Certified Color Industry Committee v. Secretary of Health, Education, & Welfare

283 F.2d 622
CourtCourt of Appeals for the Second Circuit
DecidedOctober 26, 1960
DocketNos. 350, 351, Dockets 26094, 26162
StatusPublished
Cited by1 cases

This text of 283 F.2d 622 (Certified Color Industry Committee v. Secretary of Health, Education, & Welfare) is published on Counsel Stack Legal Research, covering Court of Appeals for the Second Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Certified Color Industry Committee v. Secretary of Health, Education, & Welfare, 283 F.2d 622 (2d Cir. 1960).

Opinion

HAMLIN, Circuit Judge.

Petitions for review of two orders of the Secretary of Health, Education and Welfare, respondent, have been filed pursuant to § 701(f) [21 U.S.C.A. § 371 (f) ] of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq. (the Act). The challenged orders revoke certificates sanctioning the use of batches of seven coal-tar colors1 in food, drugs and cosmetics. The corporate petitioners2 manufacture and sell coal-tar colors or products containing coal-tar colors, and each makes or uses one or more of the colors in question.

The Act3 provides that “The Secretary shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in [food, drugs (for the purposes of coloring only) and cosmetics] and for the certification of batches of such colors * * *”4 Use of a color from a batch not certified in accordance with these regulations renders the food, drug or cosmetic contain[624]*624ing the color adulterated.5 Adulteration of food, drugs or cosmetics in interstate commerce is prohibited, as is delivery or receipt of such adulterated articles.6 Violators are subject to injunction and criminal prosecution and the articles themselves are subject to seizure.7

The only colors which may be listed and the only batches which may be certified are those which are “harmless and suitable for use.” In determining whether a color is “harmless and suitable for use,” inquiry is to be directed to the toxicity of the color itself, rather than of the food, drug or cosmetic in which it may be used. The Secretary is not required “first to attempt to analyze the uses being made of the colors in the mar-ket place * * * ” Flemming v. Florida Citrus Exchange, 1958, 358 U.S. 153, 164, 79 S.Ct. 160, 167, 3 L.Ed.2d 188. If a color is harmless, it may be listed and certified for use; if not, it may not be used at all.

The colors in question have either been delisted or their specifications amended.8 Petitioners do not question the power of respondent to do this or the propriety of his action, but they do challenge his authority to revoke the certificates on batches certified prior to effective date of the delisting, and suggest, alternatively, that even if such authority is found, its exercise would operate to deprive them of property without due process of law.

The first of the two orders under attack (the October order) was published October 21, 1959. 24 F.R. 8492.9 This order added a new regulation,10 provid[625]*625ing generally that each final order thereafter issued amending or revoking the listing or specifications for a coal-tar color would specify a date on which certificates for existing batches or portions of batches would cease to be effective. It provided that when a certificate for a color ceased to be effective, certificates issued for color mixtures containing the dye should also cease to be effective, and that use of the color or color mixture thereafter without obtaining a new certificate would result in the colored food, drug, or cosmetic being adulterated. However, a change in the status of a color after it had been used in food, drugs, or cosmetics would not be regarded as an adulteration, unless the hazard to health was such that existing stocks of the colored articles could not be safely used, in which case findings to that effect would be made and regulations appropriate for such special cases issued.

The order further specified that existing certificates for batches of six of the seven colors theretofore delisted (or whose listing was amended) would expire on January 1,1960, and that existing certificates for batches of FD&C Red No. 1 (Red 1) would expire on January 15, 1960.

The second order in question (the January order) was published on January 8, 1960. 25 F.R. 143. In the interim a number of interested parties filed objections to the first order and some requested a public hearing. The second order modified the first order in one minor respect, denied the requested hearing,11 and postponed the effective date of the first order until April 6, 1960, to allow time for filing petitions for judicial review. The instant petitions were thereafter timely filed.

When it is determined that a listed (supposedly harmless) color is not harmless, and its listing or specifications are revoked or amended, future batches may not, of course, be certified under the revoked listing or specifications. Petitioners assert, however, that respondent lacks power to withdraw his certification of batches — batches now known not to be harmless — which were certified prior to the effective date of the revocation or amendment; that power to certify harmless batches does not include power to de-certify those which are not harmless. The claimed anomaly is said to give petitioners, and presumably all persons who possess colors which were certified under the now revoked and amended regulations in the mistaken belief that they were harmless, a right to continue their use in food, drugs and cosmetics.

Petitioners concede the validity of regulations providing that certificates shall not be effective in certain cases, as where a batch changes in physical condition. 21 C.F.R. § 9.7. Such a limitation on certificates is said to be proper because where a batch changes in physical condition it no longer conforms to regulations in effect at the time of certification. This justification, of course, is inapplicable to the limitation asserted in the orders under review — a limitation based not upon non-conformity with past regulations, but upon non-conformity with present regulations. Acceptance of what we understand to be the suggested construction — that a batch may be decertified only if it fails to conform to regulations in effect at the time it was certified —would mean that a certificate given in the correct belief that the batch is harmless may in certain cases be withdrawn, but a certificate which is inaccurate from [626]*626the beginning and given in the mistaken belief that the batch is harmless may not be withdrawn. Such a result would make little sense. The purpose of the Act is to prevent other than harmless colors from being used in food, drugs and cosmetics. If this purpose is to be effectuated, withdrawal of a certificate in one case is obviously quite as important as withdrawal in the other.

Respondent has power to delist colors which are found not to be harmless, but delisting operates only to preclude certification of batches in the future. Without the collateral power to withdraw certificates issued prior to the effective date of delisting he would be partially disabled from preventing other than harmless colors from reaching the consumer in food, drugs or cosmetics.12 A certificate must be taken to mean more than that the batch conforms to regulations in effect at the time it was certified; it must also be taken as a representation that the batch is harmless, for harmless batches are the only ones respondent has power to certify.

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283 F.2d 622, Counsel Stack Legal Research, https://law.counselstack.com/opinion/certified-color-industry-committee-v-secretary-of-health-education-ca2-1960.