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Drugs and Health Products

WORKOUT SUPPLEMENTS

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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 ingredient.

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

Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)

Acid casein

Acid casein

Bos taurus

Milk

  • Alfalfa protein concentrate
  • Medicago sativa protein concentrate
  • Alfalfa protein concentrate
  • Medicago sativa protein concentrate

Medicago sativa

Herb top

Calcium caseinate

Calcium caseinate

Bos taurus

Milk

Calcium sodium caseinate

Calcium sodium caseinate

Bos taurus

Milk

  • Casein hydrolysate
  • Hydrolyzed casein
  • Casein hydrolysate
  • Hydrolyzed casein

Bos taurus

Milk

Defatted wheat germ protein

Defatted wheat germ protein

Triticum aestivum

Seed germ

Flaxseed protein

Flaxseed protein

Linum usitatissimum

Seed

Hemp protein concentrate

Hemp protein concentrate

Cannabis sativa

Seed

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 tuber protein
  • Potato protein
  • Potato tuber protein

Solanum tuberosum

Tuber

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 concentrate

  • Bos taurus
  • Capra hircus

Milk

Whey protein hydrolysate

Whey protein hydrolysate

  • Bos taurus
  • Capra hircus

Milk

Whey protein isolate

Whey protein isolate

  • Bos taurus
  • Capra hircus

Milk

Group 2: Amino acids
Group 2a: Essential amino acids

Proper name(s) Common name(s) Source material(s)
Common name(s)
  • (S)-alpha-Amino-1H-imidazole-4-propanoic acid
  • L-Histidine

L-Histidine

  • L-Histidine
  • L-Histidine hydrochloride
  • (2S,3S)-2-Amino-3-methylpentanoic acid
  • L-Isoleucine

L-Isoleucine

  • Ethyl L-Isoleucinate
  • L-Isoleucine
  • L-Isoleucine hydrochloride
  • N-Acetyl-L-Isoleucine
  • (S)-2-Amino-4-methylpentanoic acid
  • L-Leucine

L-Leucine

  • Leucine hydrochloride
  • 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-Diaminohexanoic acid
  • L-Lysine
  • L-Lysine
  • Lysine
  • L-Lysine
  • L-Lysine-L-Aspartate
  • L-Lysine monohydrochloride
  • Lysine acetate
  • Lysine dihydrochloride
  • (S)-2-Amino-4-(methylthio)butanoic acid
  • L-Methionine
  • L-Methionine
  • Methionine
  • DL-Methionine
  • L-Methionine
  • N-Acetyl-L-Methionine
  • (S)-2-Amino-3-phenylpropanoic acid
  • L-Phenylalanine

L-Phenylalanine

  • DL-Phenylalanine
  • L-Phenylalanine
  • L-Phenylalanine methyl ester
  • N-Acetyl-L-Phenylalanine
  • (2S,3R)-2-Amino-3-hydroxybutyric acid
  • L-Threonine

L-Threonine

  • DL-Threonine
  • L-Threonine
  • (S)-alpha-Amino-1H-indole-3-propanoic acid
  • L-alpha-Aminoindole-3-propionic acid
  • L-Tryptophan
  • L-Tryptophan
  • Tryptophan

L-Tryptophan

  • (S)-2-Amino-3-methylbutanoic acid
  • L-Valine

L-Valine

  • DL-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

Proper name(s) Common name(s) Source material(s)
Common name(s)
  • (S)-2-Aminopropanoic acid
  • L-Alanine

L-Alanine

  • Alanylglutamine
  • DL-Alanine
  • L-Alanine
  • L-Alanine ethyl ester hydrochloride
  • (S)-2-Amino-5-[(aminoiminomethyl) amino] pentanoic acid
  • L-Arginine

L-Arginine

  • DL-Arginine
  • L-Arginine
  • L-Arginine alpha-ketoglutarate
  • L-Arginine ketoisocaproic acid
  • L-Arginine monohydrochloride
  • (S)-2,4-Diamino-4-oxobutanoic acid
  • L-Asparagine

L-Asparagine

L-Asparagine

  • (S)-Aminobutanedioic acid
  • L-Aspartic acid

L-Aspartic acid

  • L-Aspartic acid
  • Potassium aspartate
  • Potassium magnesium aspartate
  • (R)-2-Amino-3-mercaptopropanoic acid
  • L-Cysteine

