The New Food Labels: Information Clinicians Can Use

Editor's Note:
For the first time in 20 years, the US Food and Drug Administration (FDA) has announced plans to update the Nutrition Facts label. The proposed changes reflect new dietary recommendations; consensus reports; and national survey data, including the 2010 Dietary Guidelines for Americans,^[1] nutrient intake recommendations from the Institute of Medicine, and intake data from the National Health and Nutrition Examination Survey. The FDA also obtained extensive input from a wide range of stakeholders, including the food industry, health groups, and consumer advocates. The timeline for rollout of new labels is still being developed, but the FDA anticipates working on the final regulation after the 90-day comment period ends.

Although this is primarily a consumer issue aimed at making it easier to make healthy food choices, clinicians can anticipate that several changes will result in diet-related questions from patients. Medscape spoke with Jessica Leighton, PhD, MPH, Senior Advisor for Nutrition Science and Policy, and Claudine Kavanaugh, PhD, MPH, RD, a health scientist, both in the FDA's Office of Foods and Veterinary Medicine, about the key changes that healthcare professionals should be prepared to discuss with their patients.

Medscape: Why is the FDA updating the Nutrition Facts label now?

Dr. Leighton: In 1990, Congress passed the Nutrition Labeling and Education Act, which required that nutrition information be disclosed on most packaged foods. Regulations to implement this law became effective in 1994.

The purpose of the Nutrition Facts label is to provide the general public with information necessary to choose healthy diets. Such information is just one tool to help people both maintain healthy weight and make healthier food choices. Over the 20 years since the labeling law was implemented, a lot of new science has looked at the relationship between nutrients and chronic diseases.

We also know that the public health profile of the population has changed. For example, we've seen a dramatic increase in the rates of obesity. Portion sizes and the amount of food that people are consuming have also changed. We recognize that it's important to update the label to reflect all of this new science and public health information.

On March 3, we published 2 proposals to update the requirements on the Nutrition Facts label. One of these proposed updates to nutrients required or permitted to be on the label; updates to reference values used to calculate the percent daily value; and changes to the format of the label to draw attention to such information as calories and serving size, which are important given the obesity problem in our country.

The other proposal updates the information that food companies use to calculate serving size on the package. By law, the serving size information must be based on what people are actually eating in a sitting. They are not recommended amounts. This proposal also addressed the labeling of smaller package sizes, which people tend to eat in a single sitting, rather than over time.

The comment period is open for 90 days. During that time, we encourage anyone -- industry, advocacy groups, public health organizations, or consumers -- to respond and provide comments on the proposed regulations. We will consider the comments as we are developing the final regulations, which will establish the final requirements that manufacturers must follow.

Medscape: One of the biggest changes in the proposed labels is that information about the amount of "added sugars" in a food product would now be required. The 2010 Dietary Guidelines for Americans state that intake of added sugar is too high in the US population and should be reduced. However, unlike other nutrients, there is not an accepted daily value for added sugars. What are the advantages of this change, and how should clinicians advise their patients to use this information?

Dr. Kavanaugh: The reason we're requiring added sugars on the label is to be consistent with recommendations in the Dietary Guidelines for Americans. The Guidelines state that calories from added sugars should be reduced.

The average American consumes 16% of their daily caloric intake from added sugars; this is too much. High intakes of added sugars can decrease the intake of nutrient-rich foods while also increasing the overall calories that people are consuming.

With the current label, consumers don't have information about added sugars in food products to help them comply with the recommendations of the Dietary Guideline for Americans. Some information on added sugars can be found in the ingredient label, but the exact amounts are not available on packages. Consumers may not even know which ingredients are added sugars. For example, consumers may not know that concentrated fruit juices are a form of added sugar.

We are not proposing to include a daily value for added sugar, because there are no quantitative intake recommendations from government consensus reports to set a daily value. But having added sugars on the label, if the proposals are finalized, will allow clinicians and health professionals to help their patients identify products that have added sugars, as well as compare products. A consumer would be able to look at 2 different types of yogurt, for example, and be able to easily see which has less added sugar.

Medscape: The proposed labels would also require the declaration of potassium and vitamin D. Vitamins A and C would no longer be required on the label, although manufacturers could declare them voluntarily.

Vitamin D deficiency is widely prevalent.^[2] Estimates of incidence vary significantly, with a recent 2013 study suggesting that as many as one third to one half of adults in developing countries may have some degree of deficiency.^[3] However, the consensus is that this is largely due to inadequate cutaneous production resulting from decreased exposure to sunlight, and not primarily from low dietary intake. Thus. recommendations regarding dietary intake can be complex and must take into account an individual's sun exposure, sex, and age; the region in which they live; and their skin color.

What is the best advice for clinicians to provide patients on how to use this information regarding vitamin D in foods?

Dr. Leighton: We know that vitamin D is important for health, especially for its role in bone health. We know that intakes in some population groups are not adequate and that some patients get inadequate exposure to sunlight.

