Regulation
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Background
Regulation
Aspartame
Stevia
References

Text Box: How are sweeteners regulated? Supplements:  Supplements are not regulated.  Dietary supplements can be packaged and sold as such, but can not be added as an ingredient in non-supplement foods.  For example, supplements can not be added to yogurts, soft drinks, baked goods, chewing gums, but they can be included in vitamins or sold as supplement pills or powders.  For example, it has been legal to advertise and sell the leaves of the stevia plant as a supplement, but not as a sweetener.  Only recently did Rebaudioside A (Reb A), a chemical purified from stevia, achieve Generally Recognized as Safe status.  Reb A can now be included in foods as a sweetener.  For example, Wisdom Natural Brands first marketed SweetLeaf, stevia products, as supplements. Generally Recognized As Safe (GRAS):  Safety is determined by a long history of safe use or by experts based on widely available scientific research.  GRAS indicates that the substance is safe for a specific use and for a specific population or for the population as a whole.  Typically, the company interested in marketing a food product will recruit scientists to evaluate the research and make a statement about its safety.  GRAS was established in 1958.  In the 1960's, the safety of cyclamates, then considered GRAS, was called into question and President Nixon directed the FDA to affirm GRAS status (GRAS Affirmation).  In 1997, however, the is affirmation process was considered too cumbersome and was switched to voluntary GRAS Notification, in which those marketing the product submit GRAS Notification, a summary of the research and safety evaluation by a team of  experts, to the FDA for review.  The FDA responds by stating it has no questions about the statement or that it does have questions and requires more information.  The FDA maintains a list of GRAS Notifications that is accessible to the public.  The FDA website explains, "A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.”  Currently, Reb A, an extract from the stevia plant, is considered GRAS and three GRAS Notifications, including one from Cargill and one from Whole Earth Sweetener Company LLC, have been submitted to the FDA.  Wisdom Natural Brands also states that SweetLeaf is GRAS, which may account for a pending GRAS notification listed on the FDA GRAS list. Food Additive: Food Additives must be approved by the FDA.  FDA approves food additives based on a body of research that typically is not publically available for review by experts at large.  GRAS products are not classified as Food Additives.  The FDA classifies Food Additive sweeteners as Nutritive or Non-nutritive sweeteners   Aspartame (Nutrasweet, Equal) Nutritive Sweetener; FDA regulated Neotame Non-Nutritive Sweetener; FDA regulated Saccharin (Sweet'N Low, Sweet Twin, and Necta Sweet) Non-Nutritive Sweetener; FDA regulated Acesulfame-K (Sunett, Sweet One) Non-Nutritive Sweetener; FDA regulated Sucralose (Splenda) Non-Nutritive Sweetener; FDA regulated Rebaudioside A (Truvia, PureVia) GRAS    Acceptable Daily Intake (ADI): The ADI is the amount of substance that can be ingested daily over a lifetime without appreciable risk of adverse effect and is expressed as mg substance/ kg of body weight/ day.  It is based on an examination of data available at the time the ADI is determined and can be adjusted as more data becomes available.  Both animal and human studies are analyzed in determining ADI.  Typically, the highest dose that does not produce toxicity in animals (the No Observable Effect Level) is divided by 100 to account for differences in humans versus animals.  Thus, the ADI is not a toxic dose, but considered a safe dose with a margin wide enough such that occasional intake above the ADI will not be toxic.  The FDA has set the ADI for aspartame at 50 mg/kg body weight/day.  This is roughly equivalent to an adult drinking 20 12 oz cans of aspartame sweetened soda in one day.  The European Food Safety Authority (EFSA) has set the ADI for aspartame slightly lower at 40 mg/kg body weight/day.  Animal toxicity studies look for gross demonstrations of a substance’s propensity at different doses to cause cancer, reproductive consequences, illness, or death.  Routine toxicity studies cannot predict subtle effects on higher order thinking or human behavior or mood.  Nor can they predict individual reactions to a substance based on the individual’s genetic expression pattern.  For these and other reasons, the FDA continues to collect information about adverse reactions via the Adverse Reaction Monitoring System, to which individuals can post specific individual reactions.  Some of the adverse reactions posted have lead to further research. Cumulative Estimated Daily Intake (CEDI): The amount of substance consumed daily can be estimated in a number of ways.  Recently published in Critical Reviews of Toxicology, the Burdock Group used NHANES data to estimate the average daily consumption of aspartame by Americans.  NHANES is the National Health and Nutrition Examination Survey continuously conducted by the Center for Disease Control and Prevention (CDC) to track dietary and disease trends in Americans.  The Burdock Group found an average daily intake of aspartame for a 70kg adult to be 4.85mg/kg body weight/day.  The upper 95% intake was found to be 13.29 mg/kg body weight/day.  These values fall below the ADI.  Populations that may be consuming higher levels could include children (based on their lower body weight), teenagers, and diabetics.  The Burdock group projects CEDI worst case scenarios to fall below levels of ADI, except possibly in the case of diabetic teenagers if all artificial sweeteners were replaced with aspartame, an unrealistic scenario.  It is important to bear in mind, however, that the Burdock Group publication was funded by Ajinomoto Company, a manufacturer of aspartame.  The Burdock group expresses, however, that the independent scientists who contributed to the review of aspartame did not know the identity of the sponsor.