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ment said drug “ May be habit forming." Provision is also made permitting the Secretary to designate other stimulant, depressant, sedative, or cumulative drugs.
Objection to the wording of the above sections as it places in the hands of the Secretary power to require all such drugs to bear a complete formula disclosure.
Sec. 9. False advertising.-S. 1944 (a) provides an advertisement of a food, drug, or cosmetic shall be deemed to be false if in any particular it is untrue or by ambiguity or inference creates a misleading impression regarding such food, drug, or cosmetic; (b) an advertisement of a drug shall also be deemed to be false if it includes the name of any disease for which the drug is not a specific cure, but is a palliative, and fails to state with equal prominence an immediate connection with such name that the drug is not a cure for such disease; or any representation directly or by ambiguity or inference concerning the effect of such drug.
Objection to the fact the language used in the proposed provision is so ambiguous and provides such gross criminal sentences for even “misleading impression " and the construction of what is proper advertising, labeling, etc., and what is not, all written in such a loose and broad fashion that it is completely confusing in view of the present American standards.
S. 2000 and S. 280C provide (a) an advertisement of a food, drug, or cosmetic shall be deemed to be false if it is false or misleading in any particular relevant to the purposes of this act regarding such food, drug, or cosmetic: Provided, That no advertisement shall be deemed to be false under this paragraph because of any representation concerning any effect of a drug if that representation is supported by substantial medical opinion or by demonstrable scientific facts.
Objection to the language contained in this provision as being so broad and loose that it would be subject to any kind of an interpretation at the direction of the Secretary. It is common knowledge that it is impossible to describe or ascertain the manner palliation is affected. Neither would it be possible to offer proof as to substantial medical opinion or demonstrable scientific facts.
Section 10: Tolerances for poisonous ingredients in food and cosmetics and certified coal-tar colors for food.-S. 1944, S. 2000, and S. 2800 (a) provide if the Secretary finds that the presence of an added poisonous or added deleterious substance in or on food or cosmetics is or may be injurious to health, taking into account other ways in which the consumer or user may partake of or be exposed to the same or other poisonous or deleterious substances, that the Secretary shall, by regulations promulgated after notice and hearing, or under authority of section 22, prohibit such added substances in or on food or cosmetics, or establish tolerances limiting the amount therein or thereon, to such extent as he may deem necessary to prevent such injury to health. Provision is also made regarding certification of coal-tar colors in food.
Objection.—The Secretary of Agriculture is solely authorized to determine what ingredients contained in food products shall be considered deleterious to health. A question of such broad nature and of such paramount importance to the public at large should hardly be left to one individual.
Setcion 11: Definitions and standards for food.--S. 1944. The Secretary is hereby authorized to fix, establish, and promulgate definitions of identity and standards of quality and fill of container for any food. Whenever the Secretary deems that for the purposes of this act any such definition or standard should be established for any food, he shall give notice of a proposed definition or standard and of the time and place of a public hearing to be held thereon not less than 30 days after the date of such notice.
After such public hearing the Secretary may fix, establish, and promulgato a definition or standard for such food. The definition or standard so promul. gated shall become effective on a date fixed by the Secretary, which date shall not be prior to 90 days after its promulgation. Any such definition or standard may be amended or repealed after notice and hearing as hereinbefore provided, and if amended or repealed the amendment or repeal shall become effective in the manner and at the time hereinbefore provided.
Objection.—The Secretary of Agriculture is not required under this provision to follow the recommendation of America's largest industrial bodies as given in public hearings with reference to legal definitions and standards for food. Again sole discretionary power is allotted the Secretary of Agriculture to interpret as he sees fit.
S. 2000 and S. 2800 provide that for the effectuation of the purposes of this act the Secretary is hereby authorized to promulgate regulations as provided
by section 22, fixing and establishing for any food (1) a definition and standard of identity, and (2) one objectively determinable minimum standard of quality and fill of container.
Objection.--The language used is so broad and general that the Secretary is authorized to establish legal definitions of identity and standards of quality, and fill of container of all food products. Power so great should not be invested in the Secretary nor in any committee, but specific definitions of identity and standards of quality and fill of container ought to be contained in the law. Under the above provisions it is possible that the committee and the Secretary could, if they deemed it necessary, change such definitions of identity and standards of quality and fill of container from day to day, which would result in serious loss to manufacturers. Please refer to section 22.
