Understanding Health Claims on Foods and Supplements

October 2nd, 2020 Jamie I. Baum, PhD [email protected]

Image: https://www.thedoctorsdr.com/a-cardiologists-exclusive-guide-to-5-favorite-vitamins-and-supplements/ Project D-FEND: Diet, Food, Exercise, and Nutrition during social distancing. A collaboration between the University of Arkansas System Division of Agriculture’s Center for Human Nutrition and the University of Arkansas Exercise is Medicine Program. The University of Arkansas System Division of Agriculture is an equal opportunity/affirmative action institution. Objectives • Understand the food label

• Define health claims

• Understand how health claims on foods and supplements are regulated

• Understand how to determine if claims are fact or fiction Food and Drug Administration

• Agency of the US Department of Health and Human Services

• Responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, veterinary products The Nutrition Labeling and Education Act of 1990 • Gives the FDA explicit authority to require nutrition labeling on most food packages and specified the nutrients to be listed in the nutrition label.

• Requires that nutrients be presented in the context of the daily diet Specified that serving sizes should represent “an amount customarily consumed and which is expressed in a common household measure that is appropriate to the food.”

• Required standard definitions to be developed that characterized the level of nutrients and required that FDA provide for approved health claims.

• Permitted the FDA to add or delete nutrients based on a determination that such a change would “assist consumers in maintaining healthy dietary practices.”

• The NLEA pertains only to those labels of food products regulated by FDA, which has label authority over the majority of foods. • However, meat and poultry product labels are under the authority of FSIS in the USDA, and alcoholic beverage product labels are under the authority of the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury, formerly the Bureau of Alcohol, Tobacco and Firearms. Main Goals of the Nutrition Label The purpose of FDA’s proposal was threefold: 1. To clear up confusion that had surrounded nutrition labeling for years,

2. to help consumers choose healthier diets, and

3. To give food companies an incentive to improve the nutritional qualities of their products Check the Ingredient List • Foods with more than one ingredient must have an ingredient list on the label.

• Ingredients are listed in descending order by weight. Those in the largest amounts are listed first. Specific Ingredient List Guidelines http://www.fda.gov/Food/

• List ingredients in descending order, sorted by weight. The ingredient with most weight is listed first, and the ingredient with the least weight is listed last.

• list the common or usual name for ingredients unless there is a regulation that provides for a different term. For instance, use the term "sugar" instead of the scientific name "sucrose." Example - INGREDIENTS: Apples, Sugar, Water, and Spices

• Trace ingredients do not need to be listed if a substance is an incidental additive and has no function or technical effect in the finished product. Sulfites are considered to be incidental only if present at less than 10 ppm.

• Chemical preservatives that are added to a food, must be included using both the common or usual name of the preservative and the function of the preservative by including terms, such as "preservative" "to retard spoilage" "a mold inhibitor" "to help protect flavor" or "to promote color retention." Example - INGREDIENTS: Dried Bananas, Sugar, Salt, and Ascorbic Acid to Promote Color Retention.

• Spices may be declared in ingredient lists by using either specific common or usual names or by using the declarations "spices," "flavor" or "natural flavor," or "artificial flavor." Example - INGREDIENTS: Apple Slices, Water, Cane Syrup, Corn Syrup, Modified Corn Starch, Spices, Salt, Natural Flavor and Artificial Flavor

Health claims – What are they? Types of Label Claims?

• Health Claims

• Nutrient Content Claim

• Structure/Function Claims

Health Claims - EFSA (European Food Standards Agency) https://www.youtube.com/watch?v=3zN L21gjwuo Health Claims

• A claim authorized by the US Food and Drug Administration (FDA) that must be supported by credible scientific evidence regarding a relationship between a substance (specific food or food component) and a disease or health-related condition.

• Can be authorized or qualified. Health Claims https://www.fdareader.com/blog/2018/12/17/authorized-health-claims • A health claim is defined as any claim that states, suggests, or implies that a relationship exists between a food category, a food, or one of its constituents and health.

• Authorized Health Claim • Describes a health claim that has been reviewed by the FDA and approved for use. • This means that you can make an authorized health claim on your precut without needing the FDA to approve. • There must be significant scientific agreement (SSA), which means the science supporting the health claim is unlikely to change. Authorized health claims that meet the SSA standard • Calcium, vitamin D, and osteoporosis • Dietary lipids (fat) and cancer • Dietary saturated fat and cholesterol and risk of coronary heart disease • Dietary non-cariogenic carbohydrate sweeteners and dental caries • Folic acid and neural tube defects • Fiber-containing grain products, fruits, and vegetables, and cancer • Fruits and vegetables and cancer • Fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease • Sodium and hypertension • Soluble fiber from certain foods and risk of coronary heart disease • Soy protein and risk of coronary heart disease • Stanols/sterols and risk of coronary heart disease

https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard Qualified Health Claim https://www.fdareader.com/blog/2018/12/17/qualified-health-claims • Qualified Health Claim is a statement approved by the FDA for use on food labels that has strict wording requirements.

