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Zero Compromises. Pure Results. Quality Defined

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Page 1: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

Zero Compromises. Pure Results.

Quality Defined

Page 2: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

22

WHY PURE ENCAPSULATIONS®

Only licensed health professionals may order directly from Pure Encapsulations. The most important link between our professional-strength supplements and consumers is the presence and guidance of a qualified health professional.

Quality defined is the unique intersection of creative collaboration, scientific rigor, and unwavering standards to produce the safe and effective free-from products you depend on in your practice.

Page 3: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

3

In a recent survey, healthcare practitioners defined supplement “quality” by the following criteria:1

CLINICAL TRIALS

EFFICACY

TRUST IN MANUFACTURING

HYPOALLERGENIC PRODUCTS

EFFICACY

CLI

NIC

AL T

RIA

LS

HYPOALLERGENIC P

ROD

UC

TS

TRUST IN M

ANUFACTURING

QUALITYDEFINED

For nearly three decades, we have delivered high-quality hypoallergenic products with an unwavering dedication to Zero Compromises. Pure Results.

This is why Pure Encapsulations is the leading brand in the healthcare practitioner market, ranking highest in ingredient purity, quality testing, and trust.2

1.) Nutrition Business Journal® 2016.2.) Kaiser Survey 2014.

Page 4: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

4 Secure online ordering and information at www.PureEncapsulations.com

Our commitment includes multi-million dollar investments to support key research initiatives with:

Cleveland Clinic Foundation

4-year, $1 million dollar partnership, focused on clinical research, education, medical curriculum development, and policy change

Institute of Nutraceuticals and Functional Foods

5-year, multi-million dollar research program in cardiometabolic health

Practice Research Initiative

The most comprehensive study of Functional Medicine providers and practice operations to date

Polyphenols Consortium

Award-winning, collaborative effort with academic and commercial partners to research polyphenols in cognitive health

CLINICAL TRIALS

Scientific research is a top priority for Pure Encapsulations. Only those compounds whose potency and clinical value have been validated through science or research go to market.

Investment in Science

“This company’s dedication to science goes way beyond its own individual needs... it benefits the entire industry.”

-Nutritional Business Journal®, March 2016

2016 Award WinnerScience and Innovation

In the past few years, more than 30 product-specific clinical studies have been published in leading peer-reviewed journals, which attests to the caliber of our academic research with top institutions, including:

Page 5: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

*These statements have not been evaluated by the Food & Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

Developed with Nathan Morris, M.D.,† & James Greenblatt, M.D.†

†Our Medical Advisors have been retained as consultants in advising Pure Encapsulations.

Available for download at www.PureGenomics.com

The PureGenomics® Mental Health & Memory Protocol*

GeneSNP Alleles

What it means Recommendations Pure Encapsulations®

Products*

DRD2

(Dopamine

Receptor 2)

C957T

(rs6277)

TT = -/-

TC = -/+

CC = +/+

Decreased response to

dopamine; may in turn impact

memory, particularly in older

individuals.

• l-Tyrosine

• l-Tyrosine

• DopaPlus

TPH2

(Tryptophan

Hydroxylase)

G703T

(rs4570625)

GG = -/-

GT = -/+

TT = +/+

This enzyme converts

tryptophan to 5-HTP. 5-HTP is

a precursor of serotonin, which

plays critical roles in mood and

stress management.

• 5-HTP

• 5-HTP 50 mg

• SeroPlus

BDNF

(Brain Derived

Neurotrophic Factor)

Val66Met

G196A

(rs6265)

Val/Val = -/-

Val/Met = -/+

Met/Met = +/+

Associated with deficits in BDNF

production. BDNF is important

for maintaining mood and

cognitive function.

• Lithium

• Curcumin

• Magnesium

• Zinc

• Exercise

• Lithium (orotate) 5 mg or

Lithium liquid

• CurcumaSorb Mind

• Magnesium (glycinate)

• Trace Minerals

COMT

(Catechol

O-Methyltransferase)

Val158Met

(rs4680)

Val/Val = -/-

Val/Met = -/+

Met/Met = +/+

Val: Lower dopamine levels due

to faster degradation.

Met: Higher dopamine levels due

to slower degradation.

If Val/Val or Val/Met:

• l-Tyrosine

• Rhodiola Rosea

If Met/Met:

• SAMe

If Val/Val or Val/Met:

• l-Tyrosine

• DopaPlus

• Rhodiola Rosea

If Met/Met:

• SAMe

MTHFR

(Methylene

Tetrahydrofolate

Reductase)

C677T

(rs1801133)

CC = -/-

CT = -/+

TT = +/+

Reduced conversion of folic

acid to 5-MTHF; associated with

mood concerns.

• Folate (as 5-MTHF)• Folate 1,000

• Folate 5,000

MTHFR

(Methylene

Tetrahydrofolate

Reductase)

A1298C

(rs1801131)

AA = -/-

AC = -/+

CC = +/+

Reduced conversion of folic

acid to 5-MTHF; associated with

mood concerns.