There are a limited number of foods that are naturally high in vitamin D. There are other foods that for many years have been fortified with vitamin D, most importantly milk. Milk has been voluntarily fortified with vitamin D since the early part of the last century, and dairy products have been important sources of vitamin D for many consumers.

There are some population groups, such as elderly persons and people with limited sun exposure, who are at risk of having inadequate vitamin D intakes; the labeling information would help consumers to know what foods actually do or don't contain vitamin D. Clinicians will be able to refer to consistent information related to vitamin D on a label and direct their patients to that information to see which foods are higher in vitamin D.

Medscape: The proposed label changes also update serving size requirements to reflect the amounts people currently eat, which for better or worse has changed in the 20 years since the current labels were created. By law, serving sizes must be based on what people actually eat, not on what people "should" be eating. This can be a tough message for clinicians, who must simultaneously talk to patients about moderating serving sizes. What do you suggest as best strategies for messaging?

Dr. Leighton: Current serving sizes on labels were based on data that were analyzed in the early 1990s from surveys done in the 1970s and 1980s. So that information is outdated. Clinicians can emphasize to their patients that serving size information on packages is not actually the recommended amounts, but instead reflect what people are actually eating. So if clinicians -- and consumers -- understand that, they're more likely to know that for some foods, the serving sizes consumed should be less than what is indicated on the label, depending on such factors as caloric needs.

Having the serving size information reflect what people are actually eating helps consumers be more aware of what they're consuming without having to do the math. For example, a pint of ice cream currently labeled as 4 servings would instead be only 2 servings under the new proposed requirements. People would be more able to see that if they consume a cup of ice cream, they will be getting 400 calories in that serving. They would no longer be required to do the math to figure out what is in their actual serving.

It's important that clinicians also recommend to their patients that limiting serving size is an important factor in weight control. By looking at the package, they can know how big a serving size is and how many calories they are actually consuming in that serving size.

Medscape: Sodium values reflect a slight decrease in the daily value for sodium, from 2400 to 2300 mg. However, the American Heart Association (AHA), while commending the FDA's changes, noted that this sodium recommendation was still too high. The AHA recommends that sodium intake be limited to 1500 mg/day.^[4] Can you discuss the evidence that is behind the proposed daily value of 2300 mg?

Dr. Kavanaugh: As your readers know, sodium is an essential nutrient, and increases in sodium can increase blood pressure and the risk for cardiovascular disease. Although we are proposing to change the daily value from 2400 mg to 2300 mg, people are still consuming too much. On average, people consume about 3400 mg of sodium per day. The 2300 mg recommendation we are proposing is based on the upper dietary intake limit for sodium that was established by the Institute of Medicine in 2005.^[5] If patients lower their intake to this amount, it would still result in a considerable reduction in their current intake of sodium.

Although certainly, some evidence does point to the need for a lower daily value, a 2013 Institute of Medicine report concluded that evidence from studies on direct health outcomes is inconsistent and insufficient to conclude that lowering sodium intakes below 2300 mg will increase or decrease the risk for cardiovascular disease outcomes or mortality in the general US population or in specific subgroups.^[6]

Medscape: What would you suggest as the best resources or other information that clinicians provide to their patients who wish to read more about these changes?

Dr. Kavanaugh: The FDA has materials on our Website that discuss these changes. This includes 3 consumer updates that go over the changes we're making on the label. In particular, they address the question of why we are requiring added sugars, the change in serving sizes, and the format changes, as well as the underlying science that we used to update the label. We also have some materials on how to use the current nutrition facts label on our Website that clinicians will find to be helpful resources for their patients.

Medscape: Are there any other key points you wish to emphasize for our clinician audience?

Dr. Kavanaugh: We think it is important to note that the new labels will highlight calories and serving sizes more prominently. The information about calories and serving size is a lot larger and bolder on the proposed new labels. We are proposing these changes so that people can find the information more easily. We think this is particularly important, because the majority of the US population is overweight or obese.

One other important item to note for clinicians is that the proposed labels would include the absolute amount, in grams, milligrams, or micrograms, of all of the vitamins and minerals on the label. Currently, information about some vitamins or minerals, such as calcium or iron, includes only the percent daily value contained in that food item.

A cereal box, for example, includes the daily values of a lot of nutrients contained in a serving, many of which are not required to be on the label. On the proposed labels, manufacturers would actually have to put the absolute amount of each vitamin and mineral in addition to the daily value. That can be very helpful for clinicians, who may need to instruct a patient about how much calcium they need to consume in a day. With the addition of the absolute amounts, they could see how much calcium is in a particular product in addition to using the daily value as a guide. We're adding this because of input we received from clinicians and health professionals in response to the Advance Notice of Proposed Rulemaking that this would be helpful for them.

Dr. Leighton: Clearly, clinicians can also use the label to help their patients who need to specifically reduce or increase the amount of certain nutrients because they have certain conditions, and we hope they do that. However, we want to note that the label is intended for use by the general population and those at high risk for chronic disease.

Editor’s Note: The FDA provides comprehensive online resources for consumer education.