TOILET GOODS ASSN. v. GARDNER
Legal provision: Federal Food, Drug, and Cosmetic, and related statutes
Argument of Nathan Lewin
Chief Justice Earl Warren: Number 336, the Toilet Goods Association Incorporated et al. Petitioners versus John W. Gardner, Secretary of Health, Education and Welfare, and number 438, John W. Gardner, Secretary of Health, Education and Welfare versus the Toilet Goods Association.
Mr. Nathan Lewin: Mr. Chief Justice, may it please the court.
This case which is here on cross-writs of certiorari to the Court of Appeals for the Second Circuit, demonstrate even more clearly than does the Abbott Laboratories case the harms which flow from premature judicial intervention and of the administration of the Food and Drug and Cosmetic Act.
Under the terms of that statutes enacted in 1938, the Food and Drug Administrations was to protect the nations’ consumers against certain harmful coloring ingredients in foods, drugs and cosmetics by a premarketing clearance procedure under which it was to require manufacturers to test coal-tar colors for safety.
After the Food and Drug Administration had reviewed the results of these tests, it was authorized to list such colors as it found harmless or suitable for use.
Late in 1958, this court sustained the Food and Drug Administrations’ position that the statutory scheme under that 1938 Act contemplated that only totally harmless coal-tar colors could be listed.
In other words, that the Food and Drug Administration was not required to concern itself with the precise concentration or the mixtures in which such colors would have been used in foods, drugs or cosmetics or with any of the products with which they were combined.
Only if the coloring ingredient was absolutely and totally harmless could it be listed under the existing standard that was Flemming versus Florida Citrus Exchange in 358 U.S.
Recognizing the merit of an industry complaint that such an absolute standard prohibited the use of coloring ingredients which might be totally innocuous in small quantities that actually used, the Food and Drug Administration supported the mandatory legislation which was enacted to the Color Additive Amendments in 1960.
That statute which is reprinted in relevant portions of pages 24 and 29, and 37 of our brief in this case extended the premarketing clearance procedure to all color items both natural and synthetic coal-tar and any other coloring ingredients which were derived from any other source.
It empowered the Food and Drug Administration, which had been delegated the powers of the Secretary of Health, Education and Welfare under the act to list color additives after review of testing information submitted by the manufacturer with “conditions under which the additives might be safely used.”
Section 706(a)(2)(b), and (a)(3) which appear at page 30 of our brief are quite clear on that subject.
They authorized the secretary to list a color additive for a “more limited use or uses than have been applied for” and “prescribed the conditions under which such additive maybe safely employed for such use or uses.”
The act was passed in July of 1960 with appropriate provisions, for provisional listings of color additives which had been used until the administrative machinery had gone through the process and completed verifying the information on the color additive applications, which would be submitted.
In June 1963, the commissioner of Food and Drugs after reporting notice and an opportunity to submit return comments in the Section 4 of the Administrative Procedure Act issued substantially the regulations which appear 22 CFR 8.1 to 8.52, it covers about 20 pages in the code of federal regulations.
Among those regulations were four clauses which are specifically the challenge in this case.
Section 8.1, all those four all appear at pages 37 and 38 of our brief.
Section 8.1F defined color additives as used in the statute and have been subjected to these procedures by the Congress to include “a substance that when applied to the human body results in coloring,” and it specifically enumerated lipstick, rouge, eye makeup colors and related cosmetics intended for coloring the human body.
In other words, the Food and Drug Administration construed the act as subjecting to this premarketing clearance procedure, finished cosmetic products used for coloring the human body.
The very same section of the code of federal regulation also defined color additive to include old diluents and diluents were defined in the definitionary provisions of that regulation as any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed there in to facilitate the use of the mixture in color.
In other words, anything added for purposes of -- essentially anything added to a product which contains coloring ingredient.
In addition Section 8.01(u) defines the Hair Dye Exemption Statute, the statute specifically Congress exempted from its provisions, hair dyes provisions of the Food, Drug and Cosmetic Act in the preclearance procedures, hair dyes which contain color ingredients whose harmful nature could be determined by what’s commonly known as a patch test.
A test, which the consumer could apply to his own skin and determine whether there was anything in that hair dye which would, which would harm him or her.
And the Food and Drug Administration in these regulations construed the Hair Dye Exemption of the statute as not applying to any hair dyes containing products whose harmful products, whose harmful effects could not be testified in a patch test.
It was going behind the words of the statute to the purpose of Congress.
And finally the fourth provision involved in this suit and the one on which the Food and Drug Administration was sustained by the Court of Appeals warned that if employees of the Food and Drug Administration were denied access to manufacturing facilities, processes or formulae of drugs -- of cosmetics which they were required to certificate it in effect by batch certifications to check -- though the very product itself, then the commissioner might immediately suspend the certification service there by making those products nonmarket, that was in July of 1963.
In November of that year, before the regulations were put in effect, and for compliance with any of these regulations or before an effect these procedures have been gone through, this action to declare clear those regulations invalid was instituted.
The District Judge first denied a motion to dismiss in November 1964 and then after the Abbott Laboratories case was decided by the Third Circuit in December of 1965, he certified interlocutory appeal under 28 U.S.C. 1292(b) on that issues to whether this suit was premature or it was right at this juncture or not.
The Court of Appeals affirmed the district judge's refusal to dismiss the first three counts of the complaint but concluded that the fourth count attacking the factory inspection provision was premature and should be dismissed.
So the only issue before this court, the only issue before the Court of Appeals on the interlocutory appeal was the question of rightness and prematurity.
In this case, unlike Abbott Laboratories, we do not alternatively urge for that reason that the court consider the merits if --
Justice Hugo L. Black: Do not urge what?
Mr. Nathan Lewin: We do not go on to discuss or urge the merits beyond the jurisdictional point because we think the only issue that was properly before the Court of Appeals on the interlocutory appeal was the question of pre-maturity of rights.
Justice Byron R. White: I notice the parties took pretrial discovery, they took about a year for pretrial discovery.
What were the issues?
Can you enlighten about that as to which they took the pretrial testimony?