SEC. 12. Permit factories.-S. 2000 and S. 2800 provide in substance that whenever the Secretary finds interstate distribution of any class of food, drugs, and cosmetics he is authorized to promulgate regulations relating to the issuance of permits as to manufacture, processing, and packing of such products. The Secretary is further authorized to revoke any permit upon any violation or infraction of the conditions outlined. He is further authorized to reinstate any permit in his discretion, and any officer or employee of the Secretary is given access to any establishment holding a permit. Denial of such access shall be grounds for suspension of the permit.
Objection.—Notwithstanding the admitted high standards now maintained by American food, drug, and cosmetic manufacturers it is proposed to saddle upon this industry a yoke in the form of a permit system, which is probably the most dominant and all inclusive yoke ever aimed at American commerce. SEC. 13. Factory inspection.-S. 1944 provides (a)
officers or employees duly designated by the Secretary,
are authorized (1) to enter any factory, warehouse, or establishment in which food, drugs, or cos metics are manufactured, processed, packed,
and (2) to inspect methods, processes, finished and unfinished materials, containers, and labels there used or stored."
Objection.—Regardless of the financial hazards involved manufacturers of food, drugs, and cosmetics will be compelled, at the arbitrary discretion of the Secretary of Agriculture, to submit to inspection at any time and disclose perfected methods and processes. Section 13 (6) (1) the widest injunction power ever invoked under any statute will empower the Secretary of Agriculture to deal out to American manufacturers summary trial and punishment in immediate court procedure.
S. 2000 and S. 2800 provide (a) “ in order adequately to regulate interstate commerce in food, drugs, and cosmetics, and enforce the provisions of this act, officers or employees duly designated by the Secretary, after first making reasonable request and obtaining permission of the owner, operator, or custodian thereof, are authorized (1) to enter any factory, warehouse, or establishment in which food, drugs, or cosmetics are manufactured, processed, packed, or held for shipment in interstate commerce or are held after such shipment, or to enter any vehicle being used to transport such food, drugs, or cosmetics in interstate commerce; and (2) to inspect such factory, warehouse, establishment, or vehicle and all equipment, finished and unfinished materials, containers, and labels there used or stored."
You will not that the only difference in S. 1914 and S. 2000 and S. 2800 is that the Secretary must make first a reasonable request for such inspection. That in reference to (a) (2) the Secretary is only permitted to inspect such factory, warehouse, establishment, or vehicle, and all equipment, finished and unfinished materials, containers, and labels used or stored. The reference to methods and processes being eliminated.
Objection. The language used is so broad and general that under the provisions of sections 12 and 13 it can be readily ascertained that the aforesaid sections are intended to require all manufacturers of food, drugs, and cosmetics to secure a permit to operate their factory or establishment and at the same time permit periodical inspections by inspectors of the Government. The Secretary, under these two sections, would unquestionably become the dictator of the American food, drug, and cosmetic industry.
Section 15: Investigation and institution of proceedings.-S. 1944, S. 2000, and S. 2800 provide that the Secretary or his duly authorized agents, or through any health, food, or drug officers or employees of any State, Territory, or political subdivision thereof, shall conduct investigations regarding violations of the act. In the event of prosecution the Secretary is required to afford an
opportunity for hearing of interested parties in accordance with regulations promulgated by the section.
Objection.- No provision is provided for a preliminary hearing when investigation warrants that prosecution be filed. The only notice defendant receives is upon notice of information being filed and the necessity of answering criminal proceedings.
Section 16: Seizure.--S. 1944, S. 2000, and S. 2800 provide that the Secretary shall be authorized to seize and condemn articles of food, drugs, or cosmetics shipped in interstate commerce which are adulterated or misbranded under the act, or which were not produced in a factory or establishment possessed of a permit when so required by the regulations.
Objection.—To this section is made in view of the fact that in addition to the power to regulate and control the manufacture of food, drugs, and cosmetics, it also permits the Secretary to institute multiple seizures, if in his opinion any food, drug, or cosmetic is adulterated or misbranded under the provisions of the act. The burden would be shifted from the Government to the defendant to offer proof that the articles in question were not contraband and in violation of the act. No criminal responsibility nor personal responsibility accrues to food officials for wrongful seizures.
Section 18: Liability of corporate officers.-S. 1944 provides that the slightest infraction or omission on the part of any employee is construed as the act of a corporation and all officers of such corporation, regardless of innocence, are subject to fine and imprisonment for any violation.
Objection to holding officers for acts of employees when said acts are not chargeable to said officers.
Section 19: Injunction proceedings.-S. 1944, S. 2000, and S. 2800 provide that the repetitious introduction in interstate commerce of any adulterated or misbranded food, drug, or cosmetic, or the repetitious dissemination of any false advertising shall be declared a public nuisance, and the United States district courts are authorized to restrain such acts by injunction. Violations of such injunction are punishable as contempt of court.
