Health & Fitness

Skyrocketing prices and food shortages are already looming, and are likely to become worse in the coming months. At present, many parents across the U.S. are running from store to store in search of baby formula and finding only empty shelves. How did this happen?

The shortage, it turns out, stems from the fact that the U.S. Food and Drug Administration shut down Abbott Nutrition’s facility in Sturgis, Michigan, back in mid-February 2022, after five infants were reportedly sickened with Cronobacter and Salmonella infections.¹ Two of the babies died.

February 17, 2022, Abbott voluntarily recalled Similac, Alimentum and EleCare powdered formulas manufactured in the Sturgis facility. According to the FDA, the Sturgis facility failed inspection and was ordered to halt production until required sanitary measures were carried out.

The FDA inspection came on the heels of a whistleblower report,² submitted to the FDA in October 2021, alleging several health and safety compliance issues at the Sturgis facility, including falsification of records; release of untested formula; undermining of an FDA audit in 2019; lax cleaning processes; and the failure to adequately trace its products.

Some members of Congress are now calling for an investigation to determine whether the FDA took sufficiently prompt action after receiving this information.^3,4

Feds Fail to Address Industry Monopoly

May 16, 2022, the Biden administration announced⁵ it had reached a deal to reopen the Abbott plant in about two weeks, which should result in shelves being restocked in another six to eight weeks, but while that may solve the problem in the short term, it does nothing to address the underlying problem, which is the fact that the U.S. baby formula market is monopolized by three companies.⁶

Regulatory red tape also prevents the import of infant formula from other countries. As reported by The Defender:⁷

“The $45.4 billion U.S. baby formula market is controlled by three companies — Abbott, Mead Johnson and Gerber. A 2011 market analysis⁸ by the U.S. Department of Agriculture (USDA) shows these companies accounted for nearly all U.S. formula sales ...

Abbott Nutrition ... dominates the market — the company’s sales accounted for roughly 43% of the formula market ... according to a 2011 USDA report, which contains the latest available figures ...

FDA regulations for baby formula⁹ make it nearly impossible for parents in the U.S. to buy infant formula produced outside the country ... The issue is this: FDA rules bar formula imports from Europe if the product does not have FDA-compliant nutritional labels.

The formula may be perfectly safe and produced in accordance with European standards that are at least as stringent as U.S. health and safety requirements, but it can’t be imported because the FDA has not reviewed and approved what is printed on the package — a costly and time-consuming process for producers.”

US Response to the Crisis

House Democrats have now approved an emergency spending bill to allocate another $28 million to the FDA to allow it to hire more inspectors and prepare for future baby formula shortages. Some Republicans voiced opposition to the bill, saying it doesn’t contain any instructions for how the money is actually supposed to be spent, which would likely render it ineffective,¹⁰ and as of this writing, it’s still uncertain whether the bill will pass the Senate.¹¹

May 18, 2022, Biden invoked the Defense Production Act to increase production.¹² The law allows the president to compel companies that supply various formula ingredients to prioritize the needs of formula manufacturers over other customers.

Commercial aircraft owned by the U.S. Defense Department will reportedly be deployed to pick up formula overseas and fly it back to the U.S., in an operation dubbed “Operation Fly Formula.” DoD contracts with other commercial air cargo will also be used to speed up imports and distribution.

That same day, the House also passed bipartisan legislation to allow WIC recipients to purchase any brand of formula.¹³ The Biden administration has also promised to crack down on price gouging to discourage hoarding and reselling at higher prices.¹⁴

While that’s all well and good, but the Biden administration was initially criticized for its tone-deaf response to the crisis. In “The Jimmy Dore Show” episode featured above, Dore replays Jen Psaki’s response to a reporter who asks where parents should turn if they cannot find formula for their babies. Psaki suggested they call their pediatrician.

And then what? What is the pediatrician supposed to do about it? Manufacture baby food? Do they have some sort of magic wand? Dore also points out she’s apparently unaware that millions of parents are uninsured or underinsured, and can’t afford to pay for pediatric visits to ask about how to feed their babies.

