EEUU Nota Regulatoria FDA 2016

The New and Improved Nutrition Facts Label – Key Changes
The U.S. Food and Drug Administration has finalized a new Nutrition Facts label for packaged foods that will make it easier for you to make informed food choices that
support a healthy diet. The updated label has a fresh new design and reflects current scientific information, including the link between diet and chronic diseases.
1. Servings
The number of “servings per
container” and the “Serving Size”
declaration have increased and are
now in larger and/or bolder type.
Serving sizes have been updated to
reflect what people actually eat and
drink today. For example, the serving
size for ice cream was previously
½ cup and now is ¾ cup.
There are also new requirements
for certain size packages, such as
those that are between one and two
servings or are larger than a single
serving but could be consumed in
one or multiple sittings.
2. Calories
“Calories” is now larger and bolder.
3. Fats
“Calories from Fat” has been
removed because research shows
the type of fat consumed is more
important than the amount.
4. Added Sugars
“Added Sugars” in grams and as
a percent Daily Value (%DV) is
now required on the label. “Added
Sugars” include sugars that have
been added during the processing
or packaging of a food. Scientific
Current Label
New Label
Nutrition
Facts
Serving Size 2/3 cup (55g)
Servings Per Container About 8
Nutrition Facts
data shows that it is difficult to meet
nutrient needs while staying within
calorie limits if you consume more
than 10 percent of your total daily
calories from added sugar.
Serving size
5. Nutrients
1 8 servings per container
2/3 cup (55g)
Amount Per Serving
Calories 230
Calories from Fat 72
2
Amount per serving
3
Total Fat 8g
% Daily Value*
Total Fat 8g
Saturated Fat 1g
Trans Fat 0g
Cholesterol 0mg
Sodium 160mg
Total Carbohydrate 37g
Dietary Fiber 4g
Sugars 1g
Protein 3g
Vitamin A
Vitamin C
Calcium
Iron
12 %
5%
230
Calories
% Daily Value*
0%
5%
Cholesterol 0mg
Sodium 160mg
0%
Trans Fat 0g
7%
12 %
16 %
Total Carbohydrate 37g
Dietary Fiber 4g
10%
8%
20%
45%
* Percent Daily Values are based on a 2,000 calorie diet.
Your daily value may be higher or lower depending on
your calorie needs.
Calories:
2,000
2,500
Total Fat
Less than
65g
80g
Sat Fat
Less than
20g
25g
Cholesterol
Less than
300mg
300mg
Sodium
Less than
2,400mg
2,400mg
Total Carbohydrate
300g
375g
Dietary Fiber
25g
30g
10%
Saturated Fat 1g
4
5
14%
Total Sugars 12g
Includes 10g Added Sugars
Protein 3g
20%
Vitamin D 2mcg
10%
Iron 8mg
45%
Calcium 260mg
Potassium 235mg
6
7%
13%
20%
6%
* The % Daily Value (DV) tells you how much a nutrient in
a serving of food contributes to a daily diet. 2,000 calories
a day is used for general nutrition advice.
Manufacturers will need to use the new label by July 26, 2018, and small
businesses will have an additional year to comply. During this transition time,
you will see the current Nutrition Facts label or the new label on products.
The lists of nutrients that are
required or permitted on the label
have been updated. Vitamin D and
potassium are now required on
the label because Americans do
not always get the recommended
amounts. Vitamins A and C are no
longer required since deficiencies
of these vitamins are rare today. The
actual amount in grams in addition
to the %DV must be listed for vitamin
D, calcium, iron, and potassium.
The daily values for nutrients have
also been updated based on newer
scientific evidence. The daily values
are reference amounts of nutrients
to consume or not to exceed and are
used to calculate the %DV.
6. Footnote
The footnote at the bottom of the
label has changed to better explain
the meaning of %DV. The %DV
helps you understand the nutrition
information in the context of a total
daily diet.
July 2016
For more information about the new Nutrition Facts label, visit:
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
NOTA DE MERCADO
INFORMACIÓN REGULATORIA
IVACE NUEVA YORK
SEPTIEMBRE 2016
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
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FDA: Se aprueba el nuevo etiquetado nutricional
La FDA finalizó el pasado mes de mayo la aprobación de la nueva etiqueta de información nutricional para
los alimentos envasados. Este nuevo etiquetado nutricional pretende reflejar datos científicos más
recientes sobre nutrición, como es el vínculo que existe entre la alimentación y las enfermedades crónicas
que afectan al país, como son la obesidad o enfermedades cardiacas. La nueva etiqueta pretende facilitar
la toma de decisiones de los consumidores a la hora de elegir su alimentación.
