Course:FNH200/Projects/2025/Creatine: A Food Science Perspective

Introduction

Creatine skeletal formula

Creatine ball-and-stick model

Creatine is an organic compound that is naturally occurring in the body. Creatine is found in the human brain and is made in trace amounts by the pancreas, liver, and kidneys. Creatine, stored as phosphocreatine in our muscles, helps with production of cellular energy or adenosine triphosphate (ATP), which is supplied to muscle cells during physical activity. Consequently, increasing creatine intake positively impacts ATP production rate, helping fuel cells during intense activity.

Creatine can be obtained from dietary sources such as meat and seafood and also as creatine monohydrate in supplements. Starting in the 1990s, creatine gained traction after top athletes believed creatine supplementation had benefitted their performance in the Barcelona Olympic Games. Creatine supplements are permitted for use by the International Olympic Committee (IOC) and remains one of the popular nutritional supplements among athletes.

Creatine, in the form of creatine monohydrate in nutritional supplements, is known for its ability to improve strength, increase lean muscle mass, and boost muscle recovery. It is widely used by athletes and physically active individuals.

This article explores the processing, production, packaging practices of creatine supplements along with relevant regulatory frameworks, and patterns of usage and consumption.

Processing & Production

Creatine is a naturally occurring compound that plays a vital role in cellular energy metabolism, particularly in muscle tissue. It is also widely consumed as a dietary supplement to support athletic performance and recovery. The synthesis of creatine can be understood from two complementary perspectives: how it is made biologically in the human body, and how it is manufactured synthetically for use in commercial supplements.

In the human body, creatine is synthesized from three amino acids: glycine, arginine, and methionine. The process involves two main enzymatic reactions. First, the enzyme arginine:glycine amidinotransferase (AGAT) catalyzes the transfer of an amidino group from arginine to glycine, producing guanidinoacetate (GAA) and ornithine. This reaction primarily occurs in the kidneys and pancreas. The guanidinoacetate is then transported to the liver, where the enzyme guanidinoacetate methyltransferase (GAMT) adds a methyl group donated by S-adenosylmethionine (SAM) to form creatine. Once synthesized, creatine is released into the bloodstream and transported to tissues with high energy demands, such as skeletal muscle, the brain, and the heart. Approximately 95% of the body’s creatine is stored in muscle, where it helps regenerate ATP, the energy currency of cells.

Although the body is capable of producing enough creatine to meet basic physiological needs, athletes and active individuals often supplement with synthetic creatine to enhance performance. Commercially available creatine supplements especially creatine monohydrate are not extracted from food sources but are instead produced through chemical synthesis. This industrial process is designed to be cost-effective, scalable, and capable of producing creatine with extremely high purity.

The most common industrial method for creatine production involves reacting sarcosine (a derivative of glycine) with cyanamide in a glass-lined steel reactor. Both ingredients are chosen for their purity and reactivity. The reaction occurs in the presence of water, under controlled heat, pressure, and alkaline pH conditions. When combined, sarcosine and cyanamide undergo a condensation reaction that produces creatine monohydrate the crystalline form that contains one molecule of water per molecule of creatine. The precise control of pH (usually 9–11) and temperature (up to 150°C) helps maximize yield and minimize the formation of undesirable by-products such as dicyandiamide, urea, or creatinine.

Once the synthesis is complete, creatine crystals begin to form. These are filtered and washed multiple times to remove residual reactants and impurities. Clean, wet crystals are then dried using vacuum drying techniques that preserve the molecular structure while reducing the moisture content to about 12%, the standard for creatine monohydrate. The drying process is carefully managed to prevent thermal degradation. After drying, the crystals are milled and sieved into a fine powder often around 200 mesh to improve mixability and solubility in liquids. Powdered creatine may be sold as-is or combined with flavorings or other functional ingredients in ready-to-use supplement blends.

The final product undergoes extensive quality control testing to ensure it meets safety and purity standards. Manufacturers use analytical tools like high-performance liquid chromatography (HPLC) to measure creatine content and detect impurities such as creatinine or dicyandiamide. Additional tests include microbial screening for pathogens like E. coli and Salmonella, and heavy metal assays to detect contaminants such as lead, arsenic, and mercury. Only batches that pass all tests are approved for distribution. Manufacturers who follow Good Manufacturing Practices (GMP) and hold third-party certifications such as NSF or ISO demonstrate a higher level of product safety and transparency.

