive additives

than children. 

In 

Regardless 

fact, housewives today are buying more candy

any food is consumed 

of conjecture as to what percentage of

item which is consumed 

by children, we all know that baby food is an

the use of nonnutritive 

entirely by infants and the prohibition against

(2) 

additives does not apply to baby foods.

be willing 

The 

to 

Food 

permit 

and Drug Administration has indicated that it would

nonnutritive substances 

the confectionery industry to use the same safe,

and when it should 

as it approves for general use in foods if

use by 

approve the individual additive for confectionery

equitable 

special 

and 

regulation 

unfair 

in each instance. This proposal is as inapproved for use in 

as it is absurd. If an additive is safe and

industry 

foods generally, why should the confectionery

consuming 

be 

and 

required 

expensive 

to go through a useless administrative, timepurpose to require 

procedure? It would not serve a public

to use safe 

special permission for the confectionery industry

proposal is seeking 

additives. The Food and Drug Administration by this

tionery that which 

to get Congress to approve in the case of confecCongress wisely rejected 

the Food and Drug Administration proposed and

Reference is made 

in the Food Additives Amendment of 1958.

that it should 

to the Food and Drug Administration proposal

before it might 

be convinced of the technological value of an additive

We respectfully 

be used even after its safety has been established.

lost sight of its proper 

suggest that the Food and Drug Administration has

derstand it is to 

governmental function. Its function as we unlabeling, and 

determine the safety of food additives, assure proper

by the manufacturer 

to insure plant sanitation. Recipes should be written

being the judge 

so long as safe additives are used with the public

would not have 

under 

the 

our private enterprise system. Obviously we

products we have 

variety and quality of the thousands of food

to agree to the recipe 

today if the Food and Drug Administration had in every case.

bill 

(3) 

which 

The 

would 

Food 

prohibit 

and Drug Administration seeks an amendment to the

Regarding the commingling of trinkets in confectionery.

lowing of trinkets. 

this issue they contend possible tooth damage or the swalfear rather 

We believe history shows that this is a theoretical

be authoritative 

than a 

in 

practical argument. However, we do not profess to

we think it should 

this area. If by chance commingling is an evil then

industries and not 

be dealt with across the board and apply to all

attempted to emphasize 

just to the confectionery industry. As we have

reasons 

in this statement, one of the three important

eliminate 

for 

the 

the 

discrimination 

confectionery industry seeking this legislation is to

Inasmuch against the confectionery industry.

section were 

as 

amended 

section 402(d) applies only to confectionery, if this

confectionery 

to prohibit the commingling of trinkets with

fectionery industry. 

it would represent a discrimination against the conand not at 

Furthermore, it would be striking at a symptom

Although admittedly 

the base of the problem, if indeed a problem exists at all..

mingling of trinkets 

conjecture, probably there has been more com- with cereal than with any other food product, yet
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 21

this proposal would not reach such commingling, nor would it involve

the commingling in the case of popcorn, nuts, or other food commodities. If this subject is to be dealt with, it should not be an

amendment to section 402(d) but should be considered by Congress

as a separate bill after the Food and Drug Administration has presented a report based on a comprehensive study of possible problems

which may be involved with the commingling of trinkets in all food

items—not just candy.

You spend many hours of your life listening to testimony at committee hearings and invariably the witness feels that the cause which

he espouses has special merit, but we respectfully ask you to think

over our request and inquire of yourself if you have ever heard a,

more equitable or reasonable request than that which would be accomplished by this bill. This is a request that one segment of the

food industry, specifically the confectionery industry, be allowed to

use the same safe nonnutritive substances as the Food and Drug

Administration itself approves as being safe for use in all other foods.

We urge you to report H.R. 7042 to the full Labor and Public

Welfare Committee with the recommendation that it report the bill

favorably to the Senate.

Mr. Chairman, I would like to submit to your committee a medical

report from Australia on the materials such as coins, buttons, et

cetera, being swallowed by children for your evaluation.

Senator WILLIAMS. Yes. Well, I appreciate very much your statement. Of course, I think you do indicate what Senator Javits and

I were trying to develop, that no legislation is before us dealing with

this trinket business. We would certainly be alert to consider it if it

were brought to us. It has not anything to do with the bills before

us, either the House-passed bill or the Senate bill. That was not

germane. It was brought into the discussion of Commissioner Larrick, so we will receive that, too.

This has not anything to do with the bill, but about how long has

Whitman been a division of Pet Milk?

Mr. VASSOS. Approximately 3 years. We were started in 1834,

Whitman, and that is how long we have been in business.

Senator WILLIAMS. Well, I do not follow the cases as closely as I

used to when I was practicing law. I do not see you in court very

much for having gotten anybody sick with bad candy.

Mr. VASSOS. We have never been there.

Senator WILLIAMS. Never been there?

Mr. VASSOS. NO, sir.

Senator WILLIAMS. We all appreciate, of course, that the Food and

Drug Administration is the governmental arm of protection for

consumers of food and drugs. And, thank goodness, we had the

wisdom long ago to create this agency of Government, and I do not

believe anybody would suggest that in this area it should be done

exclusively State by State. There does not seem to be any inclination

here to abolish the protection granted the consumers by the Food

and Drug Administration.

Now, I wonder if the Food and Drug Administration isn't inhibiting

its opportunity to improve its protection of the consumer by being

opposed to this legislation?

Now, in the dynamics of life and the advances of technology, I

would think candy should be able to keep pace with other foods.

Candy in a sense is a perishable product, is it not?
22 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT,

Mr. VASSOS. Yes, it is.

it could 

Senator 

spoil.

WILLIAMS. And it being perishable it reaches a point where

Mr. VASSOS. That is true.

I would 

Senator 

think 

WILLIAMS. 

that 

I do not know anything about chemistry, but

early spoiling 

chemistry could protect to a certain degree against

Mr. 

and longer preservation. Is that possible? VASSOS. Yes, it is.

law, 

Senator 

do you 

WILLIAMS. 

know 

Since the 1958 amendments that changed the

for the consumer 

of any scientific advances that could make candy

Mr. VASSOS. 

that are not permitted because of the law as it is? Yes, I do.

this 

Senator 

when 

WILLIAMS. 

you 

And I would hope Dr. Nair would consider

because you come 

are talking about it and deal with this question, too,

chemistry.

to us with a magnificent background in science and

How about you, Mr. Vassos, are you a chemist? Mr. VASSOS. Yes, I am.

Senator WILLIAMS. Well, then, you are both qualified.

oil 

Mr. 

industry 

VASSOS. 

since 

Antioxidants are used, have been used in the fats and

as corn oil, lemon 

1948, in edible fats and oils, and essential oils, such

plies to oxidation, 

oil, et cetera. And this, as the name implies, apform of rancidity.

not oxidant change, oxidation. And this is one

the 

Now, 

country, 

if we were to make butter creams and send them out all over

without any 

as we do, with about 8 percent butter, the shelf life

storage conditions. 

antioxidants may be 7 to 10 days, depending on the

to expand the shelf 

With the the use of antioxidants, we are able to

not like to buy 

life 12 weeks, and, naturally, the consumer does candy that tastes rancid.

going 

Now,. 

rancid. 

antioxidant salt is also used on nuts to prevent them from

the percentage 

And there are a number of applications. In fact,

In fact, many 

that they add is two one-hundredths of 1 percent.

usually much 

believe that all these food additives that we add are

a bigger profit. 

cheaper, and, therefore, the candy industry will make

over $2 a pound, 

But this is not so. Actually, this material runs

in fact, we are increasing 

maybe $3, $4, 

our production, 

and in order to check this rancidity=

the consumer but we are trying to assure gets a good product.

who 

Senator 

have national 

WILLIAMS. Well, it would seem to me that you people

looking to this as 

eminence in the confectionery industry would be

product in any way; 

an opportunity to improve and not to debase your am I right?

Mr. VASSOS. That is right.

picion 

Senator 

that 

WILLIAMS. 

if 

There seems to be sort of an underlay of susWhat I am suggesting 

this repeal passed, the candy would not be as good.

your product better 

is, with modern technology, wouldn't you make for the consumer?

Mr. VASSOS. Definitely so.

oil 

Another 

has about 

nonnutritive material we cannot use is mineral oil. Mineral

oil has a 

three advantages to the candy manufacturer. Mineral

holding starch, 

concentration 

and 

about one-tenth to two-tenths percent to this aids in making impressions in the molding
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 23

starch because the liquid candy is deposited into the mold and also

aids in cutting down the dusting factor which is the cause of explosions.

