FDA Wants Your Opinion on Dairy-Product Labels

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The bottle on the left shows flavored milk as you would buy it in the store now. The words “reduced calorie” signal the presence of non-nutritive (artificial) sweeteners. The bottle on the right shows how the bottle would look if FDA accepts the petitioners’ request. In both cases, the non-nutritive sweetener is listed as an ingredient. For an expanded version of this graphic, click here.

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If you’re a lover of chocolate milk, but want to watch your weight, you might reach for the carton labeled “reduced calorie.”? But dairy manufacturers would rather that the carton simply say “chocolate milk.”?

Why? According to a petition submitted to FDA, one reason is that industry groups believe labels such as “reduced calorie” or “no added sugar” are a turn-off to kids who might otherwise reach for flavored milk with non-nutritive (artificial) sweeteners at the school cafeteria or from the grocery store cooler.

The petition from the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) was published for public comment in the Federal Register and has generated much interest—and confusion. It remains open for comment until May 21, 2013.

According to Mary Poos, Ph.D., deputy director of FDA’s Office of Nutrition, Labeling and Dietary Supplements, FDA has received more than 30,000 comments on the issue to date. “Based on these comments, we’re seeing a fair amount of confusion about what the labeling change would actually mean,” Poos says.

FDA wants to hear from consumers on this issue, but also wants to ensure that they understand the exact nature of the proposed change, she adds.

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The petition from IDFA and NMPF calls for FDA to change the “standard of identity” for milk. A standard of identity is the federal requirement that determines what ingredients some food products must (or may) contain to be marketed under certain names.

Currently, if a manufacturer wants to include an ingredient that is not among those in the product’s standard of identity, the name of the food on the package’s main display panel must be modified with a nutrient content claim (such as “reduced calorie”) to show how it has been changed.

For example, under existing regulations, the replacement of a nutritive sweetener (such as sugar) with a non-nutritive sweetener (such as sucralose, acesulfame potassium, or aspartame) in flavored milk would reduce the milk’s calorie count. Because of the replacement, words such as “reduced calorie” must be prominently displayed on the package.? The specific name of the sweetener used must still be included in the list of ingredients.

The two groups asked FDA to amend the standard of identity for flavored milk and 17 other dairy products (including nonfat dry milk, heavy cream, eggnog, half-and-half and sour cream) so that non-nutritive sweeteners are among the standard ingredients. The products would then not require any additional description on the label.

“If we granted the petition, a carton of chocolate milk made with non-nutritive sweeteners would simply say ‘chocolate milk,’ the same as a carton made with nutritive sweeteners, such as sugar,” notes Felicia Billingslea, director of FDA’s Food Labeling and Standards staff. “You would need to read the ingredient list, which is typically on the back or the side of the product, in order to tell the difference between the two.”

People commenting in response to the Federal Register notice appear to be under the impression that the non-nutritive sweeteners will not be listed anywhere on the product—which is not the case. They would still be named in the ingredients list on the package.

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In their petition, the dairy groups give the following reasons for requesting the change in FDA’s regulations:

Studies show school-age children are more likely to consume flavored milk than regular milk.Flavored milk labels that bear nutrient content claims such as “reduced calorie” are unattractive to children.The proposed amendments would promote more healthful eating practices and reduce childhood obesity.Updating the standard of identity for milk in this way would promote honesty and fair dealing by creating consistency in the names of flavored milk products.

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The FDA recognizes the importance of this decision and is interested in hearing from the public and industry on the petition, says Billingslea. In particular, comments are welcome on issues such as:

Will the proposed change in FDA’s milk labeling regulations provide sufficient information for consumers to understand what is in the milk they’re buying?The petition states that flavored milk labels with descriptions such as “reduced calorie” are unattractive to children. Are children’s purchasing habits affected by flavored milk labels that currently bear these descriptions?Will the proposed change in FDA’s milk labeling regulations create an increased burden for consumers who want to know whether a product contains a nutritive or non-nutritive sweetener??

You can submit your comments at www.regulations.gov. You can search for a rule by its docket number, in this case Docket No. FDA-2009-P-0147.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

April 15, 2013

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FDA Wants YOU (to Get Involved)

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You may know that the Food and Drug Administration (FDA) is responsible for protecting your health by ensuring that the food you eat is safe, and that the drugs and medical products you and your family use are safe and effective.

But did you also know that FDA needs your help?

"It's true," says Richard Klein, director of FDA's Patient Liaison Program within the Office of Health and Constituent Affairs. "We invite consumers to get involved in the process of helping FDA make the decisions that affect their lives."

And thanks to FDA's Patient Network initiative, it's easy.

According to Klein, FDA has a long history of working with patients and patient advocates representing specific groups, beginning with the AIDS crisis of the 1980s. Since then, FDA has reached out to advocacy groups, such as the National Council of Rare Health Disorders and other disease-specific groups, to ask for their input on proposed regulations and guidance documents.

More recently, in July 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) which calls for the agency to increase patient participation in the regulation of medical products.

According to project manager James Valentine, M.H.S., the Patient Network helps to bring the unique perspective of patients, family members, caregivers and patient advocates to the decision-making processes of the FDA. There are a number of ways to become involved, including becoming a patient representative on a committee that advises FDA on key issues.

Valentine explains that the three-phase program began in 2011 with the launch of the twice-monthly newsletter Patient Network News. A recent issue includes information on a product that has been linked to potentially serious eye infections; an upcoming public meeting on breast cancer; a story on active ingredients in children's medicines; and information on pet health. "It's a good way to find out just what FDA is up to—and in ways that are relevant to you, the individual," Valentine says.

The annual Patient Network meeting, the second of which will take place this summer, is the second phase. "We're gearing up for it now," Klein notes.

By popular demand from patient organizations, Klein says, the meeting will focus on "demystifying the FDA, by providing a basic primer about medical product regulation." "We need to demonstrate that from both FDA's and industry perspectives medical product development isn't a simple 1-2-3 recipe," he adds.

Phase 3 is the FDA Patient Network website, to launch the week of April 22, 2013. The website is an interactive tool for educating patients, patient advocates and consumers on how their medications and medical devices go from idea to the shelf.

FDA launched the site to engage patients and consumers as partners, and encourage them to share ideas and concerns about the medical product development process.

"When it comes to FDA's regulatory process, we feel very strongly patients should have a say," notes Klein. "The new website provides an excellent place to start."

According to Klein, consumers have complained that they find it difficult to locate the information they need on the agency's website, and when they do, it is targeted for industry use.

"This website provides a concentrated, one-stop forum from which we can reach patients and vice versa," Valentine says. The website connects patients, caregivers, and advocacy groups to the agency through e-mail, webinars, live chats, open meetings and announcements of opportunities for patients to comment on FDA regulations.

There are sections on what FDA does, FDA advisory committees, FDA initiatives, and frequently asked questions. The website also helps patients, caregivers, and advocacy groups find information on:

getting involved in the regulatory process;finding relevant clinical trials;finding additional treatment options;getting information about diseases; andgetting information about their medications, including whether they have been issued a warning label or recalled from the market, whether there are other, off-label uses of the drug, or if anyone has had an adverse reaction to their medication.

"We've worked hard to make it easily navigable and user friendly," Valentine says.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

April 23, 2013

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