Workout Supplements

What this guide covers

• Sodium and ingredients where sodium is a substantial component (e.g. sodium chloride) are not permitted as a active ingredients on this reference due to health concerns associated with chronic supplemental use of sodium, namely hypertension, which remains the most common and most important risk factor for cardiovascular disease. However, the use of sodium as a counter-ion in medicinal or Other ingredients (e.g. sodium salts of minerals) is acceptable where warranted.

Restrictions when this reference is combined with other references (source review category II and III):

• When combining L-Carnitine with Acetylcarnitine, the total quantity of these ingredients cannot exceed 4 grams per day and 2 grams per single dose.

• Claims supported by this reference that may be selected for products recommended for occasional use only are listed in Appendices I and II.

Ingredients and preparations

¹For isolate, the potency information should be equivalent to 90% or more protein on a dry weight basis.

¹Starch ingredients should be prepared (e.g., gelatinized) such that carbohydrates are readily absorbable.

[Source note 1]

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Liquids and solutions are not permitted for products containing Creatine monohydrate, due to lack of stability of the finished product [Source note 2].

What is it used for?

Products providing at least 2.6 g of total protein, total protein and amino acids, or total amino acids from Groups 1, 2a and 2b

• Workout support/supplement

• Athletic support/supplement

• Assists in the building of lean muscle tissue/mass when combined with regular weight/resistance training and a healthy balanced diet [Source note 3].

Products containing at least one ingredient from any of Groups 3 or 4a, at or above the relevant minimum doses indicated in the Dose section below

• Workout support/supplement

• Athletic support/supplement

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 [Source note 4].

• Source of protein which helps build and repair body tissues [Source note 5].

• Source of protein which helps build strong muscles [Source note 6].

• Source of amino acids involved in muscle protein synthesis [Source note 7].

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 [Source note 8].

• Source of (an) (essential) amino acid(s) involved in muscle protein synthesis [Source note 9].

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 branched chain amino acids (BCAAs), which are involved in protein synthesis [Source note 10].

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 [Source note 11].

Products containing Beta-Alanine, at or above a minimum dose of 800 mg per single dose and 4.8 g, per day

Increases muscle carnosine levels, a factor in delaying neuromuscular fatigue in intermittent high intensity exercises [Source note 12].

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) [Source note 13].

• Helps to assist in muscle cell repair after exercise [Source note 14].

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 [Source note 15].

• Source of calories which contributes to weight gain [Source note 16].

• Helps to maintain performance/promote endurance in extended (greater than 60 min), high intensity exercise [Source note 17].

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 [Source note 18].

Additionally, the following recommended uses may be indicated for products containing the corresponding active 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 [Source note 19].

L-Carnitine sourced from L-Carnitine or L-Carnitine tartrate

• Aids in the muscle recovery process by reducing muscle tissue damage associated with a resistance training regimen [Source note 20].

• Helps support muscle tissue repair in individuals involved in resistance training [Source note 21].

• Helps improve physical performance when used in conjunction with a training regimen [Source note 22].

• Helps delay fatigue during physical activity [Source note 23].

• Helps support fat metabolism [Source note 24].

• Helps support fat oxidation [Source note 25].

Products containing L-Citrulline at or above a minimum dose of 3 g, per day

L-Citrulline is a precursor of L-Arginine [Source note 26].

Products containing L-Citrulline sourced from Citrulline malate at or above a minimum dose of 1.7 g (equivalent to 3 g citrulline malate), per day

Supports an increase in athletic performance in high-intensity anaerobic exercise with short rest period [Source note 27].

Creatine monohydrate

• Increases body/(lean)muscle mass/size when used in conjunction with a resistance training regimen [Source note 28].

• 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) [Source note 29]

Eleuthero/Siberian ginseng

Used in Herbal Medicine to help improve physical performance after periods of physical exertion [Source note 30].

Panax ginseng

Used in Herbal Medicine to help enhance physical capacity/performance (in cases of physical stress) [Source note 31].

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

• Helps (temporarily) to relieve/reduce fatigue, to promote endurance, and to enhance motor performance [Source note 32].

• Helps (temporarily) to enhance (physical) energy [Source note 33].

• Helps (temporarily) to relieve/reduce fatigue/tiredness [Source note 34].

Additional claims

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

As per the current source authority Multi-Vitamin/Mineral Supplements reference (except uses or purposes associated with pregnancy).

• The above uses can be combined on the product label (e.g. Helps temporarily to relieve fatigue and to assist in muscle cell repair after exercise).

• The terms ‘Helps’ or ‘Helps to’ and the terms ‘Source of’ and ‘Provides’ can be used interchangeably on the label.