El nuevo etiquetado ha sido recibido favorablemente por la industria alimentaria estadounidense que
considera oportuna la actualización en un momento en que las dietas, los patrones de alimentación y
preferencias de los consumidores han cambiado drásticamente desde que se introdujo por primera vez el
panel de información nutricional.
Básicamente las novedades son:
Diseño renovado
o
La imagen “emblemática” de la etiqueta se preserva, pero se introduce el aumento del tamaño
de la letra para las declaraciones de Calorías, Porciones por envase ( servings per container),
Tamaño de la porción (serving size), y cambiar a negrita el número de calorías y la declaración
de “Tamaño de la porción” para destacar esta información.
o
Los fabricantes deberán declarar la cantidad real, además del porcentaje del valor nutricional
diario de vitamina D, calcio, hierro y potasio. También pueden declarar la cantidad en gramos
de otras vitaminas y minerales de manera voluntaria. Pero ya no es obligatorio declarar las
vitaminas A y vitamina C.
o
La nota que aparece al pie de la etiqueta se ha modificado también para explicar mejor lo que
significa “porcentaje del valor nutricional diario” de una forma más coloquial. Ahora deberá decir:
“*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet.
2,000 calories a day is used for general nutrition advice.”
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
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Información actualizada sobre la ciencia de la nutrición
o
En el nuevo formato se incluyen en la etiqueta los “Azúcares añadidos” (Added Sugars), en
gramos y como porcentaje del valor nutricional diario. Los datos científicos demuestran que es
difícil satisfacer las necesidades nutricionales y mantenerse dentro de los límites calóricos si más
del 10 por ciento de las calorías diarias totales que uno consume provienen de azúcares añadidos,
coincidiendo con Guía de Alimentación para los estadounidenses de 2015-2020.
o
La lista de nutrientes que está permitido o es obligatorio declarar se actualiza. Ahora la vitamina
D y el potasio serán obligatorios en la etiqueta, y el calcio y el hierro seguirán siéndolo. Las
vitaminas A y C ya no serán obligatorias, pero pueden incluirse de forma voluntaria.
o
Aunque sigue exigiéndose el contenido de “Total Fat”, “Satured Fat” y “trans Fat” en la etiqueta,
el de las “Calories from Fat” se eliminará porque las investigaciones indican que el tipo de grasa
es más importante que la cantidad.
o
Los valores diarios (Daily Value -DV%) son las cantidades de referencia para los nutrientes que
hay que consumir o no exceder, y se usan para calcular el porcentaje del valor nutricional diario
(%VD) que los fabricantes incluyen en la etiqueta. El %VD ayuda a los consumidores a entender
la información nutricional dentro del marco de una dieta diaria completa. Para la nueva etiqueta,
los valores diarios de nutrientes tales como sodio, fibra y vitamina D han sido también
actualizados.
Actualizar el tamaño de las porciones y los requisitos de etiquetado para
los envases de ciertos tamaños
o
Por ley, las porciones deben basarse en las cantidades de alimentos y bebidas que la gente
consume en realidad y no en las que debería de consumir. Cuánto come y bebe la gente es algo
que ha cambiado desde que los requisitos de tamaño de la porción anteriores fueran publicados
en 1993. Por ejemplo, la cantidad de referencia empleada para definir una porción de helado
antes era de ½ taza, pero está cambiando a ⅔ de taza. La cantidad de referencia empleada para
definir una porción de refresco también está cambiando, de 8 onzas (237 ml) a 12 oz (355 ml)
(Figure 1).
o
El tamaño del envase afecta lo que la gente consume. Así que, para los envases de una a dos
porciones, tales como un refresco de 20 onzas (591 ml) o una lata de sopa de 15 (444 ml), será
obligatorio indicar las calorías y otros nutrientes en la etiqueta como una sola porción, ya que las
personas por lo general los consumen de una sola vez.