Objection.—No provision made requiring an offer of proof showing an intent to continue said offense.
Section 23: General administration provisions.-S. 1944 provides that the Secretary shall have full power and authority to adopt such rules and regulations deemed necessary to administer the provisions of the act. Under this provision the Secretary is clothed with power, first, to promulgate rules and regulations regarding the manufacture of food, drugs, and cosmetics; second, conduct the necessary investigations regarding violations of the act; and, third, pass upon violations of the rules and regulations promulgated by him; and his findings shall be all-conclusive.
Objection.—Never before in the history of American industry has any Government official attempted to allocate to himself such dictatorial power.
S. 2000 and S. 2800 provide that the Secretary, in the administration of the provisions of the act, shall have the assistance of a committee on public health consisting of five members designated by the President with a view to their distinguished scientific attainment and interest in public health and without regard to their political affiliation. This committee shall aid in the promulgation of rules and regulations relating to poisonous or deleterious substances in food, drugs, or cosmetics. The Secretary in the administration of the provisions of the act shall also have the assistance of a committee on food consisting of 5 members as provided in S. 2000 and a committee of 7 as provided in S. 2800, to aid in the promulgation of rules and regulations relating to food; that is, fill of containers, legal definitions of identity, and minimum standards of quality, and that when the Secretary deems it advisable that regulations under this section be adopted, a notice of public hearing shall issue to all interested manufacturers of food, drugs, or cosmetics. That any regulations in order to become effective must be approved by a majority of the members of the respective committees. You will notice that nothing contained herein requires that the Secretary or the committees shall follow the recommendations of the interested branches of the aforesaid industries; that hearing authorized or required by this act shall be conducted by the Secretary or such officers or employees as he may designate; that the findings of fact by the Secretary shall be conc'usive if in accordance with law.
Objection to this section is made as above set forth under S. 1944, section 23.
Section 26. Effective date and repeal.-S. 1944 provides that this act shall take effect 6 months after date.
Objection.-We register the most emphatic objection to this section. Practically all of the food, drug, and cosmetic manufacturers are possessed of large supplies of labels, cartons, and containers purchased during the past 2 years representing the outlay of large sums of money. It is therefore recommended that the effective date and repeal of the present Federal Food and Drug Act of 1906 become not effective for 2 years to permit manufacturers to work off and dispose of labels, cartons, and containers purchased for use under the provisions of the present law.
Section 25. Effective date and repeal.-S. 2000 and S. 2800 provide that this act shall take effect 6 months after date.
Objection.-The same as above set forth under section 26, S. 1944.
Giving all due credit to the gallant efforts of our President to revive American commerce, acknowledging the undoubted ability of the Secretary of Agriculture and other food officials long in the service to wisely enforce the provisions contained in this proposed act, it is yet our opinion that powers so broad and comprehensive should not be allotted to the determination of one individual, and we protest the theory of government that finds it necessary for the protection of the American consumers to ruthlessly confiscate and destroy the fruitful returns of the manufacturers. The proposed revision of the Federal Food and Drugs Act of 1906 not only places too much power in the hands of one individual but in the case of subordinates such power will undoubtedly lead to the opportunity and likelihood of its abuse.
The bills are objectionable further because no matter how well intended their enforcement may be they are still subject, because of their vague and uncertain language, to limitless interpretations, and they determine in large spheres and broad general terms, which are subject to rounding out and expanding many decisions which should be definite and detailed in character. And not the least of the objections is the fact that they deny the right of individuals and businesses to the protection of the constitutional guarantees of law and freedom which are inseparable from American tradition.
I also wish to call attention to the fact that every State in the Union has a State food and drug law. It has been customary in the enforcement of State food and drug laws for State officials to cooperate and follow the rules and regulations promulgated by the Food and Drug Administration of the United States Department of Agriculture. There is a serious question as to whether or not State food and drug officials, if granted the broad powers allocated to the Secretary of Agriculture, would continue such practice. It is certain that if any of the proposed bills are passed that every State will immediately intro duce similar bills in their own State legislatures. From thence on no uniformity in the administration of the Federal and State food laws will exist. The entire food, drug, and cosmetic industry will be thrown into a chaotic turmoil from which it is questionable they shall ever survive.
