We are in favor of the general objectives of this bill for the reasons set forth in our letter to you of May 15, 1947, on H. R. 2717. We indorse the changes from H. R. 2717 carried by the present H. R. 4211, since these, we believe, will substantially meet the objections raised by the salt-producing industry in the hearings of June 11 on H. R. 2717. We have noted that this bill, like H. R. 2717, amends section 301 of the Federal Food, Drug, and Cosmetic Act. As pointed out in our letter of May 15, 1947, the bill as now written would restrict regulatory action against violative products to criminal prosecutions and injunctions, and criminal prosecutions could be easily evaded by resort to the guaranty provisions of section 303 (c). Seizure action under section 304 would not be authorized. Therefore, the only sanction that could be uniformly applied would be injunction, as provided by section 302, and this alone would not be effective in preventing violations. It is our suggestion that the bill be rewritten as a misbranding provision under section 403, thus making its requirements subject to enforcement by all the sanctions of the act now applicable to adulteration and misbranding. This could be accomplished by adding a new paragraph at the end of section 403, as follows: (1) If it is salt (sodium chloride) in packages of 3 pounds or less net weight, and its granules pass through a No. 20 United States standard sieve, unless it contains suitable iodides in a quantity equivalent to not less than 75 parts and not more than 150 parts of iodine per million parts of such salt. This follows substantially the substantive provision of H. R. 4211 but leaves open the question as to whether the requirement could be evaded by including in the salt a few granules that would not pass through a No. 20 United States standard sieve. It may be that some provision should be included to avoid this possibility. The provision of section 2 of the bill making it effective 1 year after enactment seems reasonable in the light of the testimony at the hearing. We would therefore recommend that the bill, modified as suggested above, be enacted by the Congress. In view of your request that this report be submitted within the week, it has not been possible to obtain advice from the Bureau of the Budget as to the relationship of this bill to the program of the President. Sincerely yours, MAURICE COLLINS, Acting Administrator. The Honorable ROBERT HALE, SALT PRODUCERS ASSOCIATION, Chairman, Subcommittee of Interstate and Foreign Commerce Committee, House of Representatives Office Building, MY DEAR MR. HALE: I am attaching to this letter the statement with regard to the Bolton bill which we agreed to prepare for your subcommittee and have in your hands the latter part of the week of March 8. The statement itself is relatively brief and can be read in 15 or 20 minutes. Attached to the statement are a series of documents such as the resolutions of the dermatology societies, letters from a number of dermatologists, many of them nationally known, and a statement from the Wisconsin Alumni Research Foundation, showing that the trend in the use of iodized salt is upward each year for which they have records. We very much appreciate the opportunity that your committee has given us to present this statement. We are hopeful that the points which we raise in this letter will convince you and your committee of the wisdom of holding at least one more hearing on this bill. Very truly yours, W. G. WILCOx, President. STATEMENT REGARDING THE BOLTON BILL (H. R. 4211, AS AMENDED) BY W. G. WILCOX, PRESIDENT, SALT PRODUCERS ASSOCIATION, JAMES B. WESCOTT, COUNSEL, JAMES H. WINSTON, COUNSEL, FOR SALT PRODUCERS ASSOCIATION, DETROIT, MICH., AND LESLIE SALT CO., SAN FRANCISCO, CALIF. Re iodized salt bill introduced by Mrs. Bolton DEAR MR. HALE: This is a bill introduced in the supposed interest of public health. It is based upon the theory that people living in the so-called goiter belt need more iodine; this is well established and readily conceded; that although iodized salt is already available to such people and at the same price as ordinary salt, they won't buy and use iodized salt because they are scared off by the label "Iodized." And so to overcome the stubbornness or ignorance of that class of people in a limited area, this bill is offered to compel practically all salt commonly thought of as table salt throughout the whole of the United States to be iodized. If this bill is enacted, it is obvious that what is ordinarily termed uniodized or plain table salt.will be difficult or impossible to obtain in many places by the countless thousands who are sensitive to iodine or subject to certain skin diseases and therefore should avoid iodine or by the millions of inhabitants of coastal and other States where the people already get a sufficiency of iodine from their ordinary diet. Unquestionably the desire to help the health of the people of the so-called goiter belt is highly commendable but we respectfully suggest that the operation of this bill may, and we have strong reason to believe will, injure the health of others. And yet, extraordinary, drastic and far-reaching as this piece of legislation obviously