Putting Added Sugars Into Context for Consumers

By: Susan Mayne, Ph.D.

For two decades, consumers have been able to check the Nutrition Facts label to understand not only how much saturated fat, dietary fiber and sodium is in any given food, but how that amount fits in the context of their daily diet. Today, FDA proposes a supplemental rule that would provide consumers with access to that same information for added sugars. This would fill a gap by providing the same valuable content already available to consumers for other nutrients.

Susan MayneIn March 2014, FDA proposed to include the amount of added sugars in grams on the Nutrition Facts label but without the percent Daily Value, and we continue to review comments on this proposed rule. Now, in addition, we are proposing to include on the Nutrition Facts label the percent Daily Value (% DV) for added sugars and are accepting comments on this additional provision.

Why propose providing this additional information to consumers? Scientific data shows that it is difficult to meet nutrient needs while staying within calorie requirements if you consume more than 10 percent of your total daily calories from added sugar. The Dietary Guidelines Advisory Committee (DGAC), whose recommendations inform the Dietary Guidelines for Americans, the foundation for national nutrition programs, standards and education, used the same data in the analysis for their recommendations earlier this year.

FDA considered the evidence and determined that it supports setting a Daily Value for added sugars. The Daily Value, which is used to calculate the percent Daily Value that consumers see on the Nutrition Facts label, would be 50 grams of added sugars for adults and children 4 years of age and older and 25 grams for children 1 through 3 years.

FDA’s initial proposal to include the amount of added sugars on the Nutrition Facts label is now further supported by newly reviewed studies suggesting healthy dietary patterns, including lower amounts of sugar-sweetened foods and beverages, are strongly associated with a reduced risk of cardiovascular disease.

Consumers can still choose foods that have added sugars as part of a healthy diet, but the proposed Daily Value would provide a benchmark for intake. Without information like this about a nutrient, it’s hard to know if you’re eating too much or too little in a given day. For example, a consumer who drinks a 20-ounce sugared beverage may be surprised to know it contains about 66 grams of added sugar, which would be listed on the label as 132 percent of the Daily Value.

We know that consumers may need some help getting used to this new information. Coming to FDA from outside of government with a background in public health nutrition, I have a great appreciation for the need to educate people to use the information we provide to them. I look forward to working with the nutrition community in this effort.

Susan Mayne, Ph.D., is FDA’s Director of the Center for Food Safety and Applied Nutrition

Protecting Consumers from Trans Fat

By: Susan Mayne

FDA is taking a step today to remove artificial trans fat from the food supply. This action will save many thousands of lives.

Susan MaynePHOs or partially hydrogenated oils have been used as ingredients since the 1950s to improve the shelf-life of processed foods. FDA has issued a final determination that PHOs, the primary source of industrially-produced trans fat in processed foods, are not “Generally Recognized as Safe” or GRAS. This means that PHOs may no longer be added to food after June 18, 2018, unless they are otherwise approved by FDA.

In this case, it has become clear that what’s good for extending shelf-life is not equally good for extending human life. A 2002 report by the National Academy of Sciences’ Institute of Medicine found a direct correlation between intake of trans fat and increased levels of low density lipoprotein (LDL) cholesterol. LDL cholesterol is commonly known as “bad” cholesterol, because it contributes to clogged, damaged arteries.

What this means is that there is an increased risk of heart disease, so much so that this action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks each year.

In 2006, FDA required that manufacturers declare the amount of trans fat on the Nutrition Facts label because of these public health concerns. Many manufacturers responded by voluntarily changing their product formulations to reduce or eliminate trans fat, and consumers started avoiding foods with trans fat.

Despite the declines in trans fat in foods, PHOs have continued to be found in some brands of popular food products, such as frostings, microwave popcorn, packaged pies, frozen pizzas, stick margarines and coffee creamers. And for consumers who consistently choose products with added PHOs, their daily intake of industrially-produced trans fat is approximately twice as high as the average consumer. Today, FDA has issued its determination that PHOs are not generally recognized as safe.

We are establishing a three year compliance period. This will allow for an orderly process as companies make the transition — to reformulate products and if they choose, to allow companies or other interested parties to use the food additive petition process to present evidence to FDA as to whether any uses of PHOs meet our standard for safety. Thus, industry is responsible for providing evidence to FDA to demonstrate safety, while FDA is responsible for evaluating that evidence to determine whether to approve PHOs for any specific intended use.

We know that many companies have already removed PHOs and we expect that others will accelerate the phasing out of PHOs based on today’s action. FDA encourages consumers seeking to reduce trans fat intake to check the Nutrition Facts label for trans fat. The most effective way to avoid PHOs is to check the ingredient list for partially hydrogenated oils. Even if trans fat is listed as “0”, some PHOs could be in the product.

