title: The safety and regulatory process for low calorie sweeteners in the United States.
abstract: Low calorie sweeteners are some of the most thoroughly tested and evaluated of all food additives. Products including aspartame and saccharin, have undergone several rounds of risk assessment by the United States Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA), in relation to a number of potential safety concerns, including carcinogenicity and more recently, effects on body weight gain, glycemic control and effects on the gut microbiome. The majority of the modern day sweeteners; acesulfame K, advantame, aspartame, neotame and sucralose have been approved in the United States through the food additive process, whereas the most recent sweetener approvals for steviol glycosides and lo han guo have occurred through the Generally Recognized as Safe (GRAS) system, based on scientific procedures. While the regulatory process and review time of these two types of sweetener evaluations by the FDA differ, the same level of scientific evidence is required to support safety, so as to ensure a reasonable certainty of no harm.
authors.affiliation: Intertek Regulatory & Scientific Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario L5N 2X, Canada. Electronic address: ashley.roberts@intertek.com.
authors.forename: Ashley
authors.initials: A
authors.lastname: Roberts
mesh_terms: D005503:Food Additives / Q000009:adverse effects; D059022:Food Safety / Q000379:methods*; D006801:Humans; D064306:Non-Nutritive Sweeteners / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005503:Food Additives; D064306:Non-Nutritive Sweeteners
keywords: Generally Recognized as Safe (GRAS); Potency; Regulatory; Safety