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 described within. 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 the statements are synonymous. Either term or statement may be selected by the applicant. Date May 6, 2016 Proper name(s), Common name(s), and Source material(s) Group 1: Proteins Proper name(s) Common name(s) Source material Acid casein Acid casein As per NHPID 1 Alfalfa protein concentrate Alfalfa protein concentrate As per NHPID Calcium caseinate Calcium caseinate As per NHPID Calcium sodium caseinate Calcium sodium caseinate As per NHPID Hydrolyzed casein Hydrolyzed casein As per NHPID Defatted wheat germ protein Defatted wheat germ protein As per NHPID Flaxseed protein Flaxseed protein As per NHPID Hemp protein concentrate Hemp protein concentrate As per NHPID Hemp protein isolate Hemp protein isolate As per NHPID Hemp seed protein Hemp seed protein As per NHPID Casein Micelles Micellar casein As per NHPID Milk protein concentrate Milk protein concentrate As per NHPID Milk protein isolate Milk protein isolate As per NHPID Pea protein Pea protein As per NHPID Potato protein Potato protein As per NHPID
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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 described within.
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 the statements are synonymous. Either term or
statement may be selected by the applicant.
Date May 6, 2016
Proper name(s), Common name(s), and Source material(s)
Group 1: Proteins
Proper name(s)
Common name(s)
Source material
Acid casein Acid casein As per NHPID1
Alfalfa protein concentrate Alfalfa protein
concentrate
As per NHPID
Calcium caseinate Calcium caseinate As per NHPID
Calcium sodium caseinate Calcium sodium
caseinate
As per NHPID
Hydrolyzed casein Hydrolyzed casein As per NHPID
Defatted wheat germ protein Defatted wheat germ
protein
As per NHPID
Flaxseed protein Flaxseed protein As per NHPID
Hemp protein concentrate Hemp protein
concentrate
As per NHPID
Hemp protein isolate Hemp protein isolate As per NHPID
Hemp seed protein Hemp seed protein As per NHPID
Casein Micelles Micellar casein As per NHPID
Milk protein concentrate Milk protein
concentrate
As per NHPID
Milk protein isolate Milk protein isolate As per NHPID
Pea protein Pea protein As per NHPID
Potato protein Potato protein As per NHPID
Workout Supplements Page 2 of 17
Proper name(s)
Common name(s)
Source material
Rice protein Rice protein As per NHPID
Rice protein concentrate Rice protein
concentrate
As per NHPID
Sodium caseinate Sodium caseinate As per NHPID
Wheat protein isolate Wheat protein isolate As per NHPID
Whey protein isolate Whey protein isolate As per NHPID
Whey protein concentrate Whey protein
concentrate
As per NHPID
Whey protein hydrolysate Whey protein
hydrolysate
As per NHPID
1NHPID: Natural Health Products Ingredients Database
Group 2: Amino acids
Group 2a: Essential amino acids
Proper name(s)
Common name(s)
Source Ingredient(s)
Source Material(s)
L-Histidine L-Histidine L-Histidine
L-Histidine
L-Histidine
hydrochloride
As per NHPID1
L-Isoleucine L-Isoleucine L-Isoleucine
L-Isoleucine
hydrochloride
As per NHPID
L-Leucine L-Leucine L-Leucine
L-Leucine
hydrochloride
As per NHPID
L-Lysine L-Lysine L-Lysine
L-Lysine acetate
L-Lysine
hydrochloride
Lysine dihydrochloride
As per NHPID
L-Methionine L-Methionine L-Methionine
DL-Methionine
As per NHPID
L-Phenylalanine L-Phenylalanine L-Phenylalanine
L-Phenylalanine
methyl ester
DL-Phenylalanine
As per NHPID
L-Threonine L-Threonine L-Threonine
DL-Threonine
As per NHPID
L-Tryptophan L-Tryptophan L-Tryptophan As per NHPID
L-Valine L-Valine L-Valine As per NHPID
Workout Supplements Page 3 of 17
Proper name(s)
Common name(s)
Source Ingredient(s)
Source Material(s)
L-Valine
hydrochloride
DL-Valine 1NHPID: Natural Health Products Ingredients Database
Group 2b: Non-essential amino acids
Proper name(s)
Common name(s)
Source Ingredient(s)
Source Material(s)
L-Alanine L-Alanine L-Alanine
L-Alanine ethyl ester
hydrochloride
DL-Alanine
As per NHPID1
L-Arginine L-Arginine L-Arginine
L-Arginine
hydrochloride
L-Arginine alpha-
ketoglutarate
L-Arginine
ketoisocaproic acid
DL-Arginine
As per NHPID
L-Asparagine L-Asparagine L-Asparagine As per NHPID
Valine 84 1194 Note: References for doses are from NNHPD 2013. 1 When 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
Ingredient
Minimum (mg/day)
Maximum (mg/day) 1
Alanine > 0 363
Arginine > 0 9000
Asparagine > 0 93.5
Aspartic acid > 0 1000
Cysteine > 0 1000
Glutamic acid > 0 1500
Glutamine > 0 9000
Glycine > 0 1800
Proline > 0 519
Serine > 0 351
Tyrosine > 0 3600 Note: References for doses are from NNHPD 2013. 1 When 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 g, per day, not to exceed 45 g per single dose (Dietitians of Canada 2013).
