9/12/2018. An Overview of Nutrition-Related Claims Guy H. Johnson, Ph.D. The Third Age of Healthy Marie Molde, MBA, RDN. Learning Objectives

Transcription

1 An Overview of Nutrition-Related Claims Guy H. Johnson, Ph.D. The Third Age of Healthy Marie Molde, MBA, RDN Learning Objectives After completing this continuing education course, nutrition professionals should be able to: 1. Identify FDA- and USDA- supported on-pack labeling claims including FDA-authorized and qualified claims, nutrition content claims and structure/function claims. 2. Understand the scientific review and approval process for use of FDA-authorized health claims, such as "heart healthy," and how claims may be reviewed, revised or revoked as supporting scientific evidence evolves. 3. Explore functional food claims, and if and how science-based claims may impact or motivate consumer purchase behavior. 4. Translate consumer intent into action steps to help clients and the public achieve health goals. 1

2 AN OVERVIEW OF NUTRITION-RELATED CLAIMS September 13, 2018 Guy H. Johnson, Ph.D. 2018, Johnson Nutrition Solutions LLC Disclosures Current Clients Soy Connection, Editorial Board McCormick Science Institute, Executive Director California Strawberry Commission, Scientific Advisor Campbell Soup Company, External Advisory Board Former Clients Numerous commodity groups and food & beverage manufacturers Author of health petitions including those for soybean oil, canola oil, olive oil, tree nuts, macadamia nuts and unsaturated fatty acids Types of Nutrition Claims Food and Drug Association (FDA) regulated Content claims Nutrient content claims (including the implied claim healthy ) Health claims Structure/function claims 2

3 FDA Content Claims Soybean Oil 14 mg Campesterol 15 mg Stigmasterol 42 mg β-sitosterol Source: J Food Comp 2002;15:123 FDA Content Claims Canned tomato puree 25 mg Lycopene FDA Content Claims Dark Chocolate 12 mg Flavonols 3

4 FDA Nutrient Content Claims Soybean Oil A cholesterol free food A sodium free food A sugar free food Excellent source of ALA Omega-3s FDA Nutrient Content Claims Oats Good source of fiber A sodium-free food Orange Juice fortified with calcium No added sugar Excellent source of vitamin C Excellent source of calcium Use of the Implied Nutrient Content Claim Healthy according to new guidance from FDA Low in saturated fat Low in cholesterol No more than 480 mg sodium per RACC At least 10% DV of protein, fiber, vitamin A, vitamin C, calcium, iron, potassium or Vitamin D 4

5 FDA Health Claim Characterizes the relationship of any substance to a disease or health related condition Substance can be a specific food or component of food Source: 21 CFR (a) Significant Scientific Agreement FDA only awards when there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claim. Source: 21 CFR (c) Qualified Health Claims Need a credible body of scientific data The weight of the scientific evidence must support proposed claim Claim must be qualified by appropriate language so consumer are not misled Source: 67 FR 78002, December 20,

6 The Process for Unqualified Claims is Lengthy Days Required Activity 15 Receipt of petition acknowledged 100 Petition filed or rejected 90 Proposed rule published or petition rejected 270 Public comments solicited Final rule published Maximum of two 90-day extensions permitted 540 Total Days Max Final rule published Process for Qualified Claims is Faster & Easier for FDA than Unqualified Claims Days required Activity 45 Determine whether the petition is complete, return to petitioner or file 60 Public comment 165 Scientific review (internal, advisory subcommittee and/or contracted third-party Consolidate with like petitions Consult with other federal agencies Notify petitioner 270 Total Days FDA may extend timeline by days Source: FDA Guidance Document 7/10/03 6

7 General Health Claim Requirements No more than 13 g total fat per labeled serving size and RACC No more than 4 g saturated fat No more than 480 mg sodium No more than 60 mg cholesterol At least 10% DV of protein, dietary fiber, vitamin A, vitamin C, calcium or iron per serving Source: 21 CFR Only Disease Endpoints with Approved Surrogate Endpoints are Considered Biomarker Yes No Total cholesterol LDL-cholesterol Blood pressure C-Reactive protein LDL susceptibility to oxidation Flow Mediated Dilatation Polyp reoccurrence Prostate specific antigen Fasting blood glucose Insulin resistance The studies must be done on healthy people that reflect the U.S. population that is the target of the claim 7

8 Existing Unqualified Health Claims Calcium and osteoporosis Dietary lipids and cancer Dietary saturated fat, cholesterol and heart disease Sodium and hypertension Fiber-containing foods and cancer Fruits & vegetables and cancer Soluble fiber from certain foods and heart disease Sterol/stanol esters and heart disease Folate and neural tube birth defects Soy protein and heart disease Dietary noncariogenic carbohydrates and dental caries Unqualified Claim for Soy Protein Source: 21 CFR Unqualified Claims 8

9 Unqualified Claims Unqualified Claims FDA has Proposed to Rescind the Claim for Soy Protein 9

10 Other Interpretations of the Literature Argue for Retention of the Soy Protein Claim Existing Qualified Health Claims for CHD Soybean oil and reduced risk of CHD Monounsaturated fatty acids from olive oil and reduced risk of CHD Unsaturated fatty acids from canola oil and reduced risk of CHD Corn oil and reduced risk of CHD Omega-3 fatty acids and reduced risk of CHD Walnuts and reduced risk of CHD Macadamia nuts and reduced risk of CHD Qualified Claim for Soybean Oil Supportive but not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat and not increase the total number of calories you eat in a day. One serving of [name of food] provides X grams of soybean oil. 10