Uses or Purposes Restrictions

• Claims from the source authority Multi-Vitamin/Mineral Supplements reference are only acceptable in addition to at least one claim from Groups 1 to 4.

Rules for caffeine

(Class I, II and/or III applications):

• Products containing caffeine from any source (synthetic, isolated or a component of plant material) must not:

  • indicate any uses or purposes related to healthy blood pressure or heart/cardiovascular health at any dose of caffeine (except if the product only contains caffeine from a active ingredient supported for these uses such as green coffee bean extract).

  • indicate any uses or purposes related to nervine/sedative/relaxation, nor contain a sedative at therapeutic dose, at any dose of caffeine.

  • indicate any uses or purposes related to the maintenance/support of good/general health at a daily dose of 40 mg or more total caffeine from all sources.

• Products providing a total amount of caffeine per day that meets the minimum therapeutic dose (100 mg/day) must indicate a use or purpose associated with caffeine.

Rules for proteins and amino acids

(Class I, II and/or III applications):

• Products must provide at least 2.6 g of total protein and/or amino acids to support protein-related claims, with a maximum of 90 g total protein and/or amino acids.

• For safety, the maximum allowable quantity of amino acids (as defined in Tables 3 and 4) is specific to free amino acids. The quantity of amino acids as sub-ingredients is only taken into account if they are free. For example, amino acids that are components of proteins are not free. However, highly hydrolyzed proteins may contain free amino acids. It is the applicant’s responsibility to know the composition of their ingredient.

• For efficacy, the total amino acid content (from amino acids as protein sub-ingredients and as individual active ingredients) can be used to support ‘Source of’ claims. However, this does not apply to more specific amino acid claims which are based on studies that administer individual amino acids to participants as the pharmacokinetics and effects of free amino acids may differ from those of amino acids as protein sub-ingredients.

• Soy protein concentrate and/or soy protein isolate must not exceed 35 g of protein per day with a maximum of 30 mg of AIE per day.

Who does this guide cover?

Adults 18 years and older

Quantities

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

Group 1 (Proteins)

Methods of preparation for organisms: Standardized extracts

[Source note 35]

¹The potency of protein on an "as is" weight basis is required to be indicated on the product documentation form and label for each active ingredient from Group 1.

Group 2a (Essential amino acids)

[Source note 36]

Group 2b (Non-essential amino acids)

[Source note 37]

Group 3 (Carbohydrates)

[Source note 38]

Group 4a (Non-caffeinated ergogenic agents)

References: 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; Kraemer 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 : ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Mills and Bone 2000; Bradley 1992. 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; 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.

Note: When ‘decoction’ or ‘infusion’ is listed as an acceptable method of preparation, ‘decoction concentrate’ or ‘infusion concentrate’ is also allowed.

Creatine monohydrate

[Source note 40]

Group 4b (caffeine)

[Source note 41]

¹A daily dose above 400 mg does not apply as part of Workout Supplements reference for source review category I.

Group 5 (Vitamins and Minerals)

Group 6 (Complementary ingredients)

[Source note 42]

¹The method of preparation ‘powdered’ is defined as a dried and ground preparation (= unextracted).

Note:

• *For Capsicum annuum and Malpighia glabra, solvents allowed for the method of preparation “Non-standardized extracts (Dry extract)” as part of this reference are ethanol and/or water only.

• When ‘decoction’ or ‘infusion’ is listed as an acceptable method of preparation, ‘decoction concentrate’ or ‘infusion concentrate’ is also allowed.

How is it used?

All products (optional)

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

Products containing creatine monohydrate and making creatine claims

[Source note 43]

¹If more than one option is listed for a product, they should be separated with ‘OR’ for clarity. ²The dose in grams can be replaced on the label with the number of dosage unit required to reach the loading dose (X g) and the maintenance dose (Y g) (e.g. X scoop(s); sachet(s); serving(s), etc). The values for X and Y must be listed on the product documentation for as an additional direction for use statement (e.g., X = 15 g and Y = 5 g).

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

Take 2-4 hours prior to exercise [Source note 44].

Products providing more than 200 mg of caffeine, per day (i.e. to be taken in divided doses)

Wait 3 to 4 hours between each dose

Products containing whey protein

Take a few hours before or after taking other medications or health products [Source note 45].

Products in powder form

(Thoroughly) Mix product in enough liquid (water, juice, etc.) immediately before consumption.

Products for increasing exercise performance (optional)

Consume 45-90 minutes before exercising [Source note 46].