Workout Supplements Page 10 of 17
Group 4a (Non-caffeinated ergogenic agents):
Medicinal
Ingredient
Minimum (g/day)
Maximum (g/day)
Calcium beta-
hydroxy-beta-
methylbutyrate1
3 6
L-Carnitine As per NNHPD L-
Carnitine monograph
As per NNHPD L-
Carnitine
monograph
Creatine monohydrate As per NNHPD
Creatine monohydrate
monograph
As per NNHPD
Creatine
monohydrate
monograph
Eleutherococcus
senticosus
0.91 6
Panax ginseng 0.5 9 Note: References for doses are from: NNHPD 2013, NHPID 2009a, 2008a; Rowlands and Thomson 2009;
Gallagher et al. 2000a,b.
Group 4b (Caffeine):
100-400 mg, per day, not to exceed 200 mg per single dose (HC 2012).
Note
Maximum daily dose of 1000 mg 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 NNHPD Multi-Vitamin/Mineral Supplements Monograph.
Group 6 (Complementary ingredients):
Medicinal Ingredient
Minimum
(mg/day)
Maximum (/day)
Malpighia glabra > 0 48 g
Piper nigrum
(non-extracted powder)
> 0 25 mg
Beta-Alanine > 0 3 g
Choline > 0 1000 mg
Citrulline > 0 3000 mg
Capsicum annuum > 0 650 mg
Workout Supplements Page 11 of 17
Lycopene > 0 30 mg
L-ornithine > 0 1500 mg
Taurine > 0 3 g Note: References for doses are from NNHPD 2013; NHPID 2013b,c,d, 2009b,c; CNF 2012.
Directions for use
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 g carbohydrates per hour of high intensity exercise (Saunders et al. 2007; Ivy et
al. 2003).
Duration of use
For products containing Eleutherococcus senticosus:
As per NNHPD Eleuthero monograph.
Products containing Panax ginseng:
As per the NNHPD Panax Ginseng Monograph.
Products providing 0.43-9 g per day of L-Arginine:
If you suffer from a cardiovascular disease, consult your health care practitioner for use beyond 6
weeks.
Risk information Statement(s) to the effect of
Caution(s) and warning(s)
All products:
Ensure to drink enough fluid before, during, and after exercise.
If you are pregnant or breastfeeding, consult a healthcare practitioner before using this
product.
Products containing milk derivatives (such as casein/caseinates, whey and milk proteins):
This product contains milk by-products/derivatives.
Workout Supplements Page 12 of 17
Products containing over 30 g per day total protein and/or amino acids (including β-alanine):
If you have liver or kidney disease, consult a health care practitioner prior to use (Shils et al.
2006).
Products containing caffeine:
As per the NNHPD Caffeine Monograph.
Products containing Cayenne:
As per NNHPD Cayenne Monograph
Products containing L-arginine:
As per the NNHPD L- Arginine Monograph
Products containing L-carnitine:
As per the NNHPD L-carnitine Monograph.
Products containing Panax ginseng:
As per the NNHPD Panax Ginseng Monograph
Products containing Creatine monohydrate:
As per the NNHPD Creatine monohydrate monograph.
Products containing Calcium-HMB:
If you are taking medications for high cholesterol, consult a health care practitioner prior to use
(Nissen et al. 2000). Products containing vitamins and/or minerals:
As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.
Contraindication(s)
Products containing caffeine:
As per the NNHPD Caffeine Monograph.
Products containing L-arginine:
As per the NNHPD L- Arginine Monograph
Products containing Eleutherococcus senticosus:
As per the NNHPD Eleuthero Monograph.
Products containing Panax Ginseng:
As per the NNHPD Panax Ginseng Monograph
Products containing vitamins and/or minerals:
As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.
Workout Supplements Page 13 of 17
Known adverse reaction(s)
Products containing beta-alanine:
May cause a flushing, tingling and/or prickling sensation of the skin, in which case, reduce the
dose. (Harris et al. 2006; Hill et al. 2007; Jordan et al. 2010)
Products containing caffeine:
As per the NNHPD Caffeine Monograph.
For caffeine at or above 200 mg/day:
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. If those symptoms occur discontinue use and consult a health care practitioner
(Higgins 2013).
Products containing Panax ginseng:
As per the NNHPD Panax Ginseng Monograph
Products containing L-arginine:
As per the NNHPD L- Arginine Monograph
Products containing vitamins and/or minerals:
As per the 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.
References cited
Workout Supplements Page 14 of 17
Aragon AA, Schoenfeld BJ. Nutrient timing revisited: is there a post-exercise anabolic window?
Journal of the International Society of Sports Nutrition 2013;10(5).
CFIA 2012 : Canadian Food Inspection Agency. Guide to Food Labelling and Advertising,
Ottawa (ON): Canadian Food Inspection Agency and Health Canada. Internet. [Date modified
2013 July 22]. Available from: http://www.inspection.gc.ca/food/labelling/guide-to-food-