ch 10 dietary supplements

• Labels must contain a disclaimer that reads,

"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease."

Are dietary supplements regulated by the FDA?

NO or have to be proven safe or effective

• Unless the supplement contains a vitamin/mineral,

there are no DRI standards to indicate safe or effective doses

Herbal or Botanical Supplements

• An herb is a type of botanical, defined as "a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent." • Plant parts include leaves, roots, stems, bark, seeds, whole flowers, pollen, petals, pistils, stamen, and their extracts • Range from mild to very potent • Potential benefits • Systematic reviews have found evidence that: • Garlic may lower cholesterol • St. John's Wort may alleviate mild to moderate depression • Ginkgo biloba may improve Alzheimer's, vascular dementia and claudication • Potential risks • Should be considered a "buyer-beware" • Adverse effects • Headaches, rashes, GI distress to liver disease or death • Aloe consumption - toxic hepatitis • St. John's wort - lower effects of HIV drug and can interfere with drugs used for organ transplant patients, depression, seizures and certain cancers • Garlic and ginkgo can cause blood to thin • Surgical complications • Garlic, ginger, ginseng, and ginkgo biloba increase risk of bleeding - must be stopped 2-3 weeks before surgery or dental procedures • Drug interactions • Greatest risk posed by herbal medicines • No standardization of product names • No standardization of doses • No legal or regulatory definition exists for standardization in the U.S. as it applies to botanical supplements • Failure to provide information for proper use by consumers • Failure to track product use for unanticipated adverse effects

• Misconception ***

• Consumers do not need to rely on a healthy diet to provide nutrients if they take dietary supplements

The What, Who, and Why of Dietary Supplements***

• Defined by the Dietary Supplement Health and Education Act (DSHEA) of 1994 • A product containing a "dietary ingredient" that is taken by mouth and intended to supplement the diet • Vitamin • Mineral • Herb or other botanical • Amino acid • Dietary substance to supplement total dietary intake • NOT for use as a conventional food or as the sole item of a meal or diet • Unproven reasons for taking dietary supplements • Pep, energy, nutrition insurance against poor eating habits, cold prevention, stress reduction, protection from serious diseases, prolonging the aging process, losing weight, gaining strength, improved fitness and performance • Have not been proven to be safe or effective*** • Supplement misuse and abuse is common

• DSHEA also regulates the types of claims allowed on dietary supplement labels

• Supplements may NOT claim that their product will diagnose, cure, mitigate, treat or prevent a disease

Specialty Supplements

• Supplements that do not fall into the other categories • Glucosamine, melatonin, other hormones, amino acids, lecithin, fish oils • Also pose same risks of potential adverse effects, possible contamination, and contraindications for certain individuals • Omega-3 fatty acids may have beneficial effects on cardiovascular disease • Excess can increase bleeding risk

• Regulating health claims

• The Federal Trade Commission (FTC) is responsible for regulating health claims made in dietary supplement advertising*** • FTC has the power to: • Require companies to show evidence to support claims suspected of being false or misleading • Remove products from the market if their advertising is unsubstantiated

dietary supplements have not been proven to

be safe or effective

• Dietary Supplement Health and Education Act (DSHEA) is the law that

created a regulatory framework for oversight and labeling of dietary supplements***

• Health claims -

describe a relationship between a food, food component, or dietary supplement ingredient as well as reducing risk of a disease or health-related condition

• Nutrient content claims -

describe the relative amount of a nutrient or dietary substance in a product

• DSHEA requires every supplement to be

labeled properly

• (very large doses or 10x the DRI or more)*** • Misguided individuals

megadoses

• The supplement has undergone voluntary testing and meets standards for

purity, potency, and quality

• Structure/function claims -

statements describing how a product may affect the organs or systems of the body

• Dietary supplements do not need approval from the ___________before they are put on the shelves***

FDA • Nor do they have to first prove they are safe or effective***

responsible for regulating health claims made in dietary supplement advertising***

Federal Trade Commission (FTC)