Mr. Nathan Lewin: Oh, I know but the District Judge I think was concerned over with the intent of the people who are behind the legislation.
I am really not sure as to what the pretrial was concerned.
About the -- apparently the intent, the motives, the legislative intent behind the statute --
Justice Potter Stewart: Additive legislative history as I read the briefs that they interviewed people who were there at the legislative hearing, committee hearings.
Mr. Nathan Lewin: Well, the District Judge, yes the District Judge thought that was a relevant way of determining what the statute meant.
I don't know whether all, I suppose, I'm told that all the pretrial discovery concern that issue what was the legislative intent when they passed the Color Additive Amendment.
We don't necessarily agree that that's a proper way of determining legislative intent, I must say that, that was the District Judge's view.
Now, we have attempted in the introduction to our main brief and in our reply brief to explain why we think that this case in it's present posture at least insofar as it affects those first two counts, the finished cosmetic product and the diluents is particularly premature and entirely hypothetical.
Now I'll try to summarize that position as briefly as I can.
It appears to be agreed and I don't think there can be any question whatsoever that under the 1960 amendment the Color Additive Amendment of the Food, Drug and Cosmetic Act Congress intended that the Food and Drug Administration apply a safety in use standard under which it was, the administration was to determine before listing a color additive not whether that color additive in the abstract and just taken purely by itself was safe, but whether as used in a finished cosmetic or in any finished product whether that color ingredient was safe.
Consequently, the practical result of that, the administration of that kind of a test is that an applicant for listing doesn't satisfy his burden under the statute by merely testing the coloring if the color ingredient as such, just that pigment.
He has to submit to the commissioner information on how he will use the coloring ingredient and sufficient scientific data, pre-testing if you will as to the other ingredients that will be included with the pigment or the dye and the finished product.
In other words the Food and Drug Administration cannot be expected in administering a safety in use standard to list color x as safe for use in a finished product unless it has adequate information that the finished product and the ingredients that are added to the color, the color pigment or dye are safe for use, but was that true that an entirely, a pigment or dye that may appear to safe in the abstract when combined with other products or when put in a finished product may not be safe, be safe for listing, then obviously the Commissioner of Food and Drug, the Food and Drug Administration, when it finally lists color x for safe in use in a certain finished product is in effect listing the finished product as well as the coloring ingredient and that's the kind of thing which becomes obvious we submit once the total system as administrated by the Food and Drug Administration goes into effect.
If the company in this case were to submit adequate information under a safety in use standard even under their own construction of what color additive meant and if the Food and Drug Administration would then define that those pigments, those coloring ingredients as used in a finished product are safe and are listable in effect and will be listed then the controversy is over, they haven't been hurt at all.
Their finished product will be listed, their coloring ingredient will be listed, and their diluents will be listed.
Justice Potter Stewart: I thought their point was that you have jurisdiction to list or not list or control or have anything to say about their finished product as such, as such.
Mr. Nathan Lewin: Well, we think, we submit that and I don't think they really disputed is that we have jurisdiction or the Food and Drug Administration has jurisdiction to control a finished product although not as such if it had no color ingredients, but does have jurisdiction to control it as a terminal use of a coloring ingredient.
Well, that make that is precisely what makes the suit, that's in first account disappear everything because if we do have jurisdiction to make that determination then they are not they are very likely not to be hurt at all once the whole machinery has been carried through and that, it seem to me indicates to us what the harms are or it's illustrative of the harms of premature judicial intervention.
Justice Abe Fortas: Diluent, diluent, how do you pronounce it.
Mr. Nathan Lewin: The diluents, we think that's true with the diluents too.
Assuming you take a color ingredient that is totally harmless in and of itself.
If it's combined with any other product in which it appears in a finished cosmetic product produces a poisonous result because the diluent is poisonous, obviously the commissioner can't be expected to list the coloring ingredient as permissible for use with that diluent and the statute itself makes entirely clear that the listings are supposed to, are supposed to list the color ingredients for use with or without certain diluents.
Now if that's true and the commissioner is supposed to specify the diluents with which pigment x can be mixed, well then he is got to pay us on whether these diluents are safe.
And if he's got, the way he passes on that is he asks the requires of this company to make tests on the diluents to submit the results of those tests and to have the Food and Drug Administration pass upon.
So that although this astute at the present they look like a challenge to the Food and Drug Administration regulation.
If in fact we waited until the companies actually felt any kind of pinch at all, I think it will be discovered that they feel none.
Now they --
Justice Abe Fortas: I beg your pardon not that they were contending that the commissioner says I am going to list and certify the video inseparably.
Mr. Nathan Lewin: The commissioner Mr. Justice Fortas I don't has ever said that and from what I am understand the need Food and Drug Administration takes no such position.
It's position is that you can list product either let's say lipstick, ether under a common base, under a common color ingredient, you can list it together with certain diluents, list the diluents separately, but they had nothing, they had nothing in the statute and had nothing in the Food and Drug Administration of these provisions which would require them to list these separately and that we think also explores the exaggerated costs claim, their (Inaudible) estimates because one affidavit in the record and that also appear in the brief of the companies in this case, adds to the costs of complying with this because of the listing and testing provisions.
Well, the listing there is a listing deposit under the regulations issued by the Food and Drug Administration of $2600 per petition for listing, but that's a deposit only, that's to deprive the processing cost of the Food and Drug Administration and passing on the petition.
Now not with -- the Food and Drug Administration is not going to be listing or incurring this $2600 cost with each one of a lipsticks of any particular plaintiff's obviously they can list them all together under one paragraph of the Code of Federal Regulation and the total cost will not even remotely approach what the plaintiffs in this case contend.
And say things true with the pre-testing, sure they would have to be testing of the finished product and of the diluents, but there are so many common ingredients among all these, I mean the plaintiffs referred to one company's 2700 cosmetic formulae, but there are so many common ingredients let's say among all of these lipsticks that it fallacious to just simply multiply them all and say that gives you the total cost of the complying with the Food and Drug Administration regulation.
Justice Potter Stewart: Do you think this case then is quite different from one we just heard, Abbott?
