Todd Harrison & Erin Warren, Venable04.01.14
As you are likely aware, the U.S. Food and Drug Administration (FDA) proposed sweeping revisions to the iconic black and white Nutrition Facts Label recently. Specifically, the agency divided its proposed modifications into two rules: one focused on updating the information and formatting of the Nutrition Facts Label, and the other addressed serving size requirements and labeling for certain package sizes.
These proposed changes are essentially the first since the Nutrition Facts Label was created in 1993, except for the addition of heart-risky trans fats in 2006. According to FDA Commissioner Margaret Hamberg, MD, these proposed modifications bring the Nutrition Facts Panel into the 21st century and reflect the knowledge gained over the last two decades from extensive examination of the latest public health trends and research on nutrition and disease.
Counting Calories
By far the most visible change to the Nutrition Facts Label is that calorie counts would be bigger and bolder. This change helps address obesity, which is “one of the most important public health problems facing our country,” according to FDA’s Deputy Commission for Foods Michael Taylor. The proposed label would drive attention to calories and promote awareness of what consumers are eating, thus arming them with the knowledge to make healthy dietary choices throughout the day.
Much to the satisfaction of consumer advocates, serving sizes would also be modified under the proposed rules to reflect what consumers are actually eating, not what they should be eating. For example, under the proposed rules, the 500 calories of Cherry Garcia ice cream you ate for dessert [it was only one cup!] would now be declared as one serving instead of two.
Added Sugars
In what is likely to be one of the more controversial revisions, FDA has proposed to make “Added Sugars” a mandatory declaration on the Nutrition Facts Label. The agency claims this decision is based on: “1) the variability in ingredients used, 2) the need for consumers to have a consistent basis on which to compare products, 3) the need for consumers to identify the presence or absence of added sugars, and 4) when added sugars are present, the need for consumers to identify the amount of added sugars added to the food.”
FDA also touted this mandatory declaration may prompt product reformulation of foods high in added sugars (as was the case with trans fat). In further support of its rationale, the agency cited the 2010 Dietary Guidelines Advisory Committee conclusion that “strong evidence shows that children who consume more sugar-sweetened beverages have a greater adiposity (body fat) compared to those with a low intake,” and it went on to state the “sole source of calories in many sugar-sweetened beverages (e.g., soda) is added sugars.”
As noted by the Grocery Manufacturers Association (GMA) CEO Pamela Bailey, “It is critical that any changes are based on the most current and reliable science. Equally as important is ensuring that any changes ultimately serve to inform, and not confuse, consumers.”
It is evident that by distinguishing “Added Sugars” on the label, the agency is implying they pose more of a threat to public health than naturally occurring sugars. An important question that will likely be contentiously addressed during the Comments period is: can current science truly support this implication, or is the agency erroneously demonizing “Added Sugars” as it did “Calories from Fat” in the original 1993 rule?
Other Noteworthy Modifications
Nutrient Declarations. The amount of potassium and vitamin D would be required because the agency has determined the U.S. population is at a higher risk of chronic disease in their absence. Calcium and iron declarations would also continue to be required, but vitamins A and C would no longer be mandatory.
Calories from Fat. This information would be removed because research shows the type of fat is more important than the amount. Total, saturated and trans fat declarations are still required.
Daily Values. Revisions would be made to the Daily Values for nutrients like sodium, dietary fiber and vitamin D, among others, to help consumers understand nutrition information in the context of a total daily diet.
Dual Columns. “Per serving” and “per package” calories and nutrition information would be required for larger packages that can be consumed in either one or multiple sittings. Examples include a 24-oz. bottle of soda or a pint of ice cream.
Overall Format. Elements important to addressing current public health problems (e.g., obesity, diabetes, heart disease), like calories, serving size and percent Daily Value would be more prominent and/or strategically placed to garner more consumer attention.
Footing the Bill
How much will this overhaul of the Nutrition Facts Panel cost? The industry will be charged a cool $2 billion by FDA estimates. Nevertheless, by primarily lowering risk of diet-related diseases and associated healthcare costs, the agency claims the revisions will provide $20-30 billion in benefits to consumers by the year 2035. Notably, however, similar predictions were made when the FDA finalized the original regulations two decades ago, but the benefits did not materialize as expected.
Given the potential ramifications of these proposed rules, the debate expected to play out in the Comments should be both passionate and informative. The Comment period is slated to end Jun. 2, 90 days after the publication of the proposed rules. The rules, if finalized, would then provide a two-year grace period for the food industry to comply.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
Erin Warren is an associate in Venable’s Dietary Supplements, Cosmetics and Functional Foods Practice Group. The practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution and promotion of foods, dietary supplements, drugs, medical devices and cosmetics.
