OUR COMMITMENT OPEN DIALOGUE & DEBATE COMMITMENT TO EDUCATION

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1 Everyday we make choices and take actions that ensure the scientific-basis and quality of Nature Made vitamins and supplements. As a vitamin and supplement company, for Nature Made transparency means: OPEN DIALOGUE & DEBATE We are aware of the lively debate regarding the role of dietary supplements in nutrition and health, and we are an active participant. From academic researchers, to health care practitioners, to any person taking a Nature Made product for their health, we want to participate actively in the discussion of the role, benefits, and limitations of supplements. This is why we participate in the dialogue at nutrition science conferences such as the Women s Health Congress, Academy of Nutrition and Dietetics Conference, and the Scientific Assembly of the American Academy of Family Physicians. As an active participant, we do not always agree with every statement or new headline about dietary supplements, but we actively seek this public debate in order to both listen and share our scientifically-based view. Beyond that, we are committed to an open dialogue with anyone that is taking or interested in Nature Made products. We are available via our in-house call line ( ), our Registered Dietitians and nutrition experts. We welcome the dialogue. COMMITMENT TO EDUCATION Finally, we recognize how complex and confusing vitamins and supplements can be, and we commit to improving this current reality. As supplements evolve, with new science and ingredients constantly emerging, even knowledgeable consumers and medical experts can feel overwhelmed. We take seriously our responsibility to improve the available fact-based information and education tools for our products. Everyone should have the confidence to choose (or not to choose) a Nature Made supplement based on a clear, full understanding of its science.

2 EXPERT HELP OUR COMMITMENT As part of our commitment to education and encouraging an open dialogue on nutrition, vitamins and supplements, Nature Made has two registered dietitians who are available to answer your specific or general questions about nutrition, vitamins, herbs, supplements, and healthy lifestyle choices. SANDRA ZAGORIN, MS, RD, CNSC As a member of the Professional and Consumer Education team, Sandra educates healthcare professionals and consumers on nutrition, supplements, and related health concerns. Sandra writes articles for both consumers and healthcare professionals on nutrition, wellness, and dietary supplements. As part of the expert panel on naturemade.com, Sandra answers consumer s daily on nutrition and health related topics. Prior to joining Pharmavite, Sandra worked as a clinical dietitian at University of Chicago Medicine in the inpatient and outpatient settings. Clinical areas of expertise include: inpatient and outpatient adult nutrition support, cardiothoracic transplantation, gastroenterology diseases, and critical care. Sandra received her Bachelor of Science degree in Nutritional Science, with minors in Spanish and Chemistry from the University of Arizona in Tucson, AZ. She earned her Master of Science degree in Clinical Nutrition from RUSH University in Chicago, IL. As part of her Master s program, Sandra performed research on physical activity participation and correlates in urban Hispanic women. Sandra is a member of the Academy of Nutrition and Dietetics, as well as the Dietitians in Business & Communications practice group and the Dietitians in Integrative and Functional Medicine practice group. Sandra is also a Certified Nutrition Support Clinician through the American Society of Parenteral & Enteral Nutrition. In her free time, Sandra enjoys staying active by hiking, dancing, and running after her standard poodle, Remy. Sandra s favorite nutritional supplements include Nature Made Multi for Her softgels, Omega-3 Full Strength Minis, Adult Gummies Calcium, and Vitamin D IU softgels. LYNN LABORANTI, MS, RD As a registered dietitian at Pharmavite LLC since 1999, Lynn has served various roles in her position. Currently, she focuses much of her time creating educational materials and tools to educate health professionals, retail customers and consumers on nutrition and dietary supplements. Working closely with retail customers to customize education for their team is one of her true passions. Lynn also writes articles for consumers on various nutrition-related topics and dietary supplements, and is part of an expert panel on NatureMade.com, where she answers consumer s daily on nutrition and wellness-related topics. Lynn was also selected to speak at the Academy of Nutrition and Dietetics Food and Nutrition Conference on Drug Supplement Interactions and Nutrient Depletions: Applications for the Dietitian in October Prior to joining Pharmavite, Lynn was a wellness/fitness specialist and consulting dietitian for ProHealth, Inc., where she developed and conducted fitness-based programs and created health assessment profiles of its members. During this time, Lynn also served as a clinical dietitian in acute care at a local hospital. Lynn s previous clinical dietitian expertise in both acute and long-term care included nutritional screenings, patient assessments, and education and counseling at community medical centers, hospitals, and nursing homes. Her work as an outpatient dietitian focused primarily on counseling patients on weight management, diabetes, and also sports nutrition. Lynn earned a Bachelor s of Science in Nutrition with a minor in Kinesiology and Exercise Science from The Pennsylvania State University, University Park, PA. She earned a M.S. degree in Human Nutrition from Marywood University in Scranton, PA. She is a member of the Academy of Nutrition and Dietetics, Sports Cardiovascular and Wellness Nutritionists Dietetic Practice Group, and Dietitians in Integrative and Functional Medicine Practice Group. She is also certified in Adult Weight Management through the Academy of Nutrition and Dietetics. She is a mom of four children and strongly believes in setting a good example for her family through healthy eating habits and an active lifestyle. Her favorite nutritional supplements are Nature Made Multi for Her Liquid softgel, Vitamin D, Coenzyme Q10 (CoQ10), Calcium Gummies, and Fish Oil.

3 While we look forward to helping you with information and advice, we also recommend acquiring other expert information and advice: TALK TO YOUR HEALTH CARE PRACTITIONER Like all health decisions, it is essential to consult with your medical professional before taking new vitamins and supplements. Talk to your health care provider about your goals, your lifestyle, current prescriptions and dietary supplements. He or she can recommend what you need, and appropriate dosages. DO YOUR RESEARCH There are a number of reliable resources you can consult to educate yourself. Search under vitamin education and you will find several websites that you can use to education yourself. READ LABEL AND INSTRUCTIONS As with prescriptions, it is critical to adhere to strict dosage guidelines when taking dietary supplements. Also, pay special attention to any warning or caution statements about combining certain supplements with prescriptions or over-the-counter medicines.

4 HOW SUPPLEMENTS ARE REGULATED With more than 150 million Americans taking dietary supplements each year, consumers need assurance that the supplement industry is adequately regulated. The fact is dietary supplements are subject to detailed and comprehensive regulations to safeguard safety and quality. HOW ARE SUPPLEMENTS REGULATED? Regulatory authority for dietary supplements is rooted in the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) through the FTC Act and the Federal Food, Drug and Cosmetic Act (FFDCA), which was further strengthened in 1994 by the Dietary Supplement Health and Education Act (DSHEA). The FTC pursues deceptive, false and misleading advertising. The FDA is charged with inspecting manufacturing facilities, reviewing labeling and monitoring products for safety. While the FDA once required dietary supplements to meet the same good manufacturing practices (GMPs) as foods, that policy changed in Today, the FDA s new GMPs for dietary supplements impose higher standards and are working to ensure supplements are produced in a quality manner and are accurately labeled. The new GMPs became required for large manufacturers in 2008 and are now in effect and being enforced for all manufacturers.

5 WHAT LAWS DIRECTLY IMPACT SUPPLEMENTS? Dietary Supplement and Nonprescription Drug Consumer Protection Act: This 2006 act was passed to amend FFDCA (see below) with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, in addition to other purposes. 1 The law requires that the manufacturer, packer or distributor of a dietary supplement or over-the-counter (OTC) drug notify the FDA of all serious adverse events it receives associated with their dietary supplement or OTC within 15 business days. Serious adverse events are defined as those that result in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, as well as situations where medical/surgical intervention is required to prevent the previously listed events. Food Allergen Labeling Act (FALCPA): FALCPA went into effect in 2006 and requires manufacturers to clearly identify on their food labels if a food product has any ingredients that contain protein derived from any of the eight major allergenic foods and food groups: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, or soybeans. 2 Bioterrorism Act: Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 gave the FDA additional statutory enforcement powers to increase food security in order to reduce the threat of bioterrorism. The FDA was provided with increased regulatory authority over the food supply, registration of food facilities, record keeping requirements and records inspection authority, and prior notice of imported food shipments. 3 All provisions apply to conventional food and dietary supplements. 3 Dietary Supplement Health and Education Act (DSHEA): The FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products (prescription and over-the-counter). Under DSHEA, which was passed in 1994, dietary supplements that were in commerce prior to 1994 are broadly presumed safe. For these supplements, manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling them. Manufacturers must make sure that product label information is truthful and not misleading. For these products, the FDA is responsible for taking action against any unsafe or misbranded dietary supplement product after it reaches the market. 4 All new ingredients marketed within dietary supplements after 1994 that are not found in food must meet a stricter set of regulations and notification prior to release in the marketplace. 5 Nutrition Labeling and Education Act (NLEA): Signed into law in 1990, NLEA, among other things, set standards for allowing health claims on foods (including dietary supplements) if the claims are based on sound scientific evidence and are truthful, accurate and not misleading. 6 Fair Packaging and Labeling Act (FPLA): Enacted in 1967, FPLA requires that all consumer commodities be labeled to disclose the identity of the commodity- the name and place of business of the product s manufacturer, packer or distributor- as well as the net contents in terms of weight, measure or numerical count (measurement must be in both metric and inch/pound units). 7 Federal Food, Drug, and Cosmetic Act (FFDCA): Passed in 1938, FFDCA completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections. 8 Under FFDCA, dietary supplements are subject to both adulteration and misbranding provisions. Adulterated products are those that contain unlisted ingredients or are not prepared or packaged under good manufacturing conditions, and misbranded products are those with false or misleading labels. Adulterated or misbranded products and unapproved new drugs are subject to the full range of civil and criminal enforcement measures under the FFDCA and all violations of FFDCA are subject to criminal enforcement at the FDA s discretion. SOURCES:

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