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
3/7
o
Para ciertos productos de más de una porción, pero que podrían consumirse en una sola o en
varias raciones servidas, los fabricantes deberán incluir etiquetas con “columnas paralelas” para
indicar la cantidad de calorías y nutrientes tanto “por porción” como “por paquete”/“por
envase”/“por unidad”. Algunos ejemplos serían una botella de refresco de 24 onzas (710 ml), o
una pinta (473 ml) de helado. Con la disponibilidad de etiquetas con columnas paralelas, las
personas podrán saber con facilidad cuántas calorías y nutrientes estarán ingiriendo si comen o
beben el paquete o envase entero de una sola vez.
Figure 1: Cambios en el tamaño de las porciones
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
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Las novedades indicadas se pueden observar en la Figure 2, mientras que en la Figure 3 se puede ver una
comparación respecto al panel nutricional original.
Figure 2: Resumen de las novedades del nuevo panel nutricional
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
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Figure 3: Comparación del nuevo panel nutricional con el original
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
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Plazos para el cumplimiento
Los fabricantes deberán adoptar la nueva etiqueta en unos dos años (2018). Sin embargo, aquellos cuyas
ventas de alimentos sean menores de 10 millones de dólares anuales tendrán un año adicional para
cumplir con este requisito (2019).
Para más información sobre el nuevo etiquetado nutricional puede contactar con la delegación de IVACE
Internacional en Nueva York.
También se puede consultar más información en el siguiente link de la FDA:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNu
trition/ucm385663.htm
Anexos
A continuación, se adjunta hoja explicativa de la FDA donde se detallan los principales cambios a
introducir. También se incluye un documento con ejemplos de paneles nutricionales válidos, en varios
formatos.
NOTA DE MERCADO: INFORMACIÓN REGULATORIA
7/7
The New and Improved Nutrition Facts Label – Key Changes
The U.S. Food and Drug Administration has finalized a new Nutrition Facts label for packaged foods that will make it easier for you to make informed food choices that
support a healthy diet. The updated label has a fresh new design and reflects current scientific information, including the link between diet and chronic diseases.
1. Servings
The number of “servings per
container” and the “Serving Size”
declaration have increased and are
now in larger and/or bolder type.
Serving sizes have been updated to
reflect what people actually eat and
drink today. For example, the serving
size for ice cream was previously
½ cup and now is ¾ cup.
There are also new requirements
for certain size packages, such as
those that are between one and two
servings or are larger than a single
serving but could be consumed in
one or multiple sittings.
2. Calories
“Calories” is now larger and bolder.
3. Fats
“Calories from Fat” has been
removed because research shows
the type of fat consumed is more
important than the amount.
4. Added Sugars
“Added Sugars” in grams and as
a percent Daily Value (%DV) is
now required on the label. “Added
Sugars” include sugars that have
been added during the processing
or packaging of a food. Scientific
Current Label
New Label
Nutrition
Facts
Serving Size 2/3 cup (55g)
Servings Per Container About 8
Nutrition Facts
data shows that it is difficult to meet
nutrient needs while staying within
calorie limits if you consume more
than 10 percent of your total daily
calories from added sugar.
Serving size
5. Nutrients
1 8 servings per container
2/3 cup (55g)
Amount Per Serving
Calories 230
Calories from Fat 72
2
Amount per serving
3
Total Fat 8g
% Daily Value*
Total Fat 8g
Saturated Fat 1g
Trans Fat 0g
Cholesterol 0mg
Sodium 160mg
Total Carbohydrate 37g
Dietary Fiber 4g
Sugars 1g
Protein 3g
Vitamin A
Vitamin C
Calcium
Iron
12 %
5%
230
Calories
% Daily Value*
0%
5%
Cholesterol 0mg
Sodium 160mg
0%
Trans Fat 0g
7%
12 %
16 %
Total Carbohydrate 37g
Dietary Fiber 4g
10%
8%
20%
45%
* Percent Daily Values are based on a 2,000 calorie diet.
Your daily value may be higher or lower depending on
your calorie needs.
Calories:
2,000
2,500
Total Fat
Less than
65g
80g
Sat Fat
Less than
20g
25g
Cholesterol
Less than
300mg
300mg
Sodium
Less than
2,400mg
2,400mg
Total Carbohydrate
300g
375g
Dietary Fiber
25g
30g
10%
Saturated Fat 1g
4
5
14%
Total Sugars 12g
Includes 10g Added Sugars
Protein 3g
20%
Vitamin D 2mcg
10%
Iron 8mg
45%
Calcium 260mg
Potassium 235mg
6
7%
13%
20%
6%
* The % Daily Value (DV) tells you how much a nutrient in
a serving of food contributes to a daily diet. 2,000 calories
a day is used for general nutrition advice.
