APPROVED U.S. OMEGA-3 WITH VITAMIN D3 CAPSULES CLAIM January 2018

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Product Omega-3 with Vitamin D3 capsules

Country United States

Product Number 16601: Omega-3 with Vitamin D3 60 capsules

Effective January 2018 Supersedes January 2012

2 CAPSULES/DAY OMEGA-3 WITH VITAMIN D3 CAPSULES

Quality and Safety Naturally gluten-free Gluten-free Free from dairy and soy Contains naturally sourced ingredients Free from synthetic preservatives, artificial flavors and artificial colors No genetically modified DNA Reduced [fishy reflux/fishy burps] Our fish oil concentrate is processed by high vacuum molecular distillation Mannatech fish oils are purified to [reduce/minimize] contaminants common in natural fish oils Produced according to pharmaceutical standards Values for [oxidation/contaminants/pollutants] are well below those set by international regulatory standards, e.g. the European Pharmacopeia and the Global Organization for EPA and DHA (GOED) voluntary monograph Molecularly distilled Ultra-pure Purified

Overall Product Benefits Helps [maintain/support] brain health and function* Supports healthy muscle function* Helps [maintain/support] cardiovascular health* Helps [maintain/support] heart health* Provides support for healthy triglyceride levels already within [normal levels/the normal range]* Helps maintain healthy blood lipid levels already within normal [levels/ranges]* Helps retain healthy blood lipid levels* Helps maintain healthy blood platelet function* May help regulate the production of interleukin-6 (IL-6) and prostaglandin E2 in healthy individuals*

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May help regulate the production of fatty acid derivative prostaglandin E2 by restoring a more healthy balance in the ratio of omega-6 to omega-3 fatty acids* May help regulate the production of the cytokine IL-6 in healthy individuals* May support a more healthy balance of immune functions* Supports a healthy inflammatory response* The vitamin D and omega-3 fatty acids EPA and DHA support a healthy inflammatory response* Omega-3 and vitamin D intake can help keep your immune system in balance* Omega-3 and vitamin D intake can help maintain a healthy immune system* Contains vitamin D and omega-3 fatty acids for immune support*

Omega-3 Benefits Source of omega-3 fatty acids, EPA and DHA, for the maintenance of good health* Supplies 1,110 mg EPA and DHA per day when taken as recommended Supplies 660 mg/day EPA when taken as recommended Supplies 450 mg/day DHA per day when taken as recommended Concentrated fish oil Highly concentrated EPA and DHA fatty acids Omega-3 intake helps support brain [health/function]* The omega-3 fatty acids EPA and DHA support a healthy inflammatory response* Studies indicate that EPA and DHA provide the brain health and development benefits provided by omega-3 fatty acid intake* Studies indicate that EPA and DHA provide the cardiovascular health benefits provided by omega-3 fatty acid intake* Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of Mannatech’s Omega-3 with Vitamin D3 provides 1110 mg EPA and DHA fatty acids. See nutrition information for total fat, saturated fat and cholesterol content.* Omega-3 intake in pregnant and lactating women may support normal development and functioning of the brain of the fetus and nursing infant*

Vitamin D3 Benefits

Contains 830 IU vitamin D to support bone health* Vitamin D is important to bone health because it enhances calcium absorption* Vitamin D helps the body absorb calcium for strong bones and teeth* Vitamin D is essential for calcium absorption* Vitamin D contributes to the maintenance of healthy bones* Vitamin D regulates the blood concentrations of calcium and phosphorus The hormonal actions of vitamin D govern calcium balance within the body Vitamin D improves calcium absorption* A preferred source of supplemental vitamin D Vitamin D3 is a natural form of vitamin D that is produced by the body A [highly/commonly] recommended form of supplemental vitamin D Vitamin D3 is the form of supplemental vitamin D most often recommended Vitamin D3 is believed to be the most beneficial form of supplemental vitamin D Vitamin D and its metabolites act as powerful immunoregulators* Vitamin D is an important contributor to musculoskeletal health*

APPROVED U.S. OMEGA-3 WITH VITAMIN D3 CAPSULES CLAIM January 2018

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Vitamin D intake may help prevent falls and maintain physical performance in the elderly* Research suggests that vitamin D may play a role in maintaining nervous system health and function* Research shows that in addition to supporting bone health, adequate vitamin D intake may be important for maintaining immune health, nervous system health and overall quality of life* Vitamin D3 helps improve mood/maintain positive mood [during the winter months]*

