2:00pm - 3:00pm: Breakout 3 - Case Discussions Technician ...€¦ · For her residency project, Dr. ... -Joint FAO/WHO Working Group Report (2002) Probiotic Uses and Sources

ACPE UAN 107-000-11-017-L01-T 0.1 CEU/1.0 HrActivity Type: Knowledge-Based

Program Objectives for Technicians: Upon completion of this program, participants should be able to:

1. Defi ne functional foods.2. List examples of functional foods.3. Describe how functional foods are regulated.4. Determine if a product claim is a “structure-function” claim or a “health” claim.5. Recognize the potential risks and benefi ts of using functional foods.

Speaker: Marie Marcelino, PharmD, MBA, is a 2009 graduate of Drake University and is currently completing a PGY2 Specialized Ambulatory Care Pharmacy Residency at the University of Iowa Hospitals and Clinics (UIHC). Her interests include anticoagulation, disease state management, health coaching, teaching, and working with underserved patient populations. For her residency project, Dr. Marcelino will be evaluating pharmacy services in a newly established medical home for underinsured patients. After the completion of her residency she plans to pursue a clinical faculty position at a college of pharmacy.

Speaker Disclosures: Marie Marcelino reports she has no actual or potential confl icts of interest in relation to this program. The speaker has indicated that off-label use of medications will not be discussed during this presentation.

2:00pm - 3:00pm:

Breakout 3 - Case Discussions

Technician Option:

Functional Foods

FUNCTIONAL FOODS

Marie A. Marcelino, Pharm.D., MBAPGY2 Ambulatory Care Pharmacy Resident

University of Iowa Hospitals and ClinicsJanuary 22, 2011

Faculty Disclosure

Dr. Marcelino reports she has no actual or potential conflicts of interest associated with this presentation.

Dr. Marcelino has indicated that off-label use of medication will not be discussed during this presentation.

Learning Objectives

Upon completion of this program pharmacy technicians will be able to:

1. Define functional foods2. List examples of functional foods3. Describe how functional foods are regulated4. Determine if a product claim is a ‘structure-

function’ claim or a ‘health’ claim5. Recognize the potential risks and benefits of

using functional foods

Presentation Overview

Functional foods definition and classification

Regulation of functional foods Food claims Approach to using functional foods Case examples Summary

Pre-Assessment Questions1. All foods are functional foods.

a. True b. False

2. Functional foods are regulated as a specific class of foods by the FDA. a. Trueb. False

3. All food labeling claims must be approved by the FDA prior to marketing.a. Trueb. False

4. Foods can make claims to prevent certain diseases.a. Trueb. False

“Let food be thy medicine and medicine be thy food”

-Hippocrates, 460 B.C.

Food for Thought Billion-dollar sales of functional are expected to

continue to grow exponentially Health-conscious consumers are driving the

growth of this food industry trend 63% were confident that they have a “great amount” of

control over their own health 75% believe food and nutrition play the greatest role in

maintaining or improving health 71% reported receiving health and nutrition information

from the media Heart health, weight, and cancer were the top 3 health

concerns cited

Audience Activity:The Benefits of Food

Fill in the blanks with an example of a food benefit that you have heard of.

Eating ___(food)___ is good for or helps _____(‘health’ claim)____ .

Example: Eating chocolate helps decrease my risk of heart disease.

All foods are ‘functional foods.’