is, it appears not unlikely that it is going to be enacted-enacted as if it were an innocuous and routine matter. Why do we say that? It is because the only persons who have appeared before you in opposition to the bill are the Salt Producers Association; and we apprehend that our efforts have been insufficient to arouse the minds of your committee to the serious import of the bill; and further because the millions of people whose health might be injuriously affected are not informed of the pendency of the bill and therefore have not appeared to speak for themselves. The salt producers from the very beginning have helped financially and otherwise in the prevention of goiter by promoting the use of iodized salt in Michigan and other States of the so-called goiter belt where some are subject to goiter because of the lack of iodine in their ordinary diet. The salt producers have cooperated in that movement by making iodized salt at the same price just as available as ordinary salt-and this at a substantial cost to themselves. But the salt producers are earnestly opposed to this bill which in practical effect will make ordinary table salt practically unavailable to people in many areas, for it should be pointed out that in many areas the stores do not sell table salt packages larger than 3-pound size. Members of the committee can easily verify this. Contrary to what is ordinarily suspected of commercial interests, we have no selfish interests to serve. We are deeply concerned as salt producers as to how we shall label our product, if this extraordinary bill should become law. But we are conscious of the fact that being salt producers our motives may be suspect, and therefore that whatever we say in opposition may be discounted by you. That should not be the situation in the deliberations on a bill which involves the health of every man, woman, and child in the United States. Speaking as ordinary citizens of the United States, we believe that this bill is ill-advised and inherently bad legislation. In reality it is so bad that we can only conclude that even your committee does not yet realize what it is being asked to do. We feel not only justified in saying that, but we feel that it is our duty to say it because we find that Mr. Crawford of the Food and Drug Administration (delegated to follow this bill) interprets its requirement as to the labeling of iodized salt absolutely contrary to the announced purpose of the proponents of the bill, and directly contrary to what the bill plainly says and plainly means. Mr. Crawford, speaking for the Food and Drug Administration, has stated to us that if the bill is enacted the Food and Drug Administration will still require that iodized salt be labeled as "iodized salt." Mr. Crawford's and the Administration's viewpoint is good common sense and, thoroughly understandable because to the average man it is unthinkable that Congress would enact not only that all table salt shall be iodized but also that in order to fool people into taking iodized salt the warning label "iodized" shall be eliminated. In other words, that the great Food and Drug Act, which is intended to prevent deception shall be deliberately utilized to compel deception. Deception is always inexcusable but where such deception results in harming, the iodine-sensitive patient or others who must (under advice of a competent physician) avoid all iodides-such deception is most serious. Mr. Crawford has failed to grasp, and we must believe that you also have, that it is the frankly stated purpose of the proponents of the bill to remove "iodized" from the label because they believe people consider iodized salt as being medicated (which of course it is) and so they refuse to buy it. The testimony offered by the proponents of the bill abundantly shows that the chief purpose of the bill is to remove "Iodized" from the label. For example: Dr. Kimball explained that under existing law iodized salt has to be labeled "Iodized salt" and that label strikes our citizens as being medicated salt. He then said (transcript p. 16): "Now during the last 2 years we have been trying to make all salt in the United States, all table salt, iodized and to get away from the labeling as iodized salt. There would be no such thing as iodized salt, but it simply would be all iodized." On page 17 he said: "And we have found it necessary to come to Congress to ask a change in our law whereby through the Department of Foods and Drugs we can redefine table salt; make it include iodine.' Dr. Emerson (transcript p. 31) called attention to the fact that many people are so constituted that if they see a strange name added to a food label, they are apt to think it is medicated, and so a good many people have felt that they should not get the iodized salt, but would use the noniodized salt, and the result of that error on the part of the purchasing public has been an increase in the incidence of endemic goiter. He then said: "Now we have had this experience long enough, over the past 30 years, to have a pretty good convinced opinion that we shall never achieve the protection of health that is desirable throughout the country until all people have access to table salt which is recognized