Most supermarkets now carry a line of products labelled “gluten-free.” Many of us are choosing to buy and eat these new cookies, breads and other products we believe to be made without  flour. For most of us, it is a choice to avoid white flour, which we may consider not healthy for us.

For the three million Americans who have Celiac disease, a gluten free diet is there only choice  in managing their autoimmune digestive condition.

The FDA recently issued a new rule that provides standard definition to protect the health of Americans with Celiac disease. The U.S. Food and Drug Administration published a new regulation defining the term “gluten-free” for voluntary food labeling.

The press release issued by the FDA reads,“Adherence to a gluten-free diet is the key to treating Celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health. This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term “gluten-free” on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with Celiac disease to identify foods that meet the federal definition of ‘gluten-free,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

“The term “gluten” refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains.  In people with Celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of Celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.”

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with Celiac disease maintain a gluten-free diet.

The regulation was published in the Federal Register.

For more information:

• FDA: Gluten-Free Labeling
• FDA: Gluten-Free Labeling Final Rule Q&A
• Consumer Update

More women die from heart disease than from any other cause. In fact, one in four women in the United States dies from heart disease, according to the National Heart, Lung and Blood Institute (NHLBI).

“The risk of heart disease increases for everyone as they age,” says cardiologist Shari Targum, M.D., a medical officer at the Food and Drug Administration (FDA). “For women, the risk goes up after menopause, but younger women can also develop heart disease.”

FDA offers many resources to help educate women of all ages about the safe use of FDA-approved drugs and devices for the treatment and prevention of heart disease. FDA has fact sheets, videos, and other web-based tools on heart disease and conditions like diabetes and high blood pressure that may increase a woman’s risk for heart disease.

FDA created the “Heart Health for Women” site to connect women to FDA resources to support heart-healthy living. Visit the website at: www.fda.gov/womenshearthealth

“I encourage women of all ages to look to FDA for resources to help them reduce their risk for heart disease and make informed decisions about their health,” says Marsha Henderson, director of the Office of Women’s Health at FDA.

Heart Health for Women

When you think about heart disease, you probably imagine heart attacks and chest pain. But women need to know that heart health is about more than just heart attacks. Women need to take steps to reduce their risk for heart disease:

• Manage conditions like diabetes, high blood pressure, and high cholesterol that can increase your risk for heart disease.
• Learn to recognize the symptoms of a heart attack in women, including nausea, anxiety, an ache or feeling of tightness in the chest, and pain in the upper body.
• Use the Nutrition Label to make heart-healthy food choices.
• Daily use of aspirin is not right for everyone. Talk with a health care professional before you use aspirin as a way to prevent heart attacks.
• If you smoke, try to quit. See our booklet to learn more about medicines to help you quit.
• Talk to a health professional about whether you can participate in a clinical trial for a heart medication or procedure. Visit the FDA Patient Network to learn more about clinical trials.

Menopause and Heart Health

“Menopause does not cause heart disease,” says Targum. “But the decline in estrogen after menopause may be one of several factors in the increase in heart disease risk.” Other risks, such as weight gain, may also increase around the time of menopause.

Hormone therapy is used to treat some of the problems women have during menopause. “However, the American Heart Association recommends against using post-menopausal estrogen hormone replacement therapy to prevent heart disease,” says Targum.

Make a Plan, Take Action

Work with your health care team to make a plan for your heart health. Whatever your regimen, make sure to keep a list of your medicines and bring it with you to all of your appointments.

Most of us think lasers are cool. What we may not know is that when operated unsafely, or without certain controls, the highly-concentrated light from lasers—even those in toys—can be dangerous, causing serious eye injuries and even blindness. And not just to the person using a laser, but to anyone within range of the laser beam.

The Food and Drug Administration (FDA) is particularly concerned about this potential danger to children and those around them.

According to a health promotion officer at FDA’s Center for Devices and Radiological Health, “A beam shone directly into a person’s eye can injure it in an instant, especially if the laser is a powerful one.”

However, laser injuries usually don’t hurt, and vision can deteriorate slowly over time. Eye injuries caused by laser light may go unnoticed, for days and even weeks, and could be permanent.

Some examples of laser toys are:

• lasers mounted on toy guns that can be used for “aiming;”
• spinning tops that project laser beams while they spin;
• hand-held lasers used during play as “lightsabers;” and
• lasers intended for entertainment that create optical effects in an open room.

FDA Regulates Lasers

A laser creates a powerful, targeted beam of electromagnetic radiation that is used in many products, from music players and printers to eye-surgery tools. FDA regulates radiation-emitting electronic products, including lasers, and sets radiation-safety standards that manufacturers must meet. This includes all laser products that are marketed as toys.

Toys with lasers are of particular interest to the FDA because it’s often children who are injured by these products. Because advertisers promote them as playthings, parents and kids alike may believe they’re safe to use.

For toys to be considered minimal risk, the FDA recommends that the levels of radiation and light not exceed the limits of Class 1, which is the lowest level in regulated products. Lasers used for industrial and other purposes often require higher radiation levels. But in toys, those levels are unnecessary and potentially dangerous.

In recent years, lasers have increased markedly in power and have gone way down in price. And while adults may buy a laser pointer for use in work, kids often buy them for amusement.