L-Cysteine

  • Cysteine hydrochloride
  • Cysteine hydrochloride monohydrate
  • D-Ribose-L-Cysteine
  • L-Cysteine
  • N-Acetyl-L-Cysteine
  • (S)-2-Aminopentanedioic acid
  • L-Glutamic acid
  • L-Glutamate
  • L-Glutamic acid
  • Glutamic acid hydrochloride
  • L-Glutamate
  • Monosodium glutamate
  • (S)-2,5-Diamino-5-oxopentanoic acid
  • L-Glutamine
  • Glutamine
  • L-Glutamine
  • L-Glutamine
  • L-Glutamine ethyl ester

Aminoacetic acid

Glycine

  • Glycine
  • Glycine hydrochloride
  • N-Glycyl-L-Leucine
  • (S)-2-Pyrrolidinecarboxylic acid
  • L-Proline

L-Proline

L-Proline

  • (S)-2-Amino-3-hydroxypropanoic acid
  • L-Serine

L-Serine

L-Serine

  • (S)-alpha-Amino-4-hydroxybenzenepropanoic acid
  • L-Tyrosine
  • L-Tyrosine
  • Tyrosine
  • L-Tyrosine
  • L-Tyrosine ethyl ester
  • N-Acetyl Tyrosine

Group 3: Carbohydrates

Proper name(s) Common name(s) Source material(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
  • Glucose
  • D-Glucose
  • D-Glucose monohydrate

N/A

N/A

4-O-beta-D-Galactopyranosyl-D-glucose

Lactose

Lactose

N/A

N/A

Maltodextrin

Maltodextrin

Maltodextrin

N/A

N/A

D-Mannose

D-Mannose

D-Mannose

N/A

N/A

Solanum tuberosum

  • Potato starch
  • Starch - Potato

N/A

Solanum tuberosum

Tuber

Oryza sativa

  • Rice starch
  • Starch - Rice

N/A

Oryza sativa

Seed

Ribo-2,3,4,5-tetrahydroxyvaleraldehyde, D-

  • D-Ribose
  • Ribose
  • D-Ribose-L-Cysteine
  • Ribose

N/A

N/A

  • Alpha-D-Glucopyranosyl-beta-D-fructofuranoside
  • Beta-D-Fructofuranosyl-alpha-D-glucopyranoside
  • Cane sugar
  • Saccharose
  • Sucrose
  • Sugar

N/A

Acer saccharum

Sap

Beta vulgaris

Root

Borassus flabellifer

Sap

Malus domestica

Fruit

Oryza sativa

Seed

Saccharum officinalis

Leaf stalk

Triticum aestivum

  • Starch - Wheat
  • Wheat starch

N/A

Triticum aestivum

Seed endosperm

Zea mays

  • Corn Starch
  • Starch - Maize
  • Topical starch
  • Zea Mays (Corn) Starch
  • Zea mays starch

N/A

Zea mays

Seed

Zea mays

Waxy maize starch

N/A

Zea mays

Seed

Group 4: Ergogenic agents
Group 4a: Non-caffeinated ergogenic agents

Proper name(s) Common name(s) Source material(s)
Common name(s) Proper name(s) Part(s) Preparation(s)

Calcium beta-hydroxy-beta-methylbutyrate

  • CaHMB
  • Calcium beta- hydroxy-beta- methylbutyrate

Calcium beta-hydroxy-beta- methylbutyrate

N/A

N/A

Synthetic

  • (L-3-Carboxy-2-hydroxypropyl) trimethylammonium hydroxide, inner salt
  • (R)-3-carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium hydroxide, inner salt
  • L-Carnitine
  • Levocarnitine
  • L-Carnitine
  • Levocarnitine
  • L-Carnitine fumarate
  • L-Carnitine tartrate

N/A

N/A

N/A

N-(aminoiminomethyl)-N-methylglycine monohydrate

Creatine monohydrate

Creatine monohydrate

N/A

N/A

Synthetic

Eleutherococcus senticosus

  • Ci wu jia
  • Eleuthero
  • Siberian ginseng

N/A

Eleutherococcus senticosus

Root

Dried

Panax ginseng

  • Asian ginseng
  • Chinese ginseng
  • Hong shen
  • Korean ginseng
  • Korean red ginseng
  • Oriental ginseng
  • Panax ginseng
  • Red ginseng
  • Ren shen