as being protective, without being labeled as having this added substance." Again he said: "People like to buy flour as flour; their salt as salt; and if we define salt, table salt, as that which contains this very small amount of iodine, it will presently become traditional and usual to market and buy only that kind of table salt." Dr. Emerson put in evidence the proceedings of the executive board of the American Public Health Association which says, at page 38, as follows: "Only as a last resort, and after obtaining the best informed and authoritative advice of responsible administrative officers of the Federal Government, have we come to the conclusion that the object desired, that is the universal use of iodized table salt by the people of the United States of America, can be attained only if an amendment is made to the Food, Drug, and Cosmetic Act which would so define table salt as to require or permit the inclusion of the 0.01 percent of potassium iodide without the obligation of the salt manufacturers and distributors to declare that fact on the label, only such iodized salt to be allowed to be sold under the label of table salt for human consumption." That it is the purpose of the proponents of this bill to require that the word "iodized" be removed from the label on iodized salt, is further shown by the following. It will be remembered that the Bolton bill was originally introduced as H. R. 2717, as an amendment to section 301, and is now transferred to be an amendment of section 403 of the Food and Drug Act. We must assume that Mrs. Bolton had some reason for transferring her amendment from the one section to the other. What was the reason? We suggest the following: She discovered that if her amendment were a part of section 301 it would only prohibit the introduction of salt into interstate commerce unless it contained the required amount of iodine, and would not control the question of labeling or misbranding. So she transfers it to section 403, where according to the plain meaning of words it will say "Salt in 3-pound packages or less shall be deemed to be misbranded unless it contains the required amount of iodine." In our opinion that amendment redefines salt as being salt plus the required content of iodine, and therefore, it will constitute "misbranding" to label it anything other than salt. It is not only the stated purpose of the proponents of the bill to require "iodized" to be removed from the label, but we respectfully submit that giving ordinary meaning to plain language, the language of the proposed amendment can mean nothing else. Never forget that the proposed amendment becomes a part of section 403 which condemns misbranding. So far as it pertains to salt, section 403 with the proposed amendment would then read: "a food shall be deemed to be misbranded (subsections a, b, d, e, etc.). "(L) If it is salt (sodium chloride) in packages of 3 pounds or less unless it contains suitable iodides * * * Now then, if salt shall be deemed to be misbranded unless it contains the specified amount of iodides, doesn't it necessarily follow that the correct name (labeling) for salt which does contain the specified amount of iodide is salt, simpliciter. It is submitted that the practical effect of the amendment is (1) to require that all table salt be iodized, (2) to redefine salt as meaning salt plus the specified amount of iodides, and (3) to say that salt "shall be deemed to be misbranded unless it contains the specified amount of iodides." You will readily observe that in order for the amendment to mean what Mr. Crawford presently thinks it means, it would have to read "iodized salt [not 'salt'] shall be deemed to be misbranded unless it contains the specified amount of iodides." Under these circumstances when the proponents of the bill will insist that the labeling shall be "salt" merely, and the Food and Drug Administration will take the position that iodized salt must still be labeled "iodized salt" it is easy to see the dilemma in which the salt producers will be involved. Legislation should not be enacted which will leave them in that jeopardy. If Congress is willing to take the responsibility of enacting that an ordinary article of food must have an added drug, and that in order to fool or deceive people into using it, the notice that it is so medicated shall be removed from the label, it should say so in such unmistakable language that nobody can differ as to its meaning. Mr. Chairman and gentlemen of the committee, realizing as we do, that we as salt producers probably appear in the light of commercial interests "with an ax to grind" and that whatever we say or offer may on that account be discounted by you, we think it best to leave the responsibility of further investigation in your hands. But in closing permit us to make a few brief suggestions for your thoughtful consideration. The desire to help the health of people in the goiter belt is highly commendable. But in order to do so are you willing to take the responsibility of enacting that all table salt in the size of package commonly purchased shall be iodized, at the risk of thereby injuring the health of others? We suggest that health regulations which involve the health