June 27, 2014

New Rules Should Protect Quality of Baby Formula

Earlier this month, the FDA finalized new guidelines for manufacturers of infant formula in order to better protect babies from contaminated products. The move is a response to several prominent nationwide recalls of different formula products in the last several years.

As reported by MSN.com, in 2010, 5 million containers of Similac were recalled by Abbott Laboratories because they might have been contaminated by insect parts. In 2011, powdered versions of Enfamil, made by Mead Johnson Nutrition, were yanked from store shelves over concerns of contamination, which later proved unfounded.

Still, the red flag was raised, and now companies that make baby formula will be required to test for the presence of two kinds of bacteria, salmonella and cronobacter, that pose serious health risks to wee ones. They’ll also have to monitor their products for a longer period.

Salmonella can cause diarrhea and fever, sometimes to a life-threatening degree; cronobacter, which prefers dry environments such as powdered formula, can cause swelling of the brain — meningitis — in infants.

Most public health officials and medical professionals say breast milk is best for babies, but for various reasons of both necessity and convenience, many mothers don’t breast feed. So, many infants get all or part of their nutrition from formula.

Baby formula is not subject to FDA approval prior to sale. But all formula sold in the U.S. must meet federal nutrient requirements, and they do not change with the new regs. Infant formula manufacturers are required to register with FDA, and notify the agency before they market a new formula.

The FDA conducts yearly inspections of all facilities that manufacture infant formula. It collects and analyzes product samples, and inspects new facilities. If the feds determine that a formula presents a risk to human health, its manufacturer must conduct a recall.

The new requirements, according to the FDA, are meant to establish the "good manufacturing practices" that many companies voluntarily follow. These regulations establish federally enforceable standards for safety and quality.

They apply to formula sold "for use by healthy infants without unusual medical or dietary problems," said the FDA.

Under the new rules, companies must test their products' nutrient content and prove that the formulas can "support normal physical growth," the agency said. They must test the nutrient content in the final product stage, before entering the market and at the end of the products’ shelf life.

According to FDA, about 1 million U.S. infants are fed formula from birth; by the time they are three months old, about 2.7 million rely on formula for at least part of their nutrition.

Infant formula comes in three forms:


  • powder — the least expensive of the infant formulas, it must be mixed with water before feeding;

  • liquid concentrate — must be mixed with an equal amount of water;

  • ready-to-feed — the most expensive form of formula that requires no mixing.

The protein source varies among the different types of formula. The FDA’s nutrient specifications are set to meet the nutritional needs of average, healthy infants. Manufacturers use nutrient levels that usually exceed the FDA minimum. So babies fed infant formulas don’t need added nutrients unless they are fed a low-iron formula.

The formulas currently available in the U.S are either “iron-fortified” — with about 12 milligrams of iron per liter — or “low iron” — with about 2 milligrams of iron per liter. The American Academy of Pediatrics (AAP) recommends that formula-fed infants be fed iron-fortified formula to help reduce the prevalence of iron-deficiency anemia.

To learn more about safety and infant formula, such as proper storage, visit the FDA website. To learn more about childhood nutrition, see our blogs on the topic.

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February 7, 2014

Potential Help for Colicky Babies … and Their Parents

Even with the best of babies, parents of newborns live in a state of exhaustion. If your kid has colic, you’re pretty much a zombie. But scientists have found a noninvasive treatment that might help everybody in the family to feel better.

Probiotics.

Yes, it’s a trendy nutritional supplement, but according to a recent study in JAMA Pediatrics, as well as some previous studies in Europe, these “good bacteria” can reduce crying in colicky babies. The JAMA study suggests that probiotics might even prevent colic.

"We do find that the baby who took the probiotic since the first week of life, they develop less number of colic and constipation in the first month of life so they improve at least the symptoms," Dr. Flavia Indrio, a pediatric gastroenterologist at the University of Bari in Italy who led the JAMA study, told NPR.

What causes colic is not clear, but according to NPR, it affects between 8 and 15 out of 100 babies. It can be so bad as to cause depression in parents, and even thoughts of infanticide.

The babies in the JAMA study were given a form of Lactobacillus reuteri, a friendly bacteria that seems to help their digestive systems mature properly. There are countless ways to compound probiotics, and the trick is to find the right one.

"There are a number of effects that we know probiotics can have," Dr. Robert Shulman, professor of pediatrics at Baylor College of Medicine, told NPR. Many probiotics seem to affect the immune system, improve the lining of the intestine and influence the balance of bacteria living in the digestive system.

But "[W]e don't really know in babies with colic exactly how these probiotics are working," he said, and cautioned that much more research is required before babies are routinely given probiotics. The bacteria seem safe, but studies also must confirm that it’s too early to know for sure that their use has no long-term risks.

So if you see probiotics in your grocery story or pharmacy marketed as a colic remedy, be skeptical, but probably not alarmed — they’re more likely to be useless than possibly harmful.

Other than treatment for colic, probiotics are being studied to treat a range of conditions in adults from eczema to inflammatory bowel disease.