N/A

Panax ginseng

  • Root
  • Rootlet

Dried

Group 4b: Caffeine

Proper name(s) Common name(s) Source material(s)
Common name(s)
  • 1,3,7-Trimethylxanthine
  • 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione

Caffeine

  • Caffeine
  • Caffeine citrate
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

Proper name(s) Common name(s) Source material(s)
Common name(s) Proper name(s) Part(s) Preparation(s)

Malpighia glabra

  • Acerola
  • Barbados cherry tree
  • Escobillo

N/A

Malpighia glabra

Fruit

  • Dried
  • Fresh
  • 3-Aminopropanoic acid
  • 3-Aminopropionic acid
  • beta-Aminopropionic acid

Beta-Alanine

  • Beta-Alanine
  • Beta-Alanine ethyl ester

N/A

N/A

N/A

Piper nigrum

  • Black pepper
  • Pepper - black
  • Pepper - white
  • White pepper

N/A

Piper nigrum

Fruit

Dried

  • (beta-hydroxyethyl)trimethylammonium
  • 2-Hydroxy-N,N,N-Trimethylethanaminium
  • Choline

Choline

  • Choline
  • Choline bitartrate
  • Choline chloride
  • Choline citrate
  • Choline dihydrogen citrate
  • Choline orotate
  • Lecithin
  • Phosphatidylcholine

N/A

N/A

N/A

  • (S)-N5-Carbamoylornithine
  • L-Citrulline
  • N5-(Aminocarbonyl)-L-ornithine
  • Citrulline
  • L-Citrulline
  • Citrulline ethyl ester
  • Citrulline malate
  • L-Citrulline

N/A

N/A

N/A

Capsicum annuum

  • Cayenne
  • Cayenne pepper
  • Chili pepper
  • Paprika
  • Red pepper

N/A

Capsicum annuum

Fruit

Dried

  • All-trans-lycopene
  • Lycopene
  • Psi, psi-Carotene

Lycopene

N/A

Solanum lycopersicum

Fruit flesh

N/A

Lycopene

N/A

N/A

Synthetic

  • (S)-2,5-Diaminopentanoic acid
  • (S)-alpha,delta-Diaminovaleric acid

L-Ornithine

  • L-Ornithine
  • L-ornithine hydrochloride
  • L-Ornithine-L-Aspartate
  • Ornicetil

N/A

N/A

N/A

2-Aminoethanesulfonic acid

Taurine

  • L-Arginine taurinate
  • Taurine
  • Taurine ethyl ester

N/A

N/A

N/A

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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

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).
  • Source of protein which helps build and repair body tissues (CFIA 2019).
  • Source of amino acids involved in muscle protein synthesis (IOM 2005).
  • Assists in the building of lean muscle [tissue/mass] when combined with regular [weight/resistance] training and a healthy balanced diet (NNHPD 2019).

Products containing at least one ingredient from Group 2a, at or above the respective minimum dose indicated in the Dose section below

  • Source of (an) essential amino acid(s) for the maintenance of good health (CNF 2019).
  • Source of (an) (essential) amino acid(s) involved in muscle protein synthesis (IOM 2005).
  • Assists in the building of lean muscle [tissue/mass] when combined with regular [weight/resistance] training and a healthy balanced diet (NNHPD 2019).

Products containing all three of L-leucine, L-isoleucine and L-valine, at or above the respective minimum doses indicated in the Dose section below

Source of (an) (non-essential) amino acid(s) involved in muscle protein synthesis (IOM 2005).

Products containing at least one ingredient from Group 2b, at or above the respective minimum dose indicated in the Dose section below

Source of (an) (non-essential) amino acid(s) involved in muscle protein synthesis (IOM 2005).

Products containing L-glutamine, at or above a minimum dose of 5 g, per day

  • Helps restore plasma glutamine levels depleted after periods of physical stress (e.g. prolonged exhaustive exercise) (Krzywkowski et al. 2001; Bowtell et al. 1999; Castell and Newsholme 1997).
  • Helps to assist in muscle cell repair after exercise (Newsholme et al. 2003; IOM 2005).

Products containing at least one ingredient from Group 3, at or above the minimum dose indicated in the Dose section below

  • Source of carbohydrates to support energy production (IOM 2005).
  • Source of calories which contributes to weight gain (IOM 2005).
  • Helps to [maintain performance/promote endurance] in extended (greater than 60 min), high intensity exercise (Kerksick et al. 2008).