Mr. Nathan Lewin: We think it's more premature, you can put that way.
Justice Potter Stewart: Because I understood you in the Abbott case, you said there was really no question about the complete lack of ambiguity that the polarity and certainty of the meaning of the regulation there involved.
And that, in that sense at least while you use the word abstract, it really wasn't abstract it was, it's meaning was clear, its meets and bounds were clear and here you say that is not so --
Mr. Nathan Lewin: That's right.
Well, I think maybe the way they distinguished --
Justice Potter Stewart: Or at least they are arguing about the need.
Mr. Nathan Lewin: Right, well the way they distinguish--
Justice Potter Stewart: In Abbott there was no argument at all about the meaning.
Mr. Nathan Lewin: I think the way to distinguish the two is that in Abbott Labs you know exactly what the plaintiffs will have to do to comply with the regulation.
Justice Potter Stewart: Yeah.
Mr. Nathan Lewin: In this case we submit it's very likely, they will have to do nothing more than they would have to do anyway to comply with.
Justice Potter Stewart: Well, of course they disagree with you but in that respect this case is different, and then you do disagree as to the meaning of the regulations, is that true?
Mr. Nathan Lewin: I don't know whether you could put that it to the meaning of the regulation I think it's more
Justice Potter Stewart: Or the impact.
Mr. Nathan Lewin: The impact of the regulation.
Yeah I think there is that difference.
Now, the plaintiffs in this case as well as the plaintiffs in Abbott Lab talk about their harms in terms of publicity as a result of seizure or injunctions or criminal prosecution.
Well, again that's precisely the harm which this court referred to in the Mytinger & Casselberry case, in an opinion by Justice Douglas said that in the context of the Food and Drug Act that the fact that a seizure might cause irreparable harm to a business didn't mean “the hands of government must be stayed until the courts have an opportunity to determine whether the government is justified in instituting suit” that was a preliminary step to a seizure and this is -- and even more preliminary step in effect to a seizure because this is an effect the commission saying, the Food and Drug Administration saying that these are the procedural steps we will go through, and I think these are requirements we will impose on the industry before we ultimately pay us on all these color additives, the safety of the color additives the color--
Justice Abe Fortas: Mr. Lewin if an individual manufacturer for appropriate procedure challenged this in a particular case as you argue is contemplated by statute, would it be possible for him to argue that the regulation is confiscatory.
Mr. Nathan Lewin: I think he could, I don't at present concede in what way --
Justice Abe Fortas: Well then now in this case, (Inaudible) in paragraph 47 on their complaint as I see it, they're arguing they are making a kind of a substantive due process argument that this regulation is confiscatory from an industry wide basis, which does sound to me like some of the substantive due process, but on the industry wide basis, in other words, the industry as a whole says we're entitled to be considered as a whole and considering us as a whole this regulation is confiscatory.
Mr. Nathan Lewin: Well, I think paragraph 47 goes to the fee requirement again.
Mr. Justice Fortas.
I think --
Justice Abe Fortas: For the fee requirement?
Mr. Nathan Lewin: Yes to the fee requirement.
In other words what they're saying in effect is that the total fee which result from requiring separate listing is --
Justice Abe Fortas: Well it goes back to the separate listing for it.
And I was just wondering what comment you have to make as to what seems to me to perhaps erroneous, whether it be the basic theory underlying this case and perhaps remotely and indirectly in the preceding case and that is that an industry as a whole has a standing to challenge a government regulation and that the industry as a whole in this particular paragraph has standing to have the economic impact of the regulation considered on the industry as a whole for the purpose of determining whether it's confiscatory.
Mr. Nathan Lewin: I think there are really two answers to that Mr. Justice Fortas.
First did nothing in what, the claimant here on Abbott labs urge which would limit their suit to an industry wide suit as a whole that If in some way there were some means of ensuring that entire industry would bring a suit which would protect that industry's interest, I think it would take a statute for, but if there was some way of limiting the doctrine of that, then I think the questions would be substantially different.
And one of our problems with the rightness claim in this case and in Abbott Labs is that opens the door to individuals.
I think a second answer is really that neither in Abbott Lab certainly where whatever claim the whole industry has, the individual drug manufacturer has as well.
Nor in this case, where there's really no basis for the claim, can it be any industry wide claim.
Let me make -- let me see if I can make that last point a little bit clearer really.
If it were true that the Food and Drug Administration regulations prescribed an absolute $2600 fee for each listing and the Food and Drug Administrator, Commissioner said I will have to list every finished cosmetic product separately, that's the way I construe it and I won't allow you to do anything other than that, I think there might be room to argue that the harm that would be done by waiting until the actual pinch is felt would be irreparable, because the industry would be expected to forth over $2600 for each --
Justice Abe Fortas: Well did they support this lawsuit.
Mr. Nathan Lewin: Pardon me?
Justice Abe Fortas: Assuming that what you're saying were true, would that have a right to an injunction?
Mr. Nathan Lewin: I think --
Justice Abe Fortas: Could this, would they have standing to maintain this -- would this be an appropriate suit.
Mr. Nathan Lewin: Oh I think there would be much more basis for permitting that kind of a suit.
We think, and I think we try to make clear in our brief that rightness is not something that you can determine simply by any actual rule.
We think that when really a whole industry maybe hurt or will be hurt by being forced to pay confiscatory costs which they will no opportunity to litigate at any later time, in other words, the regulation either has to be challenged now or never, we think that would be right.
Justice Abe Fortas: Well, why can't then that be litigated at a later time, if this can't be, why couldn't they refuse to list and go ahead and market the product and have action brought against them at one sort or another and then contend in defense of their listing that the payment of the fee is confiscatory?
Mr. Nathan Lewin: Well that would be true with that individual fee be Mr. Justice Fortas.
But if their allegations are true, I suppose they say we've already paid -- forced to pay $7 million with all our 2700 petitions and to force us to pay 700 -- $7 million.
Justice Abe Fortas: If you are willing to concede that I have difficulty with the rest of your argument.
Mr. Nathan Lewin: Well I'm not prepared to concede it, but I'm saying that's a different, it seems that's that a difference case.