These proposed changes are essentially the first since the Nutrition Facts Label was created in 1993, except for the addition of heart-risky trans fats in 2006. According to FDA Commissioner Margaret Hamberg, MD, these proposed modifications bring the Nutrition Facts Panel into the 21st century and reflect the knowledge gained over the last two decades from extensive examination of the latest public health trends and research on nutrition and disease.
Counting Calories
By far the most visible change to the Nutrition Facts Label is that calorie counts would be bigger and bolder. This change helps address obesity, which is “one of the most important public health problems facing our country,” according to FDA’s Deputy Commission for Foods Michael Taylor. The proposed label would drive attention to calories and promote awareness of what consumers are eating, thus arming them with the knowledge to make healthy dietary choices throughout the day.
Much to the satisfaction of consumer advocates, serving sizes would also be modified under the proposed rules to reflect what consumers are actually eating, not what they should be eating. For example, under the proposed rules, the 500 calories of Cherry Garcia ice cream you ate for dessert [it was only one cup!] would now be declared as one serving instead of two.
Added Sugars
In what is likely to be one of the more controversial revisions, FDA has proposed to make “Added Sugars” a mandatory declaration on the Nutrition Facts Label. The agency claims this decision is based on: “1) the variability in ingredients used, 2) the need for consumers to have a consistent basis on which to compare products, 3) the need for consumers to identify the presence or absence of added sugars, and 4) when added sugars are present, the need for consumers to identify the amount of added sugars added to the food.”
FDA also touted this mandatory declaration may prompt product reformulation of foods high in added sugars (as was the case with trans fat). In further support of its rationale, the agency cited the 2010 Dietary Guidelines Advisory Committee conclusion that “strong evidence shows that children who consume more sugar-sweetened beverages have a greater adiposity (body fat) compared to those with a low intake,” and it went on to state the “sole source of calories in many sugar-sweetened beverages (e.g., soda) is added sugars.”
As noted by the Grocery Manufacturers Association (GMA) CEO Pamela Bailey, “It is critical that any changes are based on the most current and reliable science. Equally as important is ensuring that any changes ultimately serve to inform, and not confuse, consumers.”
It is evident that by distinguishing “Added Sugars” on the label, the agency is implying they pose more of a threat to public health than naturally occurring sugars. An important question that will likely be contentiously addressed during the Comments period is: can current science truly support this implication, or is the agency erroneously demonizing “Added Sugars” as it did “Calories from Fat” in the original 1993 rule?
Other Noteworthy Modifications
Nutrient Declarations. The amount of potassium and vitamin D would be required because the agency has determined the U.S. population is at a higher risk of chronic disease in their absence. Calcium and iron declarations would also continue to be required, but vitamins A and C would no longer be mandatory.
Calories from Fat. This information would be removed because research shows the type of fat is more important than the amount. Total, saturated and trans fat declarations are still required.
Daily Values. Revisions would be made to the Daily Values for nutrients like sodium, dietary fiber and vitamin D, among others, to help consumers understand nutrition information in the context of a total daily diet.
Dual Columns. “Per serving” and “per package” calories and nutrition information would be required for larger packages that can be consumed in either one or multiple sittings. Examples include a 24-oz. bottle of soda or a pint of ice cream.
Overall Format. Elements important to addressing current public health problems (e.g., obesity, diabetes, heart disease), like calories, serving size and percent Daily Value would be more prominent and/or strategically placed to garner more consumer attention.
Footing the Bill
How much will this overhaul of the Nutrition Facts Panel cost? The industry will be charged a cool $2 billion by FDA estimates. Nevertheless, by primarily lowering risk of diet-related diseases and associated healthcare costs, the agency claims the revisions will provide $20-30 billion in benefits to consumers by the year 2035. Notably, however, similar predictions were made when the FDA finalized the original regulations two decades ago, but the benefits did not materialize as expected.
Given the potential ramifications of these proposed rules, the debate expected to play out in the Comments should be both passionate and informative. The Comment period is slated to end Jun. 2, 90 days after the publication of the proposed rules. The rules, if finalized, would then provide a two-year grace period for the food industry to comply.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
Erin Warren is an associate in Venable’s Dietary Supplements, Cosmetics and Functional Foods Practice Group. The practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution and promotion of foods, dietary supplements, drugs, medical devices and cosmetics.