Mineral oil is also used for a slab coat, or a coating on the slab,

.a marble or steel slab, to prevent the candy from sticking. Another

use for mineral oil is the polishing of soft gums. And you probably

•wonder have we been able to replace mineral oil, and we have not. There

have been additives put into starch. There have been additives put

onto slabs and additives also on polishing, and we end up with a

deterioration of flavor of the fats that we are adding into the candy.

Senator WILLIAMS. Thank you very much.

Dr. Nair, I think it would be useful for the record, if you would

identify yourself, together with your positions and achievements over

the years.

I have read your biography, and you come to us with the highest

qualifications, and I want the record to reflect that.

STATEMENT OF JOHN H. NAIR, CONSULTANT, FOOD AND

CHEMICAL INDUSTRIES, RALEIGH, N.C.

Mr. NAIR. Mr. Chairman, my name is John H. Nair. I am an

independent consultant to the food and chemical industries and

reside in Raleigh, N.C. Educated as a physical chemist, I have

been engaged in the food industry for over 50 years, during which

time I acquired experience in research and product development, food

processing and engineering, retail food sales, technical sales service,

consumer surveys, packaging development, research administration,

and as a business executive. I retired some years ago from Thomas

J. Lipton, Inc., where I was a research executive. Since then I

have been at various times a consultant to firms such as Du Pont,

Allied Chemical, Dow, American Viscose, International Milling,

American Machine & Foundry, Nestles, Kurth Malting, Votator,

and to the Sugar Research Foundation and the U.S. Department of

Agriculture.

I have served as president of the American Institute of Chemists

and of the Association of Research Directors, am currently a director

of the American Chemical Society and president-elect of the Institute

of Food Technologists. I appear here as a qualified expert on food

matters at the request of the National Confectioners Association.

This appearance is entered in support of H.R. 7042, which passed

the House of Representatives on June 7 of this year following a unanimous favorable report of the House Interstate and Foreign Commerce

Committee, and a companion Senate bill, S. 1839, introduced by 16

Senators, 8 of whom are members of the Labor and Public Welfare

Committee. The purpose of these bills is to allow the confectionery

industry to employ in the manufacture of its products the same safe

nonnutritive substances as may be used by all other segments of the

food industry.

Under the food additives amendment enacted by the Congress in

1958 as an addition to the Food, Drug, and Cosmetic Act of 1938, it is

required that all substances added during the processing of all foods

shall be pretested to assure the safety of their use to the complete

satisfaction of the Federal Food and. Drug Administration. Only

then may their use be authorized in foods either on an unrestricted

basis or within certain prescribed limits. Thus, a new standard of
24 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

lished 

protection 

in 1958, 

for the 

assuring 

American consumer with respect to food was estabor nonnutritive, was 

that any additive employed, whether nutritive harmless.

Cosmetic 

However, 

Act 

earlier 

of 1938 

enactment of section 402(d) of the Food, Drug, and

fectionery must, with 

had required that all additives used in conwords, while all additives 

certain exceptions, be nutritive. In other

only in confectionery 

now used in processed foods must be safe,

Now, 

is it required that they also be nutritive.

years one 

if 

finds 

one traces 

that 

the 

revolutionary 

history of food processing during the past 60

ment, and packaging advances in methodology, equipnew facts which 

have occurred. Science has steadily unearthed

has been quick to 

contribute to the safety of processed foods. Industry

rule-of-thumb methods 

take advantage of such knowledge, discarding older

high-speed technology. 

and practices and instituting new automatic

widest choice of the 

Today the American consumer is offered the

attractive processed 

most nutritious, palatable, appetizing, and

assurance of their 

foods to be found in the world, with absolute safety, barring unforseen accidents.

of 

Now, 

a wide 

this 

range 

developing food technology has led to the employment

quality, improved 

of food additives to produce foods of better keeping

and more valuable 

flavor, more attractive appearance, better texture,

technological purpose 

nutritionally. 

to make 

Some of these substances serve a

retain nutritive values, 

processing easier or quicker, others help

are safely used because 

while certain ones give longer shelf life. All

must so certify 

the Federal Food and Drug Administration prior to their acceptance.

have 

But 

nutritive 

confectionery 

value per 

manufacturers can only employ them if they

any logical grounds 

se. It is difficult for a scientist to perceive

it is in the public interest 

for such discrimination against confectionery. If

utilize the newer technology 

to permit the food industry generally to.

whether nutritive built around incorporation of additives,

to prohibit the use 

or not, it would appear against the public interest

addition would be advantageous.

of certain additives in confectionery, when their

processed 

There is 

foods 

an almost 

and the 

endless list of additives approved for use in

nonnutritive. Some 

list grows longer daily. Many of these are

nized as safe, or GRAS 

are acceptable because they are generally recogexhaustively on 

for short. Many others have been tested

sultant data critically 

different species of experimental animals and the reOnly when 

reviewed by the Food and Drug Administration.

ment certify 

satisfied 

them 

as to their safety for humans does the Depart- for use.

compounds 

Now, in my 

added 

prepared 

to foods, 

brief, I have listed a number of examples of

antioxidants, which includes such things as emulsifiers,

ing agents, and 

stabilizers, 

leavening 

wetting agents, thickeners, clarifiers, foamnot go into the details 

agents. But unless the Chair wishes, I will

I would 

of these, leaving these for the record.

is meant by 

like 

the 

to 

use 

point out that it is a bit difficult to determine what

it has no caloric value. 

of the term "nonnutritive." To some it means

the body. Still others 

To others, it means it is not metabolized in

sustain life.

say that a thing is not nutritive if it will not

cited 

Now, 

in my 

some 

brief 

of 

might 

the examples of chemical additives which I have be called nutritive by one definition and non-
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 25

nutritive by another. And this serves to show ulous

results of applying a term which has no sin hich

scientists would agree.

What I am concerned with is not that an diti e bOetern i ed

nutritive or nonnutritive, but that the consu b tected . use

the additive is safe. Now, this is guarantee tie Food A ves

Amendment of 1958, and I am very happy t sa that I the

Food and Drug Administration are doing an exc erpreting and supplying this law. But I want to emp at these

additives are all quite harmless to humans at the levels at which they

are used. But their addition serves a useful end, whether it be improvement of the product, longer shelf life, or just more appetite

appeal.

Now, the Food and Drug Administration has cleared all of them

for use in all foods, but section 402(d) prevents the confectionery

segment of the industry from employing them.

t'Now, as a scientist and technologist very familiar with practices in

the food industries, I can see no basis for such discrimination. The

consuming public is amply protected, in any case. It appears to me

not only reasonable and logical, but in the public interest as well, to

enact H.R. 7042 which permits the same treatment for confectionery

in the matter of nonnutritive additives as is now accorded all other

processed foods.

Mr. Chairman

'

I would urge your subcommittee to report H.R.

7042 to the fuull Labor and Public Welfare Committee with the

recommendation that it, in turn, report the bill favorably to the Senate.

Senator WILLIAMS. Well, I am grateful, indeed, for that statement,

Dr. Nair.

Let me see if I understand the operation of 402(d). It seems to be

saying to the confectionery industry, but not to most of the food

industry, that in terms of technological advance in the improvement

of your product through nonnutritive substances, you have got to

stand still at 1958.

Mr. NAIR. That is exactly the situation; yes sir.

Senator WILLIAMS. You know, if you applied this a la Immanuel

Kant to all industry, this categorical imperative would freeze us back

in relatively the horse and buggy days.

Well, you folks are in competition with a lot of people. The

stomach, I think you said, Mr. Vassos, contains 40 ounces. Is that

the average stomach?

Mr. VASSOS. Average stomach.

Senator WILLIAMS. Average adult stomach, 40 ounces. Good

gracious, you are not only in competition with food, you are in competition with liquids just to mention one relatively inoffensive

liquid, beer. That takes up some part of that stomach space, does

it not?

Mr. VASSOS. Yes.

Senator WILLIAMS. Can the beer folks add nonnutritive substances

to their product?

