FOODS, DRUGS, AND COSMETICS 599 authorized by the McNary-Mapes amendment. As an illustration, let me cite the fact that most of the States and municipalities provide for butterfat requirements in whole milk. These range from 3 to 4 percent. Whole milk produced by certain breeds of cows contains butterfat appreciably below 3 percent. Under the language now in section 11 it can be effectively argued that no standard of quality could be established for milk above the lowest limit for fat found in any authentic whole milk. In other words, the standard of quality prescribed on the basis of fat content would not be above the requirements of the definition and standard of identity for whole milk. Thus the definition and standard of identity and minimum standard of quality would coincide. This would effectively repeal the provisions for a single standard of quality provided for canned foods by the present law. It is our belief that protection of consumers requires the deletion of the word "minimum" from section 11 so that a standard of quality somewhere between the highest and the lowest could be established and labeling could be required to show to which of the two grades thus set up the product belongs. If this is done in section 11, the word "minimum" should also be deleted in section 7, page 8, line 23, and page 9, lines 12, 13, and 15. Section 12 on permit factories has been the object of considerable attack in this hearing due almost exclusively, I am sure, to a misunderstanding of the limitations of this provision. Mr. J. D. Miller, of Sprague, Warner & Co., representing the Illinois grocery trade associations testified, if I remember correctly, that this section would give the Secretary authority to place the whole food, drug, and cosmetic industries under permit systems. Let us look at the language Whenever the Secretary finds that the distribution in interstate commerce of any class of food, drugs, or cosmetics may, by reason of conditions surrounding the manufacture, processing, or packing thereof, be injurious to health, and such injurious nature cannot be adequately determined after such articles bave entered interstate commerce, and in such case only, he is authorized to promulgate regulations requiring permits. Under this the Secretary would assume the burden, first, of showing that conditions surrounding the manufacture, processing, or packing of a food may cause it to be injurious to health and, second, that the injurious nature cannot be adequately determined after such articles have entered interstate commerce. This limitation makes it possible to require permits only in extremely infrequent cases. It deals with questions of danger to the health of consumers that cannot possibly be controlled under the other provisions of the law. Let me illustrate. Several years ago there was a large number of fatalities from the consumption of ripe olives infested with the botulinus organism. This is a soil organism. Its incubation and growth in a food product produces one of the most deadly toxins. known to science. Where raw food materials are contaminated with this organism it is essential that decent sanitary standards be observed in the plant and that the processing of the food be held to such time and temperatures as will effectively destroy the organism. No doubt the ripe olives that were responsible for the fatalities were not poisonous at the time they left the manufacturer's plant. But 600 FOODS, DRUGS, AND COSMETICS they did contain probably in a dormant state, only a few living botulinus spores, and during the course of their distribution and storage in commerce the spores of these organisms grew, inultiplied in number, and developed their deadly toxin. It is possible these organisms in many cases did not begin to grow until after the lapse of considerable time. Perhaps an examination of the ripe olives months after they had been shipped would not have revealed the presence of the deadly germ. Bacteriological methods have not yet been developed to the point where we can be sure we have not overlooked the organism before it starts the active growth during which the deadly toxin is generated. This then is one of the conditions where, to use the language of the bill, “such injurious nature cannot be adequately determined after such articles have entered interstate commerce." The only possible way of effectively safeguarding the public would be to insure, as is contemplated by the provisions of this section, that the manufacturer adopts proper sanitary and processing methods to guarantee against infected packages leaving his establishment that may later exact their toll of human life. Packers of ripe olives eventually solved their own problem and the commodity today is safe for consumption, but if the Government had been authorized to step in under the authority of the kind herein provided, the public health could have been much more effectively protected, and the packers themselves could have surmounted their difficulty more promptly. In fact, at the time of the occurrance packers asked that the Government step in and assume the regulation of all plants, but there was no authority for doing this. I can only conclude that the opposition to this section has been based upon an entirely erroneous conception of the extent of the authority it conveys. I should have no objection whatever to a deletion of the section if the other provisions of the bill were adequate to control situations of the kind I have described. But they are not. and if this section is deleted it will merely mean a repetition of instances like that of the ripe olives. I do not believe that any serious objection has been directed toward sections 13 and 14. Under section 15, paragraph (b), Mr. Miller has objected to the authority conveyed upon