On March 1, 2018, FDA announced the release of several guidance documents: final guidance on Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as Citizen Petition; final guidance on Reference Amounts Customarily Consumed: List of Products for Each Product Category Product Category; a small entity compliance guide on the new regulations regarding serving sizes; Questions and Answers for Industry on Dietary Fiber; and a Draft Guidance on Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products. The dietary fiber guidance and the added sugar in honey maple syrup and cranberry products guidance raise new issues.
Dietary Fiber Guidance
As we previously reported, in May 2016, FDA published a final rule amending the nutrition labeling regulations. Among other things, FDA redefined dietary fiber as non-digestible soluble and insoluble carbohydrates (with three or more monomeric units) and lignin that are intrinsic and intact in plants, and isolated or synthetic non-digestible carbohydrates (with three or more monomeric units)(hereinafter “added NDCs”) that FDA determines to have a physiological effect that is beneficial to human health. In November 2016, FDA issued a draft guidance describing FDA’s criteria in evaluating the evidence that an added NDC has a beneficial physiological effect. Using the approach described in the draft guidance, FDA determined that the available evidence for 26 added NDCs was insufficient to meet the standard. Therefore, these added NDCs did not qualify as dietary fiber for purposes of nutrition labeling.
As described in the final guidance, FDA has reconsidered some of its criteria and approaches used in the evaluation of evidence for added NDCs. Appendix A to the final guidance discusses the main changes in FDA’s position. Specifically:
- FDA will consider clinical studies conducted in diseased populations.
- In the draft guidance, FDA had taken the position that since foods are intended for the general U.S. population, it would not consider results from studies on individuals with a specific disease. However, as explained in the final guidance, FDA has decided that it will consider evidence from studies on individuals with a disease under certain circumstance, namely when “extrapolating to individuals who do not have the disease is scientifically appropriate.” For example, FDA would consider studies on constipated individuals when evaluating the effect of an added NDC on laxation.
- FDA also has reconsidered its position on evaluating whether a combination of two NDCs has a beneficial physiological effect. If a combination of isolated NDCs will be used as an ingredient, there are two options. Either the citizen petition provides data on a specific (fixed) combination of the added NDCs, or it provides evidence regarding the beneficial physiological effect of each individual NDC included in the combination.
- The final guidance also includes additional examples of physiological endpoints that FDA may consider, e.g. satiety and fecal output/fecal weight as measured on the basis of grams/day as a measure of laxation. However, FDA maintains its position that fermentation and changes in microbiota in the large intestine are not valid physiological endpoints.
- FDA will consider studies in which there is a statistically significant difference in baseline values between groups, provided that the statistical analysis includes adjustments for these differences or otherwise corrects for these differences.
- The final guidance provides more information about how FDA will weigh the strength of the evidence.
- In its request for data on added NDCs, FDA provided for a process to submit unpublished data. Although FDA maintains that it will consider unpublished data in its determination of whether the added NDC is a dietary fiber, it does encourage submission of publicly available data. Amending the regulation to include an additional added NDC that meets the definition of dietary fiber requires notice and comment rulemaking. This is a public process. Thus, data critical for the evaluation of the evidence of a beneficial physiological effect will need to be available to the public.
It remains to be seen to what extent FDA’s changes in its position regarding inclusion and exclusion criteria for the evaluation of evidence will affect its assessment of the data for the 26 added NDCs in 2016.As readers of this blog know, several Petitions regarding added NDCs have been submitted. The timing of FDA’s responses to these Petitions remains uncertain. In the updated Questions and Answers regarding Dietary Fiber, FDA states that it remains committed to completing the review process in the “near future.” Although the publication of the final guidance and the reconsiderations regarding key issues are a step forward, much uncertainty remains. Among other things, clarification as to what constitutes an added NDC vs. what is an intrinsic and intact NDC is needed.
Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products; Added Sugars with A Twist
FDA’s draft guidance on declaration of added sugars on honey and maple syrup and cranberry products is – for lack of a better word – interesting.
As readers of this blog may recall, a major issue in the amendment to the nutrition labeling regulations was the inclusion of the new requirement to declare added sugars. The final rule defines “added sugars,” in part, as “sugars that are either added during the processing of foods, or are packaged as such.” (Emphasis added). As a result, the term includes single ingredient products such as honey and syrups; e.g. a jar of honey and a bottle of maple syrup would need to declare added sugars in the nutrition facts panel. FDA got a large number of comments by the honey and maple syrup industries about this requirement. Specifically, the comments raised concerns that declaring added sugars on single ingredient honey and maple syrup products would suggest to consumers that the pure products contain added table sugar because added sugars are listed in the Nutrition Facts panel. Both of these product categories have a history of economic adulteration with cheaper sweeteners, and according to the comments, the declaration of added sugars might lead consumers to believe sweeteners are added.
FDA’s draft guidance provides a possible solution to this issue. FDA proposes to exercise enforcement discretion for products that use a “†” symbol immediately following the added sugars percent Daily Value in the Nutrition Facts panel. The “†” symbol may direct consumers to a truthful and non-misleading statement on the package outside the Nutrition Facts panel. In that statement, manufacturers may explain that no sugar was added to the pure honey or pure maple syrup. In short, the Nutrition Facts panel will state that the product contains added sugars but a statement outside the Nutrition Facts panel will state that these are not added sugars, but are naturally occurring.
The added sugar labeling requirement also puts certain cranberry products in a bad light. The cranberry industry submitted comments to FDA explaining that the added sugars declaration would be detrimental to the cranberry industry by implying that cranberry products are less nutritious than competing products that have similar amounts of total sugars and nutrients. Cranberries naturally contain little sugar and are extremely tart, so sugars usually are added for palatability. Other fruits that naturally contain more sugar and are palatable without additional sugar would not need to declare added sugars. For example, sweetened dried cranberries contain 29 grams of total sugars including 25 grams of added sugars per serving while raisins contain 29 grams of total sugars with zero added sugars per serving.
As with the honey and maple syrup products, FDA proposes to exercise enforcement discretion when such products use a “†” symbol immediately following the added sugars percent Daily Value in the Nutrition Facts panel. The “†” symbol may direct consumers to a truthful and non-misleading statement outside the Nutrition Facts panel explaining that addition of sugar to the cranberry product is meant to increase the palatability of the naturally tart fruit and that the amount of total sugars per serving is at a level that does not exceed the amount of total sugars in a comparable product with no added sugars.
Although these solutions might be palatable to some stakeholders, FDA’s proposed approach seems to undercut the basis for the requirement to declare added sugars. Undoubtedly consumer education will be crucial to explain that in some products added sugars are not a concern, whereas in other products these same added sugars are a concern.
To ensure consideration, comments to the draft guidance must be submitted by May 1, 2018.