Products containing at least one ingredient from Group 4a, at or above the relevant minimum doses indicated in the Dose section below

Helps increase physical performance during intensive exercise (NNHPD 2019).

Additionally, the following recommended uses may be indicated for products containing the corresponding medicinal ingredients, at or above the relevant minimum doses indicated in the Dose section below:

Calcium beta-hydroxy-beta-methylbutyrate (CaHMB)

Enhances muscle strength in previously untrained individuals in combination with intense resistance training exercise (NNHPD 2019).

L-Carnitine/Levocarnitine

L-CARNITINE TARTRATE

  • Aids in the muscle recovery process by reducing muscle tissue damage associated with a resistance training regimen (Ho et al. 2010; Spiering et al. 2008; Spiering et al. 2007; Kraemer et al. 2006; Kramer et al. 2003; Volek et al. 2002).
  • Helps support muscle tissue repair in individuals involved in resistance training (Ho et al. 2010; Spiering et al. 2008; Spiering et al. 2007; Kraemer et al. 2006; Kramer et al. 2003; Volek et al. 2002).
  • Helps improve physical performance when used in conjunction with a training regimen (Wall et al. 2011; Cha et al. 2001; Arenas et al. 1994; Huertas et al. 1992; Arenas et al. 1991; Vecchiet et al. 1990; Marconi et al. 1985).
  • Helps delay fatigue during physical activity (Cha et al. 2011; Wall et al. 2011; Karahan et al. 2010).
  • Helps support fat metabolism (Stephens et al. 2007; Karlic and Lohninger 2004; Müller et al. 2002).
  • Helps support fat oxidation (Wall et al. 2011; Stephens et al. 2007; Wutzke and Lorenz 2004; Müller et al. 2002).
  • Helps support fat metabolism and oxidation (Wall et al. 2011; Stephens et al. 2007; Karlic and Lohninger 2004; Wutzke and Lorenz 2004; Müller et al. 2002).
  • Workout support/supplement that helps improve physical performance when used in conjunction with a training regimen (Wall et al. 2011; Cha et al. 2001; Arenas et al. 1994; Huertas et al. 1992; Arenas et al. 1991; Vecchiet et al. 1990; Marconi et al. 1985).
  • Workout support/supplement that delays fatigue during physical activity (Wall et al. 2011; Stephens et al. 2007; Karlic and Lohninger 2004; Müller et al. 2002; Cha et al. 2001; Arenas et al. 1994; Huertas et al. 1992; Arenas et al. 1991; Vecchiet et al. 1990; Marconi et al. 1985).

Creatine monohydrate

  • Increases body/(lean)muscle mass/size when used in conjunction with a resistance training regimen (Brose et al. 2003; Bemben et al. 2001; Volek et al. 1999; Vandenberghe et al. 1997).
  • Improves strength/power/performance in repetitive bouts of brief, highly-intense physical activity (e.g. sprints, jumping, resistance training) (by increasing [muscle/intramuscular] [creatine/phosphocreatine/energy] levels) (Okudan and Gökbel 2005; Brose et al. 2003; Preen et al. 2003; Bemben et al. 2001; Volek et al. 1999; Vandenberghe et al. 1997; Hultman et al. 1996)

Eleuthero/Siberian ginseng

Eleuthero/Siberian ginseng is used in Herbal Medicine to help improve physical performance after periods of physical exertion (Bradley 2006; ESCOP 2003; Hoffmann 2003; Mills and Bone 2000).

Panax ginseng

(Chinese/Korean/Panax) ginseng is used in Herbal Medicine to help enhance physical capacity/performance (in cases of physical stress) (Kim et al. 2005; ESCOP 2003; Gross et al. 2002; WHO 1999; Gross et al. 1995; Sotaniemi et al. 1995; Schepdael 1993).

Products containing Caffeine (Group 4b), at or above the minimum dose indicated in the Dose section below

  • Helps (temporarily) to relieve fatigue, to promote endurance, and to enhance motor performance (Philip et al. 2006; Doherty and Smith 2005; Smith et al. 2005).
  • Helps (temporarily) to enhance (physical) energy (Philip et al. 2006; Doherty and Smith 2005; Smith et al. 2005).
  • Helps (temporarily) to reduce tiredness and fatigue (Philip et al. 2006; Doherty and Smith 2005; Smith et al. 2005).