Mr. NAIR. Yes, indeed. For example, they clarify the beer by the

use of a polymer which is called—it is a long chemical name, polypropylpyrrolidone. This is a clarifying agent, perfectly safe, harmless,

which is used in beer. And all fermented malt beverages are allowed

to use it as a stabilizing agent for the foam, which serves useful pur-
26 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

attraA 

poses, 

e 

f

to 

ousue 

the 

gtit nological advantages which make beer more

Senfttor 

consumer are denied to the confectionery people.

protectingf4ildren. 

WILLIAMS.' The Commissioner is most concerned with

ucti prepared bpn 

15::)I course, the infants these days are fed prod1\44NAIR. 

ir4ustry, not by their mother—baby food. That is ht.

nonnutrititt-suber 

SelOor WILLIA s. .Are the baby food people permitted to include ces in their products? Mr. , indeed, they are. Senator 

Mr. NAIR. 

WILLIAMS. Well, how about spoilage of the baby food?

are 

They use such things as ascorbic acid or its derivatives

It could 

used to 

be 

prevent 

metabolized 

spoilage which is identified as nonnutritive per se.

classed as a nutritive, 

and if one used this definition it might be

serves a good purpose 

but others would not use it as a nutritive. It

think of it as a 

and is not harmful. But we normally do not

widest uses 

nutritious substance, you see. And this is one of the

spoilage.

of materials in food, generally, these which prevent

mold 

For 

inhibiter 

example, 

in 

every loaf of bread you buy today will have an antiserves a useful 

the bread. It is universally used today. And it

home much longer 

purpose because it makes the bread stand up in the before it gets moldy. Senator 

Mr. 

WILLIAMS. That clarifies the situation for me.

stabilized 

NAIR. 

with 

You take ice cream, for example. Ice cream today is

digestible, and 

a derivative of cellulose, which is completely inquite 

it does a very good job. Gelatin was used originally

today 

widely, 

which 

but carboxymethyl cellulose is the additive in ice cream

completely harmless. 

is mostly preferred. It does a very fine job. It is

quality that 

It gives the kind of texture and the eating we want in ice cream, but it is nonnutritive.

against 

Senator WILLIAMS. We preserve in this amendment the prohibition

coloring. 

the 

We 

use of alcohol beyond that small fraction that is used in are not disturbing that at all. Mr. NAIR. Not at all.

rest 

Senator 

of the food 

WILLIAMS. Does the nonalcohol provision prevail in the industry, too?

Mr. NAIR. No.

was 

Senator 

completely 

WILLIAMS. There used to be an ice cream called Disk that loaded with some kind 

has 

Mr. 

alcohol 

NAIR. You will get a rum-flavored ice cream today, and this in it.

are 

Senator 

not going 

WILLIAMS. 

to 

Yes; but we are making it very clear that we change the prohibition against alcohol. Mr. NAIR. In confectionery, this is right.

a 

Senator 

categorical 

WILLIAMS. Now, there is one other thing. I have made

up a bit. The 

promise to Commissioner Larrick—well, first back

are rolling back 

House-passed bill might create some question that we

in candy.

to the old days when an article could be imbedded

so 

Now, 

there 

if there is any question on that, and question has been raised,

tion that 

is 

we 

question, I made the categorical promise that this legislafunctional foreign 

finally consider in the committee will prevent the non- article being imbedded in candy.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 27

Now, you speak for the industry, do you not, Mr. Vassos, pretty

generally?

Mr. VASSOS. Yes.

Senator WILLIAMS. What I am saying is a nonfunctional article—

there are certain things that are necessary to the product. Just as

popsickles are on a stick.

Mr. VASSOS. As many of you know, millions and millions of lollipops are made each year and we in the candy industry would like

to operate legally, but under the present law we cannot operate legally

because the stick that is in the lollipop is nonutritive.

Senator WILLIAMS. If the Congress of the United States takes

lollipops away from the youngsters, that generation that is deprived

will change the makeup of Congress when they get their chance.

Mr. VASSOS. Mr. Chairman, I glanced over Mrs. Desmond's

report before it was my turn and I do not agree—

Senator WILLIAMS. Well, I think maybe this is putting Mrs.

Desmond in the rebuttal position before the negative statement

that she is going to present, as I understand it.

Mr. VASSOS. I understand.

Senator WILLIAMS. We might- give you a rebuttal and then Mrs.

Desmond a surrebuttal, but then we will stop.

Mr. VASSOS. All right. Thank you very much.

Senator WILLIAMS. All right, thank you. We are very grateful

to you.

Our next witness is Mrs. Ruth Desmond, president of the Federation of Homemakers, and a resident of Arlington Va.

We know of your interest in this legislation, Mrs. Desmond.

STATEMENT OF RUTH G. DESMOND, PRESIDENT, FEDERATION

OF HOMEMAKERS

Mrs. DESMOND. Yes.

Senator WILLIAMS. Welcome.

Mrs. DESMOND. Thank you.

Senator WILLIAMS. You can proceed anyway you care to.

Mrs. DESMOND. Thank you, Mr. Chairman.

I am Ruth Desmond, president of the Federation of Homemakers,

a nationwide organization of public-spirited women. This federation is incorporated under the laws of the District of Columbia as a

nonprofit organization. Its officers and directors volunteer their

time to advancing federation programs and goals.

The federation's primary objective is to inform its members of the

potential harm their families may incur from ingesting chemically

treated foods—especially their young infants, children, and adolescents. Only responsible and recognized authorities are quoted in its

statements. Another objective is to acquaint its members with the

work, responsibilities, and special problems of the FDA—this being

the agency empowered by Congress to protect consumers from unwholesome, filthy, adultered, poisonous, and mislabeled foods, substandard and improperly labeled drugs, and harmful cosmetics, among

its important duties.

This federation endeavors to inform its members of pending and

recently passed food, drug, and cosmetic laws. Its board presents

statements on behalf of its members before appropriate congres,ional
28 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

lishing 

committees 

standards 

and at FDA hearings relative to regulations and estabming (HEW) 

of identity. Members supported Secretary Flemprotective Delaney 

in his valiant and successful fight for inclusion of the

additive and 

anticancer amendment in our recently passed coloring laws.

Malstrom, 

For the 

board 

subcommittee's attention, the statement of Mrs. A. I.

this organization 

chairman, is submitted to illustrate the position of

as a result 

with regard to the calculated risks the public endures of rapidly changing technology—particularly to methods with respect

when the Senate 

of food processing. This submitted statement was given

on "truth

Commerce Committee conducted its public hearing -in-packaging legislation."

ing 

This 

before 

federation appreciates the privilege and opportunity of appearto oppose 

this 

this 

Special Senate Subcommittee on H.R. 7042 and S. 1839

recommendations 

legislation shorn of the administration's strengthening

The 

and for additional reasons which will be given.

in this 

candy industry has enjoyed a remarkable growth and prosperity

leader in 

country 

manufacturing 

since the mid-19th century when England was the

inventiveness and 

confectionery known as boiled sweets. The

United States 

ingenuity of the candymakers here has led to the

a favorite with 

surpassing 

most 

all others in this great industry. Candy is

As 

of us but especially rates high with children.

behavior, 

young 

for 

children most of us received candy as rewards for good

baskets with rainbow 

"cleaning our plates" as prizes. The Easter bunny fills

delight. 

eggs and goodies as well as the chocolate-covered

tine's Day 

Halloween brings gay and spicy "tricks or treats." Valenheart-shaped 

provides "sweet" tokens of affection—many in lovely

sions candy 

containers. So does Mother's Day. On special occayoung, mature, 

is frequently presented. Candy is enjoyed by people—

Also young 

pregnant, and aging. It especially appeals to children.

is even candy 

athletes count on it for quick energy "pickups." There

artificial 

for the overweight and the diabetic—using nonnutritive

sweetener 

sweeteners but with required listing of the nonnutritive

who desire 

and warning that such agent "should only be used by those

be brightened 

to restrict 

with 

their intake of ordinary sweets." Candies may

Vegetable 

certified colors and flavored by artificial flavoring. gums may be used as stabilizers.

into 

Senator 

the permanent 

WILLIAMS. Now, this is a public record and this will go

the candy people 

records of this committee in Congress. I think

advertising. 

probably will use that as a direct quote in their It is a very fine statement.

