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Home , Dietary supplement

Dietary Supplements: How Safe and Effective are They?

Sara Zook, RDN, CD Columbus Community The Herbal Supplement Revolution

. Grown from a $2.6 billion to a $20 billion industry since 1997 . Reached over 71% of U.S. Households nationwide

“The World Organization(WHO) estimates that over 80% of the world’s population uses some form of .”

. Over the last decade more people have turned to herbal medicine and ‘natural’ treatment options than to traditional forms of medical treatment. What is ?

. Most homeopathic physicians treat patients based on history, body shape, physical, emotional, and mental symptoms.

. According to the 2007 National Health Interview Survey: . 3.9 million adults and 900,000 children used homeopathy in the . According to the 2012 National Health Interview Survey: . 5 million adults and 1 million children used homeopathy Governmental Regulation Federal Administration (FDA): 1994 - Dietary Supplement Health and Act (DSHEA) 2007 – Good practices (cGMP) require a dietary supplement to consistently meet the established specifications for identity, purity, strength, and composition.

FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.

The USP mark is a sign of quality. USP stands for the U.S. Pharmacopeial Convention, which is an independent organization that bridges the gap between government regulation of dietary supplements and the consumer’s need for safe .

Good Manufacturing Practices (GMP) by NSF International (3rd party organization that tests and audits adult nutritional supplements for quality standards).

Governmental Regulation

. The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market. . If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. . However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness. . If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. . FDA can remove dietary supplements from the market if they are found to be unsafe or if the claims on the products are false and misleading. Governmental Regulation

. Dietary supplements are ONLY allowed to make “structural or function” claims on their labeling. . Only broad statements like ‘ helps support healthy joints’ or ‘ helps establish normal sleep patterns’ may be made since the validity of these statements have NOT been proven in a new drug application/clinical trials for the FDA. . Unlike , supplements are not intended to treat, diagnose, prevent, or cure diseases. . Acceptable Claims: . “Helps maintain function, Promotes healthy , Supports regularity, Supports the , Improves absentmindedness, Reduces stress” . Unacceptable Claims: . “Protects against heart disease, lowers cholesterol, reduces pain of arthritis, laxative, prevents urinary tract infections, helps patients with reduced immune function”

. The FDA does need to at least be notified of the claim within 30 days of use and under DHSEA these claims are required to contain merit scientifically. What is a Dietary Supplement?

. The term “Dietary Supplement” wasn’t officially defined in the United States until 1994 when the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress.

. DHSEA definition of a dietary supplement: “a vitamin, a , an herb or other botanical, an , a dietary substance for use by man to supplement the by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient.”

 Dietary supplements are defined as and not drugs.  Dietary supplements include such ingredients as vitamins, , herbs, amino acids, and enzymes.  Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. Micronutrients – Vitamins & Minerals

. Vitamins are -containing molecules and are classified as either water-soluble or -soluble. . They can be changed and inactivated by heat, , light and chemical processes. . The amount of vitamins in a food depends on the growing conditions, processing, storage and cooking methods. . Minerals do not contain carbon, and are not destroyed by heat or light. . Unlike other , minerals are in their simplest chemical form. . Minerals are elements. . Whether found in bone, seashells, cast pots or the soil, they are they same as the minerals in our food and our bodies. . The mineral content of plant varies with the soil content and the maturation of the plant. Vitamins

Water-Soluble Vitamins . If you look to vitamins for an “energy boost”, you are looking in the wrong place - even if a supplement bottle says, “promotes energy,” vitamins are not energy boosters. . Many do, however, participate in energy-yielding chemical reactions in the body. . This is confusing because calorie is another word for energy. . It’s clearer to say that B vitamins help the body get calories from food. . While you’re unlikely to get more pep by taking vitamins, vitamin-rich foods will help you maintain health.

Fat-Soluble Vitamins . Fat-soluble vitamins accumulate in the and fat tissues. . These reserves may be released when dietary intakes are low. . There is research, however, suggesting that blood levels of may be low even in the presence of significant storage in the fat. . Because they can be stored so readily, the fat-soluble vitamins may be toxic in large doses.

Minerals

. Dietary Minerals are “the chemical elements required by living , other than the four elements carbon, , , and oxygen present in common organic molecules.” . Major minerals . Required in amounts of at least 100 milligrams per day . They are , , chloride, , , and

. Trace Minerals . Required in amounts less than 100 milligrams per day . They are , , fluoride, , iron, , , and

Multivitamin& Mineral Supplements

. Even healthy diets can contain gaps. . can help fill in those gaps and provide your body with some valuable nutritional . . Gender and age-specific formulas make the right choice for your specific needs even easier. Common Omega 3’s Dietary Supplements Calcium Vitamin D Cinnamon Glucosamine and Chondroitin Ground Flaxseed

