WHEY PRODUCTS

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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

April 22, 2022

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s)	Common name(s)	Source information
Proper name(s)	Common name(s)	Source material(s)	Part(s)
Whey protein isolate¹	Whey protein isolate	Bos taurus Capra hircus	Milk
Whey protein concentrate	Whey protein concentrate
Reduced lactose whey Whey, reduced lactose	Reduced lactose whey Whey, reduced lactose
Reduced minerals whey Whey, reduced minerals	Reduced minerals whey Whey, reduced minerals
Whey	Whey
Whey protein hydrolysate	Whey protein hydrolysate

References: Proper names: FCC 8, INCI 2012; Common names: FCC 8, INCI 2012; Source information: ITIS 2011.

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

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Source of (all) essential amino acids (i.e. histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine) for the maintenance of good health (CNF 2010; Potier and Tomé 2008).
Source of branched chain amino acids for the maintenance of good health (CNF 2010; Potier and Tomé 2008).
Source of (essential) amino acids involved in muscle protein synthesis (CNF 2010; IOM 2005).
(Excellent) Source of protein for the maintenance of good health (CFIA 2012).
(Excellent) Source of protein which helps build and repair body tissues (CFIA 2012).
(Excellent) Source of protein which helps build antibodies (CFIA 2012).

The following combined use(s) or purpose(s) is/are also acceptable:

Source of (all) essential amino acids (i.e. histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine) and branched chain amino acids for the maintenance of good health (CNF 2010; Potier and Tomé 2008).
(Excellent) Source of protein which helps build and/or repair body tissues and build antibodies (CFIA 2012).

The following claims are acceptable in addition to the source of protein/amino acids claims above. They should not be the only claims made for a Whey product.

Additional Claims (optional)

Source of the mineral(s) XXX (e.g. calcium, magnesium, phosphorus and/or zinc) for the maintenance of good health (CNF 2010).
Source of potassium for the maintenance of good health (IOM 2005).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

The potency of protein on an "as is" weight basis is required to be indicated on the Product License Application form and label.

Source of protein

2.6-90 grams of protein per day (CFIA 2012)

Excellent source of protein

16-90 grams of protein per day (CFIA 2012)

Source of amino acids/branched chain amino acids

3-90 grams of protein per day (CFIA 2012)

Source of mineral/potassium

Not to exceed 90 grams of protein per day (CFIA 2012)

and

Table 2. Dose requirements for minerals and potassium levels in whey
Minerals	Minimum dose (mg/day)	Maximum Dose (mg/day)
Calcium	65	1,500
Magnesium	20	500
Phosphorus	62	2,000
Potassium	100	779
Zinc	0.7	50

Notes

The use "Source of the mineral xxx or source of potassium" is only acceptable if indicated mineral or potassium is present at dosages at or above the minimum daily dose and not more than the maximum total daily dose as seen in Table 2 above.
In order to have a use for a particular mineral, the ingredient must list the respective mineral as potency on the Product Licence Application form and label.
Dose ranges for minerals are based on the NNHPD Multivitamin and Mineral Supplements Monograph.
Dose ranges for potassium are based on IOM 2005.

Direction(s) for use

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

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

All products

This product contains milk by-products (CFIA 2011; Wal 2002).
Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Products providing more than 30 g protein 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; Bell 2000).

Contraindication(s)

No statement required

Known adverse reaction(s)

Products providing more than 30 g protein per day

Some people may experience gastrointestinal discomfort/disturbance(s) (Micke et al. 2002).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Whey proteins, especially powders meant to be mixed with a liquid, often require lecithin to act as a dispersing/emulsifying agent. If present, lecithin must be added as a non-medicinal ingredient.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

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

Bell SJ. Whey Proteins Concentrates With and Without Immunoglobulins: A Review. Journal of Medicinal Food. 2000 Spring;3(1):1-13.
CFIA 2012: Canadian Food Inspection Agency. Guide to Food Labelling and Advertising [Internet]. Ottawa (ON): Canadian Food Inspection Agency and Health Canada. [Modified 2012 January 12; Accessed 2012 May 9]. Available from: http://www.inspection.gc.ca/food/labelling/guide-to-food-labelling-and- advertising/eng/1300118951990/1300118996556
CNF 2010: Canadian Nutrient File (CNF), 2010 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012 April 26; Accessed 2012 May 9]. Available from: http://www.hc-sc.gc.ca/fn-an/nutrition/fiche-nutri-data/cnf_downloads-telechargement_fcen- eng.php
Cribb PJ, Williams AD, Stathis CG, Carey MF, Hayes A. Effects of whey isolate, creatine, and resistance training on muscle hypertrophy Medicine & Science in Sports & Exercise 2007;39(2):298-307.
FCC 8: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
IOM 2005: Institute of Medicine of the National Academies. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein , and Amino Acids. Food and Nutrition Board, [Accessed 2012 May 15]
ITIS 2011: Integrated Taxonomic Information System. Canadian Biodiversity Information Facility [Internet]. Ottawa (ON): Government of Canada. [Accessed 2012 May 9]. Available from: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif
Jung H, Peregrina AA, Rodriguez JM, Moreno-Esparza R. The influence of coffee with milk and tea with milk on the bioavailability of tetracycline. Biopharmaceutics & Drug Disposition 1997;18(5):459-63.
Martindale 2009: Sweetman SC (ed), Martindale: The Complete Drug Reference. [Internet] London (GB): Pharmaceutical Press; Copyright 1933-2010. [Last modified 2009 September 05; Accessed 2013 March 12]. Available from: http://www.medicinescomplete.com
Micke P, Beeh KM, Buhl R. Effects of long-term supplementation with whey proteins on plasma glutathione levels of HIV-infected patients. European Journal of Nutrition 2002;41(1):12-8.
Potier M, Tomé D. Comparison of digestibility and quality of intact proteins with their respective hydrolysates. Journal of AOAC International 2008;91(4):1002-5.
Shils ME, Olson JA, Shike M, Ross AC, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2006.
Wal JM. Cow's milk proteins/ allergens. Annals of Allergy Asthma & Immunology 2002;89(6 Suppl 1):3-10.

