(d) Opinion evidence shall be admitted when the presiding officer is satisfied that the witness is properly qualified. (e) Affidavits, if relevant and material, shall be received and marked as exhibits, provided they are filed with the presiding officer on or before the date of the opening of the hearing. Every interested person shall be permitted to examine all affidavits which have been so filed and to file counter-affidavits with the presiding officer, within a period of time, to be fixed by the presiding officer, not more than 5 days following the close of the hearing. In any event, the Secretary will consider the lack of opportunity for cross-examination in determining the weight to be attached to statements made in the form of affidavits. (f) If any person objects to the admission or rejection of any evidence, or other limitation of the scope of any examination or cross-examination, he shall state briefly the grounds of such objection, and the transcript shall not include argument or debate thereon except as ordered by the presiding officer. Any such objection shall be made before the presiding officer in order subsequently to be relied upon in the proceeding. A ruling of the presiding officer on any such objection shall be a part of the transcript, together with such offer of proof as has been made. (g) Samples may be displayed at the hearing and may be described for purposes of the record but shall not be admitted in evidence as exhibits. § 1.708 Transcript of the testimony. Testimony given at a hearing shall be reported verbatim. All written statements, charts, tabulations, and similar data offered in evidence at the hearing shall be marked for identification and, upon a showing satisfactory to the presiding officer of their authenticity, relevancy, and materiality, shall be received and marked as exhibits in evidence. Such exhibits (including affidavits) shall, if practicable, be submitted in quintuplicate and in documentary form. In case the required number of copies are not made available, the presiding officer shall exercise his discretion as to whether said exhibit shall when practicable be read in evidence or whether additional copies shall be required to be submitted within a time to be specified by the presiding officer. Where the testimony of a witness refers to a statute, or to a report or document, the presiding officer shall, after inquiry relating to the identification of such statute, report, or document, determine whether the same shall be produced at the hearing and physically be made a part of the evidence as an exhibit or whether it shall be incorporated into the evidence by reference. Where relevant and material matter offered in evidence is embraced in a report or document containing immaterial and irrelevant matter, such immaterial and irrelevant matter shall be excluded and shall be segregated insofar as practicable, subject to the direction of the presiding officer. § 1.709 Oral and written arguments. (a) Unless the presiding officer shall issue an announcement at the hearing authorizing oral argument before him, it shall not be permitted. (b) The presiding officer shall announce at the hearing a reasonable period within which interested persons may file written arguments based solely upon the evidence received at the hearing, citing the page or pages of the transcript of the testimony where such evidence occurs. § 1.710 Filing the record of the hearing. As soon as practicable after the close of the hearing, the complete record of the hearing shall be filed in the office of the hearing clerk. The record of the hearing shall include the transcript of the testimony, including any exhibits and together with any written arguments that may have been filed with the presiding officer. § 1.711 Copies of the record of the hearing. The Department will make provisions for a stenographic record of the testimony and for such copies of the transcript thereof as it requires for its own purposes. Any person desiring a copy of the record of the hearing or of any part thereof shall be entitled to the same upon application to the hearing clerk and upon payment of the costs thereof. Suggested corrections to transcripts of the testimony shall be considered only if offered within a period (to be fixed by the presiding officer) of not more than 3 days following the completion of the testi The Secretary, within a reasonable time after the filing of the record of the hearing, will issue his proposed order, which shall be served upon the interested persons whose appearances were entered at the hearing by publication in the FEDERAL REGISTER or by mailing a copy of the proposed order to each of such persons by registered mail: Provided, however, That if, after examination of the record of the hearing, the Secretary finds that no controversy with respect to the subject of the hearing exists between the persons who appeared thereat, and that such action will promote the purposes of the act, the Secretary will issue a final order in lieu of issuing a proposed order in accordance with this section. § 1.713 Exceptions. Within a reasonable time, which shall be specified in the proposed order but shall not exceed 20 days from the time of the issuance of such order, any interested person whose appearance was filed at the hearing may file exceptions to the proposed order. The exceptions shall point out with particularity the alleged errors in said proposed order, and shall contain a specific reference to the page of the transcript of the testimony or to the exhibit on which each exception is based. Such exceptions may be accompanied by a memorandum or brief in support thereof. § 1.714 Final order. The Secretary thereafter will issue his final order. A duplicate original thereof shall thereupon be filed with the Archivist of the United States and published in the FEDERAL REGISTER. A duplicate original thereof shall also be filed with the hearing clerk for public inspection. PUBLIC NOTICE OF REGULATIONS § 1.715 Public notice of regulations. Public notice of the issuance of the foregoing rules of practice for hearings in §§ 1.701-1.714 shall be given by publishing the same in the FEDERAL REGIster. PART 3-STATEMENTS OF GENERAL POLICY OR INTERPRETATION Subpart A-Formal Statements of Policy or Interpretation Sec. 