C O U N C I L F O R R E S P O N S I B L E N U T R I T I O N 13 “More than 170 million Americans take dietary supplements each year, and the responsible industry is invested in bringing safe and quality products to meet this demand.” —CRN Statement on CNN, ‘Calls to Poison Centers About Supplements Up 50%, Especially Among Kids’ KEEPING UP WITH THE NDIs CRN actively participated in the regulatory process on New Dietary Ingredient (NDI) notifications: • Submitted comments to FDA on the development of a pre-DSHEA list of dietary ingredients as the “reasonable path forward” for the industry. • Presented CRN’s perspectives on a pre-DSHEA ingredient list at FDA’s public meeting. • Conducted a webinar for members and industry with Natural Products INSIDER following the meeting. SCIENCE-BASED RESPONSES Provided science-based analysis to support CRN responses to studies and reports, such as: • Statement emphasizing creatine’s strong safety record in response to a Pediatrics article, “Dietary Supplements and Young Teens: Misinformation and Access Provided by Retailers.” • Letter-to-the-editor published in Thyroid on iodine content of prenatal multivitamins in the U.S. • Letter-to-the-editor published in Journal of Medical Toxicology in response to study on reports to poison control centers related to dietary supplements. • Statement on Selective Androgen Receptor Modulators (SARMs). ENGAGEMENT IN KEY GROUPS • Global Retailer and Manufacturer Alliance (GRMA): Worked on development of a standard for dietary supplement GMP audits. • Dietary Supplement Quality Collaborative (DSQC): Worked with other stakeholders to raise the bar on dietary supplement quality. • AOAC International: Worked on developing standard methods for more dietary ingredients. • Regulatory Affairs Professionals Society (RAPS): Co-edited and published a bylined article— “Regulatory Focus” October publication. ADDITIONAL COMMENTS ON CRITICAL ISSUES CRN filed written comments on: • FDA’s definition of dietary fiber on labeling. • Use of the term “Healthy” in the labeling of human food products. • FDA Draft Guidance setting new standards for infant formula structure/function claims substantiation; co-signed a letter with the Grocery Manufacturers Association (GMA) and the Infant Nutrition Council of America (INCA). • FDA Draft Guidance on “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates.” • A citizen petition to FDA from the International Probiotics Association (IPA), requesting enforcement discretion on the use of colony- forming unit (CFUs) probiotic product labels (CRN partnered with IPA to release probiotics best practice guidelines, which went into effect January 2017). • A petition to FDA for a qualified health claim for magnesium and reduced risk of high blood pressure. • U.S. Department of Health and Human Services strategic plan for 2018–2022.