infant formula

FDA to Provide Flexibility to Manufacturers to Increase Infant Formula Supplies

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Today the U.S. Food and Drug Administration (FDA) issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. This action is designed to increase infant formula supplies in the United States while protecting the health of infants, for whom infant formula is often the sole source of nutrition during a critical period of growth and development. The guidance will be in effect until November 14, 2022, and we will evaluate whether any extension is necessary. 

The guidance is related to both the importation into the U.S. of infant formula produced in other countries and infant formula that is produced domestically. It describes the information that infant formula manufacturers should provide to the FDA if they want to introduce into U.S. commerce infant formula that is safe and nutritionally adequate but may not comply with all FDA requirements. The information sought includes a list of and amount of all nutrients as well as ingredients, a copy of the product label and description of packaging, current or anticipated inventory of the formula, microbiological testing results and facility inspection history. The FDA will use this information to consider on a case-by-case basis whether to exercise enforcement discretion. For example, for an infant formula with a label that does not list the nutrients in the order required, the FDA may determine that enforcement discretion is appropriate. In contrast, an infant formula containing less of a specific nutrient required might not be an appropriate candidate for enforcement discretion. Certain labeling requirements, such as the clear identification of any allergens present in the product or adequate instructions for safe product preparation and use, are connected to food safety and will be considered carefully in evaluating requests for enforcement discretion.   

Among the requirements for infant formulas, the FDA regulations specify minimum amounts for 30 nutrients that must be included.  For 10 of these nutrients, there are maximum amounts as well. In addition, any ingredient used in infant formula must be safe and suitable. The FDA also has specific requirements for labeling infant formulas.  They include directions for preparation and use, a pictogram showing the major steps for preparing infant formula and use by date.  

A voluntary recall by Abbott Nutrition in February 2022 and subsequent voluntary cease in production at their Sturgis facility, combined with the overall strains on supply chains experienced during the COVID-19 pandemic, have created concerns about the availability of certain types of infant formula. The FDA has already taken steps to support the increased supply of infant formulas, including regular meetings with infant formula manufactures to better understand their capacity to increase production and expediting review of notifications of manufacturing changes that will help increase supply—particularly of specialized formulas for medical needs such as metabolic disorders. 

Breast Is Best: Why We Need To Make Women Feel Comfortable Breastfeeding In Public, Work Spaces

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Recently, a young mother on a Virgin Australia Airlines flight was kicked off the plane while it was prepping for takeoff, taxiing on the runway. Why? She was breastfeeding her 10-month-old son. The mother in question, Virginie Rutgers, said that she was holding a cover over her son as she nursed him when a cabin supervisor asked her to remove it for safety reasons.

“I was in a state of shock honestly,” she told Seven News. Rutgers explained that the cabin supervisor “started to raise his voice” and became “quite abusive.” When flight attendants didn’t give her an explanation as to why her behavior was wrong, she continued breastfeeding. This ultimately led to her being removed from the plane and met by police shortly thereafter.

This isn’t the first time a mother breastfeeding in public was discriminated against. In 2013, a flight attendant on an American Airlines flight offered to move a mother back a few rows, saying that it was “because there are kids on this flight.” The airline later noted that mothers should be more careful when choosing to breastfeed “because of the offense that may be taken by others.”

In another recent case outlined by the American Civil Liberties Union (ACLU), a mother named Angela Ames was reportedly denied a place to pump breast milk when she returned to her job after a maternity leave. After protesting this, Ames was told to “just go home and be with your babies.” The ACLU notes that this is sex discrimination, even though the trial court held (in perhaps one of the silliest arguments ever made) that Angela’s coerced resignation from her job wasn’t sex discrimination, since men can technically lactate as well under certain circumstances.

Breastfeeding in public is often viewed as “offensive,” inappropriate, or gross. And in many cases, employers or airlines don’t have proper guidelines of how to deal or communicate with breastfeeding mothers.