• When there is emerging evidence between a food and the reduced risk of a disease or health condition, but not enough for the FDA to issue an Authorized Health Claim, the FDA may approve a "Qualified Health Claim”

Example of a Qualified Health Claim: • "Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive." https://www.fda.gov/food/food-labeling- nutrition/qualified-health-claims-letters-enforcement- discretion Qualified Health Claims • Atopic dermatitis • Cancer (e.g. green tea, tomatoes) • Cardiovascular disease (e.g. nuts, omega-3 fatty acids) • Cognitive function (e.g. phosphatidylserine) • Diabetes (e.g. whole grains) • Hypertension (e.g. EPA, DHA) • Peanut allergy • Urinary tract infection (e.g. cranberry juice) https://www.fdareader.com/blog/2 018/12/14/introduction-to-food- Requirements for a health claim product-claims

• Health claims cannot be made about the diagnosis, cure, mitigation or treatment of diseases (this is a drug claim).

• They must be complete, truthful and not misleading.

• Certain foods may be disqualified from health claims based on nutrient levels that are deemed unhealthy. Health claims must be associated with a risk or health related condition for which the US population or a subgroup (i.e. the elderly) is at risk.

• The substance that is the subject of the health claim must have a taste, aroma or nutrient value when consumed at the levels used to justify the claim. Example: Health Claim

Calcium and Osteoporosis • Claim: A diet adequate in calcium may help reduce the risk for osteoporosis, a degenerative bone disease. • Requirements: At least 200 milligrams calcium, no more phosphorus than calcium per serving, and calcium must be in a form that can be readily absorbed by the body. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ labelingnutrition/ucm064919.htm Example: Plant Sterols Nutrient Content Claims

• Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. Nutrient Content Claims, cont’d

• Most nutrient content claims regulations apply only to those nutrients or dietary substances that have an established Daily Value (DV).

• The manufacturer must ensure that the exact wording of the claim, including specific descriptive words, is consistent with FDA’s regulations, as only authorized nutrient content claims are permitted for use. http://www.heart.org Structure Function Claims • These claims describe the effect of a nutrient or dietary ingredient on normal structures or functions in the body.

• Unlike health claims, structure/function claims cannot explicitly or implicitly state a relationship between preventing, curing, or mitigating a disease or health-related condition and are not subject to FDA authorization or pre- market review.

• However, the manufacturer is responsible for ensuring that any structure/function claim on labels, like all information on food labels, is based on competent and reliable scientific research and is truthful and not misleading Example: Structure Function Claim Health Claims Gone Wrong Dairy Council to En d Ad Campaign That Linked Drinking Milk With Weight Loss - New York Times 3/ 16/ 14 5:25 PM

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Dairy Council to En d Ad Campaign That Linked Drinking Milk With Weight Loss - New York Times 3/ 16/ 14 5:25 PM

HOME PAGE MY TIMES TODAY'S PAPER VIDEO MOST POPULAR TIMES TOPICS SUBSCRIBE NOW Log In Register Now Dairy Council to End Ad Campaign That Linked More Articles in National » Dannon Agrees to Drop Ex aggerated Health Claims for Activia Yogurt and DanActive Dairy Drink | Federal Trade Commission 3/16/14 5:29 PM Drinking Milk With WUeig.S.ht Loss U.S. All NYT Safari Power Saver By KIM SEVERSON Click to Start Flash Plug-in WORLD U.S. N.Y. / REGIONPubBlishUSIedN: EMaSSy 11,TE 20CHNOLOGY07 SCIENCE HEALTH SPORTS OPINION ARTS STYLE TRAVEL JOBS REAL ESTATE AUTOS Contact Stay ConnectTeWdITTER Privacy Policy FTC en POLITICS WASHINGTON EDUCATION español FTC Cites Rice Krispies' ImmuneA S nysatetiomn Calla aimd vFeorrt Kisidins g: cShaomtsp -a igHena tlthha Nt eawss o: cNiaPRtes dairy products with LINKEDIN 3/ 16/ 14 5:27 PM Search weight loss will be curtailed because research does not support the SIGN IN TO E- claim, according to the Federal Trade Commission. MAIL OR SAVE THIS

