Food Information That’s Pro Market and Pro Consumer

By: Scott Gottlieb, M.D.

Information about how healthy our food is gives us the chance to make better choices about our diets. This same information also inspires competition among producers to formulate food in ways that make it more healthful.

Dr. Scott GottliebThese core principles are at the heart of FDA’s recent initiative to expand opportunities for food manufacturers to make voluntary claims on food products about the healthy attributes of their merchandise. Easier access to this information is something both consumers and manufactures want. More Americans are looking for healthier food options. At the same time, food producers should be able to compete on the ability to develop foods that are healthier, and make reliable, science-based claims about these attributes to consumers.

So at FDA, we’re reforming our policies to make it more efficient to develop these claims. This clarity may encourage more manufacturers to invest in making foods healthier.

These same principles also underlie our efforts to promote the disclosure of basic information about calories on chain restaurant menus. Americans drink or eat about one-third of their daily calories outside the home. While we all want to be able to share a good meal with our families, our hectic lives often have us looking to chain restaurants or take-out meals for convenience and value. Food options aren’t always healthy. But there’s no reason that convenient, affordable food can’t also be wholesome.

America is the world’s breadbasket, with some of the most innovative manufacturers. Whether companies are formulating food to be sold at grocery stores for meals we prepare ourselves — or served in restaurants or grab-and-go establishments — they should have the same incentives to compete on delivering healthy, inexpensive food options that are also tasteful. And food producers and retailers should have the same ability to make claims about the healthy attributes of their products.

Driving this “healthy” competition depends on transparency and a level playing field.

This is why FDA is implementing efficient rules to make sure that consumers are provided with some basic information about the nutritional features of food provided both through our nutrition facts label that consumers see on food sold in stores, as well as through the new restaurant menu label rule that goes into effect next week.

Over the past year we’ve worked hard to make sure this new rule can be implemented in a way where the information will be maximally beneficial to consumers and the new requirements will be minimally burdensome to restaurants and retail establishments.

National menu labeling could help make a big difference in America’s obesity rates, one of our most vexing public health challenges. Today, about 40 percent of all Americans are obese, and obesity increases the chances of developing heart disease, diabetes, and some types of cancer. Weight-related diseases and conditions reduce productivity and shorten lives due to decades of metabolic damage. Obesity also is a big driver of chronic disease.

Starting next Monday, consumers will be able to walk into any large chain restaurant and other chain establishments in the country and know, at a glance, how many calories are in the foods a restaurant offers. Surveys show consumers overwhelmingly want this information. And many use it to improve their diets and health.

Studies show that menu labeling can make an important difference in every day food choices that add up over time. Recent research shows that smart menu labeling reduces the average number of calories ordered by 30 to 50 calories per visit.

That may sound like a small amount. It comes out to less than a cookie a day. But over a year, based on that sort of reduction, you could end up consuming 10,000 to 20,000 fewer calories, making you three to five pounds slimmer. Consuming just 64 fewer calories per day, on average, would help the nation meet the government’s goal of reducing youth obesity by 2020. Better information that prompts people to cut 50 calories a day out of their diets can go a long way. And, over time, this can drive population-wide changes.

Creating a level playing field for menu labeling is only one of the steps FDA is pursuing to leverage diet as a way to help Americans reduce their burden of chronic disease.

We’re also taking final steps to implement the new Nutrition Facts label. This is the first overhaul of food labeling in more than 20 years. Consumers will soon have access to an updated food label that’s based on current science. It provides more easily understandable information to help Americans to build healthy, home-cooked menus when they’re shopping in grocery stores.

And FDA is taking new steps to modernize our approach to food claims. Claims can show that a food component may reduce the risk of a health-related condition, such as the relationship between folate and the reduction in risk of a child being born with certain birth defects, or high fiber and low fat diets reducing the risk of developing some types of cancer. Claims can also help consumers quickly identify foods that are lower in a food component that they are trying to avoid like sodium.

Combining food claims and enhanced labels can allow families to mix and match foods and meals that contain essential nutrients, while staying within caloric guidelines. Consumers also will have an easy to use and consistent baseline for the nutrition information that they need to better manage their health. These efforts were outlined in a nutrition initiative that I announced last month. Our goal is to leverage diet as a way to reduce death from chronic disease.

Consumers already are demanding more information about their diets, becoming smarter shoppers, and seeking out healthier options. In a 2016 survey of more than 1,500 consumers, virtually all responded that it’s important that the brands and manufacturers they buy from are transparent about what is in their food and how it is made. It’s in everyone’s interest to have meaningful nutrition information and claims that consumers can understand and trust.

