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. § 130.12

General methods for water capacity and fill of containers

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

(a) The term general method for water capacity of containers means the following method:

(1) In the case of a container with lid attached by double seam, cut out the lid without removing or altering the height of the double seam.

(2) Wash, dry, and weigh the empty container.

(3) Fill the container with distilled water at 68 °F to 3/16 inch vertical distance below the top level of the container, and weigh the container thus filled.

(4) Subtract the weight found in paragraph (a)(2) of this section from the weight found in paragraph (a)(3) of this section. The difference shall be considered to be the weight of water required to fill the container.

In the case of a container with lid attached otherwise than by double seam, remove the lid and proceed as directed in paragraphs (a) (2) to (4) of this section, except that under paragraph (a)(3) of this section, fill the container to the level of the top thereof.

(b) The term general method for fill of containers means the following method:

(1) In the case of a container with lid attached by double seam, cut out the lid without removing or altering the height of the double seam.

(2) Measure the vertical distance from the top level of the container to the top level of the food.

(3) Remove the food from the container; wash, dry, and weigh the container.

(4) Fill the container with water to 3/16 inch vertical distance below the top level of the container. Record the temperature of the water, weigh the container thus filled, and determine the weight of the water by subtracting the weight of the container found in paragraph (b)(3) of this section.

(5) Maintaining the water at the temperature recorded in paragraph (b)(4) of this section, draw off water from the container as filled in paragraph (b)(4) of this section to the level of the food found in paragraph (b)(2) of this section, weigh the container with remaining water, and determine the weight of the remaining water by subtracting the weight of the container found in paragraph (b)(3) of this section.

(6) Divide the weight of water found in paragraph (b)(5) of this section by the weight of water found in paragraph (b)(4) of this section, and multiply by 100. The result shall be considered to be the percent of the total capacity of the container occupied by the food.

In the case of a container with lid attached otherwise than by double seam, remove the lid and proceed as directed in paragraphs (b) (2) to (6) of this section, except that under paragraph (b)(4) of this section, fill the container to the level of the top thereof.
Notes of Decisions
Cited in 17 cases, 1971–1997 · leading case: Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974).
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Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). · cites it 64× “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973). · cites it 15× “" 21 CFR § 130.12 (a) (5) (ii). They include a "plan or protocol" setting forth the objective of the study and an adequate method for selecting appropriate subjects, [12] explaining the methods of observation and steps taken to minimize bias, providing a comparison by one of…”
Massachusetts Outdoor Advert. Council v. Outdoor Advert. Bd., 405 N.E.2d 151 (Mass. App. Ct. 1980). · cites it 2× “That negative determination was based largely on the failure of Hynson to furnish evidence stemming from “adequate and well-controlled clinical investigations” as defined by FDA regulations at 21 C.F.R. § 130.12 (a) (5) (ii) (now found at 21 C.”
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 4× “If a hearing is requested and is justified by the applicant’s response to the notice of a hearing, the issues will be defined, a hearing examiner will be named, and he shall issue a written notice of the time and place at which the hearing will commence, not more than 90 days…”
Robert F. Bradley v. Caspar W. Weinberger, Sec'y of Health, Educ. & Welfare, 483 F.2d 410 (1st Cir. 1973). “The term “substantial evidence” is defined' in the statute to mean “adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved”.”
Edison Pharm. Co. v. Food & Drug Admin., 513 F.2d 1063 (D.C. Cir. 1975). · cites it 4× “21 C.F.R. § 130.12 (a)(5)(ii)(a). . 21 C.”
E.R. Squibb & Sons, Inc. v. Casper W. Weinberger, Sec'y of Health, Educ. & Welfare, & Charles C. Edwards, Comm'r of Food & Drugs, 483 F.2d 1382 (3rd Cir. 1973). · cites it 3× “7251, amending 21 C.F.R. §§ 130.12 (a) (5) and 130.14. 9 .”
Bristol Labs., Etc. v. Elliot L. Richardson, Sec'y of Health, Educ. & Welfare, 456 F.2d 563 (1st Cir. 1971). · cites it 2× “Both American Cyanamid and Bristol have unavailingly sought FDA hearings on the acceptability of their drugs, the FDA concluding that neither had supplied the kind of data based on well-controlled clinical investigations which 21 C.F.R. § 130.12 (a) (5) requires as a…”
United States v. Articles of Food & Drug Coli-Trol 80 Medicated, 372 F. Supp. 915 (N.D. Ga. 1974). “21 CFR § 130.12 . Weinberger v. Hynson, Westcott & Dunning, 412 U.”
Sterling Drug, Inc. v. Weinberger, 384 F. Supp. 557 (S.D.N.Y. 1974). “On August 27, 1971 the FDA found that these studies were not “adequate *559 and well controlled” within the meaning of 21 C.F.R. § 130.12 (a) (5) (ii) (1973) and accordingly denied the request for a hearing.”
Ciba-Geigy Corp. v. Richardson, 446 F.2d 466 (2d Cir. 1971). “See Commissioner’s Regulations, 21 C.F.R. §§ 130.12 , 130.14. The petition raises an issue as to the conditions under which a new drug applicant is entitled to a hearing under §§ 505(d) and (e) of the Food, Drug & Cosmetic Act (the “Act”) and whether such a hearing may be…”
Edison Pharm. Co., Inc. v. Food & Drug Admin., 513 F.2d 1063 (D.C. Cir. 1975). “In the Commissioner's words, 43 There are no well-controlled studies using blind and double-blind cross-over and randomnization techniques or any other kind of control specified in 21 CFR 130.12(a)(5)(ii), so that neither the clinical nor statistical significance of the reported…”
Show all 17 citing cases →
— 21 C.F.R. § 130.12(a) — 2 cases
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
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). “If a hearing is requested and is justified by the applicant’s response to the notice of a hearing, the issues will be defined, a hearing examiner will be named, and he shall issue a written notice of the time and place at which the hearing will commence, not more than 90 days…”
— 21 C.F.R. § 130.12(a)(5) — 2 cases
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
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). “If a hearing is requested and is justified by the applicant’s response to the notice of a hearing, the issues will be defined, a hearing examiner will be named, and he shall issue a written notice of the time and place at which the hearing will commence, not more than 90 days…”
— 21 C.F.R. § 130.12(a)(5)(ii) — 4 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). “If a hearing is requested and is justified by the applicant’s response to the notice of a hearing, the issues will be defined, a hearing examiner will be named, and he shall issue a written notice of the time and place at which the hearing will commence, not more than 90 days…”
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
Edison Pharm. Co. v. Food & Drug Admin., 513 F.2d 1063 (D.C. Cir. 1975). “21 C.F.R. § 130.12 (a)(5)(ii)(a). . 21 C.”
Edison Pharm. Co., Inc. v. Food & Drug Admin., 513 F.2d 1063 (D.C. Cir. 1975). “In the Commissioner's words, 43 There are no well-controlled studies using blind and double-blind cross-over and randomnization techniques or any other kind of control specified in 21 CFR 130.12(a)(5)(ii), so that neither the clinical nor statistical significance of the reported…”
— 21 C.F.R. § 130.12(a)(5)(ii)(a) — 1 case
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
— 21 C.F.R. § 130.12(a)(5)(ii)(b) — 1 case
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
— 21 C.F.R. § 130.12(a)(5)(ii)(c) — 1 case
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “§ 355(d) (1970), a standard explicated in considerable detail by FDA regulations promulgated in 1970, 21 C.F.R. § 130.12 (a)(5) (April 1, 1973).”
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