Abstract

For more than two decades, the nutrition information panels on foods sold in the US have remained largely unchanged. But in 2014, the US Food and Drug Administration (FDA) announced changes were on the way. The details have now been announced and most food manufacturers selling foods in the US will be required to use the new labels by July 2018; companies whose annual sales are < $10 million have an extra year to comply (www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm). The rules apply to all foods and dietary supplements sold in the US, including those imported from other countries. The aim of the revised format is to help consumers make better informed food choices. The main changes are summarised below but a key development that dominated the media coverage is that labels in future will show how much added sugar the food or drink contains (in grams), as well as the total sugar content, and the added sugar level will be compared with a dietary reference value of 10% of total energy intake, the Daily Value, which is equivalent to 50 g/day assuming a total energy intake of 2000 kcal/day. Declaration of the added sugar content will not be required for products that contain <1 g added sugars in a serving if no claims are made about sweeteners or sugars. The phrase ‘not a significant source of added sugars’ will be required at the bottom of the table of nutrient values if a statement of the added sugars content is not required. Alternative statements such as ‘less than 1 g’ are also permitted. If a serving of the food contains <0.5 g added sugars, added sugars content can be expressed as zero. The justification made for the 10% energy Daily Value is that it is difficult for Americans to meet nutrient needs while staying within calorie limits if they consume more than 10% of total daily calories from added sugar, and the Daily Value is consistent with the 2015–2020 Dietary Guidelines for Americans (www.health.gov/dietaryguidelines/2015/guidelines/). Daily Values are described as reference amounts of nutrients to consume or not to exceed and are used to calculate the per cent Daily Value (% DV) that manufacturers include on the label. The stated aim of the % DV is to help consumers understand the nutrition information in the context of a total daily diet. At first glance, the Daily Value may appear to be in alignment with the recent recommendation from the World Health Organization (WHO 2015), which is that free sugars intake should be reduced to below 10% of total energy intake. However, the definitions of ‘added sugars’ and ‘free sugars’ are not identical, as will become apparent. WHO defines free sugars as all monosaccharides and disaccharides added to foods by manufacturers, cooks and consumers, plus sugars naturally present in honey, syrups, fruit juice and fruit juice concentrates. The UK has also adopted free sugars to define its new dietary reference value, following the recommendation from the Scientific Advisory Committee on Nutrition (SACN) (PHE 2015; SACN 2015). SACN went further than WHO, advising that intakes should not exceed 5% of total energy, and this recommendation has since been adopted by the Departments of Health in the UK. SACN advised that free sugars includes all monosaccharides and disaccharides added to foods by manufacturers, cooks and consumers, plus sugars naturally present in honey, syrups and unsweetened fruit juices (no specific mention of fruit juice concentrates). So the two definitions are very similar and, under both, lactose (milk sugar), when naturally present in milk and milk products, and sugars contained within the cellular structure of foods (particularly fruits and vegetables) are excluded from the free sugars definition. The UK definition replaces the previously used ‘non-milk extrinsic sugars’ (NMES) (upon which the previous UK dietary reference value was based). These free sugars definitions are helpful to some extent but do not detail the many ingredients that provide sugars. Taking fruit derivatives as an example, sugars in dried fruits are not considered to be ‘free’ (they remain within the cellular structure of fruit); on the other hand, fruit juices have been determined by both SACN and WHO to be sources of free sugars as all of the sugars are released during the juicing process, whether this is done on an industrial scale or in the home. However, not captured in either SACN's or WHO's definition are fruits processed during manufacturing or indeed at home via stewing or pureeing. Also not captured are vegetable juices – are they also sources of free sugars? Public Health England has been developing a more detailed interpretation of this free sugars definition, expanding it into a set of working principles for estimating the free sugars content of foods, including composite foods with more than one source of sugars. A discussion paper on options for defining free sugars, for use in the government's National Diet and Nutrition Survey, was on the agenda for the SACN meeting in June 2016 (http://bit.ly/29DZWn2). The paper details Public Health England's recommendations and rationale on what is in and out of scope and provides two options for processed fruit: option one is to exclude processed fruit (e.g. stewed, canned and pureed) from the free sugars definition; and option two includes 50% of the sugars naturally present in processed fruit within the free sugars definition. The second option is closely aligned with the approach previously taken in estimating NMES. In its discussion in June, SACN identified a third option, which is expected to be the approach published later this year and adopted by Public Health England for its interpretation of dietary survey data and in the monitoring of dietary change against reference values. This option means that included in the definition of free sugars will be all added sugars; all sugars in drinks except lactose in milk based drinks; fruit and vegetable juices, all sugars in fruit and vegetable purees and similar products; and all sugars in jams and preserves. Excluded from the definition will be sugars in intact whole fruit and vegetables and in all processed fruit and vegetables