Omega 3’s

. Healthy oils - which yield EPA and DHA - essential (unsaturated) fatty acids . and . Natural anti-inflammatory agents . Aids in treating arthritis, gastrointestinal imbalances and other inflammatory body conditions . May be beneficial for high cholesterol, triglycerides and blood clotting . Moisten the skin and improve bowel function . Increase levels (the 'happy' brain chemical) . Reduce symptoms of depression, anxiety and panic attacks

Recommend 2000-3000mg/day with , which yields a 3:2 ratio of EPA:DHA (Best to split dose in half and take once in the morning and once at night) Omega 3’s Coenzyme Q10 (CoQ10)

. High levels of the coenzyme Q10 are naturally found in the heart muscle but levels decline with age. . “Statin” drugs (cholesterol-lowering drugs) also deplete CoQ10 levels in the body.

. Beneficial in the treatment of heart arrhythmias, high cholesterol and angina. . In one study, patients with angina were given 150mg of CoQ10 daily for four weeks. This treatment reduced the average frequency of angina attacks by 53%. . CoQ10 is one of the most potent - which helps to quench free radicals in our bodies that promote aging. . CoQ10 helps other antioxidants, such as vitamins C and E, to function optimally. . Recommend 60 to 100 mg every day for anyone over 40 years of age and for those who are taking statin . Turmeric

. Turmeric (AKA ) naturally reduces inflammation, pain and swelling. . Part of the ginger family. . Ongoing studies for its role in prevention or treatment of Alzheimer’s, cancer, arthritis. . Interesting to note is that rates of are extremely low in cultures that consume a lot of curry, which is a rich source of curcumin. . Recommendations range from 500mg to 2000mg daily. . Be sure to take it with food to avoid heartburn or related discomfort.

Calcium

. 99% of your body’s supply of calcium is found in your bones, making an optimal amount of calcium critical for bone health now and as you age. . Milk, yogurt, green leafy vegetables and cheese are great sources of calcium. . Consuming three servings a day can help you meet the recommended daily allowance (1000 mg to 1200 mg). . For calcium, the % listed on the food label can be translated into “milligrams”. Therefore, 30% would be 300 mg. Calcium

. When it’s challenging to include the proper quantity of these foods daily in your diet, a can help fill in the gaps. . Several different kinds of calcium compounds are used in calcium supplements. . Each compound contains varying amounts of the mineral calcium — referred to as elemental calcium. . Common calcium supplements may be labeled as: . (40% elemental calcium) . Calcium citrate (21% elemental calcium) . Calcium gluconate (9% elemental calcium) . (13% elemental calcium)

Calcium

. Elemental calcium is key because it's the actual amount of calcium in the supplement. . It's what your body absorbs for bone growth and other health benefits. . The Supplement Facts label is helpful: . As an example, calcium carbonate is 40% elemental calcium, so 1,250 milligrams (mg) of calcium carbonate contains 500 mg of elemental calcium. . Be sure to note the serving size (number of tablets) when determining how much calcium is in one serving. . The percentage of calcium absorbed depends on the total amount of elemental calcium consumed at one time; as the amount increases, the percentage absorption decreases. . Absorption is highest in doses <500 mg. . For example, one who takes 1,000 mg/day of calcium from supplements might split the dose and take 500 mg at two separate times during the day. Calcium

. Calcium supplements can interact with many different prescription medications: . including blood pressure medications, synthetic thyroid hormones, bisphosphonates, antibiotics and calcium channel blockers

. Dietary calcium is generally safe, but more isn't necessarily better, and excessive calcium doesn't provide extra bone protection. . Research does exist that suggests long-term calcium supplementation in addition to a high-calcium diet, can increase risk of heart disease in women. Vitamin D

• Vitamin D benefits bone health and the immune system • Limited number of food sources rich in vitamin D (fatty fish and fish liver oils) • Relatively small amount of year-round sun exposure to obtain quality Vitamin D • A simple blood test can help you determine what your vitamin D level is and whether a supplement would be beneficial. • Possibly ask your doctor to check your vitamin D level at your next visit. • Recommendations for supplementation range from 800IU-3000IU per day. Cinnamon

. May enhance insulin signaling pathways . May help liver and other organs (muscle) effectively metabolize blood sugar . Option to help regulate blood glucose and blood pressure levels along with conventional medications to treat type 2 Diabetes Mellitus . Sources: . Ground cinnamon or cinnamon sticks . Cinnamon can be added to orange juice, oatmeal, coffee before brewing, salads, meats etc. . The active components are not destroyed by heat. . Supplements: usually found in 1000mg capsules . Recommend minimum 500 mg daily Glucosamine and Chondroitin

. Building blocks of connective tissues, the most vital components of the joints . Both are naturally occurring in the body . Potentially provide relief from knee and joint pain . When considering glucosamine, read product labels carefully to make sure you choose the correct form. . While glucosamine sulfate has been studied for treatment of arthritis, there's no clinical evidence to support the use of N-acetyl glucosamine in treating arthritis. . Because glucosamine products might be derived from the shells of shellfish, there is concern that the supplement could cause an allergic reaction in people with shellfish .