Additional claims

Products containing ingredients from Group 5, at or above the minimum doses indicated in the Dose section below

As per the current NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Note
Claims from the NNHPD Multi-Vitamin/Mineral Supplements Monograph are only acceptable in addition to at least one claim from Groups 1 to 4.

Ingredient Combinations

All ingredients included in this monograph may be combined together, across all Groups, with the following restriction:

Products containing caffeine must indicate the recommended use or purpose for Group 4b, and may not indicate any recommended uses or purposes with the wording "for the maintenance of good health".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Note
The minimum doses indicated below must be met only for medicinal ingredients which are directly supporting any indicated uses or purposes, as per the Use(s) or Purpose(s) section above.

Group 1 (Proteins)

The potency of protein on a 'as is' weight basis is required to be indicated on the Product License Application and label for each medicinal ingredient from Group 1.

Total amount of protein on a 'as is' weight basis from Group 1 in the product

2.6 - 90 grams, per day (IOM 2005).

Group 2a (Essential amino acids)

Medicinal Ingredients Doses (milligrams/day)
Minimum Maximum1

Histidine

49 mg

220 mg

Isoleucine

66.5 mg

1065 mg

Leucine

147 mg

1824 mg

Lysine

133 mg

3000 mg

Methionine

66.5 mg

1000 mg

Phenylalanine

115.5 mg

339 mg

Threonine

70 mg

301 mg

Tryptophan

17.5 mg

220 mg

Valine

84 mg

1194 mg

Reference: Doses: IOM 2005.

1When combining individual amino acids with protein ingredients, applicants must consider the contribution of the protein ingredient(s) to the total dose of each amino acid, in order to respect the maximum doses indicated above.

Group 2b (Non-essential amino acids)

Medicinal Ingredients Doses (milligrams/day)
Minimum Maximum1

Alanine

181.5 mg

363 mg

Arginine

208.5 mg

9000 mg

Asparagine

4.6 mg

93.5 mg

Aspartic acid

325 mg

1000 mg

Cysteine

50 mg

1000 mg

Glutamic acid

750 mg

1500 mg

Glutamine

342.5 mg

9000 mg

Glycine

160 mg

1800 mg

Proline

259.5 mg

519 mg

Serine

175.5 mg

351 mg

Tyrosine

139 mg

3600 mg

References: Doses: NNHPD 2019, Lenders et al. 2009, IOM 2005.

1When combining individual amino acids with protein ingredients, applicants must consider the contribution of the protein ingredient(s) to the total dose of each amino acid, in order to respect the maximum doses indicated above.

Group 3 (Carbohydrates)

Combined dose for all ingredients from Group 3 in the product

6.5 - 180 grams, per day; Not to exceed 45 grams per single dose (Dietitians of Canada 2013).

Group 4a (Non-caffeinated ergogenic agents)

Medicinal Ingredients Uses or purposes Methods of preparation Doses (grams/day) Single dose
Minimum Maximum Maximum single dose

Calcium beta- hydroxy-beta-methylbutyrate

Enhances muscle strength in previously untrained individuals in combination with intense resistance training exercise

N/A

3 g

6 g

N/A

L-Carnitine

Muscle recovery, Muscle tissue repair, Workout support/ supplement

N/A

1 g

4 g

2 g

Physical performance, Fatigue, Workout support/supplement combined with Physical performance/Fatigue

2 g

Fat metabolism, Fat oxidation

3 g

Eleutherococcus senticosus

Eleuthero/Siberian ginseng is used in Herbal Medicine to help improve physical performance after periods of physical exertion

Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

0.91 g of dried root

6 g of dried root

N/A

Panax ginseng

(Chinese/Korean/Panax) ginseng is used in Herbal Medicine to help enhance physical capacity/performance (in cases of physical stress)

Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion)

0.5 g of dried root/rootlets

9 g of dried root/rootlets

N/A

Standardized extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion)

200 mg of extract standardized to 4-7% of total ginsenosides; Not to exceed 9 g of dried root/rootlets per day

600 mg of extract standardized to 4-7% of total ginsenosides; Not to exceed 9 g of dried root/rootlets per day