State and local officials for the institution of proceedings upon the presentation of evidence satisfactory to the United States attorney. This provision is in the present law and no instance has been cited of its abuse. If the committee is interested. I can submit any number of instances where State officials have acted effectively to protect the public interest through the institution of proceedings under this authorization. Section 16 authorizes the seizure of adulterated or misbranded products in interstate commerce and of products which have been manufactured, processed, or packed in factories where the operator did not hold a valid permit under section 12, where so required by regulations under section 12. The authorization to seize and destroy goods which have been shipped from factories required to hold permits but which do not have such permits has been the subject of severe attack-again, I believe, under & misapprehension of the limitations of the conditions under which permits can be required under section 12. If a product may be injurious to health by reason of FOODS, DRUGS, AND COSMETICS 601 conditions surrounding its manufacture and such injurious condition cannot be adequately determined after its entry into interstate commerce, there exists every reason why the goods should be removed from the channels of consumption. Let me cite again the botulinus illustration. As I have pointed out, the organism may lie dormant in the food for an indefinite period, during which the product is not dangerous. No one can tell when the organism will become active, grow, multiply, and produce its deadly toxin. Where such hazards are involved, seizure and destruction of the goods is the only adequate measure for public protection. While it might be that through this provision goods which are not actually but only potentially dangerous would be from time to time destroyed, manufacturers could easily avoid this through procuring permits and observing the decent and safe standards of sanitation that would be required thereby. If they do not do so, it is better to run the risk of destroying an occasional lot of harmless goods than to incur the serious health hazards that would otherwise be involved. Dr. Beal has suggested that the shipper of the goods as a matter of right should be authorized to secure representative samples from seized goods and to accomplish this proposes that on page 24, line 16, the word "shall " be substituted for " 99 may so that the paragraph will read, "The court shall, by order at any time before trial, allow any party to a condemnation proceeding to obtain a representative sample of the article seized." I have no objection to this proposal. The only outstanding difference between this section and the seizure section of the present law will be found on page 23, beginning with line 18, where seizure is authorized by an officer of the Food and Drug Administration who has probable cause to believe that an article is so adulterated as to be imminently dangerous to health. Seizure so effected must be promptly placed within the jurisdiction of the court, after which the proceedings will follow the conventional form. This provision is merely a time-saving device to permit more prompt action where imminent danger to health is involved. To follow the conventioned procedure, filing a libel in the court before attachment of the goods, involves considerable delay, and where the health of consumers is in imminent danger an observance of this convention can hardly be justified. Objection to section 16 has been voiced by the drug industry. Certain elements in that industry object now and always have objected to so-called "multiple seizures." They argue that the authority in the present law for multiple seizures is no reason for a retention of such authority in the new bill. They insist that the authority in the present law has been abused and has been exercised in a way that was never contemplated by Congress when the original statute was enacted. I had occasion back in 1929 to discuss publicly so-called "multiple seizures", because at that time the patent-medicine industry through its trade publications and otherwise was creating a furore about this very question. There had been a particularly industrious effort on the part of the drug industry to convey the idea that the Department in enforcing provisions of the law with respect to patent medicines was proceeding in a wholesale and reckless fashion, without regard to fair play, to seize patent medicines whenever and wherever the Department could find them in any section of the 602 FOODS, DRUGS, AND COSMETICS United States. The inference was that regardless of the character of the violation, whether it was serious or insignificant, such drastic and wide-spread seizure would be instituted without notice and without limit against almost any product subject to the Food and Drugs Act. I pointed out in my discussion of this situation that almost from the beginning of enforcement of the law the Department had adopted a very definite policy in the institution of seizure proceedings either in single or multiple cases. This policy limited seizure action to the following conditions: (1) food products containing added poisonous or added deleterious ingredients which may render them harmful to health; (2) food products consisting in whole or in part of filthy, decomposed, or putrid substances; (3) drug products so grossly adulterated or misbranded that their distribution constitutes a serious imposition on the public; and (4) deliberate frauds in the shipment of adulterated or misbranded products which seriously demoralize legitimate trade. practices. This classification set up by the Department has been rigidly followed by the Food and Drug Administration and by its