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[TEMPLATE for SHORT FORM MONOGRAPHS (Jan 1St 2004)] NATURAL HEALTH PRODUCT WORKOUT SUPPLEMENTS This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients. Notes Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant’s discretion. The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant. Date August 5, 2019 Proper name(s), Common name(s), Source material(s) Table 1. Proper name(s), Common name(s), Source material(s) Group 1: Proteins Source Material(s) Proper name(s) Common name(s) Proper name(s) Part(s) Acid casein Acid casein Bos taurus Milk Alfalfa protein Alfalfa protein Medicago sativa Herb top concentrate concentrate Medicago sativa protein Medicago sativa concentrate protein concentrate Calcium caseinate Calcium caseinate Bos taurus Milk Calcium sodium caseinate Calcium sodium Bos taurus Milk caseinate Casein hydrolysate Casein hydrolysate Bos taurus Milk Hydrolyzed casein Hydrolyzed casein Defatted wheat germ Defatted wheat germ Triticum aestivum Seed germ protein protein Flaxseed protein Flaxseed protein Linum usitatissimum Seed Hemp protein concentrate Hemp protein Cannabis sativa Seed concentrate Hemp protein isolate Hemp protein isolate Cannabis sativa Seed Hemp seed protein Hemp seed protein Cannabis sativa Seed Casein Micelles Micellar casein Bos taurus Milk Milk protein concentrate Milk protein concentrate Bos taurus Milk Milk protein isolate Milk protein isolate Bos taurus Milk Pea protein Pea protein Pisum sativum Seed Potato protein Potato protein Solanum tuberosum Tuber Potato tuber protein Potato tuber protein Rice protein Rice protein Oryza sativa Seed Rice protein concentrate Rice protein concentrate Oryza sativa Seed Casein, sodium salt Sodium caseinate Bos taurus Milk Wheat protein isolate Wheat protein isolate Triticum aestivum Seed germ Whey protein concentrate Whey protein Bos taurus Milk concentrate Capra hircus Whey protein hydrolysate Whey protein Bos taurus Milk hydrolysate Capra hircus Whey protein isolate Whey protein isolate Bos taurus Milk Capra hircus Group 2: Amino acids Group 2a: Essential amino acids Source Material(s) Proper name(s) Common name(s) Common name(s) (S)-alpha-Amino-1H- L-Histidine L-Histidine imidazole-4-propanoic L-Histidine hydrochloride acid L-Histidine (2S,3S)-2-Amino-3- L-Isoleucine Ethyl L-Isoleucinate methylpentanoic acid L-Isoleucine L-Isoleucine L-Isoleucine hydrochloride N-Acetyl-L-Isoleucine (S)-2-Amino-4- L-Leucine methylpentanoic acid Leucine hydrochloride L-Leucine L-Leucine L-Leucine ethyl ester L-Leucine ethyl ester hydrochloride L-Leucine methyl ester hydrochloride N-Acetylleucine N-Glycyl-L-Leucine (S)-2,6- L-Lysine L-Lysine Diaminohexanoic acid Lysine L-Lysine-L-Aspartate L-Lysine L-Lysine monohydrochloride Lysine acetate Lysine dihydrochloride (S)-2-Amino-4- L-Methionine DL-Methionine (methylthio)butanoic Methionine L-Methionine acid N-Acetyl-L-Methionine L-Methionine (S)-2-Amino-3- L-Phenylalanine DL-Phenylalanine phenylpropanoic acid L-Phenylalanine L-Phenylalanine L-Phenylalanine methyl ester N-Acetyl-L-Phenylalanine Workout Supplements Page 2 of 34 (2S,3R)-2-Amino-3- L-Threonine DL-Threonine hydroxybutyric acid L-Threonine L-Threonine (S)-alpha-Amino-1H- L-Tryptophan