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

Consume no later than 90 minutes after exercising [Source note 47].

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

Consume 30-60 grams of carbohydrates, per hour of high intensity exercise [Source note 48].

Products containing vitamins and/or minerals

As per the current source authority Multi-Vitamin/Mineral Supplements reference.

Combinations rules

• All ingredients included in this reference may be combined together, across all Groups.

• The finished product should not exceed a total amount of piperine (from Piper nigrum (black pepper) and/or isolated piperine) of 14 mg per day.

• For combination of Whey protein isolate, Whey protein concentrate and Whey protein hydrolysate, consult the source authority Whey products reference.

How long is it used?

Products providing more than 200 mg of agmatine, per day

Ask a healthcare professional for use beyond 3 weeks [Source note 49].

Products providing 3 g or more of L-arginine, per day

Ask a healthcare professional for use beyond 8 weeks if you have a cardiovascular disease (Salmani et al. 2021; Sydow et al. 2002; Hambrecht et al. 2000; Clarkson et al.1996; Rector et al. 1996).

Products providing more than 9 g and up to 14 g of L-arginine, per day

Ask a healthcare professional for use beyond 6 months [Source note 50].

Products providing more than 14 g of L-arginine, per day

Ask a healthcare professional for use beyond 12 weeks [Source note 51].

Note: Durations of use can be combined on the label (e.g., Ask a health care practitioner for use beyond 6 months, or beyond 8 weeks if you have a cardiovascular disease).

Products providing more than 3 g of L-citrulline, per day

Ask a healthcare professional for use beyond 8 weeks [Source note 52].

Product providing more than 3 g of beta-alanine, per day

Ask a healthcare professional for use beyond 10 weeks [Source note 53].

Products containing deanol

Ask a healthcare professional for use beyond 4 weeks (de Montigny et al. 1979, Marsh and Linnoila 1979, Caraceni et al. 1978. Penovich et al. 1978).

Products containing eleuthero

Ask a healthcare professional for use beyond 4 weeks [Source note 54].

Products containing Panax ginseng

Ask a healthcare professional for use beyond 12 weeks [Source note 55].

Products containing piperine

Ask a healthcare professional for use beyond 12 weeks [Source note 56].

Products containing vitamins and/or minerals

As per the current source authority Multi-Vitamin/Mineral Supplements reference.

Warnings and precautions

All products (except products containing deanol requiring a contraindication)

Ask a healthcare practitioner/healthcare professional before use if you are pregnant or breastfeeding.

Products containing milk by-products (such as casein, hydrolyzed casein, casein micelles, whey and milk proteins sourced from Bos taurus milk)

Contains milk by-products.

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

Ask a healthcare professional before use if you have a liver or kidney disorder [Source note 57].

Products containing 40 mg to 400 mg caffeine, per day

Ask a healthcare professional before use if you have high blood pressure or glaucoma (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).

Products providing more than 300 mg of caffeine, per day

Ask a healthcare professional before use if you are attempting to conceive [Source note 58].

Products providing 400 mg caffeine, per day

When using this product avoid taking other health products, foods or beverages that contain caffeine and/or increase blood pressure [Source note 59].

Products containing CaHMB

Ask a health care practitioner /healthcare professional before use if you are taking cholesterol medications [Source note 60].

Products containing cayenne

• Keep out of reach of children. If overdose or accidental ingestion occurs, call a poison control center immediately [Source note 61].

• Ask a healthcare professional before use if you have a stomach ulcer or inflammation [Source note 62].

Products containing creatine monohydrate

• Ask a healthcare professional before use if you have a kidney disorder [Source note 63].

• When using this product you may gain weight [Source note 64].

Products providing more than 200 mg of agmatine, per day

• Ask a healthcare professional before use if you have a mood/affective or psychiatric disorder, diabetes or a cardiovascular disease [Source note 65].

• Ask a healthcare professional before use if you are taking antidepressant or opioid analgesic medications [Source note 66].

Products providing more than 0.42 g of L-arginine and/or L-citrulline, per day

• Ask a healthcare professional before use if you have a cardiovascular disease and are attempting an increase in physical activity [Source note 67].

• Ask a healthcare professional before use if you are taking medication for cardiovascular diseases, erectile dysfunction, and/or blood thinners [Source note 68].

Products containing L-tryptophan

Ask a healthcare professional before use if you are taking antidepressants [Source note 69].

Products containing L-carnitine

Ask a healthcare professional before use if you have a seizure disorder [Source note 70].

Products containing deanol

• Ask a healthcare professional before use if you are taking cholinergic or anticholinergic drugs [Source note 71].