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Billionaires With Big Ideas Are Privatizing American Dr. Neal Barnard, president of the group that brought the matter to the F.T.C., said it Science would continue to press theTh diasir tyi meindu stthrye o Fn TotChe rh calasim bs,ro whicadhe innecludd ae tnhe o ardsseerr,tio nin effect3 .si Thence Scie nlcae stof O Julderl y,and Wiser that calcium helps prevent bone fractures in older women. 4. Opinion: Where Are the People of Color in Childrenâ to clamp down on Kellogg's marketing machine. Now €Ke™s Bookllogs?g is 5. Income Gap, Meet the Longevity Gap “I think people will start tbo arerrecogdniz "fe rothamt t hema dakiiryn ing dclusatriyms, whic abh ousuetd aton hay vhee aa mltohm b- enefit of any food and-pop image, is a huge commercial entity that will exaggerate to sell its products,” Dr. 6. NICHOLAS KRISTOF: Go West, Young People! 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The immunity claim drew intense fire last fall amid growing worries about the swine flu. Kellogg withdrew it in November, but said science backed the notion that nutrients in the cereal do support the

http:/ / www.npr.org/ blogs/ health/ 2010/ 06/ 04/ 127470653/ kellogg- slapped- again- for- exaggerated- health- claims Page 1 of 2 Dietary supplements Dietary Supplement Health and Education Act of 1994 • Supplement manufacturers do not need to receive FDA approval before marketing dietary supplements.[8] Also, DSHEA does not set a limit on the amount of vitamins or minerals which can be put into a pill.

• Label must have: • A statement of identity that contains the words "dietary supplement.” • Nutrition information in the form of a "Supplement Facts" panel. • The part of the plant used, if an herb or botanical • A complete list of ingredients by their common or usual names • The disclaimer "This statement has not been evaluated by the Food and Drug Administration Example: Creatine http://www.musclegauge.com/sportsups.htm

Creatine Monohydrate- Creatine is a metabolite that the body produces naturally. It is made up of three amino acids (I-methionine, I-arginine and I-glycine). Creatine promotes the available muscle energy in the body. Creatine monohydrate is found to contain more creatine per weight of material than other sources and works to accelerate recovery time and fat loss. Once in the body this product will attract the water around the muscle cell causing it to grow and enlarge. In this phase of hydration muscles will appear fuller, promote increased strength and will enhance the physical performance of the everyday athlete. https://ods.od.nih.gov/factsheets/WYNTK- Things to keep in mind Consumer/ • Consult your healthcare provider before taking dietary supplements to treat a health condition. • Get your healthcare provider’s approval before taking dietary supplements in place of, or in combination with, prescribed medicines. • If you are scheduled to have any type of surgical procedure, talk with your healthcare provider about any supplements you take. • Keep in mind the term “natural” doesn’t always mean safe. Some all-natural botanical products, for example, like comfrey and kava, can harm the liver. A dietary supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the amount you take. • Before taking any dietary supplement, use the information sources listed in this brochure and talk to your healthcare providers to answer these questions: • What are its potential benefits for me? • Does it have any safety risks? • What is the proper dose to take? • How, when, and for how long should I take it? https://www.consumer.ftc.gov /articles/0261-dietary- Dietary Supplements Include: supplements

• Vitamins and minerals They come in a number of forms, • Amino acids including capsules, liquids, and • Enzymes powders. But while dietary • Herbs supplements might seem similar to • Animal extracts drugs, and some even have drug-like effects, there's a big difference: • Plant extracts Dietary supplements don't undergo • Probiotics FDA review for safety and • Prebiotics effectiveness before they're sold. Other things to keep in mind about dietary https://www.consumer.ftc.gov/articles supplements /0261-dietary-supplements

• Dietary supplements aren’t always safe or harmless https://www.ftc.gov/news- • Supplements claiming to be cures aren’t proven events/media-resources/truth- advertising/health-claims • Tip-offs to fraud • Claims that one product does it all and cures a wide variety of health problems • Suggests the product can treat or cure diseases • Words like scientific breakthrough, miraculous cure, exclusive product, secret ingredient, ancient remedy • Misleading use of scientific-sounding terms • Phony references to Nobel Prize winning technology or science • Undocumented testimonials by patients or doctors claiming miraculous results • Limited availability and a need to pay in advance • Promises of no-risk, money-back guarantees Dietary Supplements Verification Program - USP • USP Dietary Supplement Verification Program is a voluntary program open to manufacturers of dietary supplement finished products from around the world.

• Through a rigorous testing and auditing process, USP evaluates voluntarily submitted products against science-based quality standards – including federally recognized USP–NF standards of quality, purity, potency, performance, and consistency – and FDA current good manufacturing practices.

• https://www.usp.org/verification-services/dietary-supplements- verification-program

Summary

Nothing beats the nutrient power of a healthy diet.

Image: https://twistwest.org/lifestyle- categories/healthy-diet/balanced-diet Next week – The power of protein!