A. TrueB. False

Functional Foods Defined

There is NO universally accepted definition for functional foods

All foods are functional, but not all foods are ‘functional foods’

Broadly defined as foods that provide “health benefits beyond those of basic nutrition”

Term first introduced in Japan in the 1980s

Functional Food Classes

Conventional foodsModified foodsMedicinal foods Foods for special dietary uses

Functional Food ExamplesType Examples

Conventional Foods

Oats, Garlic, Nuts, Tomatoes

Modified Foods

FortifiedCalcium-fortified orange juice

Margarines with plant sterols and stanolsEnriched

Folate-enriched breadEnhanced

Energy bars, yogurts, teas, bottled water, etc. formulated with bioactive components

Medicinal Foods

Enteral feed formulasPhenylalanine-free formulas

Foods for Specific

Dietary Use

Infant formula/foodsGluten-free foodsLactose-free foods

Functional foods are regulated as a specific class of foods by the FDA

A. TrueB. False

Regulation of Functional Foods

The term ‘functional foods’ has no legal meaning in the US

Functional foods are regulated under existing laws for food and drugs

Regulation of functional foods depends on how the product is marketed Conventional food Food additive Food for special dietary

use

Dietary supplement Drug Medical food

All food labeling claims must be approved by the FDA prior to marketing

A. TrueB. False

Food ClaimsClaim Type Definition

Health Claim Describes a relationship between a substance and reducing risk of a disease or health-related condition

Requires FDA review of scientific evidence

Nutrient Content Claim

Indicates the presence of a specific nutrient at a certain level

Not allowed on labeling for products intended for children under 2 years of age

Structure/Function Claim

Describes the effect of dietary components on the normal structure or function of the body

Must be truthful and not misleading Not pre-reviewed or authorized by FDA

Health ClaimsHealth Claim Type Description

NLEA AuthorizedClaims

Claims that meet significant scientific agreement standard criteria

FDAMA AuthoritativeStatements

Claims based on “authoritative statements”from a scientific body of the US government or the National Academy of Sciences

Qualified Health Claims

Health claims based on emerging scientific evidenceAllowed for 6 disease categories: CancerCardiovascular diseaseCognitive functionDiabetesHypertensionNeural tube defects

NLEA – Nutrition Labeling and Education Act of 1990FDAMA – Food and Drug Administration Modernization Act of 1997

Food Claim Examples



Nutrient Content Claim

Food Claim Examples

Nutrient Content Claims

Health Claim

Approved Nutrient Content Claims

Nutrient Content Claims (cont.)Foods can make claims to prevent and treat certain diseases.

A. TrueB. False

No foods can make claims to “diagnose, treat, cure, or prevent any disease”

The Claim Game: Claim #1

Helps support a healthy immune system

A. Health claimB. Structure/function claim


May reduce the risk of certain cancers



May reduce the risk of heart disease



Helps maintain healthy bones and may reduce risk of osteoporosis


FDA Food Labeling Initiative

2009 call to manufacturers to ensure compliance with FDA regulations

Labeling must be truthful and not misleading

Warning letters to 17 manufacturers on 22 food products violating the Federal Food, Drug, and Cosmetic Act

Approach to Using Functional Foods Read the nutrition label and evaluate the claims Consult a health care provider Key questions to consider:

Is there a symptom/condition they are trying to treat?

Is this food safe to use with their current medications and medical conditions?

Is there good evidence to support this label claim? How much of this food should they consume and for

how long? Are their any potential side effects?

Cost considerations and product selection

Food Labels Patient Case #1 – Probiotic Yogurt

Patient question: I saw an ad on TV for Activia® yogurt that said it will ‘help naturally regulate my digestive system in only 14 days.’ Does it really work? Is it any better than regular yogurt?

Patient Case #1 What type of claim is this?

A. Structure/function claimB. Health claim

What recommendation would you make to this patient?