11 Qualified Claim for Walnuts Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts such as walnuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. [See nutrition information for fat content.] Qualified Claim for Corn Oil Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon (16 grams) of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil. Soybean Oil has the Least Qualifying Language of All Oil Claims Oil Qualifying Language Studies that reported significantly lower T-C and LDL-C Soybean Supportive but inconclusive 9/12 (75%) Olive Limited and not conclusive 7/12 (58%) Canola Limited and not conclusive 4/8 (50%) Corn Very limited and preliminary 2/3 (67%) 11

12 Some Claims are Highly Qualified Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. Four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer. Structure/Function Claims Do Not Require Pre-approval Structure/Function Claim for Soy Protein or Oil 12

13 Conclusions Soy protein and soybean oil are heart-healthy foods shown to favorably affect blood lipid concentrations FDA s approach to health claims has evolved Significant Scientific Agreement is exceedingly difficult to attain Higher level qualified claims require substantial scientific evidence Virtually all new health claims are qualified claims THANK YOU! Guy H. Johnson, Ph.D. guy@nutritionsolutions.net THE THIRD AGE OF HEALTHY Marie Molde, MBA, RDN 13

14 Disclosures Marie Molde, MBA, RDN Employee: Datassential Research Board Member: National Restaurant Association Nutrition Executive Study Group Menus of Change Sustainable Business Leadership Council DRIVERS OF WELL-BEING TOTAL 5-pt scale, top 2 Taking care of self and 86% family Physical condition / health 83% Emotional state 76% Financial condition 72% What I eat & drink 64% Satisfaction with work / 56% career Spirituality / religion 56% 1.0 weight management low-fat low-calorie low-carb 14

15 2.0 feel good foods local natural free-from 3.0 functional foods performance superfoods positive nutrition 15

16 1.0 weight management 2.0 feel good foods 3.0 functional foods functional foods CHIA SEEDS +396% 4-year menu growth 3.0 functional foods KOMBUCHA +406% 4-year menu growth 16

17 3.0 functional foods TURMERIC +176% 4-year menu growth nutrition labels and health claims healthcare & medical websites health & wellness blogs 17

18 Heart health Energy Weight management Sleep Immunity Bone/ Joint health Longer life Anti-inflammatory Stress reduction Disease resistance Gut/ digestive health Cognitive function Internal/ Organ health Anti-aging Detoxification Pain management Hunger control Mood enhancement Beauty Sex drive Allergy relief/ prevention Hormone health Childhood development Menopausal support Neo-natal health 55% interested 45% would purchase 45% want at restaurants 18

19 54% would like heart-healthy foods and beverages available at retailers 34% would pay more for heart-healthy foods and beverages 63% more likely to purchase soybean oil with a heart-health claim* *2018 United Soybean Board Food Industry Insights consumer study Healthy Eating & Drinking Motivators Top 22 of 32 items shown Extremely or Very Important Heart health 77% To live longer 71% To give you sustained energy for the day 71% Mental sharpness 69% Managing your weight 69% Build immunity 67% Digestive health 67% Dietary balance 67% Reducing fatigue / tiredness 66% To keep you mentally alert 66% Bone health 65% Cancer prevention 64% Mobility (joint health, flexibility) 64% Teeth / gum health 64% Helping you sleep better 63% Improving blood pressure 63% Eating sensible size portions 61% Eye health 61% Improving your mood 60% Managing anxiety / reducing stress 57% Detoxifying (cleansing body of toxins) 56% Diabetes management / prevention 55% 19

20 *2018 United Soybean Board Food Industry Insights consumer study Healthy Unhealthy Neither Vegetables 93% 2% 5% Fruit 92% 2% 6% Nuts 85% 2% 13% Beans / lentils / legumes 83% 3% 15% Yogurt 80% 3% 17% Poultry 76% 3% 21% Seafood 75% 5% 20% Eggs 70% 6% 24% Milk 67% 7% 26% Tea 60% 6% 35% Rice 50% 11% 39% Cheese 46% 14% 40% Red meat 32% 28% 40% Bread 29% 24% 47% Spicy foods 27% 20% 52% Chocolate 26% 31% 42% Noodles 23% 29% 48% Coffee 22% 25% 53% Fried foods 7% 80% 14% consumer perceptions of healthy healthy is motivating 87% of shoppers are more likely to purchase U.S.-grown vegetable oil after learning the health benefits.* *2018 United Soybean Board Food Industry Insights consumer study 20

21 VEGAN vegetarian claims have stayed stable at 35% of menus but vegan is on the rise 7% 8% 6% 5% 3% 3% 2% 2% 2% 2% 1% 1% GLUTEN-FREE 21% 18% 13% 8% 4% 1% 1% 1% 1% 1% 2% 2% PROTEIN 7.3% 2.2% 21

22 WHAT SHOULD I EAT? 0% 50% 100% Whole grains Reduced sodium Natural Reduced sugar Vitamins / minerals Protein Local Organic Fiber Vegetarian / Vegan No HFCS Pesticide-free Reduced fat Reduced calorie Lactose-free No MSG Antibiotic-free Reduced cholesterol Healthy fats Humane animals Antioxidants No trans-fats Gluten-free No GMOs Calcium-fortified Plant proteins Reduced catbs Allergen-free Probiotics Sustainable Ancient grains Ethically sourced 13% 29%? 22

23 grey area 23

24 science is still early health benefits still being verified often can t legally make claims HEALTHY 1.0 HEALTHY 2.0 HEALTHY 3.0 weight management feel good functional 1980 s to early 2000 s early 2000 s and beyond early 2010 s and beyond healthy 3.0 labels and claims health claim impact achieve public health goals 24

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