dietary supplements are not subject to the premarket safety evaluations required of other new food ingredients.

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1 Dietary Supplements: regulation and research Diane F. Birt Distinguished Professor Food Science and Human Nutrition, Iowa State University Objectives: Students will: Understand supplement definitions Be able to describe how and why regulations have evolved Understand key elements of the Dietary Supplement Health and Education Act Recognize qualified heath claims Understand the status of the science behind botanical supplements What are Dietary Supplements? product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb or other botanical; OR a concentrate, metabolite, constituent, extract, or combination of any ingredient described above; legal definition excludes claims for treatment, mitigation, cure or prevention of disease Evolution of Regulations 1938 Food Drug and Cosmetic Act all claims must be truthful and non-misleading 1994 Dietary Supplement Health and Education Act of [DSHEA] 1999 Requirements for Dietary Supplement Labels 2002 and still pending final approval- Qualified claims Dietary Supplement Health and Education Act of 1994 [DSHEA] dietary supplements are not subject to the premarket safety evaluations required of other new food ingredients. dietary supplements may carry "structure/function" claims. Companies cannot claim they prevent, treat or mitigate disease Companies are marketing functional foods as dietary supplements under a legal loophole. DSHEA Statements of nutritional support may be made without the approval of a health claim regulation if: the statement is truthful and not misleading; the labeling li prominently displays, 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 ; FDA is notified no later than 30 days after the first marketing. 1

2 Statements of Nutritional Support for Dietary Supplements (DSHEA) claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States ; describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans ; characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function ; and describes general well-being from consumption of a nutrient or dietary ingredient. Cranberries and Health Can Say: Maintains urinary tract health Cannot Say: Prevents recurrence of urinary tract infection Scientific support for cranberries and health Cranberries contain proanthocyanidins that can prevent the adhesion of certain bacteria, including E. coli,, associated with urinary tract infections to the urinary tact wall. Permissible Structure/Function Claims Helps to maintain cholesterol levels that are already within the normal range Helps support cartilage and joint function Maintains healthy lung function Improves absentmindedness Relieves stress and frustration Impermissible Disease Claims Lowers cholesterol Inhibits platelet aggregation Prevents bone fragility in post-menopausal women Maintains normal bone density in post- menopausal women Maintains healthy lungs in smokers Prevents irregular heartbeat Relieves alcohol intoxication Use as part of your diet when taking insulin to help maintain a healthy blood sugar level Promotes general well-being during the cold and flu season Anatomy of the Requirements for Dietary Supplement Labels Effective March 1999 Statement Of Identity Net quantity of contents Directions for use Supplement facts panel Other ingredients in descending order of content Name, place of business of manufacturer or distributor Structure-function claim: When you need to perform your best, take ginseng. This statement has not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. 2

3 Dec 2002 FDA announced they will allow qualified health claims Standardized Qualifying Language for Qualified Health Claims. Ranking* Appropriate Qualifying Language High significant scientific agreement Selenium and cancer: Selenium may reduce the risk of certain cancers FDA has determined that this evidence is limited and not conclusive Moderate Low Extremely low evidence is not conclusive." evidence is limited and not conclusive." little scientific evidence supporting this claim." *From Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data Changing emphasis of Medicine Dietary Supplements since DSHEA I have an earache 10,000 years ago Here, eat this root 4,000 years ago That root is poison; here, say this chant. 3,000 years ago That chant is heathen; here, say this prayer. 155 years ago That prayer is superstition; here, drink this potion. 40 years ago That potion is snake oil; here, swallow this pill. 20 years ago That pill is ineffective; here, take this antibiotic. Present time That antibiotic is artificial; here, eat this root. Before you Purchase We may think, "Even if a product may not help me, it at least won't hurt me." It's best not to assume that this will always be true. The term 'natural' does not always mean safe. Spend your money wisely. Remember: Safety first. Types of Botanical Products Fresh Plant Products Dried Non-Extracted Botanicals Dried Extracted Botanical Powders (capsules/tablets) Liquid Botanical Extracts Infusion water-based; brewed from dried or fresh herb Decoction water-based; brewed from seeds, bark, roots Tincture liquid extract, often alcohol-based Fluid extract water- or alcohol-based; herbs pressed with heavy hydraulic press; extract is concentrated 3