Three Key Problems

Three key factors have contributed to the current disaster, and none is being properly addressed. First of all, the market has been allowed to be monopolized by so few companies that the takedown of a single plant has the ability to threaten the lives of millions of babies.

Adding insult to injury, our corporate-captured government has implemented labeling regulations that effectively ban foreign imports of formula, even if they meet or exceed FDA nutritional requirements.

Far more importantly than either of those, however, is the fact that science — to say nothing of common sense — has been ignored for decades and corporate greed has been allowed to dictate infant nutrition instead.

Absolutely nothing can compare to breast milk, yet people have been brainwashed into thinking that manmade formula is better, and that breast feeding is somehow undignified and unnecessary.

Formula offered greater freedom for busy moms, and the promotion of the obnoxious idea that breastfeeding in public is shameful fueled the transition, making more moms defer to the bottle rather than their breasts. For years, women could even be fined for "public indecency" if caught breastfeeding in public.

Were breastfeeding the norm, the country wouldn’t be in a panic over low inventory of infant formula. Many children would also enjoy better health overall. The sad reality is that most commercial infant formula is complete junk food.

Most contain shocking amounts of sugar — typically in the form of corn syrup, which is the worst of all — and even far worse ingredients, including large amounts of dangerous linoleic acid from soy (the risks of which I detail in “Infant Soy Formula — A Risky Public Experiment”) and genetically modified ingredients (reviewed in this 2012 article). Infant formulas have also been found to contain hazardous contaminants, including glyphosate¹⁵ and perchlorate (rocket fuel).

We’re now also hearing about artificial breast milk, a brand-new industry heavily funded by Bill Gates, Jeff Bezos and Mark Zuckerberg. A company called Biomilq is trying to create artificial breast milk from cultured human mammary cells.¹⁶ What could possibly go wrong with that? As of yet, however, artificial breast milk is not commercially available, so that’s a concern for another day.

All of that said, as it stands, the formula shortage is an absolute disaster, because while breastfeeding is the perfect option for most new mothers, it’s certainly not an option for anyone who didn’t breastfeed from the start, or who hasn’t breastfed for a number of weeks or months. You can’t just restart lactation at will. For that reason, telling mothers who already rely on formula to “just breastfeed” is ridiculous, because they can’t.

Breast Is Best

If you are a new mother and still lactating, then giving breastfeeding a try would be your best bet at this point. Breastfeeding has several benefits over formula,¹⁷ including reducing your baby’s risk of dying,¹⁸ improving your baby’s microbiome, thereby lowering their risk of obesity, diabetes and cardiovascular disease later in life.¹⁹

Exclusively breastfed babies also tend to have higher IQs than formula-fed babies.²⁰ For an even more comprehensive list of benefits for both the baby and mother, see my 2018 article, “The US Campaign Against Breastfeeding.”

How to Make Homemade Formula

If the opportunity to breastfeed has already passed, your next-best option is to make your own infant formula.²¹ The Weston A. Price Foundation has been a leader in this for years. In the video above, former Weston A. Price chapter leader Sarah Pope demonstrates how to make the formula created by Mary Enig, Ph.D., published in the book, “Nourishing Traditions.”

However, based on my research into linoleic acid (LA), iron and other components, I have revised Enig’s original formula (which you can find on the Weston A. Price Foundation’s website²²). In my view, it’s really crucial to NOT include any kind of iron or seed oils with high LA content, for all the reasons detailed in “Iron Overload Destroys Mitochondria and Sabotages Health” and “How Linoleic Acid Wrecks Your Health.”

I don’t have any children, but if I did and the child’s mother could not breastfeed, I would never use commercial infant formula as the recipe below is decidedly superior to commercial formulas and will give your child a major head start in life and preserve their health.