without added sugar (e.g. dried, stewed without sugar, canned in water) except juices, smoothies, pulps and purees; lactose in milk; and the small amount of sugars in cereals, nuts and seeds. The principles will also help healthcare professionals advising on diet and food manufacturers seeking to improve the nutrient profiles of their food by changing the ingredients used. Converting an overarching definition to one that works in detail, in practice, is proving challenging. However, the biggest challenge following adoption of SACN's recommendations in the summer of 2015 has been helping consumers identify sources of free sugars, the types targeted for reduction, in the light of the fact that European legislation requires labelling of total sugars specifically and, as discussed in more detail below, free sugars cannot be determined directly in the laboratory, their presence has to be estimated from recipe information. So, back to the developments in the US, how do these free sugars definitions compare with the new definition used for added sugars in the US? It is evident from the commentary available in the Federal Register document (www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm) that the FDA has experienced similar challenges in defining what is or is not an ‘added sugar’. Also, there are some notable differences between the FDA's definition of added sugars and the definitions from WHO and SACN on free sugars, in terms of the ingredients captured. Before discussing these, it is worth noting that the European Food Safety Authority (EFSA) has a definition for ‘added sugars’, which is as follows: ‘sucrose, fructose, glucose, starch hydrolysates (glucose syrup, high fructose syrup) and other isolated sugar preparations used as such or added during food preparation and manufacturing’ (EFSA 2010). The US definition of added sugars includes sugars that are either added during the processing of foods or packaged as such and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from fruit or vegetable juice concentrates that are in excess of what would be provided from the same volume of 100% fruit or vegetable juice of the same type. The definition excludes fruit or vegetable juice concentrated from 100% fruit juice that is sold to consumers (e.g. frozen 100% fruit juice concentrate) as well as some sugars found in fruit and vegetable juices, jellies, jams, preserves and fruit spreads. So an obvious difference compared with the free sugars definitions referred to earlier is that pure fruit juice is not included in the US added sugars definition (but is in the free sugars definitions). The FDA documents indicate that whole fruits (including dried fruits without any added sugar), fruit pieces, pulps and purees are excluded from the definition of added sugars. Also excluded are dairy ingredients (e.g. skimmed milk powder) except for lactose. The definition will include single-ingredient foods, such as individually packaged table sugar, and added sugars present as sub ingredients. Sugars produced through incidental hydrolysis would be captured in the total sugars declaration but if a manufacturer purposely employs a hydrolysis step to increase the sugar content, then the sugar generated would be considered an added sugar. In products that undergo Maillard browning, the amount of added sugar before the Maillard browning is assumed to be a reasonable approximation of the amount of added sugars in the finished product in most if not all products. The FDA also expects that the amount of sugars added before non-enzymatic browning would be a reasonable approximation of the amount of added sugar in the finished product. The FDA provides the following examples of names for added sugars: brown sugar, corn sweetener, corn syrup, dextrose, fructose, fruit juice concentrates, glucose, high fructose corn syrup, honey, invert sugar, lactose, maltose, malt sugar, molasses, raw sugar, turbinado sugar, trehalose and sucrose, noting that this is not an exhaustive list of all added sugars. Sugar alcohols (e.g. sorbitol, isomalt and xylitol) are not considered to be added sugars. Skimming through the long Federal Register document, which lists the comments received during the consultation and the FDA's responses, it is evident that although some comments were in support of the proposed definition, other submissions said that the proposed definition is ambiguous, confusing and will lead to inconsistent application across the food industry. As has already proved to be the case in the UK with ‘free sugars’, determining exactly what is in and out of scope will take time and the US food and beverage industry, via its trade organisations, will more than likely be collecting implementation and interpretation questions from its members and will solicit feedback from the FDA. As briefly mentioned previously, total sugars values, as required for food labelling around the world, are routinely derived by laboratory analysis but, because free sugars and naturally occurring sugars are not chemically distinct, it is not possible to do a laboratory analysis to determine the amount of free sugars in a product that contains both naturally occurring sugars and free sugars (e.g. a sweetened fruit yogurt). As the FDA Federal Register document points out, the same problem applies to the estimation of added sugars. So, if both naturally occurring and added sugars are present, manufacturers in the US will have to use other information to determine a label value; it is not possible to rely on direct laboratory analysis. Under the new rules, companies will also have to make and keep records to support the declared value. This will inevitably result in the need for manufacturers and retailers to go back to their respective suppliers in order to document added sugars coming from ingredients. It seems that a report will need to be available upon request of an FDA authority as to how added sugars were calculated. It also seems that the calculation of added sugars is still unclear to many and, again as has been the case in the UK, further clarification may be needed. The Canadian government has also been reviewing its approach to