Mrs. DESMOND. Yes.

to 

Because 

restrict 

candy has such universal appeal—it seems most important

is probable the 

the 

immature 

chemicals allowed in its manufacture. Otherwise it

growing bodies of very young children and the rapidly

amounts 

bodies 

of 

of adolescents may be required to metabolize larger

Small children 

certain chemicals than actually regarded as "safe."

own, possibly 

selecting and purchasing their confectionery on their

ignorance obtain 

accompanied by an older brother or sister, could in.

dients if 

a product composed mainly of nonnutritive ingretexture. 

this bill is passed—appealing in flavor and color—even

nonnutritive 

These 

sweetener. 

tots might begin the day with cereal coated with a•

generous 

On a hot, humid day they might consume quantities of beverages containing also a nonnutritive
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 29

sweetener. Later they might consume a low calorie frozen dessert

with the same artificial sweetener. Certain of these artificial sweeteners are regarded, so we understand, as laxative when consumed in

large amounts, especially by youngsters. It is plain to see why

FDA should have the decision on what types of additives may be

approved for confectionery.

Of course, there are already preservatives in the candy—I was

checking the candy labels yesterday. Some children might get a

preponderance of a certain type of an artificial sweetener in their

daily intake.

Senator WILLIAMS. You, in good logic, then, would extend this

authority to food, too?

Mrs. DESMOND. Oh, yes. But there is a different situation.

Children sometimes do purchase their candy. Adults usually purchase

food. I do think that there should be special supervision and special

selection of these additives for candy by FDA, because, you see, there

is this possibility that children will get too much artificial sweetener

if this trend continues on.

Senator WILLIAMS. Take marshmallows covered with chocolate,

that is candy; is it not?

Mrs. DESMOND. I presume so---

Senator WILLIAMS. Then you take a marshmallow covered with

chocolate and put it on the cracker 

Mrs. DESMOND. Like the Girl Scouts have done.

Senator WILLIAMS (continuing). Then it is food.

Mrs. DESMOND. Yes.

Senator WILLIAMS. The lines are indistinct. You can add a little

bit of "food" to basically what is candy and permission is fully granted

for nonnutritive substances and yet, if it is not treated to be food,

permission is not granted. Do you not see the inaccuracy?

Mrs. DESMOND. I can see that. However, this group has petitioned

the Joint Committee on the Organization of Congress and we are

trying to get some public-spirited Members of the House to set up a

full Committee on Health and Safety in the House instead of the

present subcommittee, where more time and attention can be given

to food additives and food legislation.

We would hope, then, with a new full-time committee, if it ever is

set up, to have the Food Additives Act of 1958 thoroughly gone over

and reevaluated. We are not too happy with the result of approximately 3,000 chemicals, about 1,000 migrating from packages, in our

processed foods under the 1958 Additives Act.

Senator WILLIAMS. I can understand what you are saying, but,

you know, the children these days are growing taller than we grew

tall. I have a boy that is bigger than anyone in the family. I have

some nephews, also. I have a feeling that the youngsters of today

are getting a diet that far exceeds the diet of 20 years ago.

Mrs. DESMOND. Well, perhaps some are, sir, but I do see a lot of

them that are living it up on pizzas and artificial drinks and barbiturates, and we wonder if this cannot be helping them to get off the deep

end when they get into these riots at beaches. The draft rejections,

they are appalling, and there is an alarming increase in mental illness.

Senator WILLIAMS. I will agree with you, there is a great exuberance

in our young people. It is founded on, first, generally a healthy

body. There is nothing worse than seeing a youngster who is suffering
30 AMEND 1.1-1E FEDERAL FOOD, DRUG, AND COSMETIC ACT

from 

Those 

malnutrition. 

youngsters are 

I have traveled in Central American countries.

they are not getting the 

not exuberant at all. They just sit and bloat,

would say that I am not 

nutrition 

supporting 

that our youngsters are getting. I

exuberance into antisocial youngsters who put their healthy

them find the productive 

activities. It is our job as adults to help

is, of course, why we are 

way to express their exuberance, and that

education and poverty program 

passing a lot of legislation around here, the

Mrs. DESMOND. that deals with more children.

were bordering on 

I understood that many Central American children

people are just overexuberant 

starvation; and I would say a lot of our young

normally active. I cannot 

from chemicals, that they are not

arteries are examined, as 

agree in that regard. I believe if their

some of the Korean soldiers, 

there have been examinations at least of

with cholesterol and 

that you find them pretty well clogged

Senator 

fatty particles from a wrong diet. WILLIAMS. Who is that?

the 

Mrs. 

doctor 

DESMOND. 

who did 

This 

the 

was—Mrs. Robinson, what is the name of research?

Army. 

Mrs. ROBINSON. 

It was shown 

I cannot give you the name, but he was in the

killed in action averaging 

that 77 percent of the Korean war veterans age 22 showed arteriosclerosis, 11 percent of the Koreans while only

sclerosis, and this was 

killed in action showed signs of arterioDr. William F. Enos, office: 

done by a medical doctor with the Army,

Va. 601 South Carlin Springs Road, Arlington,

name.

Mrs. DESMOND. We can furnish his name later. We have his

and 

Senator 

I will 

WILLIAMS. 

grant you the 

Well, I served in the Armed Forces for 4 years

that they have 

diet was not the best then. I understand

and abroad.

substantially improved the diet for our forces here

diet 

Mrs. 

in 

DESMOND. 

childhood—youth.

Yes. This damage was presumed caused by a

Senator WILLIAMS. For our Armed Forces.

nonnutritive 

Mrs. DESMOND. 

emulsifiers 

Well, then there are the dubious, even suspect,

we don't like. These seem 

made from cotton fibers or wood pulp. This

less expensive than gelatin 

popular with industries because they are

with the food and beverages. 

and vegetable thickeners and blend well

stated carboxymethyl One producer of a "breakfast" beverage

pulp of the citrus blended 

cellulose blended with their product as the

able. An example, 

with orange juice. That is quite remarkgelatin in the production 

sodium carboxymethyl cellulose has replaced

ponent of several widely 

of commercial ice cream. It is a comsometimes used in cake mixes 

advertised "breakfast" beverages. It is

whipping creams. Salad 

and packaged icings—also in the "fake"

frozen treat, to be made 

dressings may contain it. Even a child's

You will note in 

at home, contains this suspect thickener.

from several researchers 

Mrs. Malstrom's, May 18, statement quotations

emulsifier should be permitted 

and physicians who do not believe this

is Dr. Hueper. Dr. Bicknell 

in food. One is Dr. Kraybill and one

Franklin Bicknell. was very suspicious of it—the late Dr.

is 

Think 

permitted 

of the 

in candies 

increase in consumption of this suspect emulsifier if it too.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 31

Before permitting these nonnutritive items in confectionery it

seems prudent to await reports from the new Institute of Environmental Health. Instead of granting permission for additions of

chemicals to candies it seems sensible to restudy and reevaluate the

1958 Food Additives Act with the desire to eliminate many of the

several thousands of chemicals now appearing in processed foods.

Senator WILLIAMS. I wonder if we could go back to the statement

of this suspect emulsifier. Whose suspicion is this?

Mrs. DESMOND. Well, I quoted three. The late Dr. Franklin

Bicknell, of England, he produced a very fine standard volume on

vitamins. He enjoyed high regard as a scientist. And our Dr.

Hueper of the National Cancer Institute. He is now just recently

retired. He received a World Health Organization award for his

cancer research. And then Dr. Kraybill of the U.S. Public Health

Service has mentioned it. And there have been several researchers

at Food and Drug who have done some research re skin injections.

Senator WILLIAMS. I was coming to that. Do you feel the Food

and Drug Administration has the ability, the knowledge, the staff to

define what is safe and unsafe in the nonnutritive area as it is applied

to foods?

Mrs. DESMOND. Perhaps it has by now. It has always had some

very fine scientists, but until about 5 years ago it was a Cinderella,

agency. It used to have about $6 million to operate on. I understand this year it has a budget of $56 million. I suppose the thalidomide tragedy, and so forth, has helped increase its budget. But as

I understand it, it has never been able to do all the research it should.

It was 25 years behind in the study of the safety of color additives.

It was so understaffed for so many years that the first Citizens

Advisory Committee which went through there in 1955 said a national

catastrophe could occur if it were not given adequate appropriations

and additional personnel.

Senator WILLIAMS. You know that any new material that comes

into use has to be pretested for safety by Food and Drug?

Mrs. DESMOND. Well, don't they go over the reports—review

reports submitted by manufacturers?