One example of premium creatine production is Creapure®, a German brand manufactured by AlzChem. Creapure is known for its exceptionally high purity and strict adherence to GMP standards. Its creatine monohydrate is used in many branded supplements worldwide and is recognized by athletes and health professionals as one of the most trustworthy sources of creatine. The company’s multi-step process includes not only chemical synthesis but also thorough purification, drying, milling, testing, and traceable packaging all conducted in a highly regulated environment.

Packaging Practices & Regulatory Framework

Creatine Package

Creatine Label

Medicinal Label

Packaging and Distribution

• In Canada, Creatine is considered a Natural Health Product (NHP) and is regulated under the Natural Health Products Regulations (NHPR) by Health Canada's Natural Health Products Directorate (NHPD). All NHPs must be labelled and packaged in accordance with the Food and Drugs Act, the Regulations, and any other applicable laws, regulations, and guidance.

• Every packager who sells NHPs must maintain the following records at the site at which the product is packaged:
  • Records of any testing conducted by or for the packager in respect of the material used to package the natural health product.
  • Records demonstrating that each lot or batch of the NHP was packaged in accordance with these requirements.
  • Records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale.
  • A list of all natural health products that are being packaged at the site.
  • A copy of the sanitation program in use at the site.

• All NHP labels (including both inner and outer labels) must include specified information:
  • Information required on the principal display panel of the inner and outer labels: brand name, product number, dosage form, "sterile" (only if applicable; not typically applicable to creatine products), net amount (total number of dosage units or content) in the container in terms of weight, measure or number.
  • Information required on the outer label: a products fact table, license holder or importer name, recommended administration, lot number, expiry date.
  • Information required on the inner label: product licence holder or importer name, contact information for the product license holder or importer, medicinal ingredients, quantity of each ingredient per dosage unit, and potency of each ingredient, at least one use or purpose, recommended administration, dose, duration of use (if any), "Contains" statement, risks information, other information (such as recommended storage), lot number, expiry date.
• Every distributor must maintain the following records at the site at which the NHPs are stored:
  • Records of information sufficient to enable the recall of every batch of the NHP made available for sale.
  • A list of all NHPs that are being stored at the site.
  • A copy of the sanitation program in use at the site.
    

Regulatory Framework

As stated before, creatine is regulated as a Natural Health Product (NHP) under the Natural Health Products Regulations (NHPR) by Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD). Products containing creatine, such as creatine monohydrate supplements, must receive pre-market authorization and be issued a Natural Product Number (NPN) before being legally sold. The regulation includes mandatory licensing of both products and manufacturing sites, and products must comply with strict quality, labeling, and safety standards.

To help standardize submissions, Health Canada provides a Creatine Monohydrate Product Monograph, which outlines acceptable doses (shown below), uses, risk information, and other specifications.

Table 1. Dose(s) for creatine monohydrate (with loading phase)

	Loading Phase			Maintenance Phase
	Min/day	Max/day	Max/single dose	Min/day	Max/day
Option 1	15 g	20 g	5 g	2 g	5 g
Option 2	3 g	5 g	N/A

Table 2. Dose(s) for creatine monohydrate (no loading phase)

Option	Min/day	Max/day
Option 3	3 g	5 g

Table 3. Direction(s) for use and duration(s) of use

Option(s)1	Direction(s) for use and duration(s) of use
Option 1 - loading phase of 15-20 g/day	Start with a loading phase of X g2 per day for 5-7 days and follow with a maintenance phase (Y g2/day)
Option 2 - loading phase of 3-5 g/day	Start with a loading phase of X g2 per day for a minimum of 4 weeks and follow with a maintenance phase (Y g2/day)
Option 3 - no loading phase	Use for a minimum of 4 weeks.

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).

Risk Information

• When using this product you may gain weight.
• Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant, breastfeeding, or if you have a kidney disorder.

Importantly, creatine is not permitted as an ingredient in food products since it is not on Health Canada’s List of Supplemental Ingredients. This restricts creatine solely to NHPs and prevents it from being added to general food items like protein bars or beverages in Canada, unlike in the United States, where creatine can be included in conventional foods marketed for fitness and performance. An important note is that liquid creatine formulations are also not permitted due to stability issues.

