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Manufacturing Chemists' Association, Inc. FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE Tentative Agenda for Meeting MCA Conference Room Washington, D. C. November 17, 1965 - 10 A.M. COMMITTEE .1 Minutes of April 21, 1965 Meeting 2. Membership - Secretary 3. Liaison with MCA Board of Directors - Mr. Marusi .4. MCA Environmental Health Advisory Committee - Mr Hagan 5. Task Group on Good Manufacturing Practice for Drug Ingredient Chemicals - Mr. Knoop , 6. Next Meeting II. LEGISLATION AND REGULATIONS 1. Federal 1.1 Proposed Regulation Concerning Vitamin D as a Food Additive, Etc. See attachment: FEDERAL REGISTER pp. 11140-1, Aug. 28, 196.' 2. State 2. pfc^lic Administration Service Study for FDA 3. International 3.1 FAO/WHO Codex Alimentarius - Dr. Spencer 4. MCA Manuals III. LIAISON 1. Liaison Advisory Committee to Food Chemicals Codex - Dr. Spencer GEB:tp October 19, 1965 cc: Mr. Lloyd Symington Mr. M. M. Hoover ASI 00001536 Proposed Rule Making DEPARTMENT OF HEALTH, EDU vitamin D fortification should be care 1. The addition of vitamin D to fluid, fully controlled so that In normal usage evaporated and dry whole milk, fluid CATION, AND WELFARE the total daily consumption will not be skim milk, and nonfat dry milk should more than 400 units (l.e. 400 units/quart be permitted and encouraged but the Food and Drug Administration -of fluid milk, or 400 units per reconsti quantity added should not exceed 400 tuted quart of formula products), which USP units per quart of fluid or re I 21 CFR Parts 3, 15, 16, 17, 18, 45, is the present practice in the United States. The addition of vitamin D to constituted milk. 2. The addition of vitamin D to milk 121, 125 1 other foods may serve only to increase substitutes and milk-based Infant for VITAMIN D the intake by infants, children and preg mulas which provide the sole or major nant , women to levels beyond require source of calories should be encouraged. Status as Special Dietary Food, Drug, Food Additive, and as Optional In gredient in Standardized Foods ment. 3. Special purpose foods, designed to serve as the total dally source of nutrient or calories of infants, children or adults, The vitamin D supplement should pro vide no more than 400 USP units in one quart of fluid when prepared for use. 3. Vitamin D supplementation of other The need for vitamin D in human nu may properly contain vitamin D. The food items should be prohibited. trition and the importance of maintain vitamin should be added in an amount 4. Supplementary vitamin prepara- ' ing a dally intake sufficient to protect that does not exceed 400 units in the tlons available to the public for purchase infants and growing children from de total daily Intake. without prescription should contain no veloping rickets is well established. It 4. At the present time, various vitamin more than 400 USP units of vitamin D Is widely recognized that a daily intake preparations provide different amounts in the suggested daily dose. of 400 U.S.P. units of vitamin D Is ample of vitamin D, some considerably. In ex 5. All vitamin preparations contain to prevent vitamin D deficiencies and Is cess'of 400 units in the recommended ing more than 400 USP units of vitamin adequate for the supplementation of the daily dosage. The Committee suggests D in suggested daily dosage should be diet of Infants, children, and pregnant that no preparations sold over the prohibited from over-the-counter sale and lactating women. It is recognized counter should provide more than 400 and should be available only by pre also that vitamin D, when ingested dally units of vitamin D In the amount of the . scription. In excessive amounts, is toxic. The product designated on the label as the 6. Consumers should be advised that question of possible excessive amount of recommended daily intake. Since it is there is no advantage to the dally in vitamin D In the diet of the public was the practice to dispense vitamin prepara take of more than 400 USP units of vita raised by Dr. Robert Cooke of Johns tions designed for use by infants in liquid min D and that the continued ingestion Hopkins University, Baltimore, Md. He form, adjustment of intake from supple of amounts much in excess of that, may expressed his concern that this may be ments to levels below 400 units/day re be hazardous. i an important factor in the development mains feasible if consideration of total Copies of these reports are on file with of infantile hypercalcemia. In doing so, vitamin D available to the Infant makes the Hearing Clerk of the Department of he called attention to the fact that there such reduction desirable. The Commit Health, Education, and Welfare, and are presently marketed a number of tee suggests that products containing may. be consulted by any interested vitamin preparations labeled for special amounts of vitamin D In excess of 400 person. dietary use or with directions for use in units In the recommended daily dosage The