Natural Products Insider

NOV-DEC 2016

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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4 INSIDER November/December 2016 In the News So far this year, the food and beverage industry witnessed increased action on the legislative front to defi ne nutritional claims in a number of key sectors. Most recently, FDA has taken on two key defi nitions— "healthy" and "natural"—that have been the source of confusion for both industry stakeholders and consumers. Defi ning Healthy Under current FDA regulations adopted 20 years ago, foods featuring a "healthy" nutrient content claim must meet certain criteria related to cholesterol, fat, saturated fat, sodium and other nutrients such as calcium and vitamin A. However, FDA notes public health recommendations for various nutrients have evolved, as refl ected by the 2015-2020 Dietary Guidelines for Americans and the updated Nutrition Facts label. For example, healthy dietary patterns now focus on food groups and the type of fat rather than the total amount of fat consumed, and they address added sugars in the diet. Nutrients of public health concern, such as vitamin D and potassium, which Americans aren't getting enough of, also are getting more attention. After nearly two decades, FDA in September began the public comment process to redefi ne the "healthy" nutrient content claim for food labeling as part of an overall plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry. No timeline for fi nal guidance has been given, but food manufacturers can continue to use the term "healthy" on foods that meet the current regulatory defi nition while the agency is considering how to redefi ne the term "healthy" as a nutrient content claim. What's Really Natural Although FDA has not established a formal defi nition for the term "natural" or its derivatives, it does have a long-standing policy concerning the use of "natural" in human food labeling. The agency considers the term "natural" to mean that nothing artifi cial or synthetic (including all color additives, regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. But the policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization or irradiation. FDA also did not consider whether the term "natural" should describe any nutritional or other health benefi t. While this policy has been in place for decades, today's health-conscious consumers are pushing for more transparency about how foods are manufactured and seeking products made with clean-label ingredients. With the amount of litigation that has surrounded this claim, FDA began working on a formal process to defi ne "natural," and in May closed the comment period for the use of the term "natural" on the labeling of food products, including foods that are genetically engineered (GE) or contain genetically modifi ed organism (GMO) ingredients. No timeline has been given for a fi nal guidance. 2016: A Busy Year for Industry In January, USDA and Health and Human Services (HHS) released the long-awaited 2015 Dietary Guidelines for Americans (DGAs) that call for consumption of a variety of nutritious foods such as vegetables, fruits, grains, low-fat and fat-free dairy, lean meats and other protein foods and oils, while limiting saturated fats, trans fats, added sugars and sodium. Key changes from the 2010 DGAs include dropping the limit on dietary cholesterol (2010 DGAs recommended less than 300 mg/d) and changes to sodium, saturated fat, trans fat and added sugar intake. In May, FDA fi nalized the new Nutrition Facts label for packaged foods to refl ect new scientifi c information, including the link between diet and chronic diseases such as obesity and heart disease. The sweeping overhaul—the fi rst in 20 years—includes modifying the list of required nutrients that must be declared on the label, updating serving size requirements, and providing a refreshed design. In the works since March 2014, the updated Nutrition Facts label regulations apply to packaged foods except certain meat, poultry and processed egg products, which are regulated by USDA's Food Safety and Inspection Service (FSIS). Most food manufacturers will be required to use the new label by July 26, 2018; however, manufacturers with less than US$10 million in annual food sales will have an additional year to comply with the new rules. Foods imported to the United States also will need to meet the fi nal requirements. In August, FDA issued its fi nal rule detailing the criteria for concluding whether the use of a substance in human or animal food is generally recognized as safe (GRAS). Unlike food additives, GRAS substances are not subject to FDA pre- market approval; however, they must meet the same safety standards as approved food additives. The fi nal rule clarifi es the criteria for the use of a substance to be eligible for classifi cation as GRAS and establishes a new administrative procedure for any person to notify FDA of the basis for a conclusion that a substance is GRAS under the conditions of its intended use. Specifi cally, the rule addresses the types of scientifi c evidence that can be used to demonstrate safety—as well as the role of publications—in evaluating whether the scientifi c evidence of safety is GRAS. GRAS criteria requires the safe use of ingredients in human and animal food be widely recognized by the appropriate qualifi ed experts. The fi nal rule also formalizes the voluntary GRAS notifi cation procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010. FDA Set to Finally Defi ne 'Healthy,' 'Natural' Claims on Food Labeling by Judie Bizzozero

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