... [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR170.50] [Page 20-21] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 170_FOOD ADDITIVES -Table of Contents Subpart C_Specific Administrative Rulings and Decisions Sec. 170.50 Glycine (aminoacetic acid) in food for human consumption. (a) Heretofore, the Food and Drug Administration has expressed the opinion in trade correspondence that glycine is generally recognized as safe for certain technical effects in human food when used in accordance with good manufacturing practice; however: [[ Page 21 ]] (1) Reports in scientific literature indicate that adverse effects were found in cases where high levels of glycine were administered in diets of experimental animals. (2) Current usage information indicates that the daily dietary intake of glycine by humans may be substantially increasing due to changing use patterns in food technology. Therefore, the Food and Drug Administration no ...

... [Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR520.550] [Page 147-148] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS -Table of Contents Sec. 520.550 Dextrose / glycine / electrolyte. (a) Specifications. The product is distributed in packets each of which contains the following ingredients: sodium chloride 8.82 grams, potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram, potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and dextrose 44.0 grams. (b) Sponsor. See No. 000069 in Sec. 510.600 (c) of this chapter. (c) Conditions of use. (1) Dextrose / glycine / electrolyte is indicated for use in the control of dehydration associated with diarrhea (scours) in calves. It is used as an early treatment at the first signs of ...

... [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR172.812] [Page 84-85] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION -Table of Contents Subpart I_Multipurpose Additives Sec. 172.812 Glycine. The food additive glycine may be safely used for technological purposes in food in accordance with the following prescribed conditions: (a) The additive complies with the specifications of the `` Food Chemicals Codex, ' 3d Ed. (1981 ), p. 140, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http :// www.archives.gov / federal -register ...

... ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION -Table of Contents Subpart D_Special Dietary and Nutritional Additives Sec. 172.320 Amino acids. The food additive amino acids may be safely used as nutrients added to foods in accordance with the following conditions: (a) The food additive consists of one or more of the following individual amino acids in the free, hydrated or anhydrous form or as the hydrochloride, sodium or potassium salts: L-Alanine L-Arginine L-Asparagine L-Aspartic acid L-Cysteine L-Cystine L-Glutamic acid [[ Page 47 ]] L-Glutamine Aminoacetic acid (glycine) L-Histidine L-Isoleucine L-Leucine L-Lysine DL-Methionine (not for infant foods) L-Methionine L-Phenylalanine L-Proline L-Serine L-Threonine L-Tryptophan L-Tyrosine L-Valine (b) The food additive meets the following specifications: (1) As found in `` Food Chemicals Codex, ' National Academy of Sciences / National Research Council (NAS / NRC ), 3d Ed. (1981 ), which is incorporated by reference (Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418, or may be examined at the National Archives and Records Administration ( ...

... [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR176.160] [Page 200-201] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 176_INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS -Table of Contents Subpart B_Substances for Use Only as Components of Paper and Paperboard Sec. 176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine. The chromium (Cr III) complex of N-ethyl-N -heptadecylfluoro-octane sulfonyl glycine containing up to 20 percent by weight of the chromium (Cr III) complex of heptadecylfluoro-octane sulfonic acid may be safely used as a component of paper for packaging dry food when used in accordance with the following prescribed conditions. (a) The food additive is used as a component of paper in an amount not to exceed 0.5 percent by weight of the paper. (b )( 1) The food-contact surface of the paper is overcoated with a ...

... , Volume 7] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR640.103] [Page 119] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS -Table of Subpart J_Immune Globulin (Human) Sec. 640.103 The final product. (a) Final solution. The final product shall be a 16.5 1.5 percent solution of globulin containing 0.3 molar glycine and a preservative. (b) Protein composition. At least 96 percent of the total protein shall be immunoglobulin G (IgG ), as determined by a method that has been approved for each manufacturer by the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. [38 FR 32089, Nov. 20, 1973, as amended at 64 FR 26287, May 14, 1999] ...

... years or older. (c) Bismuth-containing active ingredients: (1) Bismuth aluminate. (2) Bismuth carbonate. (3) Bismuth subcarbonate. (4) Bismuth subgallate. (5) Bismuth subnitrate. (d) Calcium-containing active ingredients: Calcium, as carbonate or phosphate; maximum daily dosage limit 160 mEq. calcium (e.g, 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid or salt; maximum daily dosage limit 8 grams. (f) Glycine (aminoacetic acid). (g) Magnesium-containing active ingredients: (1) Hydrate magnesium aluminate activated sulfate. (2) Magaldrate. (3) Magnesium aluminosilicates. (4) Magnesium carbonate. (5) Magnesium glycinate. (6) Magnesium hydroxide. (7) Magnesium oxide. (8) Magnesium trisilicate. (h) Milk solids, dried. (i) Phosphate-containing active ingredients: (1) Aluminum phosphate; maximum daily dosage limit 8 grams. (2) Mono or dibasic calcium salt; maximum daily ...

... [Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR582.5049] [Page 576] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 582_SUBSTANCES GENERALLY RECOGNIZED AS SAFE -Table of Contents Subpart F_Nutrients and / or Dietary Supplements \ 1 \ Sec. 582.5049 Aminoacetic acid. (a) Product. Glycine (aminoacetic acid). (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in animal feeds in accordance with good manufacturing or feeding practice. ...

... [Title 21, Volume 8] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR862.1365] [Page 200-201] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES -Table of Contents Subpart B_Clinical Chemistry Test Systems Sec. 862.1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in [[ Page 201 ]] erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in Sec. 862.9 [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8 ...

... 21, Volume 5] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR310.532] [Page 31-32] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 310_NEW DRUGS -Table of Contents Subpart E_Requirements for Specific New Drugs or Devices Sec. 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. (a) The amino acids glycine, alanine, and glutamic acid (alone or in combination) and the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the symptoms of benign prostatic hypertrophy, e.g, urinary urgency and frequency, excessive urinating at night, and delayed urination. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredients for OTC use in relieving the symptoms of benign prostatic hypertrophy. In addition, there is no definitive evidence that any drug product offered for ...