Dr. Mercola’s Preferred Healthy Homemade Infant Formula

2 cups organic, whole, cow milk, preferably raw unprocessed milk from grass fed cows. For sources of good-quality milk, see www.realmilk.com or contact a local chapter of the Weston A. Price Foundation. If the only choice available to you is commercial milk, choose whole milk, preferably grass fed organic and non-homogenized (Kalona SuperNatural non-homogenized organic milk23 is one example), and culture it with a Piima yogurt culture, available on CulturesForHealth.com,24 to restore enzymes. For sensitive bellies, raw goat’s milk may be better, but since it’s low in vitamin B12, be sure to add 2 teaspoons of frozen organic raw chicken liver, finely grated, to each batch, and begin egg-yolk feeding at 4 months of age.

4 tablespoons pure lactose (a milk sugar), available on Amazon.25

1 packet of Dr. Mercola Complete Probiotic Powder for Infants.

2 or more tablespoons of good quality, organic cream (regular, not ultrapasteurized). Use more if using milk from Holstein cows.

1 teaspoon of Carlson’s liquid cod liver oil, available from CarsonLabs.com,26 Amazon and most health food stores.

2 teaspoons organic, virgin coconut oil, available in most grocery and health food stores. The coconut oil provides medium-chain saturated fats also found in mother’s milk.

2 teaspoons Sari Foods non-fortified nutritional yeast flakes, available on Amazon.27 Nutritional yeast provides essential folic acid.

4 teaspoons Great Lakes beef hydrolysate gelatin, available on GreatLakesWellness.com.28 Before adding the gelatin into the formula, you’ll need to dissolve it in the recommended amount of water; heat gently until completely dissolved.

2 1/4 cups pure filtered water. Do NOT use tap water if your local water supplies contain fluoride. Most filtration systems cannot filter out fluoride, so only use fluoride-containing tap water if you have a water filtration system that is certified to remove fluoride.

1 teaspoon acerola powder, available on Amazon.29 Acerola is an excellent source of whole food vitamin C.

Optional: 1/4 cup homemade liquid whey (see recipe for whey, below).

Optional: Monkfruit sweetener. If your child has gotten used to the sweetness of corn syrup-sweetened infant formula and is refusing unsweetened formula, you can use a little liquid monkfruit as a sweetener, available on Amazon30 and in most grocery stores. However, AVOID any monkfruit brand that contains erythritol, which can cause gastrointestinal stress. Try to lower the amount used, over time, to discourage the development of a sweet tooth.

This recipe will make 36 ounces. Place all ingredients in a clean glass or stainless steel container and mix well. To ensure your mixing bowl is properly sanitized, place it in boiling hot water for a few minutes. Remove with tongs and let fully cool before using.

To serve the formula, pour 6 to 8 ounces into a sanitized glass baby bottle, attach the nipple and set it in a pot of simmering water. Heat until the formula is warm but not hot to the touch. Always check the temperature of the formula before feeding using either the back of your hand or your tongue. Never ever heat formula in a microwave oven. You’ll need to make a batch every other day or so, but the formula can be frozen so you have a stash for emergencies.

Homemade Whey Recipe

To make homemade whey, start with plain unsweetened yogurt, raw milk or cultured milk. Rest a large strainer lined with a clean linen kitchen towel or several layers of cheese cloth over a bowl.

If you’re using yogurt, place 2 quarts in the towel-lined strainer. Cover with a large plate and leave at room temperature overnight. The whey will drip out into the bowl. Place the whey in sanitized glass jars and store in the refrigerator.

If you are using raw or cultured milk, place 2 quarts of the milk in a glass container and leave at room temperature for two to four days until the milk separates into curds and whey. At that point, pour the mixture into the towel-lined strainer and cover with a plate. Leave at room temperature overnight to separate the whey from the curd. (The whey will drip out into the bowl.) Store in clean glass jars in the refrigerator.

Dairy-Free Formula

If your baby has a milk allergy, you can make a liver-based formula as follows. This recipe, again revised from the original Weston A. Price recipe to remove iron and seed oils, will make 36 ounces:

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This article was previously published June 29, 2019, and has been updated with new information.

Eggs are among the healthiest foods out there, but not all eggs are created equal, and sorting through the egg labels to identify the highest quality eggs can be a confusing affair.