There is a possibility certain reports are faked; laboratory-faked

reports. We have read of these. McCall's magazine covered this

situation. So I would say now these scientists at Food and Drug

will have to go through a lot of industry's reports assuming that they

are valid. But if they see something they do not think is scientifically

sound, then won't they carry out that research on their own? I do

not think FDA scientists can possibly carry out the research on 3,000

additives, can they?

Senator WILLIAMS. As I understand the law, they have to make a

determination that this substance is safe.

Mrs. DESMOND. Well, theoretically, don't they look at the research

that has been done, and if it looks generally valid agree?, There is

a very fine researcher, one of the top scientists with all the proper

qualifications, not just a food fabricator, in his opinion we have never

gone in depth into this. We have never studied the lifetime exposures. And for a long time scientists have been studying effects

of these additives on rats and mice. I have a book at home of the

Food Law Officials of the U.S. on the toxicity of various drugs and

dyes. Rats and mice are 10 times less sensitive than humans to
32 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

digestive 

drugs and 

systems. 

to coloring, 

These 

to many 

animals 

things. They seem to have cast iron,

sturdy stomachs. So now 

possess sensitive skins and very

appropriate aniAials, dogs 

researchers are substituting other more

wide variety of animals in performing 

and cats, for example. FDA now uses a

Senator safety evaluations.

suppose, on 

WILLIAMS. 

what is efficacious, 

There will always be differences of opinion, I

what is safe. MTS. DESMOND. Yes.

us 

Senator 

and tell 

WILLIAMS. 

us that Krebiozen 

Now, we have people that periodically solicit

treatment of cancer. The 

has been very useful in the control and

There will be these 

Food and Drug Administration disagrees.

area of food, this kind 

differences, 

of dramatic 

but we are not talking about, in the

the truly bland and easily 

difference. We are talking about

can improve the product and 

defined safe nonnutritive substance that

Mrs. DESMOND. 

make the product better.

methyl cellulose, and 

Well, 

I 

I still have doubts about sodium carboxySenator WILLIAMS. 

don't like to see it in infant food. I take it you are a chemist?

but 

Mrs. 

you 

DESMOND. 

can see that 

No, I am speaking, you know, as a housewife,

authorities. Our officers 

I have read a lot about it, and I am quoting

additive hearings on. We 

have attended hearings from the food

Ribicoff hearings. We have 

went to the Kefauver hearings, the

all these hearings. And 

been to water pollution, air pollution—

Senator WILLIAMS. How 

then the Humphrey hearings on drugs.

Mrs. about the cigarette hearings?

matter of 

DESMOND. 

choice. People 

We did 

do 

not bother with that because that is a

eat. not have to smoke, but people have to,

was 

Senator 

just about 

WILLIAMS. 

to light 

You 

up.

make me feel very embarrassed as I

You have a good sense of humor, Mrs. Desmond. Mrs. DESMOND. I did not mean to be disrespectful.

are 

Senator 

times for 

WILLIAMS. 

tears and 

No, not at all. We like laughter, too. There

hearing a little laughter 

there are times for laughter. In a Senate doesn't hurt.

My 

Mrs. 

darling 

DESMOND. 

husband 

May 

is 

I digress to say why I am really in this?

percent medical disability 

an Army officer discharged on a hundred

maximum life of 4 years. 

for 

And 

cancer. He had the prognosis of a

for 7 years, but he has not had 

he had reoccurrences of this cancerWalter Reed any reoccurrences for 3 years.

he can't help but 

is 

get 

amazed 

pesticides 

because this man should be dead. Now,

prepare it from scratch 

in his diet, but I make all of his food,

reading—I felt this was 

especially after going to hearings, after

honest differences of scientific 

necessary. Some people ask, when there are

I'm going to take the opinions 

opinion, what can you do? I say well,

Our bodies are old fashioned. 

of scientists who say let's be cautious.

I have shielded my husband 

Let's give a full test. So in doing this

suspect. I have been 

from all these substances I consider

everything like that, and 

making my own mayonnaise, bread, ice cream,

out. It tastes so good at 

now my husband cannot even stand to eat

been a little hard on me once 

home. I have just spoiled him. It has in a while. Senator 

Mrs. DESMOND. 

WILLIAMS. I bet you never have seen a TV dinner. Not in our house; no, sir.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 33

Senator WILLIAMS. This is the way it used to be on the farm.

MTS. DESMOND. Yes.

Senator WILLIAMS. We used to grow everything, raise everything.

'Churn the butter.

Mrs. DESMOND. I have not gotten to that yet.

Senator WILLIAMS. It used to be a full-time occupation. Eating

and getting ready was a full-time occupation for my mother and

grandmother.

Mrs. DESMOND. I remember the day.

Senator WILLIAMS. There was no time to be members of the

Federation of Homemakers.

Mrs. DESMOND. I do all the cooking and it smells so good when we

are sitting in there looking at TV while the bread is baking in the

evening. There is time for cooking and for this volunteer effort.

Senator WILLIAMS. Well, I think I am just going to surprise you

with a visit one day.

Mrs. DESMOND. Don't surprise me. Let me know because I do

not bake it—you know, with just two you only bake it once a week.

But I will be glad to cook a good meal, bake a cake.

The argument of the candy industry that it should be permitted to

employ the same additives permitted in baby foods brought to the

attention of federation officers a serious oversight in the Food Additives Act of 1858. For several years our membership has been concerned to see a definite trend of adding a widening variety of additives

to infant foods. We have on several occasions called this trend to the

attention of the chairmen of the Appropriations Subcommittees

studying the budget needs of FDA. Here we quote from the World

Health Organization Technical Report Series No. 228, page 6,

"Baby Food."

While the use of food additives is not a point of primary consideration in this

report, there is one class of foods to which special reference must be made. Foods

that are specifically prepared for babies require separate consideration from all

other foods as regards the use of food additives and toxicological risks. The

reason for this is that the detoxicating mechanisms that are effective in the more

mature individual may be ineffective in the baby. The committee strongly

urges that baby foods should be prepared without food additives, if possible.

If the use of a food additive is necessary in a baby food, great caution should be

,exercised both in the choice of additive and in the level of use.

If I may digress, I have an aged dog, over 13 years, whom I took

to the very finest veterinarian in Arlington. Her kidneys completely stopped functioning. The veterinarian prescribed unprocessed

food. We gave the dog mineral water such as President Eisenhower

drinks. We get it, too, now.

Senator WILLIAMS. I am with you in that department four square.

Mrs. DESMOND. The dog has flourished, but the funny thing was

this: I asked the veterinarian if I could give her some strained baby

meat for lunch and he said, "Oh, my gracious, no. Not only is

the protein of poor quality, but she can't stand all those poisons."

So apparently my grandson can eat this baby food, but not my aged

doe,. It is extraordinary.

enator WILLIAMS. How does your grandson feel these days?

Mrs. DESMOND. He ate his baby food in 1960 before a lot of these

things that I am going to mention were permitted and he was breast

fed. You can imagine that I stood over my daughter and saw that

she ate properly when nursing him.
34 AMEND 'ME FEDERAL FOOD, DRUG, AND COSMETIC ACT

When Dr. John 0. Nestor testified (Mar. 20, 1963) before Senator Humphrey's 

policies 

special subcommittee reviewing cooperation on drug among FDA, NIII, Veterans' Administratio ,n and other

Regulation" 

agencies (pt. 3) "Interagency Coordination in Drug Research and

small 

it was recognized in his testimony that infants and even

reduced 

children cannot handle certain medications even in greatly dosages that adults metabolize. Illustrations of this inability of immature bodies to detoxicate certain medications considered

"safe" 

"safe" for adults were given (pp. 777-1028). Yet additives assumed

Additives 

for adults are presently permitted in baby fare under the 1958

written, 

Act. Perhaps when the Food Additives Act was being studied, and acted on this situation of a variety of additives

foreseen 

permitted to process baby foods did not exist and therefore was not as a future problem. Let us hope that an alerted Congress

amendment 

will move with due speed to correct this unfortunate oversight by an to said Food Additives Act of 1958 in which additives to be permitted in infant foods will be approved under a special classification of the 1958 act.