How Supplements Are Regulated

• Dietary Supplement Health and Education Act (DSHEA) is the law that created a regulatory framework for oversight and labeling of dietary supplements*** • Dietary supplements do not need approval from the FDA before they are put on the shelves*** • Nor do they have to first prove they are safe or effective*** • FDA is reactive, not proactive • DSHEA also regulates the types of claims allowed on dietary supplement labels • Supplements may NOT claim that their product will diagnose, cure, mitigate, treat or prevent a disease • The label may contain one of three types of claims:*** • Health claim • Nutrient content claim • Structure/function claim • Health claims - describe a relationship between a food, food component, or dietary supplement ingredient as well as reducing risk of a disease or health-related condition • Nutrient content claims - describe the relative amount of a nutrient or dietary substance in a product • Structure/function claims - statements describing how a product may affect the organs or systems of the body • Labels must contain a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease." • DSHEA requires every supplement to be labeled properly • Unless the supplement contains a vitamin/mineral, there are no DRI standards to indicate safe or effective doses • Regulating health claims • The Federal Trade Commission (FTC) is responsible for regulating health claims made in dietary supplement advertising*** • FTC has the power to: • Require companies to show evidence to support claims suspected of being false or misleading • Remove products from the market if their advertising is unsubstantiated

dietary supplements are defined by who

• Dietary Supplement Health and Education Act (DSHEA) of 1994

• The label may contain one of three types of claims:***

• Health claim • Nutrient content claim • Structure/function claim

Probiotics

• Helpful bacteria (lactobacilli) found naturally in the human intestines and fermented products with "active cultures" • Thought to be beneficial for conditions such as diarrhea, irritable bowel syndrome, inflammatory bowel disease, lactose intolerance, and infections affecting normal flora

Sports Nutrition and Ergogenic Aids

• Include certain herbals as well as amino acids, whey protein, carnitine, creatine, chromium picolinate, glutamine, DHEA, and other products • Do not assume it is safe • Potential benefits • Supplemental creatine may be beneficial for anaerobic exercise involving high-intensity, repetitive activity • Potential risks • Many products sold as ergogenic aids do not increase performance and/or may have serious side effects • High-protein diets can cause abnormal strain on the kidneys • Anabolic steroids are associated with dangerous adverse effects and are banned by the Olympics

Sound vs Unsound Claims

• Many studies on dietary supplements are not well designed, executed, analyzed, and little is known about long-term efficacy and safety of products • For example, the Federal Trade Commission found many claims for weight-loss supplements were unsubstantiated - legal action has been taken • Patients may be at risk for harm if they rely on false medical information

Vitamin and Mineral Supplements

• Misconception *** • Consumers do not need to rely on a healthy diet to provide nutrients if they take dietary supplements • Supplements are used to treat clinically proven vitamin and mineral deficiencies • Potential benefits • Multivitamin with minerals • A supplement containing 100% of the Daily Value for most vitamins and several minerals • Recommended daily for: • Those who are over the age of 50 • Those on weight-loss diets and who consume less than 1200 kilocalories per day • Pregnant women should take a prenatal vitamin • Folate • Women of childbearing age should consume 400 μg/day to prevent birth defects • Vitamin B12 • Recommended for people over age 50 who do not produce enough stomach acid • Vegans • Vitamin D • Lack of sun and age-related changes can benefit from a supplement of 600 IU (800 IU over age 70) • Potential benefits • Calcium • People who are lactose intolerant, postmenopausal and older women may benefit • Not meeting the DRI of 1000 mg/day with food alone • Iron • Routinely recommended for pregnant women • Potential risks • Toxicity • Upper Limit of Safety (UL) established in DRI • Minerals have a narrower range of safety than do vitamins (A and D - narrow range) • Toxicity of iron, selenium, and chromium have been reported • Generally considered safe if the supplement is at the level of 100% of the DRI • As intake increases, so does risk • Megadoses (very large doses or 10x the DRI or more)*** • Misguided individuals • Contamination • Can contain high levels of heavy metals • Look for supplements with the USP (United States Pharmacopoeia) "Dietary Supplement Verified"logo or NSF (National Sanitation Foundation) on the label • The supplement has undergone voluntary testing and meets standards for purity, potency, and quality • Contraindications for certain populations • Iron supplementation may be dangerous for individuals (particularly men) with hemochromatosis (excess iron storage) • People with impaired kidney function are at increased risk for toxicity from magnesium supplements • Drug interactions • About 16% of people who take prescription drugs also take herbal or dietary supplements of some type • Multivitamins can interact with warfarin therapy • Beta-carotene and vitamin A were given together to prevent cancer - caused excess lung cancer incidence and mortality • Men who took 400 IU of vitamin E had more prostate cancers than those who took a placebo

