C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 130—FOOD STANDARDS: GENERAL › Subpart A—General Provisions

21 C.F.R. § 130.14

General statements of substandard quality and substandard fill of container

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For the purposes of regulations promulgated under section 401 of the act:

(a) The term general statement of substandard quality means the statement “Below Standard in Quality Good Food—Not High Grade” printed in two lines of Cheltenham bold condensed caps. The words “Below Standard in Quality” constitute the first line, and the second immediately follows. If the quantity of the contents of the container is less than 1 pound, the type of the first line is 12-point, and of the second, 8-point. If such quantity is 1 pound or more, the type of the first line is 14-point, and of the second, 10-point. Such statement is enclosed within lines, not less than 6 points in width, forming a rectangle. Such statement, with enclosing lines, is on a strongly contrasting, uniform background, and is so placed as to be easily seen when the name of the food or any pictorial representation thereof is viewed, wherever such name or representation appears so conspicuously as to be easily seen under customary conditions of purchase.

(b) The term general statement of substandard fill means the statement “Below Standard in Fill” printed in Cheltenham bold condensed caps. If the quantity of the contents of the container is less than 1 pound, the statement is in 12-point type; if such quantity is 1 pound or more, the statement is in 14-point type. Such statement is enclosed within lines, not less than 6 points in width, forming a rectangle; but if the statement specified in paragraph (a) of this section is also used, both statements (one following the other) may be enclosed within the same rectangle. Such statement or statements, with enclosing lines, are on a strongly contrasting, uniform background, and are so placed as to be easily seen when the name of the food or any pictorial representation thereof is viewed, wherever such name or representation appears so conspicuously as to be easily seen under customary conditions of purchase.

Notes of Decisions
Cited in 20 cases, 1967–2017 · leading case: Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973).
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Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973). · cites it 4× “When it clearly appears from the data in the application and from the reasons and factual analysis in the request for the hearing that there is no genuine and substantial issue of fact . . . . e. g., no adequate and well-controlled clinical investigations to support the claims…”
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). · cites it 6× “(2) The Court upheld the validity of the FDA’s regulations allowing summary withdrawal of approval from NDA s, 21 C.F.R. § 130.14 (b) (April 1, 1973). Summary action was deemed proper where it is apparent at the threshold that the applicant has not tendered any evidence which on…”
In re Trader Joe's Tuna Litig., 289 F. Supp. 3d 1074 (C.D. Cal. 2017). · cites it 2× “190 (c)(4) ; 21 C.F.R. § 130.14 (b). The FDA extended TMP for the Major Tuna Producers indefinitely on March 7, 2016.”
Usv Pharm. Corp. v. Sec'y of Health, Educ. & Welfare & Comm'r of Food & Drugs, No.24900, 466 F.2d 455 (D.C. Cir. 1972). · cites it 4× “” 21 C.F.R. § 130.14 (1968). The Commissioner, however, did not name a hearing examiner and no further action was taken in the administrative proceedings until 1970.”
Hess & Clark, Div. of Rhodia, Inc. v. Food & Drug Admin., 495 F.2d 975 (D.C. Cir. 1974). · cites it 4× “[citations omitted] Only after such a presentation could the Commissioner fairly impose upon the petitioner the heavy sanctions of 21 CFR § 130.14 31 Because of the context, we did not explicitly reach in USV the relationship between “adequate notice” and the Commissioner’s…”
Sterling Drug Inc. v. Caspar W. Weinberger, Sec'y of Health, Educ. & Welfare, & Alexander M. Schmidt, Comm'r of Food & Drugs, 503 F.2d 675 (2d Cir. 1974). · cites it 6× “§ 355 (e) and 21 C.F.R. 130.14 set up a type of summary judgment procedure in FDA administrative proceedings for the denial of NDA approval or withdrawal of such approval.”
Am. Pub. Health Ass'n v. Veneman, 349 F. Supp. 1311 (D.D.C. 1972). · cites it 3× “Though the language of 21 C.F.R. § 130.14 (b) (1971) is ambiguous, it appears that a hearing, when permitted, must commence as soon as practicable.”
Hendricks v. Starkist Co., 30 F. Supp. 3d 917 (N.D. Cal. 2014). “” 21 C.F.R. § 130.14 . . This Court agrees with others that have found the split in the authorities on the existence of a "cause of action” for "unjust enrichment” under California law is essentially founded on semantics, drawing a distinction — between unjust enrichment,…”
John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988). “The agency’s regulations provided that when it clearly appears from the data in the application and from the reasons and factual analysis in the request for the hearing that there is no genuine and substantial issue of fact which precludes .”
Renard G. Davis v. Richard H. Ichord, Quentin Young v. Richard H. Ichord, 442 F.2d 1207 (D.C. Cir. 1970). “1524) that the issue of validity “will depend not merely on an inquiry into statutory purpose, but concurrently on an understanding of what types of enforcement problems are encountered by the FDA, the need for various sorts of supervision in order to effectuate the goals of the…”
Toilet Goods Ass'n v. Gardner, 387 U.S. 158 (1967). “This will depend not merely on an inquiry into statutory purpose, but concurrently on an understanding of what types of enforcement problems are encountered by the FDA, the need for various sorts of supervision in order to effec *164 tuate the goals of the Act, and the…”
Edison Pharm. Co. v. Food & Drug Admin., 513 F.2d 1063 (D.C. Cir. 1975). · cites it 3× “21 C.F.R. § 130.14 specifies the contents of notice of hearing.”
Show all 20 citing cases →
— 21 C.F.R. § 130.14(a) — 2 cases
Sterling Drug Inc. v. Caspar W. Weinberger, Sec'y of Health, Educ. & Welfare, & Alexander M. Schmidt, Comm'r of Food & Drugs, 503 F.2d 675 (2d Cir. 1974). “§ 355 (e) and 21 C.F.R. 130.14 set up a type of summary judgment procedure in FDA administrative proceedings for the denial of NDA approval or withdrawal of such approval.”
Hess & Clark, Div. of Rhodia, Inc. v. Food & Drug Admin., Vineland Labs., Inc. v. Caspar W. Weinberger, Sec'y, Dep't of Health, Educ. & Welfare, 495 F.2d 975 (D.C. Cir. 1974).
— 21 C.F.R. § 130.14(b) — 7 cases
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “(2) The Court upheld the validity of the FDA’s regulations allowing summary withdrawal of approval from NDA s, 21 C.F.R. § 130.14 (b) (April 1, 1973). Summary action was deemed proper where it is apparent at the threshold that the applicant has not tendered any evidence which on…”
Sterling Drug Inc. v. Caspar W. Weinberger, Sec'y of Health, Educ. & Welfare, & Alexander M. Schmidt, Comm'r of Food & Drugs, 503 F.2d 675 (2d Cir. 1974). “§ 355 (e) and 21 C.F.R. 130.14 set up a type of summary judgment procedure in FDA administrative proceedings for the denial of NDA approval or withdrawal of such approval.”
Diamond Labs., Inc. v. Richardson, 452 F.2d 803 (8th Cir. 1972).
Hess & Clark, Div. of Rhodia, Inc. v. Food & Drug Admin., Vineland Labs., Inc. v. Caspar W. Weinberger, Sec'y, Dep't of Health, Educ. & Welfare, 495 F.2d 975 (D.C. Cir. 1974).
Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215 (4th Cir. 1972).
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