If that were true I think this case might be closer to Abbott Laboratories.
That fact that that isn't true I think is what makes this case disappear, makes it much clearer than Abbot Laboratories, because in this case there is no such requirement.
The industry is not being asked today to pay $42 million in listing fees or forego using it's cosmetics for the next few years.
If that were true, we think there might be some room for arguing that -- maybe they ought to be permitted to litigate that.
Chief Justice Earl Warren: Mr. Ross.
Argument of Edward J. Ross
Mr. Edward J. Ross: Mr. Chief Justice, and may it please the Court.
The basic distinction between the cosmetic case and the Abbott Laboratories case has not really been set forth yet, and this is the distinction.
In Abbott Laboratories, Congress did in fact legislate a requirement that there would be prominence to the generic name.
And the issue was whether or not the regulations properly implemented a power which was granted to the agency and that's probably why their complaint alleges the unreasonableness of the regulation.
This is not the kind of issue in our case.
Our case is one where Congress never granted a power to the agency.
The agency allocated to itself, it took new and different powers from those which congress granted.
In fact it took powers which it requested of Congress and which Congress refused to grant by declining to enact the legislation which would have accomplished the power, which was ultimately taken by the regulations.
Justice Potter Stewart: Expect in degree there, what's the difference?
The question is, is the power of the agency to do what it did under the statute, isn't it?
Mr. Edward J. Ross: Well, it's a question of degree, but a very substantial degree.
What was done here Your Honor was to subject an industry which was not subject to getting a license before it could sell it's products, to getting a license.
Now before any finished cosmetic product which imparts the color to the body may be sold.
That product must be pre-cleared by FDA and there must be a license for it and the statute doesn't require this kind of a license, it requires a license for one ingredient, the color which was added to the product, not for the entire product.
Now the hair dye allegation illustrates this very clearly.
The statue says that hair dyes are exempt they're exempt if they bear a certain kind of label which is very specifically provided for by the statute.
The exemption is so complete that even the provision with respect to clearing the color ingredient that if it is not a hair dye so that the color in the hair dye doesn't have to be cleared by the agency, nevertheless the agency rewrote the statute, changed its provisions and said from now on, the entire hair dye product must pre-cleared by the Food and Drug Administration, it may not be sold unless it gets this prior license and it may not be sold unless we list it in a regulation and this listing means setting forth the specifications and formulas of the product or at least the trade secrets, they must be published in the Federal register for all competitors the same copy if they want and then certifying the batches of it.
Now these are substantially new and substantially different powers from those which were intended to be given to the agency by Congress.
And the proof of it lies in the fact that on repeated occasions FDA sponsored legislation in which it urged that it was desired to impose this kind of a license on finished cosmetic products.
Innumerable bills were introduced for the pre-clearance of cosmetics and these were never enacted, some cases after hearing as to the necessity of this legislation.
There were several bills introduced to eliminate the statutory exemption for hair dyes, they were not inactive.
It was legislation introduced to give the Food and Drug Administration access to the formulas of all products covered by the Act and Congress examined this very critically and enacted a provision that they would have access only to the formulas of prescription drugs and not to the formulas of nonprescription drugs or the formulas of cosmetics or the formulas of food or the formulas of devices.
Now this is the kind of allocation of power to an agency, which has always been reviewable as early as Stark v. Wickard, this court held that it was an inherent judicial function by injunction in equity to challenge this type of excessive power and the only time it could not be challenged if there was a specific provision in the statute which prevented challenge, they said mere silence was not sufficient.
This was the decision in the Frozen Food case where this court will recall it said that what was being done there was to license an industry or require licensing for an industry where the act require it and it was allowed to be challenged in equity by an injunction action.
This is the very classic kind of a case in which the declaratory judgment's law was designed.
This is what the Food and Drug administration is saying if you don't believe these regulations are valid, ignore them and then face the penalties of being wrong or even face the penalties of being right because as Mr. Gazelle said the headlines, the cosmetics which are carefully tested and as to which the companies are very jealous of their reputation and goodwill, there were headlines of multiple seizures because the products were adulterated, this would ruin the industry.
Now in this field, you can't have multiple seizures because we are not dealing with the matter of labeling, we are dealing with products which will be called adulterated in the public press, if they are sold without complying with the licensed provision which we assert in the claim, is illegal and the --
Justice Abe Fortas: Mr. Ross suppose if Food and Drug administration discovered, found and discovered that a particular and common ingredient used in cosmetics cause cancer or induced cancer giving a wild example and let's suppose then under 361(a) after appropriate proceedings, and adopted a regulation saying that cosmetic shall be deemed to be adulterated if they include such and such an ingredient it or if the label doesn't say so and so.
Now under your theory of the case where an injunction applies, could a drug cosmetic company or the industry or group cosmetic companies maintain an injunction proceeding to prevent Food and Drug from administering that statute?
Mr. Edward J. Ross: I'm not sure Your Honor I hope then -- I would say--
Justice Abe Fortas: That's the key question--
Mr. Edward J. Ross: No I, I don't believe it is because if you are dealing with the question of the propriety of listing the color.
Justice Abe Fortas: No I'm not, I'm not dealing with that.
I'm dealing with question of court jurisdiction.
Now in that -- I am talking about Section 361.
Mr. Edward J. Ross: Maybe I don't understand.
Justice Abe Fortas: It's a jurisdiction here --
Mr. Edward J. Ross: If I understand your question correctly you are saying that if FDA wants to determine that a particular color ingredient--
Justice Abe Fortas: Not color ingredient, just an ingredient.
Mr. Edward J. Ross: Oh! Any ingredient?
Justice Abe Fortas: Any ingredient.
Mr. Edward J. Ross: I don't know of any provision, they would have to--
Justice Abe Fortas: 3621(a).
Mr. Edward J. Ross: They could -- if they were adulterated, then the product could be ceased after sale, there is a post marketing power after sale.