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 Termination of exemption for designated foods for which label declaration of ingredients has not been required pending standardization. Notice to packers and shippers of shelled peanuts. Notice to manufacturers, packers, and distributors of glandular preparations. Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. Disposition of incubator reject eggs. Notice to importers of Peruvian canned fish. Potassium permanganate preparations as prescription drugs. Amphetamine inhalers regarded as prescription drugs. Label declaration of vitamin E in food for special dietary use. [Added] 3.10 Notice to manufacturers and users in food products of monosodium glutamate. 3.34 Labeling of imported crabmeat. 3.35 Labeling of drug preparations containing significant proportions of wintergreen oil. 3.37 Status of certain veterinary drug components under the food additives amendment to the Federal Food, Drug, and Cosmetic Act. 3.41 3.38 Declaration of quantity of contents on labels for canned oysters. 3.39 Use of vegetable fat in products which are imitations of ice cream. Status of articles offered to the general public for the control or reduction of blood cholesterol levels and for the prevention and treatment of heart and artery disease under the Federal Food, Drug, and Cosmetic Act. 3.42 Status of folic acid in foods for special dietary use and as a drug. 3.43 Phenindione; labeling of drug preparations intended for use by man. Sterilization of drugs by irradiation. Cobalt preparations intended for use by man. 3.45 3.48 3.49 Pessaries for intracervical and intra uterine use. 3.50 Status of salt substitutes under the Federal Food, Drug, and Cosmetic Act. 3.51 Label declaration of D-erythroascorbic acid when it is an ingredient of a fabricated food. Subpart B-Informal Statements of General Policy or Interpretation FOODS 3.201 Declaration of pyroligneous acid in food. 3.202 Labeling of kosher and kosher-style foods. 3.203 Use of chemical sanitizing agents in food-manufacturing establish ments. 3.204 Net weight statement in package form that may be weighed at time of retail sale. 3.205 Jams and jellies containing artificial sweeteners. 3.206 Whipped cream products containing flavoring or sweetening. 3.509 Estradiol labeling. Use of octadecylamine in steam lines of food and drug establishments. Location of expiration date in drug labeling. Significance of control numbers on drug labeling. Labeling of drug preparations containing salicylates. 3.510 Over-the-counter drugs for minor sore throats; suggested warning. 3.511 Injectable iron preparations for veterinary use. 3.512 New-drug status of timed-release dosage forms of drugs. Subpart A-Formal Statements of Policy and Interpretation AUTHORITY: §§ 3.1 to 3.51 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371. Statutory provisions interpreted or applied are cited to text in parentheses. § 3.1 Termination of exemption for designated foods for which label declaration of ingredients has not been required pending standardization. (a) Effective September 17, 1959, the exemption from the label declaration of ingredients requirements of section 403 (i) (2) of the Federal Food, Drug, and Cosmetic Act is terminated for the following foods: Canned clams; canned fish roe; canned Olives in brine. Sauerkraut. Unmixed canned fruits, properly prepared and in sugar solution of not less than 20° Brix, not in excess of the amount necessary for proper processing, but with no other added substance. Unmixed immature canned vegetables, properly prepared and with water not in excess of the amount necessary for proper processing, with or without added salt or sugar or both, but with no other added substance. (b) Effective June 15, 1963, the exemption from the label declaration of ingredients requirements of section 403 (i) (2) of the Federal Food, Drug, and Cosmetic Act is terminated for nonalcoholic carbonated beverages. (Sec. 403 (a) (2), 52 Stat. 1048; 21 U.S.C. 343 (1) (2)) [26 F.R. 5369, June 15, 1961, as amended at 27 F.R. 4623, May 16, 1962] § 3.2 Notice to packers and shippers of shelled peanuts. Investigations by the Food and Drug Administration have shown that a number of interstate shipments of shelled peanuts in bags holding from approximately 100 to 125 pounds each have failed to bear labeling as required by the terms of the Federal Food, Drug, and Cosmetic Act. Shelled peanuts in sacks, whether or not shipped in carload lots, should bear the following information required by the law on food in package form: (a) The name of the product. (b) An accurate statement of net weight. (c) The name and place of business of the packer or distributor. This information should be conspicuously set forth. It may be printed or stenciled on each bag or, if desired, placed on tags which are securely attached to each bag. The net weight marked on the bags must be the correct net weight of the peanuts at the time they are delivered to the carrier for interstate shipment. The tare weight of the bag should not be included in the weight declaration. [20 F.R. 9541, Dec. 20, 1955] view of the requirement of section 201 (n) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C. 321 (n)), be labeled with a statement of the material fact that there is no scientific evidence that the articles contain any therapeutic or physiologically active constituents. Numerous preparations of such inert glandular materials were subsequently marketed with disclaimers of the type suggested. The term "inert glandular materials" means preparations incapable of exerting an action or effect