Low-cost, compact laser pointers used to be quite low in power but, in the last 10 years, many laser pointers have increased in power 10-fold and more. The fact that lasers can be dangerous may not be evident, particularly to the children who use them as toys, or to the adults who supervise them.

Tips to Keep in Mind

• Never aim or shine a laser directly at anyone, including animals. The light energy from a laser aimed into the eye can be hazardous, perhaps even more than staring directly into the sun.
• Do not aim a laser at any reflective surface.
• Remember that the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car or otherwise negatively affect someone who is engaged in other activity (such as playing sports).
• Look for a statement that it complies with 21 CFR (the Code of Federal Regulations) Subchapter J on the label.

If you buy a laser toy or pointer and you don’t see this information in the labeling, it’s best not to make any assumptions about its safety.

Source: FDA Consumer Updates

The Food and Drug Administration (FDA) has made it easier for parents and health care professionals to find information on pediatric medications. The FDA created a database that covers medical products studied in children under recent pediatric legislation.

The ^C4 is a one-stop resource. You can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.

OPT also maintains a Safety Reporting page⁵ with information on products that have been tied to safety problems that specifically relate to children. This page lists products that have been the subject of an adverse event report presented to FDA’s Pediatric Advisory Committee, a group of outside experts that advises the agency on pediatric treatments, research and labeling. (An adverse event is any undesirable experience associated with a medical product.)  The committee’s recommendation is also given if further actions were necessary to ensure safe use of the product in children.

“We are excited to share this goldmine of information with parents,” says Debbie Avant, R.Ph., the health communications specialist in OPT who helped develop and maintain the database. “We want parents to know they can rely on FDA for accurate, timely information about the medications their children take.”

Pediatric Medication Labels

Parents should always read medicine labeling carefully. For prescription medications and vaccines, there is a Pediatric Use section in the labeling that says if the medication has been studied for its effects on children. The labeling will also tell you what ages have been studied. (This labeling is the package insert with details about a prescription medication.)

Congress’ efforts to increase the number of studies of prescription drugs used in children have allowed FDA to build a foundation for pediatric research and discover new things. For example, researchers have found that certain drugs produce more side effects for the nervous system in children than adults, says Dianne Murphy, M.D., OPT’s director.

FDA is able to use information gathered from pediatric studies to make labeling changes specific to kids, and to share that news with the public. The database, which is updated regularly, currently contains more than 440 entries of pediatric information from the studies submitted in response to pediatric legislative initiatives. The labeling changes include:

• 84 drugs with new or enhanced pediatric safety data that hadn’t been known before;
• 36 drugs with new dosing or dosing changes;
• 80 drugs with information stating that they were not found to be effective in children; and
• 339 drugs for which the approved use has been expanded to cover a new age group based on studies.

The easiest way for parents to use the database is to search by their child’s condition to find all mentions of that condition in all of the labeling information within the database. If you know the name of the drug you want to find, sort the database’s information by trade name.

Avant says parents should note that the database contains the version of the label at the time of the labeling change. It may not be updated with later changes if they don’t affect children.

OPT has also evaluated the amount of progress in the inclusion of pediatric information in drug labeling and has published a research letter in the Journal of the American Medical Association⁶⁷on May 9, 2012. They found that in 2009, more than 60% percent of the drugs used for both adults and children that were in the Physician’s Desk Reference—a drug information resource for physicians and other health professionals—had specific information on pediatric use, compared to only 22 percent in 1975.

Critical information in the pediatric section of the labeling tells you if the product was studied in children but could not be shown to work. When a product has been studied in adults and cannot be shown to be effective, that information is not put in the label. However, Congress told FDA to put this information in labeling when a product had been studied in children and was not effective.

“There is still much work to be done, as we have only studied two thirds of the products that are already on the market,” says Murphy. “And there is a steady stream of new products approved every year for children and adults.”

Source : FDA Consumer Updates page

The 100 calorie packs available in most major food markets can be a handy way to maintain snack portion control between meals for kids and adults.

The challenge… read the nutrition label and see what the salt, fat, and carbohydrate intake is in this low calorie snack. It may be 100 calories, but it is not necessarily a healthy snack.

The site, fruits & veggies, more matters, at www.fruitsandveggiesmorematters.org/healthy-weight-management,  issued a 100 calorie list of foods that make for healthy and low calorie snacking. Here are their suggestions:

 100 Calorie Snacks

Tortilla Chips  – 3/4 c

Strawberries –  2 cups

Sliced Peppers –  2 cups

Pretzels –  1 ounce

Muffin  – 1 ounce (1 mini)

Lettuce, shredded -20 cups

Ice Cream (not premium) 3/8 cup

Fresh Blueberries  – 1 1/4 cup

Donut 3/8 –  whole

Cucumbers, sliced  – 7 cups

Chocolate Chip Cookies – 2-2inch cookies

Cherry Tomatoes –  4 cups

Cheese P-Nut Butter Snack Cracker  – 3

Cantaloupe Cubes – 2 cups

Canned Peaches (in juice) – 1 1/2 cup

Bagel –  1/4 of 5 oz. bagel

Baby Carrots – 2 cups

Apple Slices –  2 cups

American Cheese (thin slices) -2 slices

100% Vegetable Juice -2 cups (16 fluid ounces)

100% Orange Juice – 7 fluid oz.

Happy Snacking on 100 Calories!