. Recommended dose: . 1,500 mg of glucosamine and 1,200 mg chondroitin sulphate

Echinacea

. Herbal extract from a coneflower . Traditionally used to boost immune function against colds and other infections . Treat urinary tract infections, yeast (candida) infections, ear infections, athlete's foot, sinusitis, hay fever (also called allergic rhinitis), as well as slow-healing wounds . Relieve pain, reduce inflammation, and have hormonal, antiviral, and antioxidant effects . Recommend 300 mg daily (freeze-dried capsules) . Echinacea purpurea herb juice: a daily dose of 6-9 mL for up to a maximum of 8 weeks . Echinacea is likely to lose its effectiveness if taken daily. . Begin taking it at the onset of cold or flu symptoms, and continue for no more than two weeks. Ground Flaxseed

. Whole flaxseed may pass through your intestine undigested, which means you won't get all the health benefits . Whole seeds can be ground in a coffee grinder and then stored in an airtight container for several months. . Refrigerating whole seeds may also extend their freshness . High in fiber, omega-3 fatty acids and , called lignans. . Both flaxseed and flaxseed oil have been used to help reduce total blood cholesterol and LDL ("bad") cholesterol levels. . Recommend 1.1 - 1.6 grams a day for adults. . One tablespoon of ground flaxseed provides 1.6 grams of omega-3 fatty acids Probiotics

. Live, active ingested to alter the GI flora for health benefits . Friendly that live in our digestive tract . Poor eating habits and the use of certain medications, corticosteroids and antibiotics can disturb our healthy bacterial balance. . Can affect our digestive system and immune function . “Probiotics” can inhibit the spread and growth of harmful bacteria that cause infections that to many disorders. . Be sure to purchase live “probiotics” which need to be kept in the refrigerator. . Recommend to consume preferably on an empty stomach. Types of Probiotics

Hundred of species, with even more strains. . Each produce benefits when used alone, or in conjunction with others.

Lactobacillus . Acidophilus . Helveticus with longum . Delbrueckii subsp. Bulgaricus with streptococcus thermophilus . Plantarum . Reuteri . Rhamnosus GG (Culturelle®) . Casei Bifidobacterium . Bifidum . Infantis Saccharomyces boulardii Probiotics in Food

. Benefits of probiotics first noticed centuries ago, when people started eating fermented foods. . Foods include: . Vegetables . Sauerkraut (live culture, no vinegar) . Miso (fermented paste of or rice with salt/fungus) . Cheese . Kefir (fermented milk) . Yogurt (live & active cultures) . Tempeh (fermented soybeans) . Pickles . Kimchi (fermented vegetables) . Green olives . Sourdough Supplement VS Food

. While certain strains may work together to provide health benefits, there is not enough evidence to justify probiotics at high doses. . Colony Forming Units (CFU’s) – try 3-5 million CFU for a start.

Food before supplements: Supplements before food: • Benefits of fermented foods go • Fastest way to change the beyond the strains of bacteria microbiome is through diet, but • Bioavailability of vitamins and probiotic supplements can minerals is elevated by VS provide bacterial diversity fermentation process • Some fermented foods can • Probiotic effects can vary exacerbate certain GI symptoms person to person, based on the and probiotics in small doses current microbiomes you have, may be better tolerated (IBS, thus finding the supplement IBD, atopic eczema) that matches your biome can be challenging Probiotics Herbal & Dietary Supplements AND Pharmaceutical Interactions

• Please ask your Pharmacist or Primary Care Provider for more information on potential interactions with other supplements or medications, when using dietary supplements or alternative herbal supplements. https://ods.od.nih.gov/factsheets/list-all/ https://ods.od.nih.gov/factsheets/list-VitaminsMinerals/ THE END

DIETARY SUPPLEMENTS QUIZ

Name: ______

1. “The term “Dietary Supplement” wasn’t officially defined in the United States until 1994 when the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress. a. True b. False

2. What are “acceptable claims” that manufacturers can make on dietary supplement packaging and labels? (circle 2 correct answers) a. Promotes healthy cholesterol b. Supports regularity c. Reduces pain d. Lowers cholesterol

3. Choose the benefits of omega-3’s: a. Aids in treating arthritis, gastrointestinal imbalances and other inflammatory body conditions b. May be beneficial for high cholesterol, triglycerides and blood clotting c. Moisten the skin and improve bowel function d. Increase serotonin levels, reduce symptoms of depression, anxiety and panic attacks e. All of the above

4. The distinctive “USP Verified Mark” is awarded by USP to dietary supplement products that successfully undergo and meet the stringent requirements of its voluntary USP Dietary Supplements Verification Process. a. True b. False

5. The FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed. a. True b. False