If you don’t want to take supplements but do want to boost your intake of these beneficial bacteria to help digest food, make vitamins and maybe help protect against, eat yogurt (with live cultures), sauerkraut, kimchi and other fermented foods.

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November 22, 2013

Vitamin D, Calcium and Building Good Bones

For many parents, the years between 9 and 14 are particularly difficult ages for rearing children. Puberty poses a lot of challenges, but one most people don’t consider is that it defines the narrow window in which humans build the bulk of their skeletons.

A story on NPR recently explained that a lot of kids that age aren’t getting what they need to build strong bones. And it’s not just a matter of nutrition, of sufficient amounts of calcium and vitamin D. They are essential for bone health, but so is physical stress.

In short, kids need to run and jump and make their bones work.

One of NPR’s sources, an orthopedic surgeon, said that when children jumped up and down between classes, for a total of about 15 minutes a day, they added mass to their leg bones.

For bones, bigger is better — the bigger they are, the harder they are to break.

"We think the bounce probably sends an electrical or other signal right up the skeleton, saying, 'OK, time to give more, time to build more bone.' " the doctor told NPR.

Any impact activity is good — jogging, tennis, basketball, dancing… Whatever your kid is happy doing. Federal health officials say that kids should get at least one hour of exercise every day, but it doesn’t have to be all at once. And it’s most important to get during the bone-building window.

On the nutrition front, children of all ages, including teenagers, often have a diet with too little calcium and vitamin D to build the best bones.

Children from 9 to 18 should get 1,300 milligrams of calcium every day. That’s about four or five glasses of milk, or the equivalent.

Most teens don’t come close. Only about 15 in 100 high school students drink milk, and only about 9 in 100 girls do, often because they perceive it as fattening. But that's not true — one glass of skim milk contains no fat and approximately 80 calories, about the same caloric content as an apple.

Good sources of calcium other than milk are yogurt and cheese.

Vegetables can be a source of calcium, but you have to eat tons of them to get the recommended levels. A cup of broccoli, for example, has only 42 mg of calcium. But fortified orange juice, breakfast cereals and tofu are good sources.

It’s always better to get this mineral from food, not supplements, especially for kids. The body absorbs calcium better from food than it does from supplements.

Even if kids get sufficient calcium, it won’t make much difference if they’re not getting sufficient vitamin D, which enables calcium to be absorbed during digestion.

Children, and most adults, need 600 international units of vitamin D a day. It’s found in fatty fish (salmon and sardines), and like calcium, is added to milk and orange juice. And, of course, we absorb it through exposure to the sun.

Unlike calcium, vitamin D can be appropriate in supplement form for some teenagers, especially if they don’t drink milk or eat fish and other healthful foods. A reasonable supplement for them would be about 400 international units per day.

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March 20, 2013

Monster Beverage Gets Monstrous with a Nutritionist

Monster Beverage wants a pediatric nutritionist to back off her warnings about the dangers to children of consuming high-caffeine "energy" drinks, or else.

Monster threatened a defamation lawsuit against Connecticut nutritionist Deborah Kennedy. She responded by contacting her U.S. Senator, Richard Blumenthal, who got Monster to back down, a teeny bit. Imminent litigation is no longer threatened, but Monster issued a statement saying Ms. Kennedy's comments about its products are still defamatory.

Which caused her mind to reel, inasmuch as the newsletter she sent to schools who are her clients hadn't even mentioned Monster by name. Plus, her warnings about the dangers of these beverages are backed up by the American Academy of Pediatrics, which issued its own warnings about energy drinks and sports drinks two years ago.

The saber-rattling by Monster was reported by the New York Times' Barry Meier, who describes Monster's new strategy to insinuate its products into kids' lives, by rebranding them into "beverages," instead of "nutritional supplements" as they had been for years.

Not coincidentally, the beverage label gets the manufacturer off the legal hook of having to report to the Food and Drug Administration when consumers experience adverse reactions.

Bottom line is that high-caffeine energy drinks should not be consumed by children.

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February 8, 2011

Caps threaten $19.2 million jury award to family of preemie who received overdose

A jury recently awarded $19.2 million to a Florida couple whose premature infant daughter received a massive overdose of nutrients at a Fort Myers hospital, but the family may never see most of it due to a cap on liability. The little girl is in a wheelchair for life and nearly blind due to the negligence of the hospital staff.

The cap, which is based on the concept of “sovereign immunity,” applies to public institutions, including public healthcare systems. (HealthPark Medical Center, where the event occurred, is part of the Lee Memorial Health System, a public health care system created by a special act of the Florida Legislature.) Sovereign immunity means that an employee, officer, or agent of the state and local governments is not held personally liable for negligence committed during the scope of his or her employment or function, unless the employee acts in bad faith or with malicious purpose. Instead, the state takes the place of the employee and defends the claim.