Comparison to Other Countries

• In the United State, creatine is regulated as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA). There is no pre-market approval process for supplements unless they contain a new dietary ingredient, "not present in the food supply as an article used for food in a form in which the food has not been chemically altered." The Food and Drug Administration (FDA) relies mainly on post-market surveillance, which raises concerns over product quality, mislabeling, and safety.
• In Australia, creatine is treated as a complementary medicine under the Therapeutic Goods Administration (TGA) and must be included in the Australian Register of Therapeutic Goods. Products undergo risk-based categorization, and low-risk products like creatine are generally subject to less stringent pre-market approval than in Canada, although post-market surveillance is effective.

Overall, while creatine is legal in all three countries, Canada has stricter rules before it goes on the market. United States and Australia focus more on checking safety after it is sold.

Usage & Consumption

• In Canada, creatine is most commonly consumed by adolescents and young adult males, with significantly lower use among females and older adults. A recent national study of Canadians aged 16–30 found that over 50% of boys and young men reported using creatine monohydrate, compared to only 10% of adolescent girls, and 5–10% among transgender and gender-expansive (TGE) youth.
• This gendered pattern of creatine use in Canada aligns with international trends, particularly in the United States and Australia, where young males are also the predominant users . However, Canadian data emphasizes the normalization of muscle-building supplement use among youth more explicitly. For instance, nearly 60% of male adolescents in Canada reported using supplements like creatine to achieve muscular ideals, often influenced by appearance-related pressures and social media messaging .
• In contrast, countries in Europe show slightly more cautious trends, often due to stricter regulation and more prominent public health messaging around supplement safety and necessity. Across all regions, older adults and women remain underrepresented in creatine use despite growing research on its benefits for muscle preservation, cognition, and bone health . A key concern, both in Canada and internationally, is that healthcare professionals such as physicians and dietitians are not the primary source of creatine information; instead, most users report learning about creatine from friends, online sources, or gym environments, contributing to variable patterns in dosing, quality, and intended use .

In summary, creatine use in Canada reflects global patterns in terms of gender and age gaps, but Canadian studies reveal deeper social and cultural pressures among youth that may drive unusually high rates of use among young males.

Exam Question

1. Which Canadian agency is responsible for the regulations of products such as creatine supplements?

	Canadian Food Inspection Agency
	World Health Organization
	Health Canada
	Food and Agriculture Organization
	Codex Alimentarius Commission

Correct answer: Health Canada. Health Canada regulates creatine as a Natural Health Product (NHP) and ensures safety, labeling, and licensing through the Natural Health Products Regulations.

Reason to include: This question helps students learn who sets the rules for supplement safety in Canada, which is important for understanding how products like creatine are checked before being sold.

2. Which organ does NOT synthesize creatine in the human body?

	Pancreas
	Liver
	Heart
	Kidney

Correct answer: Heart. The heart uses creatine for energy but does not synthesize it. Creatine is made in the liver, pancreas, and kidneys.

Reason to include: This question checks if students understand which organs help make creatine and highlights the different roles organs play in the body, which is important for learning how the body makes and uses energy.

3. Which form of creatine is commonly used in supplements?

	Creatine sulfate
	Creatine phosphate
	Creatine monohydrate
	Creatinine

Correct answer: Creatine monohydrate. Creatine monohydrate is the most researched, stable, and effective form used in supplements, making it the industry standard.

Reason to include: This question tests applied knowledge of supplement formulation and industry standards, ensuring students can identify the most evidence based and widely accepted form of creatine used in nutrition and performance settings.

4. Which group shows the highest prevalence of creatine monohydrate use in Canada?

	Older adults
	Adolescent girls
	Boys and young men
	Transgender and gender-expansive youth

Correct answer: Boys and young men. Studies show that over 50% of boys and young men aged 16–30 use creatine, far more than other groups, due to appearance pressures and performance goals.

Reason to include: This question teaches students about real world patterns of supplement use, helping them understand how age, gender, and social factors influence health behaviours.

5. Which of the following cheese-making production processes are also used in producing creatine supplements ?

	pasteurization
	fermentation
	curd coagulation
	cutting
	cooking
	matting
	milling
	salting
	pressing
	curing and ripening
	packaging

Correct answer: Milling and Packaging are processes shared between cheese-making and creatine supplement production.

Reason to include: This question helps students review material read on the creatine production process and connect it with a familar process - cheese-making.