“My guess is that these cases aren’t a result of miscommunication but rather lack of communication to begin with,” Diana West, director of media relations at La Leche League International, a nonprofit dedicated to educate women about and promote breastfeeding, told Yahoo Parenting. “If a woman doesn’t comply with airline instructions, it’s technically a security issue, but breastfeeding shouldn’t have been a problem in the first place.”

More women should breastfeed their children not only because of the copious amount of research that have proven its health benefits, but also because it’s important to create an accepting environment in public and work spaces where women can feel safe to do so. We need to support an upward trend in breastfeeding for all the benefits explained below, of course, but also because breastfeeding is in essence a reproductive right that all women deserve to have. Women should have a right to breastfeed in public without discrimination, even if they choose to feed their babies infant formula.

1. Breastfeeding’s History

If breastfeeding is so natural and essential to reproduction, then how and why did such a negative stigma come about?

While breastfeeding has always been a part of human existence, ancient civilizations also had to find ways to save the lives of babies if mothers were, for whatever reason, unable to breastfeed. Wet nursing, which involves one woman breastfeeding another woman’s child, became popular in many societies, particularly if a mother was too ill to breastfeed or had died during childbirth. As time went on, wet nurses, who were often women in lower social and economic positions, would nurse children of women in higher social positions. Thus breastfeeding began to be considered too “common” for royalty.

Soon, the notion of mothers breastfeeding their own children came to be known as a practice undertaken by the lower, common classes. Only peasants who couldn’t afford to feed their babies formula or hire wet nurses would do it. Fast-forward to the 1880s up until the 1960s, and there was a huge decline in the number of women who breastfed their own children; the practice was replaced by infant formula. As a result, breastfeeding was branded and stigmatized as an old-fashioned practice among poor and uneducated people.

“Society’s negative view of wet nursing, combined with improvements of the feeding bottle, the availability of animal’s milk, and advances in formula development, gradually led to the substitution of artificial feeding for wet nursing,” one report on the history of infant feeding says, also noting that infant formula companies pushed advertising so much that it had a huge impact on society’s view of breastfeeding.

Throughout history, there have been times when doctors and writers advocated for a woman breastfeeding her own child, claiming that it would be better for the child than a wet nurse. But wet nursing remained a popular alternative in addition to feeding bottles, which had also been around since ancient times, and infant formula.

While breastfeeding began to gain more popularity in the 1960s (and has recently risen, with 77 percent of mothers breastfeeding their own children, according to a 2013 CDC report), the stigma still remains, particularly in public and work spaces. And while laws allowing women to breastfeed in public do exist, many times they’re not enough.

Copious amounts of research have outlined the benefits of breastfeeding; it mainly protects the baby’s immune system and prevents a variety of disorders from allergies to diabetes and obesity.
Photo courtesy of Shutterstock

2. The Benefits

Based on heaps of research, there is no doubt that breastfeeding is better for both the mother and child than infant formula.

For one thing, it’s healthier. One recent study from Henry Ford Hospital found that babies who are breastfed actually have much stronger immune systems than those who aren’t. Instead of keeping babies in a sterile environment and preventing them from being exposed to bacteria, which can be detrimental to their immune systems, breastfeeding allows for “exposure to these microorganisms” which helps “stimulate the immune system,” said Dr. Christine Cole Johnson, an author of the study. It’s the mix of cells, hormones, and antibodies from the mother’s breast milk that is protective to the child, preventing the development of a variety of disorders like allergies, childhood leukemia, obesity, type 2 diabetes, ear infections, eczema, and diarrhea.

Another recent study out of the University of North Carolina Chapel Hill found that breastfed babies developed stronger stomachs, and the process prepared them more for eating solid foods, too.

“This study provides yet more support for recommendations by the World Health Organization and others to breastfeed exclusively during the first six months of life,” Dr. Amanda Thompson, an author of the study, said in the press release. “We can see from the data that including formula in an infant’s diet does change the gut bacteria even if you are also breastfeeding. Exclusive breastfeeding seems to really smooth out the transition to solid foods.”