• Potential benefits of vitamin and mineral supplements

• Multivitamin with minerals • A supplement containing 100% of the Daily Value for most vitamins and several minerals • Recommended daily for: • Those who are over the age of 50 • Those on weight-loss diets and who consume less than 1200 kilocalories per day • Pregnant women should take a prenatal vitamin • Folate • Women of childbearing age should consume 400 μg/day to prevent birth defects • Vitamin B12 • Recommended for people over age 50 who do not produce enough stomach acid • Vegans • Vitamin D • Lack of sun and age-related changes can benefit from a supplement of 600 IU (800 IU over age 70) • Calcium • People who are lactose intolerant, postmenopausal and older women may benefit • Not meeting the DRI of 1000 mg/day with food alone • Iron • Routinely recommended for pregnant women

Nutritionally Complete or Meal Replacement Liquid Supplements

• Originally developed for medically compromised hospital patients • Generally made from: • Water, milk, soy, sugar, oil, vitamins and minerals • New markets • Breakfast alternative for healthy people on the run • Supplement for healthy older individuals to improve vitality, energy, well-being and longevity • Meal replacement for fast pace lifestyles • Healthy alternative to high-fat snacks and fast food • Supplement that will improve performance in athletes • May be beneficial for: • Dentally impaired • Frail elderly • Very sick patient (cancer, HIV/AIDS, anorexia nervosa) • "Something is better than nothing" • Alternative to not eating at all • A way to improve nutrient intake in addition to meals • An alternative to sugary beverages and non-nutritious foods for meals or snacks

• Unproven reasons for taking dietary supplements

• Pep, energy, nutrition insurance against poor eating habits, cold prevention, stress reduction, protection from serious diseases, prolonging the aging process, losing weight, gaining strength, improved fitness and performance

• Potential risks of vitamins and mineral supplements

• Toxicity • Upper Limit of Safety (UL) established in DRI • Minerals have a narrower range of safety than do vitamins (A and D - narrow range) • Toxicity of iron, selenium, and chromium have been reported • Generally considered safe if the supplement is at the level of 100% of the DRI • As intake increases, so does risk • Megadoses (very large doses or 10x the DRI or more)*** • Misguided individuals • Contamination • Can contain high levels of heavy metals • Look for supplements with the USP (United States Pharmacopoeia) "Dietary Supplement Verified"logo or NSF (National Sanitation Foundation) on the label • The supplement has undergone voluntary testing and meets standards for purity, potency, and quality • Contraindications for certain populations • Iron supplementation may be dangerous for individuals (particularly men) with hemochromatosis (excess iron storage) • People with impaired kidney function are at increased risk for toxicity from magnesium supplements • Drug interactions • About 16% of people who take prescription drugs also take herbal or dietary supplements of some type • Multivitamins can interact with warfarin therapy • Beta-carotene and vitamin A were given together to prevent cancer - caused excess lung cancer incidence and mortality • Men who took 400 IU of vitamin E had more prostate cancers than those who took a placebo

• A product containing a "dietary ingredient" that is taken by mouth and intended to supplement the diet

• Vitamin • Mineral • Herb or other botanical • Amino acid • Dietary substance to supplement total dietary intake