A. ‘Sure it works, the lady on TV said its been clinically proven in studies’

B. ‘$5 a container! You’re better off with regular yogurt’C. ‘Let’s consult our pharmacist’

Probiotics

Probiotic containing foods are one of the fasting growing food trends

Probiotic = ‘for life’ Most common species: lactobacillus &

bifidobacterium

Live microorganisms which, when administered in adequate amounts, confer

a health benefit on the host-Joint FAO/WHO Working Group Report (2002)

Probiotic Uses and SourcesProposed Uses Food Sources

DiarrheaLactose intoleranceInflammatory and irritable bowel conditionsGut transit/bowel functionGeneral health and wellnessImmune supportAtopic dermatitisVarious infectious diseases

YogurtFermented milkKefirMisoTempehKim ChiSauerkrautJuicesSoy beveragesCerealsCheeses

Key Points About Probiotics Currently no FDA approved health claims

for probiotics Effects of probiotics are SPECIES and

STRAIN specific Different preparations and strengths of the

same strain may result in different effects

Currently no guidelines for the recommended consumption levels and durations for beneficial effects

Individual microbial diversity may impact effectiveness

Safety of probiotics has not been thoroughly studied scientifically

Know side effects are mild and mainly digestive in nature (gas, bloating, etc.)

Probiotics might theoretically cause infections, unhealthy metabolic activities, and overstimulation of the immune system

Manufacturing process regulations are needed to ensure probiotic stability and concentrations in products

Yogurt starter cultures lactobacillus bulgarisand streptococcus thermophilus have GRAS status

Probiotic Safety Probiotic Research

Majority of research on probioticsconducted through small clinical trials or epidemiologic studies

More product specific studies are needed

Probiotic Yogurts

All yogurts with live and active cultures are ‘probiotic’ yogurts

No head-to-head studies between different yogurts

Yogurt starter cultures have been proven to help with lactose digestion (lactobacillus delbrueckii and streptococcus thermophilus)

National Yogurt Association Live & Active Culture seal program

Refrigerated yogurt products that contain at least 100 million cultures per gram

Frozen yogurt products that contain at least 10 million cultures per gram

Program participants Cloud Top, LLC Red Mango YoCream Dannon Yoplait Gilsa Kroger Pinkberry

Berry Chill Emmi USA Scott Brothers Johanna Foods OrangeCup Chobani Yoforia Mountain Top

Activia®

Claim: Activia®, with Bifidus Regularis®

(Bifidobacterium lactis DN 173 010), helps naturally regulate your digestive system when eaten every day for two weeks as part of a balanced diet and healthy lifestyle

Evidence Small studies evaluating bifidobacterium lactis

DN-173 010 in fermented milk products

Activia® in the News Dec 15, 2010 – “Dannon Agrees to Drop Exaggerated

Health Claims for Activia Yogurt and DanActive Dairy Drink” Proposed settlement with FTC

Dannon agrees to pay the states $21 million to resolve current investigations

Unless approved by the FDA Dannon is prohibited from claims that their any yogurt, dairy

drink, or probiotic food or drink reduces the likelihood of getting a cold or the flu

Dannon may not claim that Activia yogurt will relieve temporary irregularity or help with slow intestinal transit time, unless the claim is not misleading and the ad conveys that three servings of Activia yogurt must be eaten each day to obtain these benefits

Dannon may not claim that any other yogurt, dairy drink, or probiotic food or drink will relieve temporary irregularity or help with slow intestinal transit time

Return to Patient Case What other questions do you have for this

patient? Health provider consultation

Is there a symptom/condition they are trying to treat?

Is this food safe to use with their current medications and medical conditions?

Is there good evidence to support this label claim?

How much of this food should they consume and for how long?

What recommendation would you make?

A. Try Activia® for 14 daysB. Try any yogurt with live and active

cultures

Patient Case #2 – Heart Health

Patient question: My brother just had a heart attack and my dad died of one years ago. I read all these foods are good for heart health. How much should I eat to decrease my risk?

Heart Healthy Foods Other Foods in Cart

Whole-grain breadWhole-grain pastaOatmealTofuSoy milkMargarine with plant sterols/stanolsAlmonds, walnuts

Canned soupIce creamGround beefPotato chipsRegular soda

a

Patient Case #2 What recommendation would you make

for this patient?A. ‘You are at high risk with your family history.