N/A

References: Doses: CaHMB: Rowlands and Thomson 2009, Gallagher et al. 2000a,b. Carnitine: Wall et al. 2011, Ho et al. 2010, Spiering et al. 2008, Spiering et al. 2007, Stephens et al. 2007, Kraemer et al. 2006, Karlic and Lohninger 2004, Wutzke and Lorenz 2004, Kramer et al. 2003, Müller et al. 2002, Volek et al. 2002, Benvenga et al. 2001, Cha et al. 2001, Ahmet et al. 2000, Arenas et al. 1994, Huertas et al. 1992, Arenas et al. 1991, Vecchiet et al. 1990, Harper et al. 1988, Marconi et al. 1985. Eleuthero : Bradley 2006, ESCOP 2003, Hoffmann 2003, Blumenthal et al. 2000, Mills and Bone 2000. Panax ginseng : Vuksan et al. 2008, Reay et al. 2006, Sievenpiper et al. 2006, Reay et al. 2005, Sünram-Lea et al. 2005, Kennedy et al. 2004, ESCOP 2003, Kennedy et al. 2002, Scholey and Kennedy 2002, Engels et al. 2001, Kennedy et al. 2001, Scaglione et al. 2001, Blumenthal et al. 2000, Tetsutani et al. 2000, McGuffin et al. 1997, Engels et al. 1996, Scaglione et al. 1996, Gross et al. 1995, Scaglione et al. 1994, Scaglione et al. 1990, Petkov and Mosharrof 1987, D'Angelo et al. 1986, Soldati and Sticher 1980.

Dose(s) and duration(s) of use for creatine monohydrate

Medicinal Ingredients Phases Dose (grams/day) Durations of use
Minimum Maximum Maximum single dose

Creatine monohydrate

Loading Phase

Option 1

15 g

20 g

5 g

5-7 days

Option 2

3 g

5 g

N/A

Use for a minimum of 4 weeks

Maintenance Phase

2 g

5 g

N/A

N/A

References: Doses: Option 1: Okudan and Gokbel 2005, Preen et al. 2003, Bemben et al. 2001, Vandenberghe et al. 1997, Hultman et al. 1996. Option 2: Hultman et al. 1996. Maintenance phase: Preen et al. 2003, Bemben et al. 2001, Volek et al. 1999, Vandenberghe et al. 1997, Hultman et al. 1996.

Group 4b (Caffeine)

100 - 400 milligrams, per day and 100 - 200 milligrams per single dose (HC 2012).

Note
Maximum daily dose of 1000 milligrams from NNHPD Caffeine monograph does not apply for Workout Supplements as this maximum dose is not acceptable for prolonged use.

Group 5 (Vitamins and Minerals)

As per the current NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Group 6 (Complementary ingredients)

Medicinal Ingredients Methods of preparation Dose (grams/day)
Minimum Maximum

Beta-Alanine

N/A

> 0 mg

3000 mg

Choline

N/A

> 0 mg

1000 mg

Citrulline

N/A

> 0 mg

3000 mg

Capsicum annuum

Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion)

> 0 mg dried fruit

650 mg of dried fruit

Lycopene

N/A

> 0 mg

30 mg

L-Ornithine

N/A

> 0 mg

1500 mg

Malpighia glabra

Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion)

> 0 mg dried or fresh fruit

10 g of dried fruit

100 g of dried fruit

Piper nigrum

Dry, powdered

> 0 mg dried fruit

25 mg of dried fruit

Taurine

N/A

> 0 mg

3000 mg

References: Doses: NNHPD 2019, CNF 2019.

Direction(s) for use

All products

Ensure to drink enough fluid before, during, and after exercise.

Products containing Creatine monohydrate and making Creatine claims

Phase(s) Direction(s) for use

Loading Phase

Option 1

Step 1 (Loading Phase): Start with a loading phase of 5-7 days (15-20 g/d) and follow with a maintenance phase (2-5g/d)

Option 2

Step 1 (Loading Phase): Start with a loading phase of 4 weeks (3-5 g/d) and follow with a maintenance phase (2-5 g/d)

Maintenance Phase

Step 2 (Maintenance Phase): No statement required

Reference: NNHPD 2019.

Products containing L-Carnitine and making Muscle recovery, Muscle tissue repair, Workout support/supplement, Physical performance, or Fatigue claims

Take 2-4 hours prior to exercise (Harper et al. 1988).