Hill, 

We have already set that in motion. We have written to Senator

Delaney, 

to Commissioner Larrick and to Representatives Fogarty and about this need for a corrective amendment.

junior 

It was alarming to discover sodium nitrite in infant strained ham,

preservation 

franks and even in meat sticks—previously free of this toxic

practice 

and coloring agent. One manufacturer has initiated the of utilizing sodium carboxymethyl cellulose in its strained

FDA 

infant chicken as an emulsifier. Therefore it seems wise to permit

the 

to approve the additives to be used in baby meats rather than USDA. Officers noted that "artificial" vanillin is being placed in 

using 

one manufacturer's custard for infants. A "new" baby dessert is calcium sulfate cleared by FDA for preventing "bleeding" in

paris.

cottage cheese. That is a very refined dehydrated form of plaster of

In pleading for caution in the use of additives attention is directed to the disgraceful place of our country with regard to deaths of infants 1 week to 1 year of age. The U.S. Public Health Service reports we place 10th—the wealthiest country in the world—spending annually hundreds of millions for research to learn the causes of our ills and their treatment. To bolster this plea for caution, we quote briefly from the Sanderson Well lecture by the late Sir Edward Mellanby on "Food Manipulation" appearing in the British Medical Journal, October 13, 1951:

from 

Even 

the 

when such chemical substances have passed through a battery of tests

ultimately 

point of view of toxicology, unexpected harmful results have often been demonstrated.

It was Sir Mellanby whose test on dogs proved agene, a bleach for flour, could cause running fits and death if these animals were fed exclusively on bread. This warning reminds us that coumarin was banned in 1954 after 75 years of use as a flavoring component. Safforole, a beverage flavoring primarily, is now banned after years. of use. So are many dyes previously regarded as safe under old- fashioned tests.

Reflect on the horror of the tragically deformed Thalidomide babies and the present reports that several antinausea drugs under certain conditions may be responsible too for birth deformities.
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 35

Boric acid not too long ago was considered safe to bathe the eyes of

babies and its ointment used to soften their skin. Now it is considered

too toxic.

Here is warning from the so-called Gross committee's report to the

Surgeon General (Nov. 1, 1961), "Environmental Health Problems,"

pages 149-150:

Undigestible materials, such as alginate, pectin or modified cellulose, are

often substituted for normal food ingredients in an effort to improve texture and

keeping quantities or to lower calorie value and cost. If carried to excess, such

modifications may have serious nutritional consequences to certain segments of the

population. There are, in fact, hundreds of other artificial substances being used

in the manufacture of foods to improve texture, flavor, color, and stability. Apart

from their intended uses, these substances have physiological potentials which are,

in may instances, incompletely explored at the present time.

It does not seem wise to include plastic or metal trinkets inside

candy packets for the records prove that small children mistakenly

bite on them and are hurt. Last session Representative Fogarty

warned of this particular hazard to children's mouths and teeth when

a similar bill was under discussion. These trinkets are not safe mixed

with candies in vending machines. This federation does not approve

of talc, banned by Congress in 1906, now being permitted in candies.

It does not seem "safe" to permit mineral oil instead of butter or

vegetable oils for lubricating candy "slabs."

I don't know anything about the molds. I have only read of the

candy slabs.

The candy manufacturers of the United States enjoy a splendid

reputation both here and abroad for the quality of their products—

their integrity—their modern methods, efficient machinery. It would

be a pity to destroy this public confidence and approval by relaxing

the high standards governing candy production today, merely to add

shelf life to its products, but perhaps ultimately jeopardizing the

health of small children, its principal customers. The candyinakers

enjoy economic health. There seems no justification for lowering

regulations which have enhanced this good reputation.

Mr. Chairman, we are confident your subcommittee after thoughtful

study of all the factors will not permit candy ingredients to be so

lowered that conditions prevalent before 1906 will again prevail.

Thank you for this opportunity to express the views and concern of

our members.

Senator WILLIAMS. Well, there is no fear on that last score, Mrs.

Desmond. What we are trying to do is not go back to '1906, but

permit the candy industry to come up to 1965 and stay with the

advances that have come in foods. You know, your statement is a,

strong indictment, stronger of course on the food processors than anybody else. Food is what keeps us going. I am afraid I must disagree

on the general indictments. I think you will find that both infant

mortality rates are decreasing and life expectancy for everybody is

increasing.

Mrs. DESMOND. It had until the last decade, and I understand that

in the last decade, 1954-64, the life expectancy in the United States,

despite all of our strides in surgery and scientific advances, has not

increased; but it increased in comparable countries, of comparable

culture.

Senator WILLIAMS. Well, of course, I think there is a divine ceiling

on the utlimate life expectancy. While there are those whom we
36 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

particularly like and hope will live as long as Moses, to be 120, there is a ceiling. But I think we will have the staff look at these—I know the life insurance folks, their tables of expectancy are going up. There is a man in the back shaking his head violently no. VOICE FROM FLOOR. My agent tells me no, sir.

Senator WILLIAMS. Well, is he here?

VOICE FROM FLOOR. No, sir, but I have a paper here that I could give you that will support this.

Senator WILLIAMS. Well, this is a matter that can be examined, and I think it would be a short bit of research.

(The latest available information is as follows:)

TABLE 1.—Tables of expectancy of life insurance companies

1940 

1950

1955_

1960 

1963

Year

Life expectancy at

birth

Infant deaths

per 1,000

population

62,9 M. 9

68.2 33.0

69. 5 28. 5

69. 7 27.0

69. 9 25.4

Source: U.S. Public Health Service, Department of Health, Education, and Welfare.

Senator WILLIAMS. Just fill us in about your organization of home- makers, Mrs. Desmond. You are the president?

Mrs. DESMOND. Yes.

Senator WILLIAMS. It is a national organization?

Mrs. DESMOND. No, it is not national, but it is nationwide, because the board members are all here, except honorary members; they are all in this area, and we decide the policies and what our goals will be, and our members throughout the country receive a newsletter. They will receive a copy of this statement. Any statement that is given by Mrs. Malstrom or myself, or any other officers, the members will receive. And if, of course, a member is dissatisfied, she does not have to remain with us.

Senator WILLIAMS. How many members do you consider you have? Mrs. DESMOND. We are only 6 years old.

Senator WILLIAMS. I beg your pardon?

Mrs. DESMOND. We have never mentioned it because we are only 6 years old. We started out at a time when it was unpopular to speak about pesticide residues or excessive processing of foods. Before Thalidomide and the White House report and all these hear- ings on pollution. So at that time we had to make our friends and relatives captive members. But now people write in, people we do not know, asking us to send application forms. They want to belong with us. Of course, they are all women.

Senator WILLIAMS. You have supported us in our efforts here to pass effective, meaningful legislation dealing with air and water pollution, I believe.

Mrs. DESMOND. Well, we have attended these hearings. You know, we are a small group and we volunteer our time, and we are certainly in favor of pollution control. We have attended the hearings on these problems. We have not always presented statements because of limited time but we have statements on the illicit drug act—am-
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 37

phetamines and barbituates. This type of legislation: color additives,

i

legislation for laboratory animals. We supported Secretary Flemming n the anti-cancer-clause battle and now we are really getting

our stride. We want this full-time House Committee on Health and

Safety to consider exclusively the protection of people. Then we

also want to have an amendment to the Food Additives Act of 1958.

Senator WILLIAMS. Did you support Secretary Flemming in his

judicial determinations when aminotriazole was in the cranberry

picture?

Mrs. DESMOND. We supported Commissioner Larrick and Secretary Flemming, and reminded the cranberry people that the FDA

inspectors had been taken away from other tasks to inspect cranberries for contamination with aminotriazole.

Senator WILLIAMS. The Government indemnified the cranberry producers for that mistake.

Mrs. DESMOND. I understand to restore their public image through

advertising.

Senator WILLIAMS. Well, a lot of them to save themselves from

bankruptcy.

Mrs. DESMOND. I always eat cranberries now, you know. I hope

they are very thoroughly inspected. You know, we read all the press

releases from Secretary Flemming's office and we never thought the

newspapers in this area carried the full story because the cranberry

growers broke faith with Food and Drug and took contaminated

cranberries right out of storage and sent them to market. The Food

and Drug had no reliable method of detecting this poison. Suddenly

Food and Drug developed a detection method and learned of this

breach of faith, and that is why Department of Health, Education,

and Welfare had to make this public expose of the cranberry situation.

Senator WILLIAMS. Thank you very much.