Commissioner of Food and Drugs self-medication as well as a number of be restricted to sale only by prescription, has reached the conclusion on the basis foods with added vitamin D, which to 5. If in the future an unambiguous of these reports and on other relevant gether may supply a substantially greater causal relation between vitamin D In- , data and information available to him, dosage of vitamin D than is necessary to take of the pregnant woman or the in Including the abundant scientific evi accomplish its useful purpose. fant and the severe form of the hyper- dence that an excessive intake of vitamin In the interest of fully evaluating this calcemlc syndrome can be proved, the D is of no value, that it is prudent to problem, the Commissioner of Food and Committee would favor labeling of all issue a proposal which reflects the rec Drugs requested the Committee on Nu vitamin products containing vitamin D ommendations of these groups. trition of the American Academy of so as to Indicate potential toxicity if Therefore, pursuant to the provisions Pediatrics and an ad hoc committee of taken in excess of the recommended daily of the Federal Food, Drug, and Cosmetic the Council on Drugs and the Council on dosage. In addition, the user should be Act (secs. 401, 403(j), 409(d), 502(f), Foods and Nutrition of the American advised to seek medical "advice before 503(b)(4), 701 (a), (e); 52 Stat. 1046, Medical Association to consider the pos administering greater amounts of the 1048, 1051, 1053. 1055; 70 Stat. 919; 72 sibility of hazard that may confront the product. Stat. 1787: 21 U.S.C. 341, 343<j), 348(d), American public in the consumption of 6. Before prescribing vitamin D sup 352(f). 353(b) (4), 371 (a), (e)) and un- , currently available foods and vitamin plements for any patient, the physician der the authority delegated to him by 'supplements containing added vitamin D. should assess the total intake of vitamin the Secretary of Health, Education, and The Committee on Nutrition of the D from other sources, and unless high Welfare (21 CFR 2.90) the Commissioner American Academy of Pediatrics has submitted a report containing the fol lowing recommendations: 1. The Committee wishes to reiterate the statement made In Its published memorandum with respect to vitamin D doses of vitamin D are required to treat specific disturbances of calcium and phosphorus metabolism, he should at tempt to establish an intake of vitamin D of approximately 400 units per day from all sources. This applies for preg proposes to amend Title 21, Chapter I, of the Code of Federal Regulations In the following respects: 1. By adding to Part 3 the following r new section: fortification of foods other than milk or Infant formula products: "* * * the present practice of enriching foods other than milk and Infant formula products Is not justified, and discontinuation of this practice is to be recommended." 2. The addition of vitamin D to fluid milk, evaporated milk or to special milk products and milk substitutes designed for consumption by infants is desirable and should continue. However, the nant and lactating women as well as for infants and children. Normal adults living under ordinary conditions do not require supplementary vitamin D. The Joint ad hoc committee of the Council on Drugs and the Council on Foods and Nutrition of the American Medical Association has submitted a re port with the following recommenda tions: g 3_____ Vitamin D (vitamin Di (calcif erol, ergocalclferol) ; vitamin Dj (ac tivated 7-dchydrocholesterol, cholecalciferol)). (a) Vitamin D from any source, nat ural or synthetic, alone, or as a compo nent of a food, for supplementing the human diet la regarded as a food addi tive subject to the provisions of section 409 Of the Federal Food, Drug, and Coe- 11140 \ / ASI 00001537 Saturday, August 28, 1965 FEDERAL REGISTER 11141 metic Act and regulations promulgated ing the references to subparagraph (2) 5440, 330 Independence Avenue SW- thereunder. from paragraph (a) (5) and the last Washington, D C., 20201, written com (b) Any preparation containing more sentence of paragraph (a). ments, preferably in quintupUcate, on than 400 U.S.P. Units of vitamin D per 10. By revoking paragraph (a) (2) of this proposed. Comments may be ac dosage unit or any preparation supplying 9 16.10 Enriched noodle products * * *, companied by a memorandum or brief more than 400 UjSJ*. Units per day when which is reserved, and by deleting from in support thereof. used in accordance with Its directions paragraph (a) (5) and the last sentence for use Is regarded as a drug that by of paragraph (a) the references to the Dated; August 24, 1968. reason of Its tox: dty or other potentiality for harmful effect, or the collateral measures necessary to Its use, Is not safe for use except under the supervision of revoked subparagraph. G*o. P. Larrick. Of,11. By revoking paragraph (a) (2) of 1 Commissioner of rood and Drugs. 