Start eating large amounts of the ‘heart healthy’ foods’

B. ‘I am not sure what your risk is, we should first check with the pharmacist’

C. ‘That heart healthy food is expensive and doesn’t taste great, just eat smaller portions of regular food’

Risk Factors for Heart Disease

Unmodifiable factors Age Family history Gender Race

Modifiable factors Diet and nutrition Tobacco smoking Alcohol intake High blood pressure High cholesterol Weight Physical inactivity Stress

Diet and Lifestyle Recommendations

Use up at least as many calories as you take in

Eat a variety of nutritious foods from all food groups

Eat less of the nutrient poor foods Don’t smoke tobacco and stay away from

tobacco smoke

Diet Recommendations Eat fruits and vegetables Eat unrefined whole-grain foods Eat fish at least twice a week Choose lean meats and poultry Select fat-free, 1% fat, and low-fat dairy products Cut back on foods containing partially hydrogenated

vegetable oils Cut back on foods high in dietary cholesterol Cut back on beverages and foods with added sugars Choose and prepare foods with little or no salt (eat

less than 1,500 milligrams of sodium per day) Only drink alcohol in moderation Watch portion sizes

Heart Healthy FoodsFood Effective Levels

Soy protein 25 grams/day6.25 grams/serving

Plant sterols 1.3 grams/day0.65 grams/serving

Plant stanols 3.4 grams/day1.7 grams/serving

Almonds, hazelnuts, some pine nuts, peanuts, pecans, and pistachios

1.5 ounces/day*Qualified health claim

Psyllium seed husk soluble fiber

7 grams/day0.75 grams/serving (4 times/day)

Whole oat soluble fiber 3 grams/day0.75 grams/serving

Health Claim: 3 grams of soluble fiber daily from oatmeal, in a diet low in saturated fat and cholesterol,

may reduce the risk of heart disease

How many servings should the patient consume per day to reduce her risk of heart disease?A. ½ a servingB. 1 servingC. 1½ servingsD. 2 servings

Patient Case #2 (cont.)

What additional questions do you have for this patient?

What do you think of the items in her cart?

What recommendations can we make?

Future of Functional Foods

Market will continue to grow and change based on consumer demands and health concerns

Nutrigenomics (“personalized nutrition”) Application of the human genome to nutrition

and personal health to provide individual dietary recommendations

Research in preliminary stages

Take Home Points First try to eat a healthy well-balanced diet

of whole foods and then incorporate functional foods

Diet is only ONE aspect of a comprehensive lifestyle approach to good health Regular exercise Tobacco avoidance Stress reduction

Be informed

Websites

American Heart Association – www.heart.org National Yogurt Association – www.aboutyogurt.com US Food and Drug Administration – www.fda.gov US Department of Agriculture – www.mypyramid.gov

Post-Assessment Questions

1. Which of the following is a health claim?a. Calcium builds strong bonesb. Diets low in saturated fat and cholesterol may

reduce the risk of heart diseasec. Fiber maintains bowel regularityd. Antioxidants maintain cell integrity

2. Structure/function claims require FDA review and authorization prior to marketing. a. Trueb. False

Post Assessment Questions3. Which of the following nutrients should you try to

limit intake of?a. Dietary fiberb. Calciumc. Sodiumd. All of the above

4. Which of the following is not an aspect of a healthy lifestyle?a. Dietb. Stress reductionc. Tobacco cessationd. All of the above are aspects of a healthy lifestyle

Questions

References1. Hasler CM. Functional foods: benefits, concerns and challenges – a position paper from the american

council on science and health. J Nutr. 2002;132:3772-3781.2. Berardi, Rosemary, Stefanie P. Ferreri, Anne L. Hume, et al. "Functional and Meal Replacement

Foods." Handbook of Nonprescription Drugs: an Interactive Approach to Self-care. 16th ed. Washington: American Pharmaceutical Association, 2010.