There is no premarketing clearance of cosmetic, there is a premarketing clearance of the --
Justice Abe Fortas: I understand that but suppose the secretary adopted, promulgated a regulation and they said that these cosmetics shall not contain this ingredient or shall not contain this ingredient unless there is a warning on the label that's under 361, and I just, I want to know whether industry or company, if it thought that that was confiscatory, might very well be in practical effect, could bring an injunction proceeding.
Mr. Edward J. Ross: I would think that that would be a classic case where the expertise of the agency would be involved and any court --
Justice Abe Fortas: Then district court here say that expert testimony would be helpful?
Mr. Edward J. Ross: Well it did and principally in connection with the legislative history, they wanted to have the testimony as to what type of technical problem was involved in particularly testimony from those who help to shape the legislative history.
But just to finish my answer to your question Your Honor when you are dealing with a question of the safety or propriety of a particular ingredient and that is the matter for these special components of expertise of the Food and Drug Administration.
And normally, I would say that the proper procedure would be to go before the agency, have your evidentiary hearing, obtain your findings and then appeal to the Court of Appeals based upon that record.
The reason I expressed doubt is because in connection with this case for the first time I heard the government say that the saving cost in the statute is not a broad saving cost as the courts below held and as I always understood it can be, but it was a saving cost to give two remedies for the type of case that involved this administrative hearing.
They say in their brief and it was said in the oral argument that the saving cost applies only to those proceedings to which the administrative procedure applies, and is an additional remedy doesn't apply to a remedy such as we have sought here and that's why and that came as a surprise to me which is why I said, I was doubtful to what the answer was.
But normally I would say this is a type of proceeding that goes before administrative agency with administrative hearings involving the special competence and expertise of the agency with direct appeal to the Court of Appeals, but this is of course not the issue with respect to whether the statute goes as far as these regulations and I might note this is conceded by the government because in their brief they say if they are wrong as to reviewability nature, they don't think any evidence is needed for a trial and the record as it now stands is sufficient for the court to adjudicate this issue of statutory interpretation.
Justice Potter Stewart: By contrast with the Abbott case the government is not asking us to adjudicate the merits--
Mr. Edward J. Ross: No they are not they are asking–-
Justice Potter Stewart: They're asking us not to--
Mr. Edward J. Ross: That's correct what they are saying is that the District Court was wrong in denying my motion for summary judgment which was opposed by the government and they say the district court --
Justice Potter Stewart: But the for the court --
Mr. Edward J. Ross: The court could now determine these as questions of law without the necessity of any further evidence and as I point out in the brief where in fact someone filed objections before the administrative agency and to a different regulation and urged as a ground for objection, that there was no authority in the statute.
They refused to accept these objections of compelling and they raised issues of law, which couldn't be covered in administrative hearing, which is exactly our opposition on this case.
I would like briefly to answer Mr. Lewin's argument with respect to the right of speech.
It is based in my judgment on a misreading of the regulations.
The regulations apply now, the statute is very plain it says that if something is a color additive it must now be listed and certified by the Food and Drug Administration.
So anything which the regulation defines to be a color additive requires this license before it may be sold.
The regulations say in their definitions that a diluent is a color additive and therefore it follows that the diluents must now be listed and must now be subject to certification.
Regulations further say that lipstick, rouge, eye make-up colors and all related cosmetics for coloring of body are color additives.
These color additives, if they are color additives a license is now required, a listing petition must be presented which must be accompanied by the $ 2,600 fee.
Now in the discovery proceedings which we had to try to clarify the intent of its regulation, it was very clearly testified to by the Deputy Commissioner of Food and Drug Administration with reference to this 2,700 cosmetics of Kolmar Laboratories that if as we cite each one is a different formula that a separate petition would have to be filed for each of these 2700 cosmetics and a separate fee of $2600 would be payable.
Justice Abe Fortas: Was that, was that the trust of pre-trial to find out purpose of regulations.
Mr. Edward J. Ross: Well, the trust was multiple, we were seeking to list as much of a background as we could, statements that were made by Food and Drug officials as to what was intended to be covered.
Justice Abe Fortas: You mean, you put Food and Drug people on the stand and examine them as to what they intended by these regulations.
Mr. Edward J. Ross: That's correct yes sir.
Justice Abe Fortas: Now can you do that when you go to a Court of Appeals to review an administrative regulation?
Mr. Edward J. Ross: I doubt it now but the court --
Justice Abe Fortas: I mean, this is something new that's been added in administrative law?
Mr. Edward J. Ross: Well it was new to me but the court said to do it so I did it.
Justice Abe Fortas: Why was that -- the court felt that it needed some light, is that right?
Mr. Edward J. Ross: Court felt that my guess is and I'm only speculating on what was in the judicial mind that this was a very substantial issue and District Courts are very often reluctant to decide broad issues on summary judgment.
Justice Abe Fortas: Well it may be--
Mr. Edward J. Ross: But with government opposing summary judgment they felt they ought to have a trial.
Justice Abe Fortas: It suggested in my mind, I may be wrong Mr. Ross that Judge felt the absence of what you get when you have a specific case before you, after there has been an attempt to enforce a regulation and in that way you get an idea of the meaning attached to it by the administrative agency and absence of that, the court said that you probably just go around and poke in to the administrative mind whatever that would be.
Mr. Edward J. Ross: Well, this is what he wanted, he was doubtful about it, many times in conference in chambers he indicated that perhaps he was wrong and he was charting a new cost that wasn't sound, but anyway, it was his idea that there ought to be this kind of probing before he would determine this issue, but he was very firm in his mind, that the issue was one of statutory construction.
He thought that these depositions and interrogatories might throw some light on what the statutory construction was and they did because I'm going outside the record of course this much of this wasn't made part of the motion papers of the government on a renewed motion.
But what is included in the record are statements to the effect by, testimony by FDA officials that each cosmetic would require a listing and that the listing is now required, we put this question to the interrogatories is a, each finished cosmetic product, a color additive and will it now require listing.
The answer was, listing would be required, these are answers to interrogatories where there is more time to think about it than on the depositions which corroborated these answers.
We received as I said an answer that if there were 2700 separate products made by Kolmar Laboratories because it makes products with variety of companies that each one would require a separate listing petition and each one would require a separate fee of $ 2600.