At the heart of FDA’s mission is a responsibility to ensure that the foods we eat, and share with our family, are as safe as possible. It’s a responsibility to protect health by taking action when needed, based on the best available science. This action will ultimately allow all of us to enjoy safer foods and healthier lives.

Susan Mayne, Ph.D., is the Director of FDA’s Center for Food Safety and Applied Nutrition

The Meaning of Wearing Red

By: Margaret A. Hamburg, M.D.

Last night I had the pleasure of attending the annual Woman’s Day Red Dress awards ceremony in New York City. The event is one of the highlights of American Heart Month, and it was created by that magazine to educate Americans about, and help fight, heart disease, which has become the number one killer of women. Many are surprised to learn that while breast cancer is the cause of death of one in every 31 American women, one of every three women dies of heart disease. So I found it particularly meaningful, both as a doctor and a woman, to be honored for FDA’s work to improve women’s cardiovascular health.

Commissioner Hamburg at Event

FDA Commissioner Margaret A. Hamburg, M.D., at the Woman’s Day Red Dress awards ceremony in New York City

One of our efforts toward this end that was cited by the magazine was the proposal to update the Nutrition Facts Label. The proposed updates would more prominently highlight calorie and serving size information, inform consumers about “added sugars,” update the daily values for nutrients, and ensure that the serving size requirements reflect the amounts of food people actually consume. They would encourage consumers to use the label to take note of foods high in sodium, saturated fat, and trans fat, which can increase the risk of coronary heart disease.

We also published final rules on restaurant menu and vending machine labeling. Calorie information is the key component of these requirements, and obesity is associated with a range of heart disease related problems. The new rules also require that other nutrition information, such as sodium, is provided upon the consumer’s request. High sodium intake can increase blood pressure, a major risk factor for heart disease. As with the nutrition facts label, these menu labeling requirements will give consumers nutrition information they need to be able to make healthy food choices for themselves and their families.

Another part of FDA that matters for cardiovascular health is our Center for Tobacco Products. Though its work is designed to protect the health of all Americans, it has special significance for women who, sadly, are catching up to men in the prevalence of tobacco-related diseases.

In the last 50 years, a woman’s risk of dying from smoking has more than tripled, and is now equal to that for men – not what we desire when we talk about equality. The more than 20 million women in the U.S. who smoke cigarettes are at risk not just for heart attacks, lung cancer, and strokes, but also emphysema and other serious chronic illnesses such as diabetes.

Our actions on smoking and nutrition have been complemented by the work of the Office of Women’s Health. Its outreach initiatives have helped provide women with tips and resources they can use to make better heart health decisions for themselves and their families. This Office has also supported research on treatment of heart disease in women.

FDA’s responsibilities also include reviewing, approving, and helping advance new and innovative medical products to diagnose, treat and prevent heart disease, including life-saving medical devices such as artificial hearts, stents, and heart valves, essential tests like echocardiograms, and important drugs for hypertension, lowering cholesterol and treating other aspects of cardiovascular disease.

Over the years, FDA’s support of women’s health has grown thanks to scientific advances, changes in society, and improvements in the agency itself. We will continue to promote these goals, not just in the area of cardiovascular health, but in women’s health more generally.

Of course, we can’t do it alone. And that’s why I sincerely welcome such events as the National Wear Red Day and Woman’s Day’s red dress awards. They help focus our nation’s attention and energy on the fight against women’s heart disease to which we, at FDA, are fully committed.

Margaret A. Hamburg, M.D., is the Commissioner of Food and Drugs

Planning Healthy Changes to the Nutrition Facts Label

By: Margaret A. Hamburg, M.D.

When the Nutrition Facts Label was created in 1993, it was revolutionary. For the first time, consumers could read the nutrition information on a food package to know what was in it and that the information was held to government standards for consistency and accuracy. This rectangular box has since become one of the world’s most recognized graphics, with countries around the world adopting their own version.

Margaret Hamburg, M.D.To continue the spirit and purpose of the Nutrition Facts Label, we are proposing important changes to bring it fully into the 21st century. A lot has changed in the past 20 years. Much more is known about food consumption and nutrition, the health of our population and the dietary choices that can help keep us healthy or make us vulnerable to an array of chronic diseases.