We’ve already seen healthy changes in the restaurant market supported by consumers, like coffee chains shifting their recipes from whole milk to two percent milk. You can still order whole milk, but now the default option is better for your health and your waistline. Many kid’s meals now come with the option of apple slices instead of fries. These are changes for the better without taking away anyone’s choices. This is how information drives competition by producers to make food more healthful, and also make consumers more discerning. Armed with reliable information, consumers are making these choices.

I know not everyone has supported restaurant menu labels. Not every chain wants to display calorie information. But consumers want this data. And FDA has taken steps to make it easy for manufacturers and restaurants to provide this information in cost effective ways already found in many chains. In addition, firms won’t need to deal with a patchwork of different requirements for calorie labeling across the country.

In the guidance we’ll soon release, we took the concerns of the industry to heart, particularly that it could be costly to display calorie information. So, we lay out flexible options for complying with the requirements ranging from low-tech paper menu handouts to utilizing the electronic kiosks that are becoming commonplace in food establishments around the country. These options won’t require costly changes to existing infrastructure.

Further, we’ve made clear that materials used for marketing don’t have to have calorie counts on them. That picture of a delicious cheeseburger doesn’t require a calorie declaration. And when it comes to build-your-own foods, like choose-your-topping pizzas, calorie ranges can be used to make the various combinations fit on a standard-size menu board. We also provide more flexibility when it comes to the calories information that restaurants need to disclose. We know that prepared food can diverge from one entree to the next. So we allow room for that variability.

Pizza makers don’t need to worry about that extra slice of pepperoni.

America’s food industry is ripe for innovation. Consumers want healthier options and food producers want to develop these choices and make claims about these attributes. We support those innovations. And science-based regulations and transparent labels make it easier for consumers to understand the impact that day-to-day food choices have on their long-term health. They also make it practical for producers to compete on these features.

Consumers also want to have the chance to make informed choices about the meals they eat out based on access to nutritional information. Our goal is to establish a menu labeling framework that allows our broad food industry to meet these desires in an efficient and cost-effective manner that also accommodates the industry’s diverse business models.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

New Weight-loss Drugs Offer Promise in the Fight Against Obesity, But They’re Not for Everyone

By: Eric Colman, M.D.

More than one-third of the adult U.S. population is obese, a proportion that has risen dramatically in the last three decades. With FDA’s recent approval of two new prescription weight loss drugs, marketed under the trade names Belviq and Qsymia, the outlook for successful drug therapies to fight our nation’s growing obesity epidemic has improved. Before these two approvals, there had not been a new weight loss drug approved by FDA in more than 13 years.

In clinical testing prior to approval, compared with lifestyle modification alone, patients treated with Belviq plus lifestyle modification had an average weight loss of about 3.5% and patients treated with Qsymia plus lifestyle modification averaged weight loss of approximately 6% to 9%. Although these results are a step in the right direction, there are a few important things to keep in mind about these products.

First, if you’re looking to lose a few pounds before going to the beach or after over- indulging on vacation, these drugs are not for you. They are not even intended for use by otherwise healthy people who are significantly overweight. Both are only intended for use in people who are obese, defined as having a body mass index (BMI) over 30, or for certain overweight patients who are not obese but have a significant health problem like diabetes, high blood pressure, or high cholesterol.

These new products have received a great deal of media attention, but one aspect of their use not highlighted by the media is that these drugs are intended for chronic use as part of a comprehensive weight loss program that includes modifications to diet and increased exercise. Obesity is a chronic disease, similar to diabetes or high blood pressure, and requires long-term treatment to help patients avoid regaining weight once a treatment program is stopped. Some patients may require long-term use of a weight loss drug in order to achieve and sustain a healthy body weight, which can be associated with significant improvements in co-morbid conditions such as diabetes and hypertension.

Another point to keep in mind is that Belviq and Qsymia are both associated with potentially serious risks, which is a key reason why they are approved by FDA only for use in obese patients whose risk from the health consequences of obesity and its related health issues outweigh the risks associated with using the drug. For instance, among other adverse effects, Qsymia can cause birth defects and Belviq can cause a dangerous chemical imbalance called “serotonin syndrome.” Doctors and patients who are considering the use of these drugs as part of an individualized weight management program must carefully consider the potential benefits and the potential risks and carefully follow the label instructions for how to use these drugs safely and effectively, including stopping use of the drugs if weight loss is not achieved.

After 13 years without a new weight loss drug on the market, Belviq and Qsymia represent new hope for many who have been struggling with obesity, and will be valuable tools in their efforts to overcome the condition. Finally, however, what may be most important to remember about these two new products is that they are not “cures” for obesity. A balanced diet, exercise and other healthy lifestyle choices will remain critical components of successfully achieving and maintaining a healthy weight.

Eric Colman, M.D., is Deputy Director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research