Kids & food allergies – Today Show

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As someone who cares about what your family eats, you make it a practice when shopping to read the labels on food packages. And you have the right to expect that the information on the label, including the ingredient list, is accurate.

The good news is that the Food and Drug Administration (FDA) has your back.

The Federal Food, Drug and Cosmetic Act—which provides authority for FDA’s consumer-protection work—requires that labels on packaged food products in interstate commerce not be false or misleading in any way.

To that end, as resources permit, FDA monitors food products to ensure that the labels are truthful and not misleading, explains Michael W. Roosevelt, acting director of compliance at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). If a product is not labeled as required by law, the agency takes appropriate action.

For example, when FDA received complaints from U.S. firms and attorneys alleging that imports of pomegranate juice concentrates were not, as labeled, 100% pomegranate, the agency took a closer look.

After conducting its own analyses, FDA found that some of the samples contained undeclared ingredients, including artificial colors, sweeteners and less expensive fruit juices, such as black currant, apple, pear or cherry juices, in place of pomegranate juice.

FDA issued an import alert for pomegranate juice exported by certain companies in Iran and Turkey, based on findings that the samples FDA analyzed were “not as they were represented to be on the labels and therefore adulterated and misbranded.” An import alert allows FDA to detain, without physical examination, imported products that appear to violate the Federal Food, Drug, and Cosmetic Act. When a shipment is detained, the importer has a window of opportunity to introduce evidence to overcome the appearance of a violation, during which time the product cannot be distributed.

In other circumstances, when the agency identifies a food product with labeling that is false or misleading (misbranded), it may inform the manufacturer, often in the form of a warning letter, of the violation of law and ask the firm to correct the problem. Most firms contacted by FDA about a labeling violation voluntarily comply, Roosevelt says.

Those that do not can be subject to additional legal action to remove the misbranded products from commerce. Under such circumstances, these products cannot return to the market until the manufacturers take action to correct the violations.

“In the case of the pomegranate juice,” Roosevelt says, “the burden is on the importer to show that the product labeling is accurate.” “Otherwise, the juice is not going to make it into the U.S.”

Another example: In 2012, FDA issued an import alert for shipments of honey exported from India, Malaysia, New Zealand, Turkey and Vietnam due to findings that certain honey products from these countries had been adulterated through the partial substitution of cane or corn sweeteners.

Import alerts are listed on fda.gov, and there are a number of different ways to search for firms and products. FDA also maintains an alphabetical list of warning letters by subject in which consumers can find previous examples of past warning letters citing misbranding or adulteration of food.

In addition, FDA regulations include formal standards of identity for many kinds of food, including milk and cream; cheese and related cheese products; frozen desserts; bakery products; cereal flours and related products; macaroni and noodle products; canned fruits; canned fruit juices; fruit butters, jellies, preserves and related products; fruit pies; canned vegetables; vegetable juices; frozen vegetables; eggs and egg products; fish and shellfish; cacao products, tree nut and peanut products; beverages; margarine; sweeteners and table syrups; and food dressings and flavorings.

These regulations help to protect consumers against the intentional substitution of ingredients without declaring those ingredients in labeling (e.g. using an unlisted, less expensive ingredient to reduce the cost of manufacturing). The standards of identity require that products contain the ingredients required by the standard.

“In other words,” says Roosevelt, “the product is what the label says it is.”

FDA receives much of its information on possible product labeling violations from competitors in industry, at which point the agency often examines or tests the product to confirm or disprove the claims.

If consumers suspect a label is inaccurate, however, FDA welcomes information from them as well. Consumer complaint coordinators located in 19 FDA district offices throughout the United States and Puerto Rico will listen, document your complaint or concern, and determine the appropriate contact for follow-up. You can find the number of the complaint coordinator in your area at fda.gov.

You can also report adverse events from foods, drugs and other FDA-regulated products through MedWatch.