We have hundreds and hundreds of pages of testimony which support this, there was a very thorough airing of what the regulations mean.
In the first time it was suggested that these regulations might not now be right to review because they don't apply now they only apply at some future date and even that speculatory contention has been in this court in the proceedings below no one ever questions the immediacy of these regulations and their impact upon the industry.
Justice Hugo L. Black: Did your challenge here involved a challenge to the power of the commission to (Inaudible) for a license, is that a --
Mr. Edward J. Ross: No sir, I don't think that's the essence of our complaint.
Justice Hugo L. Black: Is that a part of it?
Mr. Edward J. Ross: That is the part of that in the sense that not only do we wish to show the excess of statutory authority and the immediate application of the regulations, but also to complete the picture that they are burdensome, they have an impact on us and would cause us a irreparable harm.
Justice Hugo L. Black: What is the $600 license for?
Mr. Edward J. Ross: $2600 for each cosmetic that you must get this license for before you can sell it, requires a petition and each petition must be accompanied by a filing fee of $2600.
Justice Hugo L. Black: Filing fee.
Mr. Edward J. Ross: What?
Justice Hugo L. Black: Did you say a filing fee?
Mr. Edward J. Ross: A filing fee yes.
Justice Hugo L. Black: Is that just beginning of the charges.
Mr. Edward J. Ross: Well, that's the essence of the charge.
We have estimated based upon the kind of testing which would have to be done for these cosmetics, what FDA said would be the testing, would cost this one company about $8 million to perform the minimum testing and some $42 million to perform the kind of testing which FDA indicated it probably would require because this testing means --
Justice Hugo L. Black: Before you get your license?
Mr. Edward J. Ross: Before you get your license to sell the cosmetics.
Justice Hugo L. Black: Testing of--
Mr. Edward J. Ross: Testing the cosmetic to be.
Justice Hugo L. Black: $8 million.
Mr. Edward J. Ross: I beg your pardon.
Justice Hugo L. Black: Testing involving cost of $ 8 million?
Mr. Edward J. Ross: Over eight million yes sir because the testing would have to be performed for thousands of products.
The testing takes many, many years to perform it's -- what they do is put the lipstick on mice and beagles and do it for seven or eight years to see whether they suffer any harm and what we are dealing with here are products which have been used for 50 to 100 years.
When I ask FDA how long lipstick of this type were used he said since the days of Egyptian times, these aren't new products that are put on the market, these are products that have been generally recognized as safe, have been used for centuries by women, and I might note also that the color ingredient that we're talking about here is the same color that's used in food and drugs.
Justice Hugo L. Black: Is the purpose of agency to put a prohibitive cost on the spreading --?
Mr. Edward J. Ross: No I think the purpose was to take -- they feel they would like to have this power to license cosmetics when Congress did not give it to them.
Justice Hugo L. Black: But do they have to charge something, is that much in order to get the power -- the license.
Mr. Edward J. Ross: They say that's what, that's the fee that's involved in obtaining the listing.
Justice Byron R. White: Is that a fee or a deposit?
Mr. Edward J. Ross: They call deposit but I never heard of anyone getting deposit back and if got --
Justice Byron R. White: What's the deposit for?
Mr. Edward J. Ross: The deposit is to cover the cost of the agencies testing it reviewing the application and it is a reasonable deposit as it applies to the dye because --
Justice Byron R. White: (Inaudible)
Mr. Edward J. Ross: As applies to the dye or the color ingredient.
Justice Abe Fortas: The Congress provided for the fee or is this --
Mr. Edward J. Ross: No the fee was established by the agency.
Justice Abe Fortas: Was it authorized by the Congress?
Mr. Edward J. Ross: I think the statute would authorize a fee, we don't object to the fee as applied to the color ingredient we thinks it's a --
Justice Hugo L. Black: Does this $8 million involve the color ingredient?
Mr. Edward J. Ross: $8 million dollars is the minimum cost of testing the products of one company that makes 2700 cosmetics.
Justice Hugo L. Black: But who tests that, pays that cost?
Mr. Edward J. Ross: The Company pays that cost.
Justice Hugo L. Black: It makes 2700 kinds of cosmetic?
Mr. Edward J. Ross: That's right.
Because if the company that makes it for other companies which then sell the cosmetics under different brand names, it's a contractor for other companies that use brand names.
Justice Abe Fortas: I suppose the cost to companies, that much money it must cost the government a lot of money to make it test too isn't it?
Mr. Edward J. Ross: No because the government – it depends on what we are talking about, if we are talking about the testing of the dyes and color -- all the statute contemplates then, then there are only a handful of those colors and the burden of testing them isn't too great although the FDA said it will take 20 years it is a substantial burden but one which the industry can assume.
But when you change the meaning of the statute and say that the finished cosmetic product is now the color additive and it must be tested and listed then you are dealing with an entirely different situation and one which Congress never encompassed, isn't a word is a long legislative history of these amendments, which suggest that they were intending to impose a requirement of premarketing clearance on cosmetics.
The fact as I point out in the brief during the hearing some congress woman said as along as you are dealing with the matter of colors, let's take up the question of the other ingredients of the cosmetic, may be some of them should be approved.
Her suggestion wasn't adopted; the Congress did not address itself to that.
I might I wanted express one additional factor and that is this that these colors aren't directed only to cosmetics, it so happens that the definition hits the cosmetic industry, but these are colors which are added to foods and drugs.
Now the same color is used in the mouthwash that's used in the lipstick and the same color is used in candy for children, that is used in the lipstick and obviously the ingestion in the food and candy is far greater than anything in the lipstick.
Yet Food and Drug Administration approves these colors as used in foods without even suggesting they must pre-clear the entire food products and there is no reason why the same thing cannot be done with respect to the cosmetic.
In fact when this statute was enacted it was represented to Congress that what they were doing was taking the exact language of the Food Additive Amendments of 1958 which required the testing and listing of additives in foods and that was, the safety for use principle and applying it to cosmetics.
Now since 1958 the Food and Drug Administration has been listing additives for foods and they determined the tolerance and the maximum quantity of this additive that may be used in the food, but they never said we must give a license to food industry you can't sell the entire finished food product until we give you this license.