Omega-3 Background Most American diets provide more than ten times as much omega-6 than omega-3 fatty acids, even though there is general scientific agreement that individuals should consume more omega-3 and less omega-6 fatty acids to promote good health Supplemental omega-3s can help reduce an imbalance in the ratio of omega-6 to omega-3 fatty acids often caused by the common Western diet Omega-3s are called essential fatty acids because the body cannot synthesize omega-3s Omega-3 fatty acids are nutrients essential to health and must be obtained through the diet* Humans are dependent upon dietary intake of omega-3s to get an adequate amount, a necessity for good health in people of all ages* EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) are two omega-3 fatty acids that [are important to/contribute to] health* In evaluating the beneficial effects of omega-3 fatty acids, researchers have focused on EPA and DHA Alpha-linolenic acid (ALA), which is present in vegetable oils such as flaxseed and canola oils, is poorly converted to EPA and DHA in the body. Thus direct dietary intake of these compounds is important Omega-3 fatty acids include ALA, EPA and DHA. ALA is present in vegetable oils such as flaxseed and canola oils, whereas EPA and DHA are found in algae and fish oils. ALA is chemically the parent compound but the body does not efficiently convert it to EPA and DHA. Thus direct dietary intake of EPA and DHA is important Intake of omega-3 fatty acids has been identified as one of twelve modifiable behaviors (along with quitting smoking, lowering salt intake, etc.) that can contribute to increased longevity. A study showed that individuals with intake levels of 250 mg per day of EPA and DHA tended to live longer.* There is continuing scientific debate as to whether or not dietary omega-3 fatty acids contribute to weight loss. However, higher blood levels of omega-3 fatty acids are associated with a healthier body weight* International experts suggest that individuals should aim to achieve an average daily intake of at least 650 mg of EPA and DHA combined, with at least 220 mg of each. The U.S. Institute of Medicine has not established an adequate intake level for omega-3 fatty acids but other countries, including Canada, Sweden, the UK, Australia and Japan, recommend intake of 300 to 500 mg per day of EPA and DHA. International experts suggest that pregnant and lactating women should aim to achieve an average daily intake of at least 200 mg DHA. This amount is thought to be sufficient to help support optimal visual and cognitive development in the fetus and nursing infant.* Mannatech's Omega-3 with Vitamin D3 supplies 450 mg DHA per day when taken as recommended.

Vitamin D3 Background

APPROVED U.S. OMEGA-3 WITH VITAMIN D3 CAPSULES CLAIM January 2018

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Research suggests that high vitamin D [intake/blood levels] can support breast and colorectal health*

An estimated 70 percent of the U.S. population has diets deficient in vitamin D The typical American diet provides only about 30 percent of the recommended daily intake of

vitamin D A deficiency in vitamin D will reduce the amount of dietary calcium that is absorbed by 10-15

percent Vitamin D deficiencies have reached epidemic status throughout the world The following populations are at risk for vitamin D deficiency:

o children and adults with dark skin pigmentation o those with a lack of exposure to sunlight o those who consistently wear a sunscreen with a protection factor of 30 or higher o older adults living in institutions without exposure to sunlight o pregnant and lactating women whose bodies must meet the demands of growing fetuses

or infants o pregnant and lactating women o those over the age of 70, as vitamin D absorption may decline with age o those over the age of 70 o obese children and adults (BMI > 30 kg/m2), as vitamin D is sequestered in body fat o obese children and adults o people taking the following medications: anti-convulsants, glucocorticoids, antifungals

(e.g. ketoconazole) and drugs for AIDS/HIV o vegans, vegetarians and those who do not consume enough animal food products, such

as milk, eggs, fish or meat, may be at risk for a deficiency in vitamin D o older adults with a history of falls

The major source of vitamin D is exposure to natural sunlight Insufficient sunlight is a well-known risk factor for vitamin D deficiency Human skin requires several minutes of regular and direct exposure to sunlight (UVB rays) in

order to produce vitamin D3. Dark skin, sunblock use, and insufficient sun exposure (due to limited outdoor activity, seasonal/temporal/atmospheric factors, and geographic latitude) have all been associated with lower circulating hydroxyvitamin D levels

Very few foods naturally contain or are fortified with vitamin D Vitamin D deficiency in the elderly increases the risk of bone fracture The National Academy of Science’s Institute of Medicine (IOM), which sets the Daily Reference

Intakes for the U.S., has set the Recommended Dietary Allowance (RDA) for vitamin D at 600 IU per day for all life stages with the exception of people over 70 years old for which the RDA is 800 IU per day. The IOM Committee found that vitamin D blood levels of 20 ng/ml 25 (OH)D are sufficient for bone health. Vitamin D deficiency was defined as serum levels below this amount.

An international group of vitamin D experts in The Endocrine Society challenged the IOM findings, suggesting that vitamin D insufficiency be defined as 25 (OH)D levels of 21-29 ng/ml and sufficiency as levels of 30-100 ng/ml (75-250 nmol/L).

The Endocrine Society suggested the Upper Limit (UL) be 10,000 IU for adults and 4,000 IU for children ages 1-18, rather than the 4,000 IU to 2,500 IU UL’s set for these age groups by the IOM.

The Endocrine Society Task Force finds that, although 400 to 600 IU/day vitamin D may be sufficient for children aged 0-1 year and 1 to 18 years, an amount of 1,000 IU/day may be required to raise blood levels of 25(OH)D above 30 ng/ml.

APPROVED U.S. OMEGA-3 WITH VITAMIN D3 CAPSULES CLAIM January 2018

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The Endocrine Society Task Force finds that, although adults 19-50 years require at least 600 IU/day, 1,500-2,000 IU vitamin D/day may be required to raise blood levels of 25(OH)D above 30 ng/ml

Omega-3 and Vitamin D3 Background

Omega-3 fatty acids and vitamin D are both required nutrients. There is significant evidence that much of the world’s population is deficient in both There are a limited number of foods that are naturally rich in vitamin D and/or omega-3 fatty acids. Fish is one such source, but given concerns that certain types of fish can be contaminated with ocean pollutants, especially mercury, it is advised to limit consumption of fish known to be lower in mercury, such as salmon, to only 2 servings (12 oz.) per week.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

APPROVED U.S. OMEGA-3 WITH VITAMIN D3 CAPSULES CLAIM January 2018