Health conscious consumers know to look for designations like "organic," "free-range," "pastured" and "cage-free,"¹ but while you may think many of these are interchangeable, they're actually not. In some ways, these labels are little more than creative advertising.

The featured video, "Egg Crackdown," a CBC Marketplace report by investigative reporter Asha Tomlinson, investigates the marketing of supermarket eggs and visits egg producers to get a firsthand look at what the company's label actually means.

There Is a Confusing Array of Egg Labels

Unfortunately, while the Humane Farm Animal Care, a nonprofit certification agency, has set standards for free-range and pastured poultry for products bearing its Certified Humane label,² there's no legal definition of these terms in the U.S.

The "free-range" definition established by the U.S. Department of Agriculture applies to chickens only,³ not their eggs. As a result, the commercial egg industry is able to run industrial farm egg laying operations while still calling them "free-range" eggs, despite the fact that the birds' foraging conditions are far from natural.

Confusing matters further, while organic poultry and eggs are guaranteed to be free-range, as required by organic standards, free-range poultry are not required to be organic.⁴ Importantly, the organic label is also the only way to ensure you're getting eggs from chickens that have not been fed antibiotics for growth purposes, as this is not allowed under the organic standards.

For chickens, the USDA's definition of free-range does not specify the amount of time the hens must spend outdoors or the amount of outdoor space each hen must have access to. Nor do they indicate that the hen must have access to a pasture diet.

True free-range eggs, now typically referred to as "pasture raised" as a way to differentiate them, come from hens that roam freely outdoors on a pasture where they can forage for their natural diet, which includes seeds, green plants, insects and worms.

Large commercial egg facilities typically house tens of thousands of hens and can even go up to hundreds of thousands of hens. Obviously, they cannot allow all of them to forage freely. However, they can still be called "cage-free" or "free-range" as long as they're not confined to an individual cage.

Overall, the cage-free and free-range labels say little to nothing about the conditions in which the chickens are raised, and more often than not, they're still deplorable. So, for the best quality eggs, from the most humanely-raised hens, the label you're looking for is "pastured."

Putting Eggs to the Test

In the featured video, CBC Marketplace also conducts a taste test to see how the different farming methods translate into flavor. Included in the taste test are conventional battery caged eggs, free-range, organic and pastured eggs. The two conventional brands tested were Burnbrae and Gray Ridge.

In terms of flavor, the conventional eggs were deemed "bland," and some of the testers expressed concerns about animal welfare being one of the reasons they avoid conventional eggs. Tomlinson visits a CAFO in Ontario to investigate the conditions in which these egg-layers are raised.

The facility houses 20,000 chickens, and operations are automated. Each cage houses six chickens, the space being just tall and wide enough for the chickens to fit with minimal space to move. The eggs drop through an opening onto a conveyer belt.

Next up in the taste test were Small Flock's Delight's brown eggs "from hens on grass," a Canadian free-range brand, the label of which states: "Back to the old way, small flocks of happy hens picking and scratching through soil and green plants." Some taste testers said these eggs had a much more robust flavor and aroma, while others guessed they were conventional.

Enriched Colony, Nest-Laid Eggs Are CAFO

Next, Tomlinson visits a CAFO with "enriched housing" facilities. Eggs such as these cost about 50 cents Canadian more than conventional eggs and are marketed as being more ethical. But are they? The hens raised in enriched housing facilities get double the square inch of space given conventional chickens, and each cage has a scratch pad and perch rail.

They also have a darkened "privacy quarter" in which they can lay their eggs, as scientists claim hens prefer to lay eggs in a dark, private area. Other than that, the facilities and methods are identical to those of a regular CAFO. Eggs such as these are typically labeled as "enriched colony," "enriched coup" or "nest-laid."

Pastured Eggs — A Superior Choice in Flavor and Nutrition

As noted in the featured video, while "free run," "free-range" and "pastured" may sound like interchangeable terms, they're not. And the reality behind these terms isn't necessarily what you might expect:

As noted in the video, the diet of the chicken can impact not only the taste of the egg, but also its nutritional value. CBC Marketplace had the different types of eggs tested for their nutritional content, and the differences were significant.