of some significant or measurable benefit in one way or another, i.e., in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in affecting the structure or any function of the body. Manufacturers have heretofore taken advantage of § 1.106 (b) of this chapter, permitting omission of directions for use when the label bears the prescription legend. Section 1.106 (b) (3) of this chapter requires that the labeling of the drug, which may include brochures readily available to licensed practitioners, bear information as to the use of the drug by practitioners licensed by law to administer it. Obviously, information adequate for the use of an inert glandular preparation is not available to practitioners licensed by law. The Department of Health, Education, and Welfare is of the opinion that inert glandular materials may not be exempted from the requirements of section 502 (f) (1) of the act that they bear adequate directions for use; and, accordingly, that their labeling must include, among other things, representations as to the conditions for which such articles are intended to be used or as to the structure or function of the human body that they are intended to affect. Since any such representations offering these articles for use as drugs would be false or misleading, such articles will be considered to be misbranded if they are distributed for use as drugs. The amended regulations provide also that in the case of drugs intended for parenteral administration there shall be no exemption from the requirement that their labelings bear adequate directions for use. Such inert glandular materials for parenteral use are therefore subject to the same comment as applies to those intended for oral administration. [20 F.R. 9542, Dec. 20, 1955, as amended at 22 F.R. 10685, Dec. 25, 1957] § 3.4 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. In the past few years research studies have altered medical opinion as to the usefulness and harmfulness of mineral oil in the human body. These studies have indicated that when mineral oil is used orally near mealtime it interferes with absorption from the digestive tract of provitamin A and the fat-soluble vitamins A, D, and K, and consequently interferes with the utilization of calcium and phosphorus, with the result that the user is left liable to deficiency diseases. When so used in pregnancy it predisposes to hemorrhagic disease of the newborn. There is accumulated evidence that the indiscriminate administration of mineral oil to infants may be followed by aspiration of the mineral oil and subsequent "lipoid pneumonia." In view of these facts, the Department of Health, Education, and Welfare will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act a drug for oral administration consisting in whole or in part of mineral oil, the labeling of which encourages its use in pregnancy or indicates or implies that such drug is for administration to infants. It is also this Department's view that the act requires the labelings of such drugs to bear a warning against consumption other than at bedtime and against administration to infants. The following form of warning is suggested: "Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician." This statement of interpretation does not in any way exempt mineral oil or preparations containing mineral oil from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act. [20 F.R. 9542, Dec. 20, 1955] § 3.5 Disposition of incubator reject eggs. (a) Investigations by the Food and Drug Administration and a number of State regulatory agencies have revealed that incubator reject eggs, removed as infertile or otherwise unhatchable during hatching operations, are being diverted for human food use. Such eggs are regarded as adulterated within the meaning of section 402(a) (3) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1046; 21 U.S.C. 342(a) (3) because they are unfit for food. (b) The introduction or delivery for introduction into interstate commerce of adulterated eggs is prohibited under section 301 (a) of the aforesaid act (52 Stat. 1042; 21 U. S. C. 331 (a) unless they have been broken, crushed, or smashed and then denatured with kerosene, creolin, or other suitable denaturant to preclude their diversion to human food channels. (Secs. 301, 402, 52 Stat. 1042, 1046; 21 U. S. C. 331, 342) [23 F. R. 6834, Sept. 5, 1958] § 3.6 Notice to importers of Peruvian canned fish. In collaboration with the United States Department of State and officials of the Government of Peru, the Food and Drug Administration of the Department of Health, Education, and Welfare has made a study in Peru of the canning of bonito and tuna packed for exportation to the United States. The fish known in Peru as bonito constitutes a major portion of the pack. Representative specimens of Peruvian bonito have been identified as the species Sarda chilensis. This confirms previous information that the species of fish constituting the commercial bonito fishery in Peru is the same species of bonito that has been packed in this country in small quantities and sold as bonito, for many years. Minor quantities of another bonito, Sarda velox, are apparently caught in Peruvian waters but do not enter the commercial pack to any significant degree. The bonitos, Sarda chilensis and Sarda velox, are not classified as tuna and under the provisions of the Federal Food, Drug, and Cosmetic Act have never been legally labeled as tuna, but must be labeled as "bonito" or "bonito fish." Two species of tuna, "skipjac" (Katsuwonus pelamis) and "yellowfin" (Thunnus macropterus), are commercially canned in Peru but constitute a relatively small proportion of the Peruvian pack of canned fish exported to the United States. Information developed during the investigation in Peru shows that the bonito (Sarda chilensis) can be readily distinguished from the tunas. Consequently no difficulty should be encountered by packers in keeping separate the fish in |