L-Tryptophan indole-3-propanoic acid Tryptophan L-alpha-Aminoindole- 3-propionic acid L-Tryptophan (S)-2-Amino-3- L-Valine DL-Valine methylbutanoic acid L-Valine L-Valine L-Valine ethyl ester L-Valine ethyl ester hydrochloride L-Valine hydrochloride N-Acetyl-L-Valine Group 2b: Non-essential amino acids Source Material(s) Proper name(s) Common name(s) Common name(s) (S)-2-Aminopropanoic L-Alanine Alanylglutamine acid DL-Alanine L-Alanine L-Alanine L-Alanine ethyl ester hydrochloride (S)-2-Amino-5- L-Arginine DL-Arginine [(aminoiminomethyl) L-Arginine amino] pentanoic acid L-Arginine alpha-ketoglutarate L-Arginine L-Arginine ketoisocaproic acid L-Arginine monohydrochloride (S)-2,4-Diamino-4- L-Asparagine L-Asparagine oxobutanoic acid L-Asparagine (S)-Aminobutanedioic L-Aspartic acid L-Aspartic acid acid Potassium aspartate L-Aspartic acid Potassium magnesium aspartate (R)-2-Amino-3- L-Cysteine Cysteine hydrochloride mercaptopropanoic acid Cysteine hydrochloride monohydrate L-Cysteine D-Ribose-L-Cysteine L-Cysteine N-Acetyl-L-Cysteine (S)-2- L-Glutamate Glutamic acid hydrochloride Aminopentanedioic L- Glutamic acid L-Glutamate acid Monosodium glutamate L-Glutamic acid (S)-2,5-Diamino-5- Glutamine L-Glutamine oxopentanoic acid L-Glutamine L-Glutamine ethyl ester L-Glutamine Aminoacetic acid Glycine Glycine Glycine hydrochloride Workout Supplements Page 3 of 34 N-Glycyl-L-Leucine (S)-2- L-Proline L-Proline Pyrrolidinecarboxylic acid L-Proline (S)-2-Amino-3- L-Serine L-Serine hydroxypropanoic acid L-Serine (S)-alpha-Amino-4- L-Tyrosine L-Tyrosine hydroxybenzenepropan Tyrosine L-Tyrosine ethyl ester oic acid N-Acetyl Tyrosine L-Tyrosine Group 3: Carbohydrates Source material(s) Proper name(s) Common name(s) Common name(s) Proper name(s) Part(s) D-Fructose D-Fructose N/A Malus domestica Fruit D-Fructose N/A N/A D-Galactose D-Galactose D-Galactose N/A N/A D-Glucose Dextrose D-Glucose N/A N/A D-Glucose D-Glucose Glucose monohydrate 4-O-beta-D- Lactose Lactose N/A N/A Galactopyranosyl-D- glucose Maltodextrin Maltodextrin Maltodextrin N/A N/A D-Mannose D-Mannose D-Mannose N/A N/A Solanum tuberosum Potato starch N/A Solanum Tuber Starch - Potato tuberosum Oryza sativa Rice starch N/A Oryza sativa Seed Starch - Rice Ribo-2,3,4,5- D-Ribose D-Ribose-L- N/A N/A tetrahydroxyvaleraldehyd Ribose Cysteine e, D- Ribose Alpha-D- Cane sugar N/A Acer saccharum Sap Glucopyranosyl-beta- Saccharose Beta vulgaris Root D-fructofuranoside Sucrose Borassus Sap Beta-D- Sugar flabellifer Fructofuranosyl-alpha- Malus domestica Fruit D-glucopyranoside Oryza sativa Seed Saccharum Leaf stalk officinalis Triticum aestivum Starch - Wheat N/A Triticum aestivum Seed endosperm Wheat starch Workout Supplements Page 4 of 34 Zea mays Corn Starch N/A Zea mays Seed Starch - Maize Topical starch Zea Mays (Corn) Starch Zea mays starch Zea mays Waxy maize starch N/A Zea mays Seed Group 4: Ergogenic agents Group 4a: Non-caffeinated ergogenic agents Source material(s) Proper name(s) Common name(s) Common Proper Part(s) Preparation(s) name(s) name(s) Calcium beta-hydroxy- CaHMB Calcium beta- N/A N/A Synthetic beta-methylbutyrate Calcium beta- hydroxy-beta- hydroxy-beta- methylbutyrate methylbutyrate (L-3-Carboxy-2- L-Carnitine L-Carnitine N/A N/A N/A