Interestingly enough, in addition to providing the infant with greater immune protection, breastfeeding has been shown to increase a child’s IQ. According to one study, babies who were breastfed for 12 months grew up to have a higher IQ, complete more education, and make more money compared to babies who were breastfed for less than one month. Scientists still aren’t sure why this is the case; it’s possible that because breast milk is rich in long-chain saturated fatty acids, it can contribute significantly to brain development.

On top of all this, breastfeeding is much safer than infant formula as it provides babies with better nutrition and makes it easier for them to absorb all the protein, calcium, and iron in it. Infant formula, on the other hand, contains higher levels of arsenic, according to one recent study.

It’s important to raise awareness about the benefits of breastfeeding, and also the notion that it truly is a woman’s reproductive right. The Patient Protection and Affordable Care Act requires employers to “provide reasonable break times” for a mother to nurse her child up to one year after birth, and requires them to provide a safe place, shielded from view, that can be used by the employee. Yet, the stigma remains and makes it difficult for women to breastfeed at work or in public without some form of discrimination, no matter how subtle. It’s up to us to change that view in society, and provide a healthier alternative to infant formula to mothers and children across the country.

Environmental Toxins Linked to Rise in Autism.

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Story at-a-glance
Mounting research indicates that brain disorders are the result of excessive exposure to toxins from multiple sources, including the mother, while in utero
One recent study found that for every one percent increase in genital malformations in newborn males within a particular county, there was an associated 283 percent increase in autism
The correlation between genital malformation and autism offer strong support for the notion that autism is the result of parental overexposure to environmental toxins
Fluoride alone, which is still being added to many public water supplies around the US, can contribute to a seven-point drop in a child’s IQ score, on average
When the US National Toxicology Program was enacted in 1978, some 62,000 chemicals that were already in use were simply grandfathered in, even though they’d never been tested for toxicity

Environmental Toxins

Three decades ago, when I was still in medical school, autism affected one in 10,000 children.1, 2 What changed between then and now to cause one in 50 children3 to become autistic?

Mounting research—not to mention plain logic—indicates that brain disorders are the result of excessive exposure to toxins from multiple sources—including the mother, while in utero. One 2005 study4 by the Environmental Working Group (EWG) found that blood samples from newborns contained an average of 287 toxins.

Of these, 180 are known to cause cancer in humans or animals; 217 are toxic to your brain and nervous system; and 208 have been found to cause birth defects or abnormal development in animal tests. Clearly, nothing good can come from exposure to so many toxic compounds.

Genital Malformations and Autism—The Result of Overexposure to Toxins

A more recent study, published in the journal PLOS Computational Biology,5, 6, 7, 8 last month, found that every one percent increase in genital malformations in newborn males within a particular county was associated with a 283 percent increased rate in autism.

According to the researchers, genital malformations such as micropenis, undescended testicles, and hypospadias (when the urethra forms on the underside of the penis) are signs of exposure to harmful toxins. And the correlation between genital malformation and autism in turn offer strong support for the notion that autism is the result of parental overexposure to environmental toxins.

In all, 100 million American medical records were analyzed, and rates of genital malformations and autism were assessed by county. Deviations from the nationwide baseline were interpreted as being the result of local environmental factors. According to one of the authors, Andrey Rzhetsky, Ph.D., professor of genetic medicine and human genetics at the University of Chicago:

“Autism appears to be strongly correlated with rate of congenital malformations of the genitals in males across the country. This gives an indicator of environmental load and the effect is surprisingly strong… We interpret the results of this study as a strong environmental signal.”

Interestingly, every additional $1,000 in income above the county average was also associated with a three percent increased rate in autism. Could this mean that those with higher incomes buy more household, personal care, and beauty products that turn out to be toxic?

11 Brain-Harming Culprits Identified

Last month, researchers at the Harvard School of Public Health and the Icahn School of Medicine at Mount Sinai published a report identifying one dozen common chemicals (listed below) known to disrupt brain development and cause brain damage, neurological abnormalities, reduced IQ, and aggressiveness in children.9, 10 The authors call for the implementation of urgent preventive strategies to quell the trend of brain damage, stating:

“We postulate that even more neurotoxicants remain undiscovered. To control the pandemic of developmental neurotoxicity, we propose a global prevention strategy.