Products containing Whey protein

Take a few hours before or after taking other medications (Martindale 2009; Jung et al. 1997).

Products in powder form

Mix product well in 1-2 cups of liquid (water, juice, etc.) immediately before consumption.

Products for increasing exercise performance (optional)

Consume 45-90 minutes before exercising (Aragon and Schoenfeld 2013).

Products for repairing body tissues/muscles and restoring plasma glutamine levels (optional)

Consume no later than 90 minutes after exercising (Aragon and Schoenfeld 2013).

Products for endurance based on ingredients from Group 3 (Carbohydrates) (optional)

Consume 30-60 grams of carbohydrates, per hour of high intensity exercise (Saunders et al. 2007; Ivy et al. 2003).

Duration(s) of Use

Products providing 0.42 g and more of L-Arginine, per day

Consult a health care practitioner/health care provider/health care professional/doctor/ physician for use beyond 6 weeks if you suffer from a cardiovascular disease (Shao and Hathcock 2008; Sydow et al. 2002; Hambrecht et al. 2000; Clarkson et al.1996; Rector et al. 1996).

Products containing Eleuthero

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 1 month (ESCOP 2003).

Products containing Panax ginseng

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 3 months (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000; McGuffin et al. 1997).

Risk Information

Caution(s) and warning(s)

All products

Consult a healthcare practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Products containing milk derivatives (such as casein/caseinates, whey and milk proteins)

This product contains milk by-products/derivatives.

Products providing more than 30 g total protein and/or amino acids (including β-alanine), per day

Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have liver or kidney disease (Shils et al. 2006).

Products containing Caffeine

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have high blood pressure, glaucoma, and/or overactive bladder syndrome (detrusor instability) (Cornelis and El-Sohemy 2007, Chandrasekaran et al. 2005, Noordzij et al. 2005, Avisar et al. 2002, Arya et al. 2000, Jee et al. 1999, Creighton and Stanton 1990).
  • Avoid taking with health products or foods that contain caffeine and/or increase blood pressure (e.g. medications, coffee, tea, colas, cocoa, guarana, mate, bitter orange extract, synephrine, ocotopamine, ephedra, ephedrine) (Bui et al. 2006; Bouchard et al. 2005; Haller et al. 2005; FDA 2004; Berardi et al. 2002; Vahedi et al. 2000; Zimmerman 1992; FDA 1988).
  • This product is not intended as a substitute for sleep (Berardi et al. 2002, Zimmerman 1992, FDA 1988).

Products providing 200 mg or more of Caffeine, per day and recommended for endurance, motor performance, physical energy or to be taken prior to workout

Caffeine has been shown to reduce blood flow to the heart muscle during exercise which might lead to cardiovascular complications such as chest pain, and irregular heartbeat even in healthy individuals. Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if those symptoms occur (Higgins and Babu 2013).

Products providing more than 300 mg of Caffeine, per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician if you are of childbearing age, pregnant or breastfeeding (Nawrot et al. 2003).

Products containing CaHMB

Consult a health care practitioner /health care provider/health care professional/doctor/ physician prior to use if you are taking medications for high cholesterol (Nissen et al. 2000).

Products containing Cayenne

  • Keep out of the reach of children.
  • Call a Poison Control Center immediately if overdose or accidental ingestion occurs (CPS 2008).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have stomach ulcers or inflammation (Brinker 2010; Bradley 2006; Boon and Smith 2004).

Products containing Creatine monohydrate

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have kidney disease/disorder (Pline and Smith 2005; Pritchard and Kalra 1998).
  • May result in weight gain (Volek and Rawson 2004; Bemben et al. 2001; Mihic et al. 2000

Products providing more than 0.42 g of L-Arginine, per day

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you suffer from cardiovascular disease and are attempting an increase in physical activity or if your cardiovascular condition worsens (Doutreleau et al. 2010; Doutreleau et al. 2006; Schulman et al. 2006; Nagaya et al. 2001; Bednarz et al. 2000; Ceremuzynski et al. 1997; Rector et al. 1996).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking medication for cardiovascular diseases, erectile dysfunction, and/or blood thinners (Huynh et al. 2002; Parker et al. 2002; Siani et al. 2000; Adams et al. 1995).

Products containing L-Carnitine

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a seizure disorder (CPS 2008).