hydroxypropyl) Levocarnitine fumarate trimethylammonium L-Carnitine hydroxide, inner salt tartrate (R)-3-carboxy-2- hydroxy-N,N,N- trimethyl-1- propanaminium hydroxide, inner salt L-Carnitine Levocarnitine N-(aminoiminomethyl)- Creatine monohydrate Creatine N/A N/A Synthetic N-methylglycine monohydrate monohydrate Eleutherococcus Ci wu jia N/A Eleutheroc Root Dried senticosus Eleuthero occus Siberian ginseng senticosus Panax ginseng Asian ginseng N/A Panax Root Dried Chinese ginseng ginseng Rootlet Hong shen Korean ginseng Korean red ginseng Oriental ginseng Panax ginseng Red ginseng Ren shen Workout Supplements Page 5 of 34 Group 4b: Caffeine Source material(s) Proper name(s) Common name(s) Common name(s) 1,3,7-Trimethylxanthine Caffeine Caffeine 3,7-Dihydro-1,3,7-trimethyl-1H- Caffeine citrate purine-2,6-dione Group 5: Vitamins and Minerals Proper name(s) Common name(s) Source material(s) As per the current NNHPD Multi-Vitamin/Mineral Supplement monograph Group 6: Complementary ingredients Source material(s) Proper name(s) Common name(s) Common Proper Part(s) Preparation(s) name(s) name(s) Malpighia glabra Acerola N/A Malpighia Fruit Dried Barbados cherry tree glabra Fresh Escobillo 3-Aminopropanoic acid Beta-Alanine Beta- N/A N/A N/A 3-Aminopropionic acid Alanine beta-Aminopropionic Beta- acid Alanine ethyl ester Piper nigrum Black pepper N/A Piper nigrum Fruit Dried Pepper - black Pepper - white White pepper (beta- Choline Choline N/A N/A N/A hydroxyethyl)trimethyla Choline mmonium bitartrate 2-Hydroxy-N,N,N- Choline Trimethylethanaminium chloride Choline Choline citrate Choline dihydrogen citrate Choline orotate Lecithin Phosphatid ylcholine Workout Supplements Page 6 of 34 (S)-N5- Citrulline Citrulline N/A N/A N/A Carbamoylornithine L-Citrulline ethyl ester L-Citrulline Citrulline N5-(Aminocarbonyl)- malate L-ornithine L- Citrulline Capsicum annuum Cayenne N/A Capsicum Fruit Dried Cayenne pepper annuum Chili pepper Paprika Red pepper All-trans-lycopene Lycopene N/A Solanum Fruit flesh N/A Lycopene lycopersicum Psi, psi-Carotene Lycopene N/A N/A Synthetic (S)-2,5- L-Ornithine L- N/A N/A N/A Diaminopentanoic acid Ornithine (S)-alpha,delta- L-ornithine Diaminovaleric acid hydrochlor ide L- Ornithine- L- Aspartate Ornicetil 2-Aminoethanesulfonic Taurine L-Arginine N/A N/A N/A acid taurinate Taurine Taurine ethyl ester References: NHPID 2019. Route of administration Oral Dosage form(s) This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document. Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document. Workout Supplements Page 7 of 34 Note Liquids and solutions are not permitted for products containing Creatine monohydrate, due to lack of stability of the finished product (Dash and Sawhney 2002). Use(s) or Purpose(s) Note See Ingredient Combination section below. Products containing at least one ingredient from any of Groups 1, 2a, 2b, 3, 4a or 4b, at or above the relevant minimum doses indicated in the Dose section below Workout supplement Athletic support Products containing at least one ingredient from Group 1, at or above the minimum dose indicated in the Dose section below Source of protein for the maintenance of good health (CFIA 2019).
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