nutrition labelling and communication of information about the sugars content of a food (http://bit.ly/29AjnZX) and is proposing a different approach to the US. Instead of an added sugars declaration within the nutrition panel, the plan is to group added sugars together in brackets in the ingredients list following the common term ‘sugars’, in weight order from most to least. In this context, ‘sugars’ includes sugar, glucose-fructose, honey, malted barley, ‘fancy’ molasses, fruit juice, concentrates and purees that are added to replace sugars in food. Accompanying this in the nutrition panel will be a value for (total) sugars alongside a % Daily Value figure; the daily value has been set as 100 g per day (http://bit.ly/29Aknxa). So, if 15 g of sugars are provided, the % DV will be 15%. In addition, it is proposed that guidance is given at the bottom of the table as follows: 5% or less is a little, 15% or more is a lot. Other points of interest in the proposals are that labelling information is presented per serving (presented in both household measures and metric measure equivalent); and that serving sizes will become more consistent and realistic. As referred to later for the US, these serving sizes will better reflect the amount that Canadians typically eat in one sitting and will make it easier to compare similar foods. More details can be found at http://bit.ly/29KMnDq. Along with the inclusion of added sugars, there are a number of other features that are illustrated in Figure 1, which compares made-up food labels using the old and new US formats. For example, the list of nutrients that are required or permitted to be declared is being updated. Vitamin D and potassium will in future be required on the label. Calcium and iron will continue to be required. Vitamins A and C will no longer be required but can be included on a voluntary basis. While continuing to require ‘Total Fat’, ‘Saturated Fat’ and ‘Trans Fat’ on the label, ‘Calories from Fat’ is being removed because research has shown that the type of fat is more important than the amount. Daily Values for some nutrients (e.g. sodium, dietary fibre and vitamin D) are being updated to reflect newer scientific evidence from the Institute of Medicine and other reports such as the 2015 Dietary Guidelines Advisory Committee Report (www.health.gov/dietaryguidelines/2015-scientific-report/), which was used in developing the 2015–2020 Dietary Guidelines for Americans referred to earlier. Source: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm The overall appearance of the label remains the same but the typeface (font) size will be increased for the word ‘Calories’, ‘servings per container’, and the ‘Serving size’ declaration, and the number of calories and the ‘Serving size’ declaration will be in bold to highlight this information. Manufacturers will have to declare the actual amount, in addition to the % DV, for vitamin D, calcium, iron and potassium. They can voluntarily declare the amount in grams for other vitamins and minerals. A footnote is to be used to better explain what % DV means. It will read: ‘the % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2000 calories a day is used for general nutrition advice’. In the US, by law, serving sizes must be based on amounts of foods and beverages that people are actually eating, not what they should be eating; this approach differs from that advocated in some other countries. How much people eat and drink has changed since the previous serving size requirements were published in 1993. For example, the reference amount used to set a serving of ice cream was previously ½ cup but this is changing to ⅔ cup. The reference amount used to set a serving of carbonated drink is changing from 8 fluid ounces to 12 fluid ounces. Time will tell whether this change will act as a signal to moderate intake or, controversially, will justify or legitimise the larger quantities as ‘what other people consume’ or even ‘what is recommended’ (i.e. the social norm). There is evidence that package size affects what people eat (Hollands et al. 2015; see Buttriss 2016). So for packages that are between one and two servings, such as a 20-ounce drink or a 15-ounce can of soup, the calories and other nutrients will be required to be labelled as if the package provides one serving because in the US people will typically consume it in one sitting. For certain products that are larger than a single serving but that could be consumed in one sitting or multiple sittings, manufacturers will have to provide ‘dual-column’ labels to indicate either the amount of calories and nutrients on both a ‘per serving’ and ‘per package’/‘per unit’ basis. Examples would be a 24-ounce bottle of carbonated drink or a pint of ice cream. The FDA says that with dual-column labels available, people will be able to easily understand how many calories and nutrients they are getting if they eat or drink the entire package/unit at one time. Figure 2 illustrates the main changes between the old and new labels. Source: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm Having sugars definitions that differ from one country or region to another will no doubt result in challenges for companies operating across different regions. Of course, the various definitions also capture different proportions of sugars, making it very difficult to compare sugars intake data (other than data for total sugars) in surveys from one country versus another (e.g. UK vs. US). The different labelling definitions can also be expected to be adopted as definitions in research studies conducted in various parts of the world, making comparisons between studies and meta-analyses problematic. The added sugars definition adopted for the US appears to capture fewer sources of sugars, not only is processed fruit excluded, but also fruit juices. So, to reduce intake of ‘added sugars’ to 10% or less of energy will seemingly be easier than to achieve 10% of energy from ‘free sugars’; the challenge is of course compounded in the UK as the recommendation is to reduce intake of free sugars to less than 5% of energy intake.

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