Untested chemicals should not be presumed to be safe to brain development, and chemicals in existing use and all new chemicals must therefore be tested for developmental neurotoxicity.

To coordinate these efforts and to accelerate translation of science into prevention, we propose the urgent formation of a new international clearinghouse.”

What many don’t realize is that there are literally tens of thousands of chemicals in use that have never been tested for safety. When the US National Toxicology Program was enacted in 1978, some 62,000 chemicals that were already in use were simply grandfathered in, even though they’d never been tested for toxicity.

The ramifications of this action is now becoming increasingly evident, and with regular intervals we realize that yet another prevalent chemical is causing harm that no one ever suspected. Bisphenol-A (BPA), used in plastic products, is just one of the most recent examples.

Lead (processed chocolate, gasoline, paint, toys, batteries, pipes, pottery, roofing materials, and cosmetics) Methylmercury (organic mercury found primarily in fish) Polychlorinated biphenyls (PCBs) (fish, especially farmed fish)
Arsenic(a common contaminant in fluoride added to water supplies. Also found in wood preservatives and pesticides) Toluene (paint thinner, fingernail polish, and leather tanning) Manganese (drinking water and soy infant formula)
Fluoride (fluoridated tap water, dental products, some antibiotics and medicines, tea, processed foods, and drinks) Chlorpyrifos (an organophosphate insecticide used in pest bait containers) Dichlorodiphenyltrichloroethane (DDT) (a pesticide banned in 1972 that still persists in the environment, including in the food chain)
Tetrachloroethylene (PERC)11 (dry-cleaning fabrics and metal degreasing operations) Polybrominated diphenyl ethers (PBDEs) (flame-retardant chemicals found in upholstery, mattresses, clothing, television, and computer housings) Ethanol
Organic Diet Is Part and Parcel of a Less Toxic Life

A recent article in The Atlantic,12 which is well worth reading in its entirety, discusses this Harvard report and offers a number of excellent quotes from the researchers with regards to how we can protect ourselves while regulatory wheels keep turning at a snail’s pace. James Hamblin writes:

“‘So you recommend that pregnant women eat organic produce?’ I asked Grandjean, a Danish-born researcher who travels around the world studying delayed effects of chemical exposure on children. ‘That’s what I advise people who ask me, yes.

It’s the best way of preventing exposure to pesticides.’ Grandjean estimates that there are about 45 organophosphate pesticides on the market, and ‘most have the potential to damage a developing nervous system.’

Landrigan had issued that same warning, unprompted, when I spoke to him the week before. ‘I advise pregnant women to try to eat organic because it reduces their exposure by 80 or 90 percent,’ he told me. “These are the chemicals I really worry about in terms of American kids, the organophosphate pesticides like chlorpyrifos.”
Fluoride and Glyphosate—Two Toxins That Need to Be Urgently Addressed

 

When you consider how pervasive those 12 toxins are (not to mention the thousands of others, which we still know little about), it’s no wonder so many children are born with severe health problems and disabilities. Fluoride alone, which is still being added to many public water supplies around the US, can contribute to a seven-point drop in a child’s IQ score, on average!13, 14

Why in the world are we still adding fluoride to water supplies? Even if ingesting fluoride had a benefit on teeth (which it clearly doesn’t), is it really worth sacrificing intelligence for fewer cavities? Fluoride isn’t the sole culprit, of course. According to a 2012 paper15 published by the National Institutes of Health (NIH), Americans have collectively “forfeited” a whopping 41 million IQ points as a result of lead, mercury, and pesticide exposure.

All of these brain-harming toxins also take a massive toll on aging Americans. According to recent research,16 the annual death toll from Alzheimer’s disease (a severe form of dementia) is now estimated to be 503,000, making it the third most lethal disease in the US. Approximately 200,000 of these deaths occur in those under the age of 65, who develop early onset of Alzheimer’s.