4 Dietary Supplement Research Centers Awards to Institutions Pennington Biomedical Research Center, LSU Memorial Sloan-Kettering Cancer Center Wake Forest University Iowa State University University of Illinois at Chicago Purdue University Awarding Organizations: ODS,NCCAM, ORWH Optimizing Echinacea and Hypericum, and Prunella vulgaris for potential human health benefit Diane F. Birt Distinguished Professor Department of Food Science and Human Nutrition Iowa Center for Research on Botanical Dietary Supplements Iowa State University Echinacea (purple coneflower or Kansas snakeroot) facts Perennial herbs native to eastern half of North America. Nine species; three are commonly used for medicinal purposes. Widely used by Native Americans. Both oral and topical preparations are used. Proposed Health Uses of Echinacea (Antibacterial, Antiviral, Immunostimulant) Hobbs, Herbal Gram, 1994 Colds, flu infections Inflammation Burns HerpesH Skin ulcers Rheumatoid Arthritis Anti allergy Toothache, earache Blood/food poisoning Boils, abscesses Immune dysfunction Anti-inflammatory inflammatory activity of Echinacea Highest anti-inflammatory inflammatory activity in selected species: E. simulata, E. pallida, E. angustifolia Highest in fractions rich in alkamides Purified alkamides (lipids found in Echinacea species) have potent anti-inflammatory inflammatory activity and specific alkamides (Bauer 10a, 11 and 23 for E angustifolia) appear to contribute to the inhibition of inflammatory responses. LaLone and Birt, accepted for publication St. John's wort (Hypericum perforatum) facts Flowering perennial. Grows wild in Europe and as an escaped weed in North America. More than 400 species in nature. Folk medicine with a long history of use to treat a wide range of ailments. 4

5 Proposed Health Uses of St. John s Wort (Antidepressant, Anti-inflammatory, Antiviral, MOA Inhibitor) Insomnia Bed wetting Headache Rheumatism Depression Anxiety Burns Nervousness Menstrual Cramps Spasms Ulcers Respiratory Problems Bronchitis HIV Stress Anti-inflammatory inflammatory activity of H. perforatum Highest in fractions rich in flavonoids Purified flavonoids were effective only at much higher concentrations (~30-100X) than were found in anti-inflammatory inflammatory extracts. Combinations of purified quercetin, amentoflavone, chlorogenic acid, and pseudohypericin (required) accounted for the anti-inflammatory inflammatory activity of one fraction. Hammer et.al., Phytochemistry, 2008 Prunella vulgaris Immune modulation Anti-inflammatoryinflammatory Anti-viral Anti-oxidant Prunella vulgaris (Self-heal) use inflammatory bowel disease Fever Headache Diarrhea liver disease mouth and throat ailments Antiviral activity of Prunella vulgaris Potent anti-viral activity against HIV and EIAV in aqueous extracts. Activity is found in fractions rich in phenolics or in polysaccharides. Evidence for synergism among constituents. P. vulgaris extracts prevent entry of viral particles into permissive cells. Iowa Botanical Center Unique ability to control and study genetic diversity among species and genera o Currently studying Echinacea, Hypericum and Prunella Strong collaborations to identify constituents contributing to bioactivity Actively identifying complex interactions among constituents From Brinkley and Maury 2009 University of Iowa 5

6 Review: Echinacea and colds What can the manufacturer say:? Supports immune system And/or Prevents colds Echinacea and colds Can Say: Supports immune system Cannot Say: Prevents colds Bottom Line The data in support of health claims made under DSHEA are not based on a substantial body of data. Thank You / Questions? There is not significant scientific agreement But studies are underway to increase the science on botanical supplements 6