• Ask a healthcare professional if you have a psychological disorder [Source note 72].

Products containing eleuthero

Ask a healthcare professional before use if you have an acute infection [Source note 73].

Products containing Panax ginseng

• Ask a healthcare professional before use if you have diabetes [Source note 74].

• Ask a healthcare professional before use if you are taking antidepressant medication, blood thinners or digoxin [Source note 75].

Products containing piperine

Ask a health care practitioner /healthcare professional before use if you are taking medications or any other health products, as piperine may alter their effectiveness [Source note 76].

Products containing vitamins and/or minerals

As per the current source authority Multi-Vitamin/Mineral Supplements reference.

When should it be avoided?

Products providing more than 9 g of L-arginine, per day

Do not use if you have had a heart attack/myocardial infarction [Source note 77].

Products containing deanol

Do not use if you are pregnant or breastfeeding [Source note 78].

Products containing eleuthero

Do not use if you have high blood pressure [Source note 79].

Products containing whey proteins and providing 100 mg or more potassium, per day

Do not use if you are taking other potassium-containing salt-substitutes or supplements [Source note 80].

Products containing vitamins and/or minerals

As per the current source authority Multi-Vitamin/Mineral Supplements reference.

Possible side effects

Products containing beta-alanine

When using this product reduce the dose if flushing, tingling or prickling sensation of the skin occurs [Source note 81]

Products containing deanol

Stop use and ask a healthcare professional if you experience drowsiness, confusion, headache, changes in mood, nausea, or gastrointestinal disorders [Source note 82]

Products containing caffeine at any dose

Stop use and ask a healthcare professional if hypersensitivity/allergy occurs [Source note 83].

Products providing 40 mg to 400 mg caffeine, per day

When using this product diuretic effect may occur.

Products providing 200 mg or more caffeine, per day

Stop use and ask a healthcare professional if symptoms such as chest pain and irregular heartbeat occur [Source note 84].

Products providing more than 200 mg of agmatine, per day or more than 9 g of L-arginine, per day or more than 30 g of protein and/or amino acids, per day

When using this product you may experience gastrointestinal discomfort/disturbances [Source note 85].

Products containing Panax ginseng

Stop use and ask a healthcare professional if you experience insomnia, anxiety or headaches [Source note 86].

Products containing vitamins and/or minerals

As per the current source authority Multi-Vitamin/Mineral Supplements reference.

Other ingredients

Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.

Storage

Must be established in accordance with the requirements described in the applicable product regulations.

Preparation and quality requirements

• The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.

• The active ingredient must comply with the requirements outlined in the source ingredient database.

Hemp seed protein concentrate and Hemp seed protein isolate

this reference is for Cannabis sativa seed protein from hemp only. Hemp is defined in the Industrial Hemp regulations (IHR) as “a cannabis plant, or any part of that plant, in which the concentration of THC is 0.3% w/w or less in the flowering heads and leaves”. Approved hemp cultivars are set out in the List of Approved Cultivars, published by the Government of Canada on its website, as amended from time to time. Additional cultivars may be permitted such as those on the Association of Official Seed Certifying Agencies (AOSCA) list which also meet the definition of Hemp set out in the IHR.

Products containing hemp seed protein concentrate or hemp seed protein isolate must not contain more than 10 parts per million delta-9-Tetrahydrocannabinol (THC), or phytocannabinoids that have been isolated or concentrated, or synthetic duplicates of phytocannabinoids. The determination of the THC concentration must take into account the potential to convert delta-9-tetrahydrocannabinolic acid (THCA) to THC.

Creatine monohydrate

The finished product and/or raw material specifications must meet the process-related impurity acceptance criteria outlined in the USP Creatine reference (or any other internationally recognized pharmacopoeia). Note that the source authority will accept these process-related impurity acceptance criteria for either the finished product or the raw material; however, the procedures described in the USP Creatine reference are specific to the testing of creatine monohydrate as raw material. As per the source authority source’s product quality guidance, if alternate methods are used for testing to meet pharmacopoeial specifications, the relevant pharmacopoeia should be consulted for information on whether or not the alternate methods are considered suitable.

Soy protein concentrate/isolate

For an accurate measure of specific isoflavones in AIE, follow the methods outlined in AOAC 2008.03 [Source note 87].

Appendix I

Acceptable Workout Supplements claims at Class II and III for products recommended for occasional use only.

Appendix II

Acceptable Multi-Vitamin/Mineral Supplements claims at Class II and III for products recommended for occasional use only. Refer to the introductory notes in Appendix IX of the Multi-vitamin/mineral Supplements reference for more information.