References Reviewed

Bégin F, Santizo MC, Peerson JM, Torún B, Brown KH. Effects of bovine serum concentrate, with or without supplemental micronutrients, on the growth, morbidity, and micronutrient status of young children in a low-income, peri-urban Guatemalan community. European Journal of Clinical Nutrition 2008;62(1):39-50.
Casswall TH, Sarker SA, Faruque SM, Weintraub A, Albert MJ, Fuchs GJ, Alam NH, Dahlström AK, Link H, Brüssow H, Hammarström L. Treatment of enterotoxigenic and enteropathogenic Escherichia coli-induced diarrhoea in children with bovine immunoglobulin milk concentrate from hyperimmunized cows: a double-blind, placebo-controlled, clinical trial. Scandinavian Journal of Gastroenterology 2000;35(7):711-8.
Cribb PJ, Williams AD, Stathis CG, Carey MF, Hayes A. Effects of whey isolate, creatine, and resistance training on muscle hypertrophy Medicine and Science in Sports and Exercise 2007;39(2):298-307.
CTFA 2008: Gottschalck TE, Bailey JE, editors. International Cosmetic Ingredient Dictionary and Handbook. 12th edition. Washington (DC): The Cosmetic, Toiletry and Fragrance Association; 2008.
Eisenstein J, Roberts SB, Dallal G, Saltzman E. High-protein weight-loss diets: are they safe and do they work? A review of the experimental and epidemiologic data. Nutrition Reviews 2002;60(7 Pt 1):189-200.
Fonteh FA, Grandison AS, Lewis MJ. Variations of lactoperoxidase activity and thiocyanate content in cows' and goats' milk throughout lactation. Journal of Dairy Research 2002;69(3):401- 9.
IOM 2005: Institute of Medicine. Panel on Macronutrients, Panel on the Definition of Dietary Fiber, Subcommittee on Upper Reference Levels of Nutrients, Subcommittee on Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington (DC): National Academies Press; 2005.
Krissansen GW. Emerging health properties of whey proteins and their clinical implications. Journal of the American College of Nutrition 2007;26(6):713S-23S. Review.
Lands LC, Iskandar M, Beaudoin N, Meehan B, Dauletbaev N, Berthiuame Y. Dietary supplementation with pressurized whey in patients with cystic fibrosis. Journal of Medicinal Food 2010;13(1):77-82.
Lothian JB, Grey V, Lands LC. Effect of whey protein to modulate immune response in children with atopic asthma. International Journal of Food Sciences and Nutrition 2006;57(3-4):204-11.
Marshall K. Therapeutic Applications of Whey Protein. Alternative Medicine Review 2004;9(2):136-56. (Review).
Moreno YF, Sgarbieri VC, da Silva MN, Toro AA, Vilela MM. Features of whey protein concentrate supplementation in children with rapidly progressive HIV infection. Journal of Tropical Pediatrics 2006 Feb;52(1):34-8.
Pal S, Ellis V, Dhaliwal S. Effects of whey protein isolate on body composition, lipids, insulin and glucose in overweight and obese individuals. British Journal of Nutrition 2010; 9:1-8.
Poortmans JR, Dellalieux O. Do regular high protein diets have potential health risks on kidney function in athletes?International Journal of Sport Nutrition and Exercise Metabolism 2000;10(1):28-38.
Scherze I, Muschiolik G. Effects of various whey protein hydrolysates on the emulsifying and surface properties of hydrolysed lecithin. Colloids and Surfaces B: Biointerfaces 2001;21(1- 3):107-117.
Séverin S, Wenshui X. Milk biologically active components as nutraceuticals: review. Critical Review in Food Science and Nutrition 2005;45(7-8):645-56.
Tarnopolsky MA, MacDougall JD, Atkinson SA. Influence of protein intake and training status on nitrogen balance and lean body mass. Journal of Applied Physiology 1988;64(1):187-93.
US FDA 2000: United States Food and Drug Administration, Agency Response Letter GRAS Notice No. GRN 000037, CFSAN/Office of Premarket Approval. April 21, 2000. [Accessed 2013 March 12] Available from: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASL istings/ucm154133.htm
Williams M. Dietary Supplements and Sports Performance: Amino Acids. Journal of the International Society of Sports Nutrition 2005; 2(2):63-67.
Wright BJ, Zevchak SE, Wright JM, Drake MA. The impact of agglomeration and storage on flavor and flavor stability of whey protein concentrate 80% and whey protein isolate. Journal of Food Science 2009;74(1):S17-29.