Now this is what has been done with respectively cosmetic industry.
Justice Hugo L. Black: Would it be more dangerous?
Mr. Edward J. Ross: I beg your pardon.
Justice Hugo L. Black: Would it be more dangerous either from the number of additive issues for any other cause?
Mr. Edward J. Ross: on the contrary it's far less dangerous because for most cosmetics, there is no ingestion at all.
Rouge is put on the face, lipstick has a bit of ingestion because the woman using lipsticks inevitably swallow some as she eats.
But the additives that are put into foods are consumed and ingested by everyone who takes the food and when they determine that a certain quantity of a color ingredient is safe for use in a food, it isn't necessary to then test a whole cosmetic product to determine that same quantity can be safely used in the product.
And that's why we feel or we would say that the testing of the entire product would not be necessary, but this is not the – the regulation that Mr. Lewin described is not the one that's before the court.
If that regulation should be issued than we might challenge it on unreasonableness to administrative hearing.
But what we're saying is that this requirement of a license before you can do business when Congress did not require that license is what is beyond the powers of the agency and is presently right to review.
These are the allegations of the complaint and this court of course has many times said in this type of a case, the complaint must be accepted as true for purposes of determining whether there is this controversy.
Justice Abe Fortas: Well, is it possible that there are some products in which you can test the color additives standing by itself, another products or species or varieties or how do you I don't know what the proper word is, in which you'll have to test the whole product in order to find out what the effect of the color additive is.
I remember Mr. Ross, maybe I am wrong but I remember the hearing, it's all started because of a lot of publicity with respect to deleterious effects of some cosmetics, isn't that right?
Mr. Edward J. Ross: No, no, the hearing started because this court in Fleming v. Florida Citrus Exchange decided that if I a color in a tremendous quantity might be harmful it couldn't be used even though it is --
Justice Abe Fortas: I know, but the whole background of this is belief in some quarters or the publicity or propaganda whatever you wanted to say, to the effect that some cosmetics have been harmful.
Mr. Edward J. Ross: No I don't believe so Your Honor the cosmetics--
Justice Abe Fortas: There have been any such--
Mr. Edward J. Ross: There have been--
Justice Abe Fortas: Have been any such belief?
Mr. Edward J. Ross: There was such a case with respect to a type of cosmetic, which was more than a cosmetic that was the anti-wrinkle cosmetic which had to qualify as a drug and that came under the drug regulations rather than the cosmetic regulations.
Justice Abe Fortas: Then you are saying to me that the Food and Drug Administration has not in any time contented that cosmetics might be -- certain cosmetics might be harmful.
Mr. Edward J. Ross: I wouldn't say that I don't know if they have ever taken such a position, it is conceivable that there maybe some ingredient in a cosmetic which is harmful.
And if that was so, then under that particular circumstance they might want to look at the entire product, but that's quite different from requiring the license for that product and a separate fee, a separate test for the entire product.
Justice Abe Fortas: Let's get to my precise question, is it possible and perhaps you've already answered it, that there in, that in some instances you can test the color additives standing alone.
In other instances, you have to look at the total product in order to find out whether the color additive is or is not harmful?
Mr. Edward J. Ross: It is possible there maybe cases of the latter pattern.
Justice Abe Fortas: Yes, and so that you might have a very different situation depending upon the facts of the particular case and the characteristics of the particular product.
Mr. Edward J. Ross: Right and Congress does authorize under the statute that in determining whether you will clearly call a additive, you can determine its intended use.
Justice Abe Fortas: Right now what you are trying to do here is to get a procedure, device a procedure by which an injunction being -- ask court for an injunction on the basis of a generalization?
Mr. Edward J. Ross: Oh! No sir.
Justice Abe Fortas: And the other possibility is that you might guess – you have to wait until a particular situation is presented to the courts in the context of a particular administrative action.
Mr. Edward J. Ross: I don't believe so.
I think what I'm doing is basically -- I think I gave an illustration in the brief that I might restate, which illustrates what I have in mind.
The Act -- to get off the subject of cosmetics, the Act authorizes the Food and Drug Administration have certain powers over devices, now a bicycle fits the statutory definition of a device because it's an apparatus that might affect the structure of the body, but it seems to me that a Food and Drug Administration came in and said, now we're going to regulate the whole bicycle industry and before anyone may sell a bicycle, you must get a license from us in advance.
Its inherent power of court of equity come in and say this isn't what the statute intended, and isn't what the statute means and this is an excess of statutory power.
Justice Abe Fortas: But here we are dealing with cosmetics and not bicycles.
Mr. Edward J. Ross: That's correct I was arguing by analogy, but at the same time we are dealing with an ingredient of a cosmetic and not with the cosmetic itself, which we say is not subject to pre-marketing clearance, it's subject only to post-marketing jurisdiction.
I thank you; I think my time is up, thank you very much.
Chief Justice Earl Warren: Mr. Lewin.
Rebuttal of Nathan Lewin
Mr. Nathan Lewin: I'd just take the few minutes remaining to clarify possibly this question of course which has come up again.
We submit that the figures given by the plaintiffs in this suit, is completely inflated because there is nothing in the regulations that requires separate listing for each finished cosmetic product.
They have the particular cosmetic company that produces 2700 cosmetic products could, for all we know, submit ten petitions to cover all those 2700 products and they would not be required to pay more than ten deposits.
And those $2600 fees, which the regulations provide for are merely deposits, they are to cover the processing cost of the Food and Drug Administration.
Justice Byron R. White: You mean one petition cover many cosmetic products?
Mr. Nathan Lewin: Oh, it can cover, it can cover a whole range of lipsticks for example, the Food and Drug Administration will list -- let's say on the basis of a common base that the 20 or 30 lipsticks have a whole sequence of different colors that the company may provide or may supply.
Justice Byron R. White: What is your explanation so on for the government saying well there maybe 20 different lipsticks which has, each of which has only one color ingredient, one color additive in each of them and yet we are not going to just list the color additive as safe for use and we are going to require every lipstick that has this color additive units be separately certified or separately listed then what does it imply?
