FDA proposes major revisions to Nutrition Facts Label
SILVER SPRING, Md. — The Food and Drug Administration on Thursday proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and such chronic diseases as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.
“Our guiding principle here is very simple: that you as a parent and a consumer should be able to walk into your local grocery store, pick up an item off the shelf, and be able to tell whether it’s good for your family,” stated First Lady Michelle Obama. “So this is a big deal, and it’s going to make a big difference for families all across this country.”
“For 20 years consumers have come to rely on the iconic nutrition label to help them make healthier food choices,” commented FDA Commissioner Margaret Hamburg. “To remain relevant, the FDA’s newly proposed Nutrition Facts label incorporates the latest in nutrition science as more has been learned about the connection between what we eat and the development of serious chronic diseases impacting millions of Americans.”
Some of the changes to the label the FDA proposed Thursday would:
- Require information about the amount of “added sugars” in a food product. The 2010 Dietary Guidelines for Americans states that intake of added sugar is too high in the U.S. population and should be reduced. The FDA proposes to include “added sugars” on the label to help consumers know how much sugar has been added to the product;
- Update serving size requirements to reflect the amounts people currently eat. What and how much people eat and drink has changed since the serving sizes were first put in place in 1994. By law, serving sizes must be based on what people actually eat, not on what people “should” be eating. Present calorie and nutrition information for the whole package of certain food products that could be consumed in one sitting;
- Present “dual column” labels to indicate both “per serving” and “per package” calorie and nutrition information for larger packages that could be consumed in one sitting or multiple sittings;
- Require the declaration of potassium and vitamin D, nutrients that some in the U.S. population are not getting enough of, which puts them at higher risk for chronic disease. Vitamin D is important for its role in bone health. Potassium is beneficial in lowering blood pressure. Vitamins A and C would no longer be required on the label, though manufacturers could declare them voluntarily;
- Revise the Daily Values for a variety of nutrients such as sodium, dietary fiber and vitamin D. Daily Values are used to calculate the Percent Daily Value on the label, which helps consumers understand the nutrition information in the context of a total daily diet;
- 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; and
- Refresh the format to emphasize certain elements, such as calories, serving sizes and Percent Daily Value, which are important in addressing current public health problems like obesity and heart disease.
The Nutrition Facts label has been required on food packages for 20 years, helping consumers better understand the nutritional value of foods so they can make healthy choices for themselves and their families. The label has not changed significantly since 2006 when information on trans fat had to be declared on the label, prompting manufacturers to reduce partially hydrogenated oils, the main source of trans fat, in many of their products.
The changes proposed today affect all packaged foods except certain meat, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service.
The FDA is also proposing to make corresponding updates to the Supplement Facts label on dietary supplements where applicable.
The agency is accepting public comment on the proposed changes for 90 days.
UCLA study questions acetaminophen safety in pregnant women
LOS ANGELES — A long-term study by UCLA, in collaboration with the University of Aarhus in Denmark, has raised concerns about the use of acetaminophen during pregnancy, UCLA announced earlier this week.
In a report in the current online edition of JAMA Pediatrics, researchers from the UCLA Fielding School of Public Health show that taking acetaminophen during pregnancy is associated with a higher risk in children of attention-deficity/hyperactivity disorder and hyperkinetic disorder.
"The causes of ADHD and hyperkinetic disorder are not well understood, but both environmental and genetic factors clearly contribute," stated Beate Ritz, professor and chair of the department of epidemiology at the Fielding School and one of the senior authors of the paper. "We know there has been a rapid increase in childhood neurodevelopmental disorders, including ADHD, over the past decades, and it’s likely that the rise is not solely attributable to better diagnoses or parental awareness. It’s likely there are environmental components as well."
"That gave us the motivation to search for environmental causes that are avoidable," added the University of Aarhus’ Jørn Olsen, another senior author and former chair of the UCLA. "Part of the neuropathology may already be present at birth, making exposures during pregnancy and/or infancy of particular interest. Because acetaminophen is the most commonly used medication for pain and fever during pregnancy, it was something we thought we should look at."
The UCLA researchers used the Danish National Birth Cohort, a nationwide study of pregnancies and children, to examine pregnancy complications and diseases in offspring as a function of factors operating in early life. The cohort focuses especially on the side effects of medications and infections.
The researchers studied 64,322 children and mothers who were enrolled in the Danish cohort from 1996 to 2002. Acetaminophen use during pregnancy was determined using computer-assisted telephone interviews that were conducted up to three times during pregnancy and again six months after childbirth.
The researchers next followed up with parents when their children reached the age of 7. They first asked parents about any behavioral problems in their children using the Strength and Difficulties Questionnaire, a standard behavioral screening questionnaire used by scientists. It assesses five domains, including emotional symptoms, conduct problems, hyperactivity, peer relationship and social behavior in children and adolescents between the ages of 4 years and 16 years.
In addition, they obtained diagnoses of hyperkinetic disorder among the cohort’s children (at an average age of 11) from the Danish National Hospital Registry or the Danish Psychiatric Central Registry. Last, they identified if ADHD medications, mainly Ritalin, were redeemed for the children using the Danish pharmaceutical prescription database.
More than half of all the mothers reported using acetaminophen while pregnant. The researchers found that children whose mothers used acetaminophen during pregnancy were at a 13% to 37% higher risk of later receiving a hospital diagnosis of hyperkinetic disorder, being treated with ADHD medications or having ADHD-like behaviors at age 7. The longer acetaminophen was taken — that is, into the second and third trimesters — the stronger the associations. The risks for hyperkinetic disorder/ADHD in children were elevated 50% or more when the mothers had used the common painkiller for more than 20 weeks in pregnancy.
"It’s known from animal data that acetaminophen is a hormone disruptor, and abnormal hormonal exposures in pregnancy may influence fetal brain development," Ritz said.
Acetaminophen can cross the placental barrier, Ritz noted, and it is plausible that acetaminophen may interrupt fetal brain development by interfering with maternal hormones or through neurotoxicity, such as the induction of oxidative stress, which can cause the death of neurons.
"We need further research to verify these findings, but if these results reflect causal associations, then acetaminophen should no longer be considered a ‘safe’ drug for use in pregnancy," Olsen said.
Nutrisystem gearing for national retail launch
FORT WASHINGTON, Pa. — Nutrisystem will make a national retail launch in 2014, noted Dawn Zier, Nutrisystem president and CEO, during a conference call Wednesday. The company already has distribution through 2,500 Walmart locations and will be introducing its weight loss kits into Target in the second quarter.
"We successfully launched and tapped into 2,500 Wal-Mart stores for diet season 2014 and both the diet and diabetic kit as well as the shakes and snack pack continues to perform well," Zier said. "Channel expansion will be focused on mass and club with a test line approach before expanding nationally. Our first test is with Target in Q2," she said. "We are adding additional resources to our retail team to support our growth strategy."
Retail contributed $5.9 million in the quarter, representing 8.4% of total revenues. The company expects a $25 million from the retail channel in the next fiscal year.