3. 2007 International Food Information Council (IFIC) consumer attitudes toward functional foods/food for health. <http://www.foodinsight.org/Content/6/IFICExecSum SINGLE_vF2.pdf>. Accessed Nov. 23, 2010.

4. American Dietetic Association. Position of the american dietetic association: functional foods. J Am Diet Assoc. 2009;109:735-746.

5. Hasler CM. Functional foods: their role in disease prevention and health promotion. Food Technology. 1998;52:57-62.

6. "Claims That Can Be Made for Conventional Foods and Dietary Supplements." FDA. Sept. 2003. <http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ ucm111447.htm>. Accessed Nov. 23, 2010.

7. “MyFoodPyramid.” USDA. 2005 <http://www.mypyramid.gov/>. Accessed Nov. 23, 2010. 8. Lichtenstein AH, Appel LJ, Carnethon M, et al. AHA Scientific Statement: diet and lifestyle

recommendations revision 2006. Circulation. 2006:114:82-96.9. “NYA Position Statement on Probiotics.” National Yogurt Association 2006. <

http://www.aboutyogurt.com/AboutYogurt08/files/ccLibraryFiles/Filename/000000000026/Probiotics.pdf>. Accessed Nov. 23, 2010.

10. Dannon Agrees to Drop Exaggerated Health Claims for Activia Yogurt and DanActive Dairy Drink. FTC Press Release Dec. 15, 2010. <http://www.ftc.gov/opa/2010/12/dannon.shtm> Accessed Dec. 16, 2010

11. Activia Website <http://www.activia.us.com/>12. Quaker Oats Website <http://www.quakeroats.com/>

Functional Foods Activities 2011 IPA Educational Expo January 22, 2011

The Benefits of Food Fill in the blanks with an example of a food benefit that you have heard of.

Eating _____________________ is good for or helps ______________________________________ . (food) (‘health’ claim)

The Claim Game Categorize the following claims as a health claim or a structure/function claim (circle one). Helps support a healthy immune system health claim structure/function claim

May reduce the risk of certain cancers health claim structure/function claim

May reduce the risk of heart disease health claim structure/function claim

Helps maintain healthy bones and may reduce health claim structure/function claim risk of osteoporosis Patient Case #1 – Probiotic Yogurt Patient question: I saw an ad on TV for Activia® yogurt that said it will ‘help naturally regulate my digestive system in only 14 days.’ Does it really work? Is it any better than regular yogurt? What type of claim is this? A. Structure/function claim B. Health claim What recommendation would you make to this patient? A. ‘Sure it’s worth the extra money, the lady on TV said so’ B. ‘$5 a container! You’re better off with regular yogurt’ C. ‘Let’s consult our pharmacist’ What other questions do you have for this patient?

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Which recommendation would you make? A. Try Activia for 14 days B. Try any yogurt with live and active cultures Patient Case #2 – Heart Health Patient question: “My brother just had a heart attack and my dad died of one years ago. I heard all these foods are good for heart health. How much should I eat to decrease my risk?”

Heart Healthy Foods Other Foods in Cart

Whole‐grain bread Whole‐grain pasta Oatmeal Tofu Soy milk Margarine with plant sterols/stanols Almonds Walnuts

Canned soup Ice cream Ground beef Potato chips

How many servings should the patient consume per day to reduce her risk of heart disease?

A. ½ a serving B. 1 serving C. 1½ servings D. 2 servings

What additional questions do you have for this patient?

_________________________________________________________________________________________________________________________________________________________________________________________________________ What do you think of the items in her cart?

_________________________________________________________________________________________________________________________________________________________________________________________________________ What recommendations can we make?

_________________________________________________________________________________________________________________________________________________________________________________________________________

Documents

2:00pm - 3:00pm: Breakout 3 - Case Discussions Technician ...€¦ · For her residency project, Dr. ... -Joint FAO/WHO Working Group Report (2002) Probiotic Uses and Sources