Products containing Eleuthero

Consult a health care practitioner/health care provider/health care professional/doctor/physician if you have any type of acute infection (Brinker 2010; Barnes et al. 2007; ESCOP 2003; Mills and Bone 2000).

Products containing Panax ginseng

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have diabetes (Brinker 2010; Vuksan et al. 2008; Seely et al. 2008; Sievenpiper et al. 2006; ESCOP 2003; Tetsutani et al. 2000; Sotaniemi et al. 1995; Chin 1991).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking antidepressant medication, blood thinners or digoxin (Brinker 2010; Lee et al. 2008a; Dasgupta and Reyes 2005; Janetzki and Morreale 1997; Gonzalez-Seijo et al. 1995; Shader and Greenblatt 1988; Jones and Runikis 1987; Shader and Greenblatt 1985).

Products containing Vitamins and/or Minerals

As per the current NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Contraindication(s)

Products providing more than 0.42 g of L-Arginine, per day

Do not use this product if you have had a heart attack/myocardial infarction (Schulman et al. 2006).

Products containing Eleuthero

Do not use this product if you have high blood pressure (Brinker 2010; Barnes et al. 2007; Blumenthal et al. 2000; Mills and Bone 2000; McGuffin et al. 1997).

Products containing Vitamins and/or Minerals

As per the current NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Known adverse reaction(s)

Products containing Beta-alanine

Reduce the dose if flushing, tingling and/or prickling sensation of the skin occurs (Harris et al. 2006; Hill et al. 2007; Jordan et al. 2010)

Products containing Caffeine

Stop use if hypersensitivity/allergy occurs (Infante et al. 2003; Hinrichs et al. 2002).

Products providing more than 0.42 g of L-Arginine, per day

Some people may experience gastrointestinal discomfort (such as diarrhea) (Grimble 2007; Evans et al. 2004; Clarkson et al. 1996).

Products containing Panax ginseng

Stop use if you experience insomnia, anxiety or headaches (Lee et al. 2008b; Vuksan et al 2008; de Andrade et al. 2007; Sievenpiper et al. 2006; Coon and Ernst 2002; Ellis and Reddy 2002; Scaglione et al. 2001; Siegel 1979).

Products containing Vitamins and/or Minerals

As per the current NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Store in a cool, dry place.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

Hemp protein, Hemp protein isolate and Hemp seed protein

Must not contain more than 10 parts per million delta-9-Tetrahydrocannabinol (THC), or phytocannabinoids that have been isolated or concentrated. The determination of the THC concentration must take into account the potential to convert delta-9-tetrahydrocannabinolic acid (THCA) to THC. These hemp derivatives must also be compliant with the Industrial Hemp Regulations (IHR). All sources of hemp falling under the IHR are expected to be of an approved cultivar, defined in the IHR as any variety of industrial hemp set out in the List of Approved Cultivars, published by the Government of Canada on its website, as amended from time to time. (GC 2018a; GC 2018b; GC 2003; HC 2019; HC 2018)

Creatine monohydrate

The finished product and/or raw material specifications must have limits for the following impurities: not more than 100 ppm creatinine; not more than 50 ppm dicyandiamide; non-detectable dihydrotriazine. The method used to detect dihydrotriazine must have a limit of detection of not more than 5 ppm.

Whey protein

The medicinal ingredient proper name should be determined by the potency of whey protein on a dry weight basis as published in the Food and Chemical Codex (FCC 8):

Proper name(s) Potency of whey protein1(dry weight basis2) (%)

Whey protein isolate

≥ 90

Whey protein concentrate

25-89.9

Whey protein hydrolysate3

≥ 104

1Potencies of whey protein on a "dry weight basis" are based on values derived from FCC 8.

2Chemical and physical components are typically reported on an "as is" (wet) weight basis or dry (0% moisture) weight basis. A wet weight basis result is the percentage of the component of interest out of the entire sample including moisture. A dry weight basis result is the percentage of the component out of the entire sample neglecting moisture

3Refers to partially hydrolyzed proteins composed of peptides and polypeptides resulting from the partial or incomplete hydrolysis of peptide bonds present in edible whey protein catalyzed by heat, food-grade proteolytic enzymes, and/or suitable food-grade acids. Their degree of hydrolysis typically ranges from 3% to 85% on the basis of peptide bond cleavage (FCC 8).

4Minimum quantity of protein is based upon a minimum of 10% (dry weight basis) of protein found in dry whey.

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