Organic Meadow's pastured eggs received the highest nutritional rating, having three to five times more vitamin E, twice as much omega-3 fat and significantly higher amounts of vitamins A and D than the other eggs.

When it came to taste, Burnbrae's conventional eggs came in last place, with none of the taste testers selecting it as their favorite. The free run eggs came in fifth place, followed by the free-range brand (Small Flock's Delight) and Burnbrae's Organic. Interestingly, the win was a tie between Gray Ridge's conventional and Organic Meadow's pastured eggs.

Pastured Eggs Less Likely to Carry Pathogenic Contamination

While not discussed in this CBC Marketplace report, pastured eggs are also far less likely to be contaminated with disease-causing pathogens. CAFOs are known to be hotbeds for Salmonella infection.⁵

Eggs can become contaminated while they are being formed if the Salmonella bacteria exist inside a chicken's ovaries. As noted in the report,^6,7 "Food Safety and Cage Egg Production" by the Humane Society, published in 2011:

"All 16 scientific studies published in the last five years comparing Salmonella contamination between caged and cage-free operations found that those confining hens in cages had higher rates of Salmonella, the leading cause of food poisoning-related death in the United States."

Today, we also have antibiotic-resistant strains of salmonella to contend with, which makes potential contamination even more worrisome. While there's no way to guarantee 100% safety at all times, the benefits of free-range poultry are becoming more well-recognized, and reduced disease risk is definitely part of that benefits package.

Eggs Are an Important Part of a Healthy Diet

As mentioned, eggs are one of the healthiest foods around, loaded with valuable vitamins and minerals, including selenium, vitamins B2 (riboflavin), B5 (pantothenic acid), B7 (biotin) and B12, high-quality protein, iodine, vitamin D, zinc, omega-3 fats and more.⁸

Eggs are also an important source of lutein and zeaxanthin, two antioxidants known to play a role in healthy vision and the prevention of cataracts and macular degeneration, and are one of the best sources of choline available, providing 430 milligrams of choline per 100 grams.⁹

Choline helps keep your cell membranes functioning properly, plays a role in nerve communications and prevents the buildup of homocysteine in your blood, which is good because elevated levels are linked to heart disease.

Choline also helps reduce chronic inflammation and has been shown to lower your risk of nonalcoholic fatty liver disease, in part due to its role in phosphatidyl choline and transporting fats out of your liver,¹⁰ and part due to the fact that it's an important part of the mitochondrial membrane, and mitochondrial dysfunction is a central mechanism in the pathogenesis of NAFLD.¹¹

Choline deficiency is thought to play a major role in NAFLD because it disturbs mitochondrial bioenergetics¹² and fatty acid oxidation.¹³ Choline also enables your body to make the brain chemical acetylcholine, which is involved in storing memories. In pregnant women, choline helps prevent birth defects such as spina bifida, while also playing a role in your baby's brain development.

According to a study¹⁴ published in the journal Nutrients, only 8.03 to 0.56% of U.S. adults are getting enough choline — including only 8.51 to 2.89% of pregnant women. Among egg consumers, however, 57.3% meet the adequate intake levels for choline.

Based on the outcomes, the study authors concluded that "it is extremely difficult to achieve the adequate intake for choline without consuming eggs or taking a dietary supplement."¹⁵

Some of the symptoms associated with low choline levels include lethargy, memory problems and persistent brain fog. Because your body can only synthesize small amounts of this nutrient, you must get it from your diet on a regular basis.

Where and How to Find Organic Pastured Eggs

So to summarize, what you're really looking for is eggs that are both certified organic and true pasture-raised. Barring organic certification, which is cost-prohibitive for many small farmers, you could just make sure the farmer raises his chickens according to organic, free-range standards, allowing his flock to forage freely for their natural diet, and doesn't feed them antibiotics, corn or soy.