not only of the abnormal, but also of the normal, should only be enacted if primary regard is had for the well being of the normal. But here it would seem that the sole consideration is the abnormal condition existing in the so-called goiter belt. Don't forget that iodine powerfully affects the glands, the proper functioning of which controls the well being of the human body. Don't overlook the fact that iodine is a powerful drug. It is so powerful that the relatively small amount in iodized salt is sufficient, in the opinion of physicians, to prevent endemic goiter in the case of people who live in areas where they get no iodine at all. Are you satisfied, upon the basis of such evidence as you have thus far heard, that this amount of iodine compulsorily added to the diet of people who live in areas where they already get enough iodine will not be too much? We recognize that the resolutions of medical associations which have been offered to you must be impressive. Frankly, we are astonished at these resolutions, because they are so much at variance with the personal opinions of so many eminent doctors with whom the members of our association have talked. We can only conclude that in passing those resolutions, attention was focused upon the question of helping the health of people in the goiter belt, and that they were overlooking the health of the millions of people who are already getting a sufficiency of iodine, and that of the many people who are allergic to iodine in any quantity whatsoever. Are you going to impose iodized salt on them? The eminent Dr. Fishbein in his book entitled "Modern Home Medical Adviser" says at page 517: "DRUG IDIOSYNCRASIES "Individuals of allergic strain frequently become sensitive to one of the drugs such as quinine, aspirin, the iodides, drugs of cocaine series or morphine series. This type of sensitiveness frequently develops to such a degree that one aspirin tablet can cause a desperate illness of several days' to several weeks' duration; in fact, a small quantity of aspirin or cocaine can prove fatal or all but fatal to a highly sensitive case. It is extremely important for people to be acquainted with sensitiveness of this type, since the drugs which are commonly used in the symptomatic treatment of asthma are the ones which tend to sensitize." We are attaching hereto the opinions of eminent dermatoligists, who are opposed to the compulsory iodization of salt. We attach a 22-page bibliography listing 417 articles on iodine-sensitiveity and the effects of iodine in certain skin diseases. We could produce to you hundreds of like opinions, but we realize that no matter how many such opinions we produced, they would be discounted because they would be offered by an industry supposed to have some kind of selfish interest. Consequently we earnestly suggest that before you take the responsibility of enacting such extraordinary legislation, you consult dermatologists of your own choice. Respectfully submitted. W. G. WILCOX, President Salt Producer Association. JAMES B. WESCOTT, Counsel. JAMES H. WINSTON, Counsel. Speaking for Salt Producers Association, Detroit, and Leslie Salt Co., San Francisco. WISCONSIN ALUMNI RESEARCH FOUNDATION, Mr. WENDEL G. WILCOX, DEAR MR. WILCOX: You have requested that I supply to you some figures showing the trend in tonnage of iodized salt for human consumption stabilized by licensees and sublicensees of the foundation under the Hart et al patent No. 2,144,150 beginning with the year 1942. You have not asked that we disclose to you information regarding the tonnage of such stabilized iodized salt produced by individual licensees or sublicensees of the foundation under the above-mentioned patent and naturally we do not feel at liberty to release such information without the consent of such licensees and sublicensees. However, we are glad to supply to you information regarding the general trend. Using the year 1942 as the base and considering 1942 as 100 percent, the tonnage of stabilized iodized salt sold for human consumption is as follows: Figures are available for the first three quarters of 1947 and the estimate for the total year is based upon the available figures. According to the information we have, the drop in tonnage from the peak year 1945, as reflected in the foregoing figures, is based upon two factors. One of the foundation's licensees under the above identified patent discontinued the production of stabilized iodized salt for human consumption under the patent in about the middle of 1946 and from that time until the early fall of this year did not produce the patented product. However, production of stabilized iodized salt for human consumption under the patent has been resumed by this licensee within the past month or two. This resumption in production will not, of course, be reflected completely until figures are available for the year 1948. The tonnage of this particular licensee in 1945 represented about 13 percent of the total tonnage. The second factor involved in the reduction is that tonnage figures of two of our sublicensees show a marked decline from the tonnage shown by these two sublicensees in 1945. While we do not have specific information as to the reasons |