Mrs. DESMOND. You are welcome.

Senator WILLAIMS. I hope you will come back frequently when

we are about to do the business of improving our society.

Mrs. DESMOND. Thank you.

Senator WILLIAMS. Finally, Mr. Roger Folz, of Chicago, director

and past president of the National Vendors Association, and Mr.

Donald Mitchell, of Chicago, general counsel. Gentlemen.

You knew you were going to be mentioned here and that is why

you are here, although I know you heard the discussion we had when

Senator Javits was here that we are dealing, this legislation does not

deal with your area of business activity. It just deals with the

manufacturer of candy free of imbedded articles, but permitting

nonnutritive safe substances to be used. So what you are reallytalking to is something that might be considered here by this committee at another time if legislation is developed. But we are glad

to give you the floor because you were mentioned.

STATEMENT OF ROGER FOLZ, DIRECTOR AND PAST PRESIDENT,

NATIONAL VENDORS ASSOCIATION; ACCOMPANIED BY DONALD

A. MITCHELL, GENERAL COUNSEL

Mr. MITCHELL. Senator, I think our statement will fully disclose

that we do not oppose the act as it has been interpreted by the court

today, and any amendment that would favor the use of nonnutritives
38 AMEND 1.ar.. FEDERAL FOOD, DRUG, AND COSMETIC ACT

nor 

by the 

would 

candy 

we 

industry, 

oppose the 

as pointed out today, we would not oppose,

of trinkets as interpreted 

existing standards insofar as the imbedding by the courts.

Mr. 

Mr. 

Mitchell 

FoLz. 

is 

My 

from 

name 

Chicago. 

is Roger Folz. I am from Oceanside, N.Y.

Vendors Association, and I 

I am president of the New York Bulk

National Vendors Association.

am a director and past president of the

comprised 

The National 

of 

Vendors Association is a national association

vending machines 

operators, 

and equipment, 

manufacturers, and distributors of bulk

America. throughout the United States of

nuts, 

Bulk 

hard 

vending 

candy, 

machines primarily offer for sale colored gumballs,

machines may be 

jellybeans, 

found 

and trinkets, in penny portions. These

grocery store, drug 

in almost every supermarket, neighborhood

Many such machines 

store, toy store, or similar locations in this country.

benefit of local charities 

are 

and 

operated in conjunction with and for the

income, on a part-time basis 

many more as an additional source of

additional funds with 

by postmen, firemen and others seeking

income. which to raise a family and ultimate retirement

The 

We are 

industry 

the group 

is geared primarily to furnish products to children.

-charms in the 1-cent 

that 

vending 

vends ball gum, nuts, and miniature toys and

many a child's face 

machines. Because of these machines

sincerely believe we have 

has been 

developed 

changed from tears to smiles—and we

diversions for children from 

healthy and happy appetites and 3 to 60.

in 

Some 

a landmark 

years ago, the very foundation of this industry was threatened

Drug Administration, 

case, U.S. 

under 

v. Cavalier Vending, filed by the Food and

-sought to condemn section 402, wherein the Department

•which plastic trinkets 

as 

were 

adulterated, per se, a bulk vending machine in mixed with gumboils.

did 

The 

not 

Department 

of itself fall within 

conceded that the gum was not adulterated and

position that the mingling 

the condemnation of the act, but took the resulted in an "indistinguishable food" which contained trinkets mass of

the giving of trinkets along 

within the meaning of the act and that

anything to the articles of 

with the sale of candy or gum does not add

articles in any way.

food for consumption, nor, do they affect such

of 

The 

no public 

Cavalier 

need 

decision 

which 

was rendered some 14 years ago, and we know

We estimate that 

should cause Congress to overrule its effect.

in operation in the 

there are well over 1 million bulk vending machines

of no serious cases of 

United 

injury 

States and yet, as an association, we know

As a matter 

to health as a result of such commingling.

bility insurance 

of fact, 

rates 

our 

in 

industry has one of the lowest product liasubstantiating a claim 

the food industry. We know of no one ever

candy from a bulk vending 

of illness as a result of chewing gum or eating machine. •

as 

It 

stones, 

is true 

marbles, 

that children 

pins, 

are prone to swallow inedible objects such

We can only presume 

rattles, nipples, and other similar objects.

of the vending machine, 

that a child old enough to master the operation

and a piece of candy 

is old enough to distinguish between a trinket or gum.

argue 

History 

with the 

would 

danger 

certainly 

of 

indicate this to be the fact. We do not nonfunctional inedible objects being imbedded
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 39

in confections. We have no objection to the provisions of section 402

as they are interpreted by the Cavalier decision.

However, we have little doubt that if doctors were polled concerning

injuries to children, they would list a number of instances in which

children were cut by a table knife, speared by a fork, caught by a

fishhook, hit by a baseball, became ill through overeating, coughed on

chicken or fishbones, chipped teeth on cherry pits, and on and on and

on, illustration after illustration. Yet, in all these instances, obviously

the risks of living and the occasional injuries occasioned thereby, are

a part of maturation.

Our entire industry would be irreparably damaged financially

and possibly be put out of business if such an amendment were

passed, and we strongly concur with the report of the House of

Representatives subcommittee which reported there is no threat

to the public health sufficient to warrant the adoption of any amendment which would have disastrous consequences for a segment

of our domestic industry.

Thank you for your consideration, Mr. Chairman.

Senator WILLIAMS. Thank you very much. How did you determine that your insurance rate compares so favorably with insurance

rates in other industries that are dealing with food?

Mr. MITCHELL. We checked it with our insurance broker. The

National Vendors Association has its own insurance program and

has had for 10 years. And all of our members are insured with the

same company. And we, therefore, have statistics, at least our broker

has and we know what our rates have been and our statistics and

our brokerage rates have shown only a reduction in rates rather than

an increased rate for liability and product liability.

Senator WILLIAMS. Interesting and demonstrative of the minimal

problem here is the hazard to youngsters. You cannot be a tot and

operate a lot of these machines.

Mr. MITCHELL. Senator, it takes a certain degree of maturity in

corder to operate what psychologists would call a complicated device,

which a vending machine is to a child. Basically, infant children

are prone to swallow inedible objects. Children that crawl naturally

pick up stones. They swallow them. However, a child that is old

.enough to operate a vending machine is old enough to know what

he wants out of it and to distinguish between the trinket and the

piece of gum or the piece of candy which he gets from the machine.

He does not get an indistinguishable mass of objects that he cannot

distinguish.

Senator WILLIAMS. Well, if it were otherwise, I would think you

fellows would spend most of your day in court defending lawsuits.

Mr. FoLz. Correct.

Senator WILLIAMS. Because anybody that has any problem with

food—we had an outbreak of food poisoning in one of our resort

cities some years ago. Better than 50 percent of the people got a

lawyer before they got a doctor. You hear from the folks that are

suffering. I have tried some cases dealing with a carbonated beverage

bottle that exploded. They sue.

Thank you very much.

Mr. FoLz. Thank you, Senator.
40 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

morning. 

Senator 

If 

WILLIAMS. 

there are 

We 

any 

have no further scheduled witnesses this

want to submit we will 

other statements other members would

At this point I will 

keep the record open until early next week.

Scott and various 

insert in the record a statement from Senator letters received. (The statement and letters follow:)

STATEMENT BY HON. HUGH SCOTT, A U.S. SENATOR FROM THE STATE OF PENNSYLVANIA

S. 

Senator 

1839, which 

SCOTT. 

ultimately 

As you know, I am . one of the two initial sponsors of

companion bill to H.R. 7042 

acquired a total of 16 sponsors. This is a

mittee is currently 

concerning which your special subcom- holding hearings.

have 

It is 

been 

readily 

good 

admitted 

reason 

that, near the turn of the century, there may

nonnutritive additives 

for the discriminatory prohibition of the use of

makers, in a 

in the production of candy. Unscrupulous

to increase bulk 

quest 

and 

for greater profits, added unsafe substances merely

so has scientific development. 

weight. But as the years have gone forward,

arid other additives Emulsifiers, stabilizers, preserv4ives,

nevertheless 

have been developed which, while nonnutritive,

qualities to food 

aid 

products. 

in the production process and impart desirable

added by all the other 

Although these are commonly used and

candy. food industries, they cannot now be used in

ability 

Such 

to 

needless 

determine 

discrimination cannot be justified because of an inconsumption. I want 

which of these additives are safe for human

additives which, according 

to emphasize that the bill covers only those

have already been certified 

to the Food Additive Amendment of 1958,

tion. No special 

as safe by the Food and Drug AdministraA further 

favor to the confectionery industry is involved.

additives to candy 

objection, that rescinding the prohibition of nonnutritive

toy objects—which 

would allow the "commingling" of trinkets and other would be dangerous if swallowed—ignores more basic fact that the the

be industrywide to be either 

prohibition of "commingling" would have tonot be considered in 

effective or fair. Such prohibition should connection with the "nonnutritives" this applies only to bill, since

Act, the confections 

section 

section.

