Pure Encapsulations Frequently Asked Questions (FAQ)*
Welcome to the Pure Encapsulations FAQ. Here you’ll find clear, evidence-based answers to common questions about our manufacturing, quality standards, and ingredient sourcing. This resource is designed for healthcare professionals and informed consumers seeking transparency and regulatory-compliant information.
Manufacturing and Quality Standards
Do you manufacture your own supplements?
Yes. Pure Encapsulations products are researched, developed, and manufactured in our own state-of-the-art facility in Sudbury, Massachusetts, USA. This allows us to maintain strict control over every step of the process and ensure consistent product quality.
What quality control procedures do you follow?
We implement our Pure Quality Process, which includes eight rigorous quality controls. Each batch is tested for identity, potency, microbial contaminants, heavy metals (including mercury, arsenic, cadmium, and lead), solvent residues, and allergens. Herbal ingredients are tested for over 70 pesticide compounds, and our fish/krill oils are tested for dioxins, furans, and PCBs. Probiotics are verified with DNA testing. Our facility and products are inspected twice annually by NSF for compliance with FDA Good Manufacturing Practices (GMPs).
How are your products tested?
- Raw materials are tested for identity, potency, contaminants, and allergens.
- Finished products undergo additional testing for purity and potency.
- Fish oils are tested for oxidation and environmental contaminants.
- Herbal extracts are standardised and tested for active constituents.
- Probiotics are DNA-verified for strain accuracy.
Product Ingredients and Sourcing
Do your products contain artificial ingredients or common allergens?
Our supplements are non-GMO and formulated to be FREE FROM:
- Gluten
- Wheat, eggs, tree nuts, peanuts
- Artificial colours, flavours, and sweeteners
- Shellacs, unnecessary binders, fillers, and preservatives
- Magnesium stearate, titanium dioxide
- Trans fats and hydrogenated oils
Most products are also free from soy, dairy, and preservatives unless otherwise stated on the label. All ingredients, including trace amounts, are listed on the product label, and any potential allergens are clearly identified.
Where do you source your ingredients?
We select premium raw materials from trusted suppliers in the USA, France, Japan, Switzerland, Germany, and Italy. All ingredients are tested for purity and potency by independently certified laboratories. Suppliers must meet strict quality criteria to qualify.
Are your products gluten-free and non-GMO?
Yes. Pure Encapsulations is certified gluten-free by the Gluten-Free Certification Organisation (GFCO). All ingredients, including those derived from corn, are non-GMO, with supplier certification and PCR testing for certain nutrients.
Are your products organic?
While we aim to source certified organic ingredients, this is not always possible due to our strict microbial standards. All plant-derived ingredients are tested for a full panel of pesticides (approx. 70 compounds), as well as identity, potency, solvent residues, heavy metals, and microbial contamination.
Product Labelling and Transparency
Is everything in the capsule listed on the label?
Yes. Every ingredient, even in trace amounts, is listed on the label. We also specify the source of any potential allergens and list minerals by their true elemental weight, as well as standardisations of herbal extracts.
Are Pure Encapsulations products kosher?
No, our products are not certified kosher.
What is the source of your vegetable capsules?
Our capsules are made from softwood, including Southern Pine grown in North America, and are pesticide-free.
What does “standardised herbal extract” mean?
A standardised extract guarantees a precise concentration of the active constituent, ensuring consistency and maximum nutritional benefit in every capsule.
Allergen and Additive Information
Do your products contain corn?
Some nutrients (e.g., vitamin C, B12, B2) are derived from corn dextrose fermentation. The process removes allergenic proteins and sugars, but we do not routinely test for corn allergens, so those with severe corn allergies should exercise caution.
What is your allergen management policy?
We have strict standard operating procedures to prevent cross-contamination. Allergen-containing ingredients are flagged, segregated, and equipment is thoroughly cleaned. Random testing is performed monthly, and staff are trained twice annually.
Do you use synthetic ingredients?
Some ingredients are synthetically derived if they are identical to naturally occurring compounds, which can help reduce allergen risk. When identical synthesis is not possible, we use fermentation-derived ingredients.
Soy-Related Questions
Do Pure Encapsulations products contain soy?
Most products are soy-free. However, some ingredients are derived from soy (e.g., vitamin E, phytosterols, soy lecithin, phosphatidylserine, and certain fermentation media). These ingredients are highly purified and contain negligible soy protein or isoflavones, but are not recommended for individuals with soy allergies. Please refer to product labels for specific information.
Additives and Excipients
Why do you use additives like ascorbyl palmitate?
Ascorbyl palmitate is used to aid encapsulation and also provides vitamin C support. It is a fat-soluble form of ascorbic acid, easily hydrolysed in the body, and offers antioxidant activity without affecting water-soluble vitamins.
Regulatory and Compliance Information
Are your products compliant with European regulations?
Pure Encapsulations products are manufactured to meet or exceed international quality standards, including those set by Health Canada. All health claims are based on established scientific evidence and comply with Health Canada guidance for food supplements.