The changes that we’re proposing reflect that knowledge, based on an extensive examination of the latest public health trends and research on nutrition and disease, including obesity. There is a lot of information on FDA.gov about our plans, but I’d like to hit the highlights:

  • “Added sugars” would be listed on the label along with the current “Sugars” declaration (which includes both naturally occurring and added sugar). This alone is huge: The average American takes in many calories every day in sugars added during food production. Experts call these “empty calories” that often take the place of foods rich in nutrients.
  • Speaking of nutrients, listing the amount of Vitamin D and potassium – which many of us don’t get enough of – would be required. They would join calcium and iron as nutrients important to public health.
  • People generally eat differently today than they did 20 years ago. The serving size requirements would be updated to more accurately reflect what we’re actually eating. By law, serving sizes must be based on what people actually eat, not on what people “should” be eating.
  • Certain packages that are typically eaten in one sitting would be required to be labeled as a single serving, which would mean you would know how many calories and nutrients you are consuming for the whole package. For example, a 20-ounce soft drink would be one serving under the proposal, not more. Certain larger packages that could be consumed in one sitting or in multiple sittings would be required to be labeled per serving and per package.
  • While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.
  • The format would be modernized. Calories and serving sizes would be displayed more prominently in larger, bold type. The %DV (daily value) would be moved to the left, so that you can immediately put a nutrient in the context of your daily dietary needs.

I’ve been asked if we’re proposing these changes because an increasing number of people in this country, including children, are obese and at risk of serious diseases tied to food consumption.

The answer is both no – and yes.

No, because the Nutrition Facts Label is for everyone. FDA does not regulate diets, but we can make sure that you know exactly what you’re eating. Having more information can enable you to make an educated decision about the foods you eat and serve your family.

Yes, because we know that too many people’s health is being compromised by the food they eat. This includes those at risk for serious disease like cardiovascular disease, hypertension, strokes, diabetes, and obesity and all of us to wanting to have healthy diets can tell at a glance what is in a particular food.

As a consumer myself, I would find a Nutrition Facts Label that reflects the current science very helpful when making food choices for myself and my family. These changes should make it easier than ever to judge a food by its label.

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration.

Trans Fat: Taking the Next Important Step

By: Michael R. Taylor 

With all of our worthy focus on implementing the Food Safety Modernization Act this past year, we must not lose sight of other critical areas in which FDA, and specifically the Center for Food Safety and Applied Nutrition, must work and be effective to protect public health. 

One of our core regulatory functions is ensuring that food, including all substances added to food, is safe.  If evidence suggests that a product already in use is unsafe, we take steps to protect the public health. That is what we are doing in the case of partially hydrogenated oils, the major source of artificial trans fat. 

There is a lot of evidence showing that trans fat intake can increase the risk of heart disease by raising low density lipoprotein (LDL) cholesterol, commonly referred to as “bad” cholesterol. Trans fat has been a concern for some time, and that is why ever since 2006, FDA has required that food manufacturers declare the amount of trans fat on the Nutrition Facts label. 

We’ve come a long way since then. In the United States, consumption of trans fat from products containing partially hydrogenated oils has declined dramatically from 4.6 grams per day in 2003 to about 1 gram per day in 2012, according to FDA estimates. And food manufacturers have made significant progress to reduce the levels of trans fat in processed foods. But there are still many processed foods with trans fat including some snack foods, microwave popcorn, frozen pizzas, cakes, cookies, stick margarine products, coffee creamers, pies, and ready-to-use icing products. Many restaurants are also cooking with less trans fat. Elimination of industrially produced trans fat from foods could prevent 20,000 heart attacks and 7000 heart-related deaths each year. 

So now we are ready to take the next important step that could lead to the removal of partially hydrogenated oils from processed foods. Partially hydrogenated oils have long been considered by industry to be “generally recognized as safe,” or GRAS, for their use in food. GRAS status implies that they are regarded by experts as safe under the conditions of intended use. This means they can be added to food without being approved in advance by FDA. 

Because of the evidence linking trans fats to an increase in the risk of heart disease, however, FDA has preliminarily determined that partially hydrogenated oils are no longer GRAS for any use in food. We are providing a 60-day comment period to ask for additional information. If, after reviewing the comments and scientific information submitted, FDA makes the final determination that partially hydrogenated oils are not GRAS and are not otherwise authorized for use in food, such oils become unapproved food additives. That would make their use unlawful unless a company or other petitioner could prove to FDA that one or more specific uses are safe under the “reasonable certainty of no harm” safety standard. 

If FDA ultimately determines that partially hydrogenated oils cannot be used in food, we recognize that it may take some time to phase out their use. Therefore, in our notice we are seeking input on the time that industry would need to remove partially hydrogenated oils from the food supply. If we finalize our tentative determination, we would provide industry with time to comply. 

Consumers who are interested in reducing their trans fat intake can take steps now. First, choose products that are labeled as having “0” trans fat. But under current regulations, even these products can have up to 0.5 grams of trans fat per serving, which can add up depending on what foods you choose. So in addition to choosing products labeled “0” trans fat, you can check the ingredients statement and avoid products that contain partially hydrogenated oils. 

Protecting the safety of the food supply can mean a lot of different things, and this action is just one of the many initiatives FDA is taking to meet its public health responsibility. 

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine