What’s In the Bottle?: A Look at the Dietary Supplement Industry

1. What’s In the Bottle?: A Look at the Dietary Supplement Industry Presented By CJ Pickering Live Your Best Life

2. Agenda What are dietary supplements Places that sell supplements What can and cannot be done by manufacturers Regulation of supplements Important information to look for before you purchase a supplement Best way to protect you and your family

3. What Are Supplements? Any substance that you can eat or drink that includes: vitamins, minerals, amino acids, essential fatty acids, herbs, or other plant/animal parts (WebMD, 2009) They can come in a pill, tablet, capsule, powder, or liquid form Purpose of a supplement is to “add to” the diet, not a substitute for food or good nutrition

4. Where To Find Supplements? Health food stores Pharmacies Fitness centers Grocery stores Online wholesalers/retailers Through the mail Some doctor’s offices All of these places and many more are offering supplements in the United States

5. Do’s and Don'ts of Labeling Manufacturers cannot legally state on their labels or in their advertisements that a dietary supplement can diagnose, cure, treat, or prevent disease Manufacturers can state that their product contributes to health maintenance and well-being

6. How Are Supplements Regulated? • The U.S. Food and Drug Administration (FDA) does not regulate dietary supplements with the same stringent guidelines as they do for medicines • The Food Drug and Cosmetic Act (FDCA) -amended by Dietary Supplement Health and Education Act of 1994 (DSHEA) DSHEA is the law that regulates supplements It regulates dietary supplements as foods, not drugs

7. Supplements Regulated Continued • Supplement manufacturers do not register or obtain approval with the FDA, prior to producing/selling products • Supplement manufacturers are not required to report “adverse events” to FDA, related to their products -FDA monitors through the voluntary reporting of “adverse events”, including: labeling claims, product literature, and laboratory testing

8. Supplement Regulation Continued Regulation of dietary supplement advertising: -Federal Trade Commission (FTC): regulates dietary supplement advertising for misleading claims and false information

9. Good Manufacturing Practices (GMPs) • GMPs are a list of firm and detailed procedures to ensure that products, such as drugs, dietary supplements, and food, are manufactured with the highest quality and fit for human consumption -Systems to prevent product contamination, sanitary manufacturing, correct product labeling, and any other errors that could occur during production that may effect human health

10. GMPs Continued -GMP products can be identified, tracked, and solved quickly -have a strict documentation process for all products, from production of raw ingredients to the distribution of the products

11. How To Protect Yourself Look for independent certification programs, which test for toxic contaminants, and that the ingredients on the label are contained in the bottle in the proper amounts United States Pharmacopeia (USP) manages Dietary Supplementation Verification Program (DSVP)

12. How To Protect Yourself Continued • Products that contain USP seal indicate that it has been tested for purity, integrity, dissolution, and safe manufacturing • USP is the only certification program that conducts random off-the-shelf testing • ConsumerLab.com – another company, which independently tests dietary supplements, results are available to subscribers • Reported that 25% of supplements have some kind of problem, and about 50% of all multi-vitamins

13. Other Certification Programs NSF International -National Sanitation Foundation - not for profit, non-governmental organization -provides standards, product certification, auditing, education and risk management for public health and safety

14. Other Certification Programs Continued • Natural Products Association -formerly known as the National Nutritional Foods Association (NNFA) -largest/oldest non-profit organization representing the natural products industry, with interest in the manufacturing and distribution of health food products -products include: health foods, dietary supplements, natural ingredient cosmetics, and sports nutrition products

15. In Closing… • Dietary supplements are an integral part of an over-all health and wellness program, which includes sound nutritional practices and regular physical activity • It is important to stay up-to-date on the current policies and regulations regarding the manufacturing and distribution of dietary supplements • Before use, make sure to research and find products that adhere to strict manufacturing practices, which bear such logos as the USP • Be sure to contact/consult with your physician prior to starting any supplement regimen

16. References WebMD. (2009, June 30). Dietary supplements. Retrieved from www.webmd.com/food/dietary-supplements www.usp.org www.consumerlab.com http://www.nsf.org/ http://www.npainfo.org/ http://www.nccam.nih.gov/ Consumer Reports. (2012 Aug 2). Consumer reports investigates vitamins and supplements: ten dangers that may surprise you. Retrieved from http://pressroom.consumerreports.org/pressroom/2012/08/my-entry.html Federal Trade Commission. (2010 July 14). Dietary supplement maker to pay 5.5 million to settle ftc false advertising charges. Retrieved from http://www.ftc.gov/opa/2010/07/iovate.shtm

17. References Continued Higdon, Jane. (2007 Jan 2). An evidence-based approach to dietary phytochemicals. Thieme. Hughes, Kerry, and Talbott, Shawn M. (2006 Sept 28). The health professional’s guide to dietary supplements. Lippincott Williams and Wilkins. Hurley, Dan. (2006). Natural causes: death, lies, and politics in America’s herbal supplement industry. Broadway Books. Nutrition Business Journal. (2011 Sept 1). Supplement business report. Retrieved from http://newhope360.com/2010-supplement-business-report-0 NSF. (2004). The importance of certification. Retrieved from http://www.nsf.org/consumer/dietary_supplements/dietary_certification.asp?program=DietarySup