402(d) of the Federal Food and Drug

has 

What 

been 

is 

carried 

at issue 

over 

here is an unfair and archaic regulation which

carryover has had the 

from previously necessary legislation. This

market many beneficial 

detrimental effect of withholding from the

candy by newly developed, 

product qualities which could be given to

The Food safe, nonnutritive additives.

would support 

and 

an 

Drug 

amendment 

Administration has told the industry that it

the same substances already 

permitting confectionery makers to use

provided that the 

available to the rest of the food industry,

individual regulation 

FDA approve such use by the issuance of an

individualistic and cumbersome 

in each case. Rather than taking such an

present discrimination and 

approach, S. 1839 would remove the

same basis as the other segments 

place the confectionery industry on the

proposed bill in the firm 

of the food industry. I support the

done. belief that it is just and proper that this be
AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 41

NATIONAL CONSUMERS LEAGUE,

Washington, D.C., August 31, 1965.

Hon. HARRISON A. WILLIAMS, Jr.,

Chairman, Special Subcommittee on H.R. 7042, Committee on Labor and Public

Welfare, U.S. Senate, Washington, D.C.

DEAR SENATOR WILLIAMS: The National Consumers League wishes to go on

record in opposition to H.R. 7042.

Since its organization in 1899, the league has supported legislation which will

provide the consumer with pure, safe products, and has closely associated itself

with major reforms such as the pure food and drug law. We oppose H.R. 7042

because we feel that its passage would substantially weaken this important consumer safeguard.

In effect, H.R. 7042 would (with minor exceptions concerning alcohol) nullify

section 402(d) of the Federal Food, Drug, and Cosmetic Act. This section now

provides that a confectionery may not contain any nonnutritive article or substance except authorized coloring, harmless flavoring, harmless resinous glaze not

in excess of four-tenths of 1 percent, natural gum, and pectin. If enacted, H.R.

7042 would allow manufacturers to add cheap fillers such as white clay, talc, and

barytes into candy merely in order to substitute less expensive substances for the

nutritive ingredients now permitted.

The industry has argued that many of these materials now banned in the

manufacture of candy are already allowed in food products, including baby foods.

This, it seems to us, is more reason to forbid their inclusion in candy. The full

cumulative effects of increased ingestion of such ingredients is not yet known.

Indeed, the increase in infantile hypercalcemia has already caused the Food and

Drug Administration to issue regulations reducing the amount of vitamin D in food

products, in the hope that this would result in less calcium being absorbed by the

blood of infants. To permit the inclusion of more calcium products in candy

would hardly seem to be indicated in the face of this present threat to the heart

and mental normality of infants.

Furthermore, the confectionery industry argues that it merely seeks the right

to use safe nonnutritive substances in the manufacturing process when such

substances serve a useful technological purpose. This is probably the intent of

the majority of the candy manufacturers. But passage of this bill would leave

us open to the practices of the few unscrupulous manufacturers, and to the

irreparable damage they might cause to the health and welfare of the Nation,

especially of our children.

The league would not oppose an amendment to section 402(d) as suggested

by Commissioner Larrick of the FDA in his testimony, and submitted previously

in the Department's report of August 18, 1965, which would allow the industry

to use safe nonnutritive substances deemed by the FDA to have a technological

value in the production of confectionery. We believe that candy, because of

its special appeal to children, should continue to be considered a separate food

under the law. Not only are children unsophisticated consumers, they are also

less able to safely assimilate certain chemicals into their systems. Chemicals

that show no effect on adults may be toxic to children. Therefore, stricter precautions must be used when dealing with a food such as candy. We believe it

is extremely important that the FDA approve each additive included in candy

manufacture. Possibly the old adage "An ounce of prevention is worth a pound

of cure" should be our guideline.

The league is also opposed to the embedding of trinkets of plastic, metal, and

other materials in candy, as prohibited by the present law, as well as to the

commingling of such items in candy machines, which the present law apparently

does not forbid.

Candy manufacturers in the United States enjoy a reputation for products of

high quality. The public has confidence in the purity and wholesomeness of

candy. The economic position of the industry is sound, and, if the popularity

of their product is any criterion, their economic position is secure. The league

believes that it is in the best interest of the industry as well as of every U.S.

citizen that nothing be done to impair the purity and wholesomeness of this

product by weakening the Federal Food, Drug, and Cosmetic Act. We therefore

strongly urge that your committee vote against H.R. 7042.

We respectfully request that this letter be made a part of the record of your

hearings.

Sincerely yours, SARAH H. NEWMAN, General Secretary.
42 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

Hon. HARRISON WILLIAMS,

Chairman, Special Subcommittee,

Labor and Public Welfare Committee,

U.S. Senate, Washington, D.C.

conducting 

DEAR MR. 

hearings 

CHAIRMAN: It is understood that your special subcommittee is now

by Senator Hartke 

on H.R. 7042, by Representative Macdonald, and S. 1839,

Food, Drug, 

add 15 other Senators, to amend section 402(d) of the Federal'

confectionery 

and Cosmetic Act which applies only to confectionery so that the industry will be placed on the same basis as all other food industries in 

to 

the 

be 

use of food additives which the Food and Drug Administration determines safe for food use.

of 

When 

all additives 

the Food Additives Amendment of 1958 was enacted to insure the safetytration 

used in all foods, it was the first time the Food and Drug AdminisIn 

acquired fully effective control over additives used by all food industries.

industry, 

the case 

the 

of the confectionery industry, however, with the cooperation of the

Food and Drug 

Food and Drug Administration's control began in 1906 with theAct of that year. At that time the yardstick used was nutritiveThat 

ness. 

is 

It 

an 

was again applied in the Federal Food, Drug, and Cosmetic Act of 1938. outdated and illogical gage today for determining food wholesomeness

and 

and I 

Drug 

believe 

Administration 

Congress was right in 1958 in limiting the function of the Food

rather than 

to determining the safety of an additive for food use its technological value which is a function of the manufacturer.

and 

After 

Drug 

the 

Administration 

Food Additives Amendment of 1958 was enacted I think the Food

section 402(d), 

should have proposed promptly an amendment to'

partment 

as is now proposed in H.R. 7042 and S. 1839. Instead the detionery 

has taken a position of wanting to apply a double standard to confecthereby 

while 

penalizing 

applying only a single standard to every other food industry and the confectionery industry for its past cooperation.

favorable 

Representing a member firm of the confection industry, I strongly urge the

same 

consideration of H.R. 7042 and S. 1839. Placing our industry on the basis as others in the food industries is only right and fair. Cordially yours,

J. W. FEIGHNER,

President, Tom Huston Peanut Co.

Re: Nonnutritive substances in candy.

Hon. HARRISON A. WILLIAMS, JR.,

Senate Office Building, Washington, D.C.

special 

DEAR 

subcommittee 

SENATOR WILLIAMS: We understand that you are the chairman of a

nonnutritive substances 

to consider H.R. 7042 which would permit the use of in confectionery.

amendments. 

We wish to advise you of our strong support for the bill without any crippling

ingredients.

We particularly oppose any special additive control over candy

cyclamates 

Our interest in this matter comes from our position as a manufacturer of

passed. 

(artificial sweeteners) which could be used in candy if the bill were

and are, therefore, 

These artificial sweeteners are generally recognized as safe by FDA. not food additives although they are nonnutritive. Sincerely yours,

T. R. MULCAHY,

Director of Public Affairs.

Senator WILLIAMS. Thank you, all of you who participated. It. was a very illuminating and enjoyable morning.

. (Whereupon, at 12:20 p.m., the hearing was adjourned.)

AUGUST 23, 1965.

THE PILLSBURY CO.,

Minneapolis, Minn., August 5, 1965.

0