Recent research17 has also linked exposure to the pesticide dichlorodiphenyltrichloroethane (DDT) with an increased risk of Alzheimer’s. The use of DDT began during the second half of World War II, when it was liberally sprayed to control diseases such as malaria and typhus. Once the war was over, it began being used as an agricultural pesticide. (Monsanto was one of more than a dozen companies that manufactured the chemical.) It was eventually banned in 1972, when the health risks revealed in the book Silent Spring led to public outcry.

The suggestion that DDT exposure may contribute to Alzheimer’s, decades after exposure, hint at what the ramifications of glyphosate are likely to be in the years to come. According to Dr. Don Huber, an expert in an area of science that relates to the toxicity of genetically engineered (GE) foods, the harmful effects of glyphosate actually surpass those of DDT! It’s quite clear that the toxicity of this weed killer has been grossly underestimated.

Glyphosate (the active ingredient in Roundup) was approved in 1974 in the US,18 and has been aggressively used since then. An estimated ONE BILLION pounds of it is used on crop fields each and every year. As with DDT, we’re now seeing research linking glyphosate exposure to dramatic jumps in disease rates, including autism. The primary difference is that the effects are showing far sooner, and appear more evidently linked than in the case of DDT.

Soy Formula Associated with Seizures in Autistic Children

In related news, a researcher at the University of Wisconsin-Madison has found a possible link between infant soy formula and increased rates of seizures in autistic children. According to Medical News Today:19

“The study found excess seizures among girls and in the total sample of 1,949 children. The soy-seizure link reached borderline significance among boys, who comprised 87 percent of the children described in the database under study. Seizures – caused by uncontrolled electrical currents in the brain – occur in many neurological disorders including epilepsy, Alzheimer’s disease, Down syndrome, and autism…

[C]hildren with autism who were fed soy formula had 2.6 times as many febrile seizures as the children fed non-soy formula in the database… [T]hat increase is worrying, [Cara] Westmark says. ‘The prevalence of autism is increasing and currently affects one American child in 88. Soy is a widespread ingredient in many food products and 25 percent of infant formulas are soy based, so this is something that needs to be studied. If the child is lactose intolerant, there are alternatives that a pediatrician can recommend.'”

Parents Beware: Infant Soy Formula Can Cause Severe Harm

This certainly isn’t the first time infant soy formula has been linked to health risks. It’s often touted as an ideal alternative for colicky babies or those who are unable to tolerate milk based formulas, but evidence actually suggests that soy formula may be one of the absolute most dangerous foods you can give your child, whether he or she is autistic or not. For starters, it’s been estimated that infants who are fed soy formula take in three to five birth control pills’ worth of estrogen every day, depending upon the particular batch of formula and whether your baby is a big eater. As a result of such astronomical amounts of this female sex hormone, infants who are fed soy formula have an increased risk of:

Infants who are fed soy formula are also at increased risk for developing behavioral problems due to the phytates found in soy, which block the absorption of essential minerals such as calcium, magnesium, iron, and zinc, all which are crucial to the proper brain and emotional development. Phytates also cause poor bone development. Besides that, soy infant formula also contains another dangerous element: manganese. While manganese is an essential nutrient found in soil and ground water, it becomes highly toxic when consumed in excess, and can adversely affect your child’s intelligence if consumed during the stage of early brain development. Last but certainly not least, the vast majority of soy grown in the US is genetically engineered soy, which has its own health risks over and above those associated with Roundup.