• Folate (as 5-MTHF)• Folate 1,000

• Folate 5,000

SNPHow to prioritize nutritional support* Nutritional Monitoring Considerations*

DRD2 (C957T)• Address if memory is an important objective, particularly in older

individuals.*

• Zinc (serum) or alkaline phosphatase (marker of zinc status)

TPH2 (G703T)

• Address if mood and emotional wellness are important objectives

based on clinical evaluation.*

• Zinc (serum) or alkaline phosphatase (marker of zinc status)

• Magnesium status (RBC)

• Trace mineral hair analysis

BDNF (Val66Met)• High priority. Address this SNP first to provide foundational support

for emotional and neurocognitive health.*

• Zinc (serum) or alkaline phosphatase (marker of zinc status)

• Magnesium status (RBC)

• Trace mineral hair analysis

COMT

(Val158Met)

• Val/Val (-/-) or Val/Met (-/+): Prioritize only if patient requires support

for mood, cognition and mental sharpness.*

• Met/Met (+/+): Prioritize for mood, relaxation and stress management.*

• Magnesium status (RBC)

MTHFR (C677T)• High priority. Address this SNP first to provide foundational support

for emotional and neurocognitive health.*

• Serum homocysteine is useful as an indicator of overall

methylation competence. It is also a nonspecific method

for folate, B12 and B6 monitoring.

MTHFR (A1298C)• High priority. Address this SNP first to provide foundational support

for mood.*

• RBC folate or formiminoglutamate (FIGLU), a functional

marker of folate status.

490 Boston Post Road, Sudbury, MA 01776 USA

PE

P-P

GM

H-0

417

This information is intended for use by healthcare practitioners, is for informational purposes only, and does not establish a doctor-patient

relationship. Please be sure to consult your physician before taking this or any other product. Consult your physician for any health problems.

©2017 Pure Encapsulations, Inc., All Rights Reserved

Please note that patients may not require all supplements listed. The selection can be fine-tuned by assessing nutrient levels (refer to suggested monitoring below) or by other testing you would normally include in

the patient evaluation.*

5

Our strength lies in our collaborations, unified in purpose, toward a more vibrant future of nutritional wellness. We partner with leaders in the most important nutritional health areas: genomics, mental health and emotional well-being, weight management, immunology, and more. A few of our distinguished medical partners include:

Caroline J. Cederquist, M.D.,† a board-certified bariatric physician

who specializes in nutrition and metabolism

Felice L. Gersh, M.D.,† an award-winning integrative gynecologist focused on women’s health

Izabella Wentz, Pharm.D., FASCP,† a nationally acclaimed thyroid specialist

and licensed pharmacist

James Greenblatt, M.D.,† a dually-certified child and adult psychiatrist and a pioneer in integrative psychiatry

Nathan Morris, M.D.,† a certified functional medicine practitioner and a leader in the field of nutritional genomics

EFFICACY

Our team of scientific and medical experts work diligently to formulate effective products using optimal ingredient levels in premium forms.

Nothing demonstrates efficacy more than results in clinical practice. Our Medical Advisors put our products to the test and have developed a series of protocols based on their experience with the effectiveness of our products.†

When sourcing raw ingredients, we selectively partner with suppliers from around the world whose quality standards match the rigor of our own.

All raw materials and finished products are independently tested for purity and potency by our third-party laboratories:

Collaboration at Every Step

†Our Medical Advisors have been retained as consultants in advising Pure Encapsulations.

Download our protocols at:PureEncapsulations.com

Page 6: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

6 Secure online ordering and information at www.PureEncapsulations.com

Details Make the Difference

All manufacturing takes place in temperature, humidity, and dust-controlled rooms

Our comprehensive allergen SOPs prevent ingredient cross-contamination

Production employees receive extensive, ongoing training on the safe handling of raw materials and finished products

Each piece of equipment is completely dismantled, sterilized, and inspected before every production run

Machine operators inspect the capsules every 15 to 20 minutes, and quality assurance specialists inspect them every 60 to 90 minutes

Stability procedures are employed for retained potency throughout shelf life

TRUST IN MANUFACTURING

Exacting production standards and an insistence on transparency require an unrivaled confidence in quality assurance and hypoallergenic products.

Highest-Quality Ingredients

Raw materials are tested for identity, potency, microbial contaminants, heavy metals (including mercury, arsenic, cadmium and lead), 32 solvent residues, and allergens

Herbal ingredients are tested for 70 different pesticide compounds

Essential fatty acids and fish/krill oils are tested for dioxins, furans, PCBs, and other agents

Suppliers undergo rigorous qualification procedures and audits

Unwavering Standards

Pure Encapsulations is NSF-GMP registered in the U.S., GMP certified in Canada and exceeds the standards of the United States Pharmacopeia (USP) for supplement manufacturing.

1.) Nutrition Business Journal® 2016.

Page 7: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

7

GMO Policy

All ingredients, including those derived from corn, are GMO-free. We obtain statements from each of our suppliers certifying that the ingredients do not contain GMOs. For some nutrients, we conduct PCR testing to confirm the absence of genetically modified material.

Certified Gluten-Free

We have received gluten-free certification from The Gluten-Free Certification Organization (GFCO). The GFCO logo is an internationally recognized, trusted symbol signifying that a product meets the highest standards in quality for gluten-free certification.

Our hypoallergenic supplements are meticulously manufactured and tested to ensure they are FREE FROM:

Wheat and gluten

Egg

Peanuts

Trans fats and hydrogenated oils

GMOs

Magnesium stearate

Coatings and shellacs

Artificial colors, flavors and sweeteners

Unnecessary binders, fillers and preservatives

HYPOALLERGENIC PRODUCTSTransparency From Start to Finish

Our Door is Always OpenVisit our manufacturing facility in Sudbury, Massachusetts anytime, without notice

Page 8: Quality Defined · The most important link between our professional-strength ... †Our Medical Advisors have been retained as consultants in advising Pure Encapsulations. Download

The information contained herein is for informational purposes only and does not establish a doctor-patient relationship. Please be sure to consult your physician before taking this or any other product. Consult your physician for any health problems. QAB17

©2018 Pure Encapsulations, Inc., All Rights Reserved

1.) Nutrition Business Journal® 2016.

2.) Kaiser Survey 2014.