Mr. Nathan Lewin: The Food and Drug Administration has found Mr. Justice White that the coloring ingredient in and of itself maybe harmless, but when it's combined with some of the diluents that appear in the cosmetic, the product is harmful.
Justice Byron R. White: Why not, why not list the diluents and the additives?
Mr. Nathan Lewin: Well, it's the combination of the two that may cause the harm they interact chemically--
Justice Byron R. White: I know but you don't list diluents that are harmful and that with certain additives, we won't clear them --
Mr. Nathan Lewin: Well, that precisely that's exactly -- that's all the power that the Food and Drug Administration --
Justice Byron R. White: I know but why do you have to have two goals at it, both the color additives the diluents and the lipstick.
Mr. Nathan Lewin: Well, we don't it doesn't have to be separately listed that's exactly our point, they can all be -- they will all appear in the one paragraph--
Justice Byron R. White: Once you get a case which presents the question of whether if one additive is safe to be used with this diluents, once you've decided that why do you have to have every other product in the world that's got those two products to be separately listed -- once you have made the decision, why do you have to do it over and over and over again.
Mr. Nathan Lewin: Oh, well, because presumably the other products in the world that are being combined with that are being combined--
Justice Byron R. White: Presumably but there's no --
Mr. Nathan Lewin: No, no realistically that they are different from this product because there is a third diluent that's in, there is another -- that's what distinguishes them from this and that we don't know what the coloring ingredient—
Justice Byron R. White: But your regulation will cover the situation where this other lipstick has only those same two products?
Mr. Nathan Lewin: No then it will not have to separately listed.
Justice Byron R. White: Well, why is that exemption?
Mr. Nathan Lewin: Well, the being statute specifically provides Mr. Justice White that the Secretary or the Commissioner has authorized to list color ingredients generally if he feels that really if it combined with any other product they will cause no harm.
Justice Byron R. White: But you haven't, you said -- you say you wanted to get it to final product.
Mr. Nathan Lewin: If there is a possibility that it will cause harm yes, and I think the Commissioner --
Justice Byron R. White: Does it make any difference to you if this one company makes product A and it got one color additive and one diluent --
Mr. Nathan Lewin: Yes.
Justice Byron R. White: They file that one, you listed $2600 and then it wants to sell product C under another name for another company, pack it for another company whatever you call it and you say they have to have that listed too although.
Mr. Nathan Lewin: No, no.
Justice Byron R. White: Why not?
Mr. Nathan Lewin: Because the listing will say color ingredient A when added to diluent A is safe and no matter who produces it, we don't care who the manufacturer is no matter who produces he will be permitted under the statute --
Justice Byron R. White: Well, then why is this your answer to the claim of 2700 separate listing for the same -- they wouldn't even have to list in one petition or in 100 petitions, all of these products.
Mr. Nathan Lewin: If they are all identical definitely, but all that we are saying if they if one had one diluent and the other one has two and the third one has three, they do have to list those which differ to the extent they differ and even the $2600 cost if there is nothing, if there is nothing --
Justice Byron R. White: I want to make sure, you are saying that if this situation took place just possibly, the secretary would say not that this product is safe, I mean this particular brand is safe, what would he say?
Mr. Nathan Lewin: He would say that the combination of base, a base made up of certain chemicals with a certain ingredients is permissible, he wouldn't, he would list it that way, he does it with his brand name.
Justice Byron R. White: Then he -- he puts our an order like that.
Mr. Nathan Lewin: Yeah.
Justice Byron R. White: Or whatever he does.
Mr. Nathan Lewin: He is listed in a Federal register, in the Federal regulation.
Justice Byron R. White: Then the next company decides, well I've got the same product, I am just going to sell it no listing.
Mr. Nathan Lewin: If it's chemically identical it's listed, you can sell it.
Justice Byron R. White: So this regulation really doesn't mean what it says does it, that everybody, you have to list every, every --
Mr. Nathan Lewin: Every finished product to the extent that it differs not to the extent that it's label is different, not to the extent that its put up on a different brand.
Justice Byron R. White: Is that what the regulation says?
Mr. Nathan Lewin: Yes, Well I think the regulations just speaks --
Justice Byron R. White: Because then you really don't have to list every cosmetic, do you?
Mr. Nathan Lewin: Well not every brand, no I don't think anybody has ever suggested that you have got to --
Justice Byron R. White: Whether its brand or not, you say you don't have anything that the secretary is already passed on, you don't need to list it, you don't need to --.
Mr. Nathan Lewin: If it's chemically identical you don't have to list it again, the perfect illustration is cellophane which we cite in our brief, the regulation which covers a variety of cellophane product, it never mentions certainly particular brand, it just covers them in one paragraph with a wide variety of chemical, different chemical products.
Justice Potter Stewart: The food additive, that's a food additive.
Mr. Nathan Lewin: Well and we think the same thing could apply to a cosmetic additive.
Justice Potter Stewart: Yeah with the cellophane question it doesn't, it never comes under the cosmetic products.
Mr. Nathan Lewin: Oh, no, no, but it's just that the very same technique could be used by the commissioner or will be used by the commissioner in the food field and that the food additive problem of course is quite different.
Justice Potter Stewart: Quite different, yes.
Mr. Nathan Lewin: Yes, because but the usual things that are combined with coloring ingredients of food are generally totally harmless or at least that standard while obviously in cosmetics there are, of the kinds of the chemicals are being combined or not the kind of things you can swallow and you just don't know, the commission doesn't know until it is testing what, how they interact with the coloring ingredients.
And of course, finally so far as costs are concerned, the ultimate answer to the plaintiffs in this suit or any claim where they objected of course is to request a reduction in cost if they think that the fees are higher, the deposits are too high and since all that's involved here is $2600 deposit not a fee, but a deposit and the total, the total budget for the Food and Drug Administration last year for preclearance of food additives in these related areas was $1.5 million, it's hardly conceivable that $7 million could be spent on the processing that the food drug administration does in this area.
It doesn't test itself except to very limited extent, just reviews the testing that's done by the manufacturers.