Therefore it is our recommendation that this honorable committee weigh carefully the question of a complete revision and rewrite of the Federal Food and Drugs Act of 1906. We further recommend that the present Federal Food and Drugs Act of 1906 be amended to meet with the present trend of time. This can be accomplished by a careful consideration of the Stephens bill, S. 2355. and we urgently request the adoption of the Stephens bill in substitution of all bills pending proposing a complete revision and rewrite of the Federal Food and Drugs Act of 1906. Respectfully submitted. FLAVORING EXTRACT MANUFACTURERS' ASSOCIATION
OF THE UNITED STATES, By John S. HALL, Erecutive Secretary.
PETITION OF THE NATIONAL ASSOCIATION OF MANUFACTURERS
OF FRUIT AND FLAVORING SYRUPS AND NATIONAL MANUFACTURERS OF SODA WATER FLAVORS
Your petitioners, the National Association of Manufacturers of Fruit and Flavoring Syrups and the National Manufacturers of Sode Water Flavors, respectfully present to this honorable committee for its consideration the following objections to the passage of S. 1944, S. 2000, and S. 2800 proposed revision of the Federal Food and Drugs Act of 1906.
The National Association of Manufacturers of Fruit and Flavoring Syrups was organized in 1906, and its members consist of manufacturers engaged in the manufacture, production, preparation, packing, distribution, and sale of crushed fruits, finished or fountain sirups, concentrates and unfermented fruit juices intended for use in the dairy, ice cream, confectionery, soda-fountain, and stillbeverage industries for further manufacturing purposes.
The National Manufacturers of Soda Water Flavors was organized in 1905 and its members consist of manufacturers engaged in the manufacture, production, preparation, packing, distribution, and sale of soda-water flavors and concentrates intended for use in the still and carbonated beverage industries for further manufacturing purposes.
Our members wish to register their opposition to the passage of S. 1944, S. 2000, and 2800 (proposed revision of the Federal Food and Drug Act of 1906) now pending before this honorable committee. It is further the contention of our members that the aforesaid bills suggest that this great industry abandon the reasonable regulatory provisions under which the industry has thrived in this country and substitute in lieu thereof industrial control by political and bureaucratic officials.
The Constitution of the United States and the constitutions of the various States have well defined the right of sovereignty as the basic or organic principle of law, and from this source is derived the authority to enact, construe, administer, and enforce laws. The theory of our Government, National and State, has always been opposed to the granting of unlimited power to any officials. The legislative, judicial, and executive branches of our Government are all of limited and well-defined powers. Very wisely, in the enactment of the present Federal Food and Drugs Act of 1906 the Congress then considering the aforesaid law follows these principles. It is well to direct the attention of this honorable committee to the profound wisdom exemplified by the author of the Federal Food and Drugs Act of 1906, which was known as the Heyburn bill in the Senate. I quote Senator Heyburn (Cong. Rec., vol. 40, pt. 3, p. 2721): This bill does not provide
for the fixing of standards by anybody the chief chemist
is simply the agent of the courts to gather testimony upon these questions for the purpose of being used at the trial in the court room and nowhere else
this bill fixes no standards upon anything; it authorizes no officer to fix any standards. It provides that the courts, and the courts alone, may determine whether or not an article is contraband under the provisions of this act.
Inasmuch as standards vary, it would be impossible for an act of Congress, a general law, to avoid some conflict with some of those State laws if you should undertake to fix standards.
“ Page 2723. * * I wish to have it understood that this bill does not permit the chief chemist of the Bureau of Chemistry to fix standards or to punish anybody or to brand his goods as fraudulent, under any circumstances. It does not permit the Secretary of Agriculture to do so. It does not permit anyone except the court, after a trial by a jury, if the party shall appeal to that right, to brand the goods as being fraudulent or obnoxious to the provisions of this bill."
For the past 27 years food, drug, and cosmetic manufacturers have cooperated with the officials of the United States Department of Agriculture and in cooperation with the Food and Drug Administration have by rules and regulations formulated definitions and standards for use of the food industry which have been effective in the enforcement of the Federal Food and Drugs Act of 1906.
It is now intended that the food industry be regimented under the direction of the Secretary of Agriculture and adopt legal definitions and standards such as may be promulgated by the Secretary of Agriculture.
Therefore we wish to register objections to the following provisions contained in the bills :
Section 2: Definition of terms.-(j) “The term 'advertisement' includes all representations of fact or opinion disseminated in any manner or by any means other than by the labeling.”
We object to the inclusion of the words “ or opinion." It is our recommendation the the words “ or opinion” be stricken from the bill.
Section 3: Adulterated food.—(6) (4) “If any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight in a deceptive appearance."