Manufacturers will need to use the new label by July 26, 2018, and small
businesses will have an additional year to comply. During this transition time,
you will see the current Nutrition Facts label or the new label on products.
The lists of nutrients that are
required or permitted on the label
have been updated. Vitamin D and
potassium are now required on
the label because Americans do
not always get the recommended
amounts. Vitamins A and C are no
longer required since deficiencies
of these vitamins are rare today. The
actual amount in grams in addition
to the %DV must be listed for vitamin
D, calcium, iron, and potassium.
The daily values for nutrients have
also been updated based on newer
scientific evidence. The daily values
are reference amounts of nutrients
to consume or not to exceed and are
used to calculate the %DV.
6. Footnote
The footnote at the bottom of the
label has changed to better explain
the meaning of %DV. The %DV
helps you understand the nutrition
information in the context of a total
daily diet.
July 2016
For more information about the new Nutrition Facts label, visit:
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
The New Nutrition Facts Label
Examples of Different Label Formats
with Explanations of Details
FOR REFERENCE ONLY
For more information, visit
Industry Resources on the Changes to the Nutrition Facts Label
Standard Vertical
(Side-by-Side Display)
Nutrition Facts
No smaller than 10 pt with 1 pt of leading
Bold, no smaller than 10 pt 1
Bold, no smaller than 6 pt
Bold, no smaller than 16 pt
3 pt rule
No smaller than 8 pt with 4 pt of leading 2
Bold, no smaller than 8 pt with 4 pt of leading 3
¼ pt rule centered between nutrients
(2 pt leading above and below)
Shortened rule above
Added Sugars declaration
8 servings per container
Serving size
2/3 cup (55g)
Amount per serving
Calories
% Daily Value*
Total Fat 8g
Saturated Fat 1g
Trans Fat 0g
Cholesterol 0mg
Sodium 160mg
Total Carbohydrate 37g
Dietary Fiber 4g
Total Sugars 12g
Includes 10g Added Sugars
Protein 3g
Vit. D 2mcg 10%
Iron 8mg 45%
No smaller than 6 pt with 1 pt of leading
1
“Serving size”
declaration may be
decreased to no smaller
than 8 pt bold if
additional space is
needed for the
declaration
2
230
10%
5%
0%
7%
13%
14%
20%
• Calcium 260mg 20%
Potas. 235mg 6%
•
* The % Daily Value (DV) tells you how much a nutrient in
a serving of food contributes to a daily diet. 2,000 calories
a day is used for general nutrition advice.
Saturated fat, Trans Fat,
Dietary Fiber, Total
Sugars, Added Sugars,
voluntary nutrients (if
listed) and their g/mg
values: No smaller than
8 pt with 4 pt of leading
3
Total Fat, Cholesterol,
Sodium, Total
Carbohydrate, and
Protein: Bold, no smaller
than 8 pt with 4 pt of
leading
4
Bold, no smaller than all other point
sizes except numerical value for
“Calories”
7 pt rule
Bold, no smaller than 22 pt
Bold, no smaller than 6 pt
Bold, no smaller than 8 pt 4
All labels enclosed by ½ point box rule
within 3 point of text measure
No smaller than 8 pt with 4 pt
of leading and 10 pt bullets 5
% Daily Values for
nutrients above lower
7 pt rule: Bold, no
smaller than 8 pt
5
Vit. D, Calcium, Iron,
Potas., voluntary
nutrients (if listed) and
their mg/mcg values and
% Daily Values: No
smaller than 8 pt and
with 4 pt of leading
Tabular Format
Bold, no smaller than 9 pt 1
No smaller than 10 pt
Bold, no smaller than all other point sizes
except numerical value for “Calories”
Nutrition
Facts
Amount/serving
10 servings per container
Serving size
2 slices (56g)
Calories
per serving
Bold, no smaller than 6 pt
170
% Daily Value*
Total Fat 1.5g
Saturated Fat 0.5g
Trans Fat 0.5g
Cholesterol 0mg
Sodium 280mg
2%
3%
0%
12%
Amount/serving
No smaller than 6 pt
% Daily Value*
Total Carbohydrate 36g
Dietary Fiber 2g
Total Sugars 1g
Includes 1g of Added Sugars
Protein 4g
13%
7%
2%
* The % Daily Value
(DV) tells you how
much a nutrient
in a serving of
food contributes to
a daily diet. 2,000
calories a day is
used for general
nutrition advice.