Other Environmental Factors That Likely Contribute to Autism

Besides overexposure to the environmental toxins already mentioned, I believe there’s a variety of other important factors that also contribute to the rise in autism spectrum disorder, including but not limited to the following. The countless possible combinations of these and other factors could help explain why there’s such a wide spectrum of autistic behavior:

Gut dysbiosis, especially in combination with vaccines and their additives like mercury (thimerosal), aluminum, and others, which are known to damage your mitochondria—the powerhouses in your body’s cells that produce energy. Your gastrointestinal system is often referred to as your “second brain,” containing some 100 million neurons—more than in either your spinal cord or your peripheral nervous system. Research by Dr. Natasha Campbell-McBride shows that children born with severely damaged gut flora are at a significantly increased risk of vaccine damage, which may help explain why some children develop symptoms of autism after receiving one or more childhood vaccinations while others do not.
Vitamin D deficiency. The link between vitamin D deficiency in pregnant women and the proportionate jump in autism has been highlighted by Dr. John Cannell. Vitamin D receptors appear in a wide variety of brain tissue early in the fetal development, and activated vitamin D receptors increase nerve growth in your brain. I believe vitamin D deficiency during pregnancy is a MAJOR contributing factor to autism, especially when you consider that vitamin D also helps in the detoxification of mercury. Without sufficient amounts of vitamin D, any subsequent toxic assaults—regardless of the source—will be further magnified
Electromagnetic radiation (EMR) from cell phones, cell towers, Wi-Fi devices, which can trap heavy metals inside of nerve cells, accelerate heavy metal toxicity, and hinder natural detoxification processes
Microbial toxins, such as mold. Children with autism not only have overwhelmed detoxification pathways and often heavy metal toxicity, but, according to Dr. Klinghardt, their bodies are also frequently beset by toxic microbes
How to Limit Your Chemical Exposure

There’s no doubt that most people are being exposed to too many toxic chemicals. The results are plain for all to see, as brain disorders in both the very young and the elderly are skyrocketing; not to mention that people of all ages are increasingly ravaged by chronic diseases of all kinds as well. If you want to protect your own health, and the health of your family, I believe you simply must become more vigilant about the chemicals you come into contact with on a daily basis, and this certainly includes the foods you eat.

Organically-grown, biodynamic whole foods are really the key to success here, and, as an added bonus, when you eat right, you’re also optimizing your body’s natural detoxification system, which can help eliminate toxins your body encounters from other sources. Here are a dozen recommendations that will help limit your family’s toxic exposure. Please remember that all of these become even more important if you’re pregnant or planning a pregnancy, since your toxic load will be transferred on to your child.

As much as possible, buy and eat organic produce and free-range, organic foods to reduce your exposure to agricultural chemicals. Eat mostly raw, fresh foods, steering clear of processed, prepackaged foods of all kinds. This way, you automatically avoid artificial food additives, including dangerous artificial sweeteners, food coloring, and MSG.
Rather than eating conventional or farm-raised fish, which are often heavily contaminated with PCBs and mercury, supplement with a high-quality purified krill oil, or eat fish that is wild-caught and lab tested for purity.
Store your food and beverages in glass rather than plastic, and avoid using plastic wrap and canned foods (which are often lined with BPA-containing liners).
Have your tap water tested and, if contaminants are found, install an appropriate water filter on all your faucets (even those in your shower or bath).
Only use natural cleaning products in your home.
Switch over to natural brands of toiletries such as shampoo, toothpaste, antiperspirants, and cosmetics. The Environmental Working Group has a great database20 to help you find personal care products that are free of phthalates and other potentially dangerous chemicals. I also offer one of the highest quality organic skin care lines, shampoo and conditioner, and body butter that are completely natural and safe.
Avoid using artificial air fresheners, dryer sheets, fabric softeners, or other synthetic fragrances.
Replace your non-stick pots and pans with ceramic or glass cookware.
When redoing your home, look for “green,” toxin-free alternatives in lieu of regular paint and vinyl floor coverings.
Replace your vinyl shower curtain with one made of fabric, or install a glass shower door. Most all flexible plastics, like shower curtains, contain dangerous plasticizers like phthalates.
Limit your use of drugs (prescription and over-the-counter) as much as possible. Drugs are chemicals too, and they will leave residues and accumulate in your body over time.
Avoid spraying pesticides around your home or insect repellants that contain DEET on your body. There are safe, effective, and natural alternatives out there.