If you live in an urban area, visiting a local health food store is typically the quickest route to finding high-quality local egg sources. Your local farmers market is another source for fresh organic pasture-raised eggs, and is a great way to meet the people who produce your food.

With face-to-face contact, you can get your questions answered and know exactly what you're buying. Better yet, visit the farm and ask for a tour. Your egg farmer should be paying attention to proper nutrition, clean water, adequate housing space and good ventilation to reduce stress on the hens and support their immunity.

To get an idea of what you're looking for in a superior egg producer, take a look at Joel Salatin's Polyface farm operation below. He's truly one of the pioneers in sustainable agriculture, and you can take a virtual tour through his chicken farm operation in the following video.

As a general rule, you can tell the eggs are pastured by the color of the egg yolk. Foraged hens produce eggs with bright orange yolks. Dull, pale yellow yolks are a sure sign you're getting eggs from caged hens that are not allowed to forage for their natural diet.

For store-bought eggs, be sure to check out Cornucopia's organic egg scorecard that rates 136 egg producers based on 28 organic criteria. According to Cornucopia, their report "showcases ethical family farms and their brands, and exposes factory farm producers and brands in grocery store coolers that threaten to take over organic livestock agriculture."

Another Alternative: Raise Your Own Backyard Chickens

This is the choice I have actually taken. I had a chicken coop built for 20 chickens and I now have 17 hens. The key is what you feed them. I give them 1 1/2 pounds of two-day sprouted field peas and 1 cup of white rice that is cooked with the peas in an Instapot with 4 ounces of tallow.

To that I add 1 ounce of our organic beef organ complex and 1 1/2 ounces of calcium carbonate and a mineral complex. Also feed them 8 ounces of barley. This produces eggs that are VERY low in linoleic acid (about 75% less). As noted in the featured Marketplace report, backyard chickens are making a comeback, as more homeowners are adding free-roaming chickens to their gardens. If you are so inclined, it's by far your best egg sourcing option.

As you can see in the Polyfarm video above, raising chickens is not very difficult. If you are interested in the possibility of raising a few chickens yourself, a good place to begin is by asking yourself a few questions (see below). You can also visit Joel's Polyface Farm Web site for more details on raising chickens.

1. Can I dedicate some time each day? — You can expect to devote about 10 minutes a day, an hour per month and a few hours twice a year to the care and maintenance of your brood.
2. Do I have enough space? — They will need a minimum of 10 square feet per bird to roam, preferably more. The more foraging they can do, the healthier and happier they'll be and the better their eggs will be.
3. What are the chicken regulations in my town? — You will want to research this before jumping in because some places have zoning restrictions and even noise regulations (which especially applies if you have a rooster).
4. Are my neighbors on board with the idea? — It's a good idea to see if they have any concerns early on.
5. Can I afford a flock? — There are plenty of benefits to growing your own eggs, but saving money isn't one of them. There are significant upfront costs to getting a co-op set up, plus ongoing expenses for supplies.

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N-acetylcysteine (NAC), a form of the amino acid cysteine and a common dietary supplement, has been on the market for nearly six decades. Among its many benefits is helping increase glutathione and reduce the acetaldehyde toxicity¹ that causes many hangover symptoms, but anyone who overdoses on acetaminophen (Tylenol) also receives large doses of NAC in the emergency room, as it helps prevent liver damage by increasing glutathione.

However, the U.S. Food and Drug Administration suddenly cracked down on NAC in 2020, claiming it is excluded from the definition of a dietary supplement, as it was approved as a new drug in 1963,² before it was marketed as a dietary supplement or as a food.

Retailers, including Amazon, pulled supplements containing NAC from their shelves in response, as the FDA’s move meant that NAC could no longer legally be marketed as a supplement, even though there are no fewer than 1,170 NAC-containing products in the National Institutes of Health's Dietary Supplement Label Database.³

Draft guidance released by the FDA in April 2022 gives a glimmer of hope that NAC will continue to be available over-the-counter,⁴ but it’s still uncertain whether NAC will end up becoming a banned supplement.