Vitamin D 0mcg 0% • Calcium 80mg 6% • Iron 1mg 6% • Potassium 470mg 10%
Thiamin 15% • Riboflavin 8% • Niacin 10%
Bold, no smaller Bold, no smaller
than 22 pt
than 8 pt 2
No smaller
than 8 pt 3
No smaller
than 8 pt 4
Bold, no smaller
than 8 pt 5
Bold, no smaller than 10 pt for “Calories”
1
“Serving size”
declaration may be
decreased to no smaller
than 8 pt bold if
additional space is
needed for the
declaration
2
Total Fat, Cholesterol,
Sodium, Total
Carbohydrate, and
Protein: Bold, no
smaller than 8 pt
3
Vitamin D, Calcium,
Iron, Potassium,
voluntary nutrients (if
listed) and their mg/mcg
values and % DV values:
No smaller than 8 pt
4
Saturated fat, Trans Fat,
Dietary Fiber, Total
Sugars, Added Sugars,
voluntary nutrients
(if listed) and their g/mg
values: No smaller
than 8 pt
5
% DV values for
nutrients above thick
bar: Bold, no smaller
than 8 pt
Tabular Display for Small Packages
Bold, no smaller than all other point sizes
except numerical value for “Calories”
Nutrition
Facts
No smaller than 9 pt
Bold, no smaller than 9 pt
5 servings
per container
Serving size
1/6 cup (28g)
1
Bold, no smaller than
10 pt for “Calories”
Calories
per serving
90
Amount/serving
“Serving size”
declaration may be
decreased to no smaller
than 8 pt bold if
additional space is
needed for the
declaration
2
% DV Amount/serving
Total Fat 2g
Sat. Fat 1g
Trans Fat 0.5g
Cholesterol 10mg
Sodium 200mg
% DV
Bold, no smaller than 8 pt 2
3% Total Carb. 15g
5%
5% Fiber 0g
0%
Total Sugars 14g
3%
Incl.13g Added Sugars 26%
9% Protein 3g
No smaller than 8 pt 3
Vitamin D 0% • Calcium 6% • Iron 6% • Potassium 10%
Bold, no smaller
than 14 pt
1
Bold, no smaller than 6 pt
% DV values for
nutrients above thick
bars: Bold, no smaller
than 8 pt
3
No smaller
than 6 pt 5
Sat. Fat, Trans Fat,
Fiber, Total Sugars,
Added Sugars, voluntary
nutrients (if listed) and
all g/mg values: No
smaller than 8 pt
Bold, no smaller than 8 pt 4
4
Total Fat, Cholesterol,
Sodium, Total Carb. and
Protein: Bold, no smaller
than 8 pt
5
Vitamin D, Calcium,
Iron, Potassium,
voluntary nutrients
(if listed) and their
% DV values: No
smaller than 8 pt
Linear Display for Small Packages
Bold, no smaller than
all other point sizes
except numerical
value for “Calories”
“Amount per serving”:
No smaller than 6 pt
“Calories”: Bold, no
smaller than 10 pt
“Servings” No smaller than 9 pt
Nutrition Facts Servings: 12, Serv. size: 1 mint (2g),
5
Amount per serving: Calories
, Total Fat 0g (0% DV), Sat. Fat 0g (0% DV),
Trans Fat 0g, Cholest. 0mg (0% DV), Sodium 0mg (0% DV), Total Carb. 2g (1% DV),
Fiber 0g (0% DV), Total Sugars 2g (Incl. 2g Added Sugars, 4% DV), Protein 0g,
Vit. D (0% DV), Calcium (0% DV), Iron (0% DV), Potas. (5% DV).
No smaller than 6 pt 2
1
“Serving size”: Bold, no smaller than 9 pt 1
“Serving size” declaration may be
decreased to no smaller than 8 pt bold
if additional space is needed for the
declaration
2
Number of calories:
Bold, no smaller
than 14 pt
Bold, no smaller than 6 pt 3
Sat. fat, Trans Fat, Fiber, Total Sugars,
Added Sugars, Vit. D, Calcium, Iron,
Potas., voluntary nutrients (if listed) and all
g/mg values and % DV values: No smaller
than 6 pt
3
Total Fat, Cholest., Sodium, Total Carb.,
Protein: Bold, no smaller than 6 pt