17.2 Enriched bread and enriched rolls [PR. DOC. 68-9134; Piled, Aug. 1968: * * *, which Is reserved, and by deleting 8:48 am.) ,. a practitioner licensed by law to admin from the last sentence in paragraph (a) ister drugs. The label of any such ar the reference to the revoked sub- ticle shall bear the statement "Caution: paragraph. Federal law prohibits dispensing with 12. By deleting the phrase "not less out prescription" and its labeling shall than" from paragraph (a) (2) of 18.520 bear adequate information for its use by Evaporated milk * * *. a practitioner licensed by law to admln- 13. By deleting the parenthetical , ister It. phrase "(with or without any accom (c) Any drug containing vitamin D panying vitamin D and with or without whose labeling bears directions for use In vitamin D concentrate) " from paragraph self-medication of vitamin D deficiency (a) (3) (ill) of 9 45.1 Oleomargarine, In recommended-dosages greater than margarine * * *, Copied by MCA 400 U.S.P, Units per day will be regarded 14. By deleting the Items "Vitamin D." as misbranded within the meaning of and "Vitamin D," from the list in para October 19, 1965 sections 502 (a), (f>, and (j) and 503(b) graph (d) (5) of 9 121.101 Substances (4) of the act. that are generally recognized as safe. <d) Preparations supplying 400 or less 15. By adding to Subpart D of Part 1 U.S.P. Units of vitamin D represented or 121 the following new section: intended for use as drugs for the treat ment of vitamin D deficiency by the lay public may be regarded' as misbranded 121._____ Vitamin D (Vitamin Di, Vi tamin Ih). under sections 502 (a), (f), and (J) and Vitamin D may be safely used in food 503(b) of the Federal Food, Drug, and in accordance with the following pre Cosmetic Act, since adequate directions scribed conditions: for safe and effective use for the self- (a) It is added to fluid milk, fluid non treatment of vitamin D deficiency by the fat milk, dry whole milk,' evaporated laity without medical supervision cannot milk, concentrated milk, or Infant-feed be written. ing formulations used in place of milk In an amount, in the case of fluid milk, 2. By deleting from paragraph (b) of fluid nonfat milk, dry whole milk, evap S 3.17 Labeling of oleomargarine or mar orated milk, or concentrated milk to garine, subparagraph 7, which Is re provide 400 U.S.P. Units per quart of milk served, and by deleting from paragraph or reconstituted milk and, In the case of (d) of this section the phrase "vita infant-feeding formulations used In min D, or both". place of milk In an amount to provide ' 3. By revoking paragraph (b) of 400 U.S.P. Units per quart of such food - S 15.10 Enriched flour * * *, which is as customarily or usually prepared for reserved, and by changing the last sen consumption; or tence In the section to reflect the deletion. (b) It is a vitamin supplement or a 4. By revoking paragraph (b) of component of a vitamin supplement that I 15.60 Enriched self-rising flour * * *, when Ingested according to its labeled which is reserved, and by changing the directions for use furnishes not more last sentence in the section to reflect the than 400 U.S.P. Units per day; and deletion. (c) The food is labeled with a state- 3 5. By revoking paragraph (a) (2) of ment that vitamin D has been added: a ' ! 15.140 Enriched farina * * *, which Is statement of the number of U.S.P. Units reserved; by deleting the next to the last, of vitamin D in a specified quantity of t sentence In paragraph (a), and by the food; and in case it is an article j changing the last sentence of this para covered by paragraph (b) of this section, _ graph to eliminate the reference to sub- it bears a label statement warning that paragraph (2), unless prescribed by a physician the art!- 1 6. By revoking paragraph (a) (2) of cle should not be used to supplement the 5 15.513 Enriched corn meals * * *, diet in excess of 400 U.S.P. Units per day which Is reserved, and by changing the from all sources. ` third sentence in subparagraph (3) to reflect this deletion. 7. By revoking paragraph (a) (2) of 15.514 Enriched corn grits * * *, which is reserved, and by changing the fourth sentence of subparagraph (3) to reflect the deletion. 8. By revoking paragraph (a) (2) of 1 15.525 Enriched rice * * *, which Is reserved, and by deleting the references to the revoked subparagraph (2) from paragraphs (a) (3), <b), and (c). 16. By deleting the last sentence of . paragraph (a) (1) of 9 125.3 Label state- ments relating to vitamins and by delet ing the last sentence of 9 125,5 starting s with the words, "The provisions of para- , graph (c) **.' Any Interested person may, within 60 . days from the date of publication of this notice in the Federal Register, file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 0. By revoking paragraph (a) (2) of Nonfat dry milk not Included due to Its f 16Jt Enriched macaroni products statutory definition (Public Law 78-344, 68 * * *, which is reserved, and by delet- Btat. 108,' 70 Stat. 486; 31 VAC. 331c). No. 167------ 3 ASI 00001538