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Recommendations Summary

GDM: High-Intensity Sweeteners 2016

Click here to see the explanation of recommendation ratings (Strong, Fair, Weak, Consensus, Insufficient Evidence) and labels (Imperative or Conditional). To see more detail on the evidence from which the following recommendations were drawn, use the hyperlinks in the Supporting Evidence Section below.


  • Recommendation(s)

    GDM: Use of High-Intensity Sweeteners

    In pregnant women with gestational diabetes mellitus (GDM), who choose to consume high-intensity sweeteners, the registered dietitian nutritionist (RDN) should educate the woman to select only those approved or generally recognized as safe (GRAS) by the US Food and Drug Administration (FDA) and to limit her intake to the acceptable daily intake (ADI), established by the FDA. The FDA has concluded the safety of six high-intensity sweeteners [saccharin, aspartame, acesulfame potassium (Ace-K), sucralose, neotame and advantame] when consumed within the ADI by the general population, including pregnant women. Steviol glycosides and Luo Han Guo (monk fruit) extracts are also GRAS when consumed within the ADI.

    Rating: Consensus
    Conditional

    • Risks/Harms of Implementing This Recommendation

      In a 1985 review of saccharin, the American Medical Association suggested pregnant women should consider avoiding saccharin, due to limited epidemiological studies in pregnant women and children (Council on Scientific Affairs, 1985). To date, more than 30 human studies have found that saccharin is safe for human consumption (FDA, 2015). Saccharin is approved for use as a non-nutritive, high-intensity sweetener by the FDA (FDA, 2015).      

    • Conditions of Application

      • This recommendation applies to pregnant women with GDM who are considering use of high-intensity sweeteners as a replacement for higher calorie sweeteners (sucrose, fructose, honey, etc.)
      • This recommendation applies only to high-intensity sweeteners within ADI levels (amount considered safe for consumption for each day over a person's lifetime) approved by the FDA and those that are GRAS in the United States  
      • Individuals with phenylketonuria (PKU), a rare hereditary disease, have difficulty metabolizing phenylalanine which is a component of aspartame. Those with PKU should control their intake of phenylalanine from all sources, including aspartame (FDA, 2015).  
      • Individuals should not add high-intensity sweeteners to their diet with the intention of improving blood sugar levels. Consumption of high-intensity sweeteners has not been found to have a significant impact on glycemic control in non-pregnant adults with Type 1 and Type 2 diabetes (AND, 2015).

    • Potential Costs Associated with Application

      There are no obvious costs associated with the application of this recommendation.

    • Recommendation Narrative

      • High-intensity sweeteners are commonly used as sugar substitutes or sugar alternatives because they are much sweeter than sugar, but contribute little to no carbohydrates or calories. High-intensity sweeteners are regulated by the FDA as a food additive, unless they are GRAS. Use of a GRAS substance does not require premarket approval by the FDA. For a substance to be determined GRAS there must be common knowledge within the expert scientific community regarding safety, and reasonable certainty that the substance is not harmful within intended use (Federal Register, 2016).
      • Six high-intensity sweeteners are FDA-approved as food additives in the United States: Saccharin, aspartame, acesulfame potassium (Ace-K), sucralose, neotame and advantame. These high-intensity sweeteners met safety standards for consumption by the general population, including pregnant women under certain conditions of use, as identified by the FDA (FDA, 2015). 
      • An ADI level, which is the amount considered safe for consumption for each day over a person’s lifetime, was set for each of the high-intensity sweeteners. GRAS notices have been submitted to the FDA for steviol glycosides and Luo Han Guo extracts (FDA, 2015).  
      • The position of the Academy of Nutrition and Dietetics is that use of nutritive sweeteners is acceptable during pregnancy, but there is very little evidence to support the use of nonnutritive sweeteners in GDM. However, FDA-approved nonnutritive sweeteners are acceptable, with the exception of aspartame in women with PKU (Fitch & Keim, 2012; Kaiser and Campbell, 2014). Based on FDA guidance, the American Diabetes Association (ADA, 2007) and Sweet Success (Shields and Tsay, 2015) also state that use of high-intensity sweeteners within the ADI are considered safe for consumption in the pregnant population.

    • Recommendation Strength Rationale

      Consensus: This topic was not included in the EAL systematic review. The recommendation is based on consensus publications.

    • Minority Opinions

      None.