FDA has published two Federal Register notices (see here and here) announcing the availability of draft guidance documents that are intended to help address issues raised by the agency’s final rules (see here and here) amending Nutrition Facts and Supplement Facts labeling requirements. The draft guidance documents are:
- Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; and
- Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category.
These draft guidance documents are being distributed for comment purposes only.
The first draft guidance document, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format for Nutrition Facts and Supplement Facts panels. The draft addresses the following questions (note: “Nutrition Facts” includes Supplement Facts in these questions, as applicable):
- Must the updated Nutrition or Supplement Facts label appear on all foods sold by July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales)?
- When determining whether labels need to be in compliance with the new requirements, should the determination as to whether my company has $10 million or more in annual food sales be based on domestic food sales or total food sales, including international sales, and how many years of sales should I consider?
- Are there certain approved companies or nutrition databases manufacturers can use to get their nutrition values for their products?
- Who is responsible for the accuracy of the Nutrition Facts label on a food product’s label? Who is responsible for maintaining the records needed to verify the accuracy of certain nutrient declarations?
- How will FDA exercise enforcement discretion with respect to mandatory and dual-column nutrition labeling for bottled water products and coffee beans (whole or ground), tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that would have been exempt under §101.9(j)(4) prior to the effective date of the Nutrition Facts label final rule?
- Do sugars found in fruits and vegetables that have been processed to change the form of the fruit or vegetable (e.g., concentrated fruit and vegetable purees, fruit and vegetable pastes, and fruit and vegetable powders) need to be declared as added sugars on the label?
- How should I calculate the amount of added sugars in a fruit juice blend containing the juices of multiple fruits that have not been reconstituted to 100 percent (full-strength)?
- Can I use Brix values to calculate the added sugars declaration for a product containing fruit juice concentrates?
- I add 100% fruit juice to my product, but water is removed from the product during processing. Therefore, the fruit juice is concentrated during processing of my product. How do I determine the amount of added sugars in the finished product?
- The definition of added sugars excludes the “fruit component of fruit spreads.” What constitutes the “fruit component” of a non-standardized fruit spread?
- Should the added sugars contribution from concentrated fruit or vegetable juices be determined on a volume basis or on a weight basis?
- The regulation says in 21 CFR 101.9(c)(6)(iii) that added sugars are a “statement of the number of grams of added sugars in a serving, except that label declaration of added sugars content is not required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content.” What does FDA consider to be a “sweetener?” Do sweeteners include sugar alcohols and other low-calorie sweeteners?
- Some ingredients contain mono- and disaccharides (DP1 and DP2 (one and two degrees of polymerization)) that are created through processes such as hydrolysis. Do the mono and disaccharide portions of ingredients that are created through hydrolysis need to be declared as added sugars on the label?
- If sugars are added to a food that already contains inherent sugars (e.g. to cranberries, tart cherries, or yogurt), does that make “added sugars” a Class I nutrient for purposes of compliance under 21 CFR 101.9(g)? If so, does that mean that the composite must be formulated to be at least equal to the value for the added nutrient (added sugars) declared on the label per 21 CFR 101.9(g)(4)(i), or is 21 CFR 101.9(g)(5) allowing up to 20% in excess of the value declared applicable?
- Do sugars present in a sweet fermented beverage after fermentation need to be declared as total or added sugars on the label?
- Ingredients made primarily from sugar and created through non-enzymatic browning are added to some products for coloring and flavoring purposes. After non-enzymatic browning occurs, the sugar is reduced in the ingredient. In such a case, how much sugar must be declared as added sugars on the label?
- If sugar is added for fermentation during the leavening process of a baked good and some of the sugars are consumed by yeast, should the reduction in the amount of sugars be accounted for the declaration of added sugars?
- There is a chance that added sugars content prior to non-enzymatic browning and/or fermentation may be higher than the total sugars content of the finished food determined through chemical analysis. How do I approximate the added sugars value in this case?
- What are the specifications for thickness of lines and leading (e.g. space between lines) on the Nutrition Facts label?
- What are the requirements (e.g. for rounding) for the declaration of quantitative amounts of vitamins and minerals declared on the Nutrition and Supplement Facts labels? What does “levels of significance” mean in this context?
The second draft guidance document, when finalized, will provide examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in FDA’s regulation. The draft provides examples of products in each product category in Table 1 and Table 2 of the regulation.
While comments may be submitted at any time on guidance documents, to be considered by FDA in finalizing these two guidance documents, comments should be submitted by March 6, 2017. Submitted comments may address any of the topics discussed in the draft guidance documents. With regard to the first draft guidance document, FDA specifically seeks responses to the following questions:
- What, if any, concerns are there for manufacturers to use Brix values from 21 CFR 101.30 when calculating the added sugars content of products containing fruit juice concentrates?
- For purposes of calculating the amount of added sugars, what, if any, concerns are there if we consider that all of the water in a formulation with fruit or vegetable juice concentrate is used to reconstitute the fruit or vegetable juice? To illustrate the issue, assume that fruit juice concentrate is added to a food and that the manufacturer also adds water to the food. We recognize that the water may reconstitute the fruit juice, but also recognize that some portion of the water may have other purposes or affect ingredients other than the fruit juice concentrate. Nevertheless, to calculate the amount of added sugars, we would consider that all of the water goes towards reconstituting the fruit juice.
- What, if any, concerns are there if we consider that all of the water that has been removed from a product during processing contributes towards the concentration of juice added as an ingredient during the formulation of the product?