With the books closed on 2012, we can confirm–as expected–that a majority of the major FDA vaccine approvals went to trivalent influenza vaccines. (The FDA is continuing this trend with the first vaccine approval of 2013 going to Flublok, a trivalent influenza vaccine made using an insect virus expression system and recombinant DNA technology.) Manufacturers, after all, need to reformulate them each season. But two new quadrivalent flu vaccines from GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) also joined the ranks, scheduled to hit the market later this year.

Of 11 major FDA vaccine approvals, 10 went to flu vaccines. (GlaxoSmithKline did get the OK for MenHibrix, a combination vaccine to prevent disease from meningococcal groups C and Y as well as Haemophilus influenzae type b, or Hib.)

GSK’s Fluarix Quadrivalent and AstraZeneca’s FluMist Quadrivalent should debut in time for the 2013-2014 flu season. Until February 2012, when the FDA gave FluMist Quadrivalent the go-ahead, all approved flu vaccines covered only two influenza A strains and one influenza B strain.

Trivalent influenza vaccines hit the market in the 1980s, Dr. Leonard Friedland, VP and head, GSK North America Vaccines Clinical Development and Medical Affairs, told FierceVaccines. World health experts and researchers select strains for a seasonal flu vaccine based on forecasts about which viruses will most likely cause illness in a given season. The idea is to match the strains in the vaccine with the strains making the rounds. By 2000, health experts noticed that two influenza B lineages–Yamagata and Victoria–began cocirculating.

“In 6 of the last influenza seasons, the predominant B strain that circulated was of a lineage not selected to be in the vaccine,” Friedland said.

The World Health Organization recently called for manufacturers to start including a second B strain in their vaccines. For its part, GSK began working on a quadrivalent flu vaccine in 2010, Friedland said, the outcome being Fluarix Quadrivalent. The company has a second quadrivalent flu vaccine in the works.

“What we’re excited about with the quadrivalent vaccine is now there won’t be any question, ‘Did we choose the right B strain in the vaccine?’ Friedland said. “Because both B lineages will be in the vaccine. It provides the opportunity for broader protection in the vaccine.”

Still, only about 47% of individuals received the flu vaccine in the 2011-2012 season. And the U.S. Centers for Disease Control reports an estimated 36.5% got the jab by November this season. So there’s a market present, it’s just a matter of tapping into it.

We’ll keep an eye on the quadrivalent flu vaccines as they roll out at the end of the year. Until then, take a look at which vaccines nabbed a major thumbs-up from the FDA in 2012.

Using a DNA vaccine could one day be as easy as applying a temporary tattoo, according to U.S. research published in Nature Materials.

DNA vaccines in animals trigger robust immune responses, but these aren’t always replicated in humans, and as a consequence, there is still no DNA vaccine that is commercially available, despite a couple of decades of research. Another challenge is getting the DNA into the cell. Although techniques such as electroporation have improved delivery, this still involves a shot, and the sensation can be unpleasant or even painful.

The researchers, including a team from MIT, have created a patch of microneedles half a millimeter long, coated with multilayers of vaccine-loaded polymer film. The idea is that the patch is placed on the skin for a few minutes and then peeled off, leaving a “tattoo” of thin polymer films painlessly embedded in the skin. The polymers break down and release the vaccine DNA, with an RNA adjuvant that boosts the immune response, into the epidermis, which is populated with immune cells. The DNA tangles with the polymer as it breaks down, helping it get inside the cells.

In animal studies the DNA vaccine lasted between days and weeks, depending on the number of layers and the makeup of the polymer. In mice, the vaccine tattoo triggered immune responses against HIV similar to those of a vaccine delivered using electroporation. In cultured skin samples from nonhuman primates, the patch triggered gene expression 140-fold higher than that of a transdermal injection and enhanced the production of memory T cells. The next step is to carry out tests in nonhuman primates and then in humans.

As well as successfully triggering an immune response and avoiding shots, these multilayered tattoos could be more stable than other formulations of DNA vaccine, allowing storage at room temperature. Their stability, size and weight could mean that they could be posted or couriered out quickly to areas of need in epidemics and pandemics without worrying about refrigeration. Their simplicity also means that they could be self-administered or administered by people with little specialist training.