predecessor, the Bureau of Chemistry. An analysis of the records of those instances in which more than three or four seizures of a drug product have been made (and the drug industry is the only industry which has ever raised serious objection to so-called " "multiple seizures") shows that in every instance the product was a serious imposition on the public, and, in most instances, the public health was at stake. For example, the drug product against which the greatest number of seizures has been made was " B & M. External Remedy ", a horse liniment labeled for tuberculosis, influenza, pneumonia, and a long list of other serious diseases, which I have exhibited to the committee. Many deaths resulted from reliance of tuberculosis victims upon this worthless nostrum instead of upon rational methods of treatment. Yet in this case, serious as it was from the standpoint of public health, the manufacturer was successful in securing a reversal of the decision of the lower court that the Department would not be enjoined from further seizures of the rostrum. Let me quote an excerpt from the decision of the Supreme Court of the District of Columbia reversing the lower court: Inasmuch as every district attorney to whom the Department makes certification must institute appropriate proceedings, by indictment or libel for condemnation, or both, it is evident that, even though the findings of the Depart. ment are merely administrative, nevertheless if such certification should be made to the district attorney in every district where a product might be found, the manufacturer would be crippled or ruined long before the final adjudication in the court could be bad. Such a result, we think, was not contemplated by Congress, except possibly in unusual cases where drastic action would be necessary for the immediate protection of the public. Is this a case of that character? We think not. Bear in mind this conclusion was reached by the court where the product at issue was a horse liniment labeled "for tuberculosis" and where many lives had been lost because of reliance upon the faise claims. The argument is now made by the drug industry that since the bill provides for injunction to restrain repetitious violations there is no longer need for authorization for multiple seizures. This is true except where dangerous or grossly fraudulent products have FOODS, DRUGS, AND COSMETICS 603 flooded the market before an injunction can be secured. Very frequently such products are on the market for some time before the evidence of their adulterated character can be established. The adulteration may have been accomplished under skilled technical guidance and prolonged scientific work may be required for its detection. If the public is to be protected in such circumstances the bill should not prevent the removal of such products from the market, whatever the number of outstanding shipments. * And if language is drafted in the bill permitting multiple seizures only where the violation is gross, or to borrow a phrase from section 22 of the Dunn bill, where "it appears that the public interest requires (such) proceeding to safeguard the public health or to protect the purchasing public from gross deception * **", then the question arises as to just where the line lies that marks the division between violations on which multiple seizures may be instituted and those on which seizures must be restricted in number. Certainly, the language of the Dunn bill furnishes no clear line of demarcation. How bad must a deception be to become gross! Obviously, under this provision there would be admittedly adulterated and misbranded products in interstate commerce that would not be subject to multiple seizure, and in every instance where the Department in its effort to protect the public against dangerous or deceptive products had exceeded the minimum number of seizures allowed the issues could be befogged by the contention that the violation was not gross, and thus the real issues as to adulteration and misbranding could easily be relegated to obscurity and real protection to the consumer denied. Frankly, I do not believe that in view of the complexity of the problem language can be drafted in the bill that would restrict the Department to the equitable policy that is now and has always been followed, without at the same time interposing insurmountable obstacles to seizure in cases where the public welfare dictates the removal of the goods from the market. As I have stated before in the course of this hearing, I am sympathetic with the proposal that legislation should be drafted so as to guarantee, if possible, against administrative abuse, but I merely wish to call your attention to the fact that in attempts to draft legislation from this point of view there is a real danger that the purposes of that legislation may be defeated. I believe that the history of the enforcement of this measure in the Department of Agriculture has demonstrated that administrative abuse of authority has not characterized our operations. It may be significant that this plea for restrictions on multiple seizures coines from the patent medicine industry, the very industry whose abuses against public welfare have been least effectively controlled by the present law. The injunction proceedings authorized by section 19 will greatly minimize the need for multiple seizures, but this authority will not be effective in protecting consumers against goods which may have been shipped out in large volume prior to granting of an injunction. Dr. Woodward made the recommendation that the minimum fines prescribed in section 17 be omitted and that merely maximum fines be provided. One of the troubles we have experienced in securing compliance with the act is the fact that the courts too frequently 48076-34-39 |