FDA Announces ‘Enforcement Discretion’ for NAC Products

According to the FDA, their draft guidance, once finalized, will:⁵

“… explain our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements.

This enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act.”

In July 2020, the FDA sent out warning letters to seven companies that marketed NAC as a remedy for hangovers.⁶ Nine months after the FDA issued warning letters with their position that NAC supplements could not legally be sold, Amazon began removing products containing the supplement.⁷

The new verbiage suggests, however, that the FDA will not be enforcing their policy that NAC cannot be marketed as a dietary supplement, even though it’s technically still illegal to do so. And therein lies the problem. Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), explained:⁸

"That still leaves some exposure for the industry for a state [attorney general] to say, 'Well if it's technically illegal under the federal law,' we don't care that FDA's not enforcing it. We could do it. It also leaves you potentially exposed [to] a plaintiff's attorney."

Further, payment processing platforms, including PayPal, are among those that added policies prohibiting the sale of NAC products labeled as supplements following the FDA’s 2020 warning. It’s unknown whether PayPal will reverse its policy, or whether other major retailers, like Amazon, will begin to offer NAC supplements again.

Former FDA official Robert Durkin suggested that, in theory, the “draft guidance in and of itself should provide enough comfort to retailers to start marketing NAC-containing dietary supplements now."⁹ Whether that will be the case in practice remains to be seen.

Two Citizen Petitions Filed With the FDA

After the FDA decided that NAC could no longer be marketed as a dietary supplement, CRN and the Natural Products Association (NPA) filed separate citizen petitions with the FDA requesting that the agency reverse its position.

The CRN letter in December 2020 challenged the FDA’s determination that NAC should be precluded from supplementary use.¹⁰ They then filed a citizen position petition June 1, 2021, requesting the FDA reverse its position and outlining why this sudden policy change is “legally invalid on multiple grounds.”¹¹

The NPA filed a separate citizen petition with the FDA¹² requesting that the agency not exclude NAC as a dietary supplement or, alternatively, that the Department of Health and Human Services (HHS) issue a regulation finding NAC is lawful in supplements.

November 24, 2021, the FDA announced they were requesting more information about how NAC has been marketed as a dietary supplement,¹³ including information and data on the date that NAC was first marketed as a dietary supplement, reports of adverse events and details on how the products are marketed and sold.¹⁴ In their latest draft guidance, the FDA suggests it is still considering the petitioner’s requests:¹⁵

“… we have not yet reached a final decision on one petitioner’s request to issue a regulation to permit the use of NAC in dietary supplements, and we are considering initiating rulemaking to provide by regulation that NAC is not excluded from the definition of dietary supplement.

If, among other considerations, the FDA does not identify safety-related concerns as we continue our review of the available data and information, we are likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement.”

FDA Acknowledges There Are No Safety Concerns

In a positive step, while the FDA stated that their full safety review of NAC is ongoing, its initial review “has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement.” The agency further explained:¹⁶

“In addition, NAC-containing products represented as dietary supplements have been sold in the United States for over 30 years and consumers continue to seek access to such products. Accordingly, while the FDA continues its evaluation of the request to initiate rulemaking, the FDA issued this draft guidance to explain our policy regarding products labeled as dietary supplements that contain NAC.

Unless we identify safety-related concerns during our ongoing review, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (if we move forward with such proceedings) or we deny the citizen petition’s request for rulemaking.

If the FDA determines that this enforcement discretion policy is no longer appropriate, we will notify stakeholders by withdrawing or revising the guidance.”

With the draft guidance suggesting that no safety concerns have been noted, and enforcement is unlikely, Marc Ullman, counsel to the law firm Rivkin Radler LLP, suggested it should be perceived as “a win for industry” and that Amazon should “rescind its ban” on NAC dietary supplements in response:¹⁷

"FDA has said there's no safety issue and it's not going to take enforcement action. I think it would be an incredible overabundance of caution for any retailer to say, 'We shouldn't get NAC back into commerce.'"