In Florida, sovereign immunity also limits the amount of recovery in any claim against the state to $100,000 per person and $200,000 per incident. (Effective Oct. 1, 2011, the limits will rise to $200,000 per person and $300,000 per incident.)

The verdict came after a two-week trial for medical negligence brought against the Lee Memorial Health System by the parents of Kiarra Summer Smith, who was born in 2007 weighing 1.5 pounds and 3 months premature. Kiarra was give a formula of neonatal nutrition including amino acids and carbohydrates as well as vitamins and trace minerals based upon her body weight. When she was 15 days old, the pharmacy misread an updated physician order sheet and calculated the dosage of trace elements as if it were for a person weighing about 160 pounds. As a result, Kiarra received a dose of trace elements, including zinc, copper, manganese and others, about 100 times larger than she should have.

The lawsuit states Kiarra’s body fluids became highly acidic and she went into cardiac arrest, requiring cardiopulmonary resuscitation and transfusion of all the blood in her body. She also suffered a brain hemmorhage. The long-term result is Kiarra has permanent neurological damage, a type of cerebral palsy where all four extremities are spastic, and is nearly blind. She also is completely disabled and in a wheelchair.

Lee Memorial admitted negligence but denied the overdose caused damage. “Although Lee Memorial Health System accepts responsibility for this unfortunate event, we believe the verdict is excessive and against the greater weight of the evidence,” a Lee spokeswoman said after the trial. “We admitted error in administrating nutrition but we believe strongly that this was not the cause of the child’s condition.”

To overcome Lee Memorial’s sovereign immunity protection, a specific bill would have to be passed by the Florida Legislature, which could only happen after all appeals had been exhausted, which could take years.

Source: Fort Myers News-Press

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February 3, 2011

Caffeine-laced energy drinks worry researchers

A review of studies about the contents of energy beverages has raised serious questions about their efficacy and safety. The review, published in the November issue of the Mayo Clinic Proceedings, noted that the drinks contain high levels of caffeine and could pose dangerous, even life-threatening effects on blood pressure, heart rate and brain function to some susceptible individuals.

The study found four documented cases of caffeine-associated death and five separate cases of seizures associated with consumption of energy/power drinks. Other reports included: (1) an otherwise healthy 28-year-old man who suffered a cardiac arrest after a day of motocross racing; (2) a healthy 18-year-old man who died playing basketball after drinking two cans of Red Bull; and (3) four cases of mania experienced by individuals known to have bipolar disorder.

Noting that teens and young adults are consuming energy drinks “at an alarming rate,” the study authors said it was important to determine whether long-term use of these beverages “will translate into deleterious effects later,” such as liver and cardiovascular disease, insulin resistance and diabetes.

Currently, the drinks are labeled as “dietary supplements,” which exempts them from regulations governing sodas and juices and allows manufacturers to make “ “structure and function” claims, like “enhances athletic performance” and “increases caloric burn and mental sharpness.”

The American Beverage Association says most mainstream energy drink brands voluntarily put statements on their containers, including advisories about use by people sensitive to caffeine, and many also list the amount of caffeine on their product labels or have provided caffeine content information through their Web sites and consumer hot lines.

But the study authors worry that some athletes who exercise intensively are substituting energy drinks for sport drinks (which only contain sugar and electrolytes). They say the high doses of sugar in energy drinks can impair absorption of fluids and result in dehydration, noting that a 16-ounce can of an energy drink may contain 13 teaspoons of sugar and the amount of caffeine found in four or more colas.

Source: The New York Times

You can view an abstract of the study published in the Mayo Clinic Proceedings here.

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June 22, 2010

Liquid Vitamin D: Too Much of a Good Thing for Babies

In a recent news release, FDA warns parents and caregivers of the risk of overdosing infants with liquid vitamin D. The liquid supplement is administered with droppers that are sold with the supplement itself. However, some of the droppers hold more vitamin D than is appropriate for babies.

Vitamin D supplements are recommended for some children to promote growth of healthy and strong bones. However, if fed with excessive amount of vitamin D, infants experience a myriad of symptoms ranging from nausea to muscle weakness, and sometimes even kidney damage.

Here are the FDA’s recommendations for parents whose children receive vitamin D supplements:

* Ensure that your infant does not receive more than 400 international units (IUs) of vitamin D a day, which is the daily dose of vitamin D supplement that the American Academy of Pediatrics recommends for breast-fed and partially breast-fed infants.
* Keep the vitamin D supplement product with its original package so that you and other caregivers can follow the instructions. Follow these instructions carefully so that you use the dropper correctly and give the right dose.
* Use only the dropper that comes with the product; it is manufactured specifically for that product. Do not use a dropper from another product.
* Ensure the dropper is marked so that the units of measure are clear and easy to understand. Also make sure that the units of measure correspond to those mentioned in the instructions.
* If you cannot clearly determine the dose of vitamin D delivered by the dropper, talk to a health care professional before giving the supplement to the infant.
* If your infant is being fully or partially fed with infant formula, check with your pediatrician or other health care professional before giving the child vitamin D supplements.

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