Was FDA’s Ban Fueled by COVID-19 Treatment Hopes?

The FDA’s crackdown on NAC coincided with research suggesting COVID-19 treatment as a new indication. According to one literature analysis,¹⁸ glutathione deficiency may be associated with COVID-19 severity, leading the author to conclude that NAC may be useful both for its prevention and treatment.

Previous research has shown NAC inhibits the expression of proinflammatory cytokines in cells infected with highly pathogenic H5N1 influenza virus. Proinflammatory cytokines also play a crucial role in COVID-19 severity.¹⁹ Considering many COVID-19 cases also involve blood clots in addition to excessive oxidative stress, and NAC effectively addresses both, I believe NAC should be included in the standard of care for COVID-19. As noted in the FASEB Journal:²⁰

"COVID-19 may cause pneumonia, acute respiratory distress syndrome, cardiovascular alterations, and multiple organ failure, which have been ascribed to a cytokine storm, a systemic inflammatory response, and an attack by the immune system. Moreover, an oxidative stress imbalance has been demonstrated to occur in COVID-19 patients.

N-Acetyl-L-cysteine (NAC) is a precursor of reduced glutathione (GSH). Due to its tolerability, this pleiotropic drug has been proposed not only as a mucolytic agent, but also as a preventive/therapeutic agent in a variety of disorders involving GSH depletion and oxidative stress …

Thiols block the angiotensin-converting enzyme 2 thereby hampering penetration of SARS-CoV-2 into cells. Based on a broad range of antioxidant and anti-inflammatory mechanisms … the oral administration of NAC is likely to attenuate the risk of developing COVID-19, as it was previously demonstrated for influenza and influenza-like illnesses.

Moreover, high-dose intravenous NAC may be expected to play an adjuvant role in the treatment of severe COVID-19 cases and in the control of its lethal complications … including pulmonary and cardiovascular adverse events."

Another study published in 2021 compared consecutive patients hospitalized with moderate or severe COVID-19 pneumonia.²¹ One group received only standard care and the other group received 600 milligrams of NAC twice daily for 14 days. There were 42 in the NAC group and 40 in the control group. Treatment with NAC led to lower rates of severe respiratory failure and significantly lower mortality rates.

NAC Offers a Multitude of Benefits

NAC has been described as an “old drug with new tricks” because scientists are continually uncovering new ways to use it.²² Along with antioxidant, anti-inflammatory and mucolytic properties, NAC may be a useful adjuvant for a variety of chronic diseases and other medical conditions, including:²³

Polycystic ovary disease	Male infertility	Sleep apnea	Acquired immune deficiency syndrome
Influenza	Parkinsonism	Multiple sclerosis	Peripheral neuropathy
Stroke outcomes	Diabetic neuropathy	Crohn’s disease	Ulcerative colitis
Schizophrenia	Bipolar illness	Obsessive compulsive disorder	As a chelator for heavy metals and nanoparticles

Recently, it was found that NAC may also prevent strokes in people with hereditary cystatin C amyloid angiopathy (HCCAA), a rare genetic disorder.²⁴ People with HCCAA have an average life expectancy of just 30 years, and most die within five years of their first stroke,²⁵ so reducing their incidence could prove to be essential to increasing survival.

The finding is even more significant because it was conducted by researchers from Children’s Hospital of Philadelphia (CHOP), which is notoriously against supplements. NAC appears to work by preventing the formation of amyloid-producing proteins, which promote amyloid deposits linked to strokes.²⁶

It could also have potential for Alzheimer’s as, according to the CHOP researchers, the process of protein deposition that occurs in HCCAA is similar to what occurs in Alzheimer’s, although at an accelerated pace, which is why dementia occurs later in life than Alzheimer’s.

With so many potential health benefits, the root of the motivation to ban NAC as a supplement likely lies in protecting the finances of pharmaceutical companies. Hopefully in this case, however, the FDA will determine that NAC should be allowed to exist under the dietary supplement definition, ensuring widespread access to this important compound will continue the way it did for decades.

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