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I posted about this recall on February 22.

A quick review: The FDA is advising consumers not to use certain Abbott’s powdered formula products because they might be contaminated with  Cronobacter sakazakii or Salmonella Newport.

To date, one infant is ill with Salmonella Newport, and four ill with Cronobacter sakazakii with two deaths.

This is a shocking tragedy.  Formula-fed babies are entirely dependent on those products.  They are heavily regulated, or supposed to be.

The three powdered formula brands at issue are Similac, Alimentum, or EleCare.  The FDA says not to use them if:

• the first two digits of the code are 22 through 37; and
• the code on the container contains K8, SH or Z2; and
• the expiration date is 4-1-2022 (APR 2022) or later.

Abbott’s recall announcement has more information about the specific products.

Politico’s Helena Bottemiller Evich is following this case closely.

She interviewed parents of children harmed, sometimes terribly, by consuming contaminated formula.

In an earlier report, she detailed the history of FDA’s inspections of the Abbott laboratory and the agency’s surprising delay in getting Abbott to do a “voluntary” recall.

Food safety lawyer Bill Marler also has questions about the quality of production and FDA’s surprising lack of action.

Fortunately, House Appropriations Chair Rosa DeLauro has called on the Department of Health and Human Services’ Inspector General to invesigate whether the FDA “took prompt, appropriate, and effective action” in this situation.

As for Abbott, its statement says:

The company said all of its finished products are tested for the pathogens before they’re released, and samples it retained tested negative for the infections related to the complaints.  “We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust and resolve this situation.”

I have my own question: Why isn’t there far more media attention to the formula recalls?  Babies’ lives are at stake.  Parents, understanably, are frantic.

What should they do?

• Feed liquid formula.  It, at least, is sterile.
• Scream for federal action (if enough people do, it might get some).

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:

• the first two digits of the code are 22 through 37; and
• the code on the container contains K8, SH or Z2; and
• the expiration date is 4-1-2022 (APR 2022) or later.

The FDA and CDC are investigating.

[They have received] four consumer complaints of infant illness…All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.

Bill Marler’s Food Poison Journal has more about Cronobacter sakazakii (formerly known as Enterobacter sakazakii) in infant formula.

The FDA reports:

On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well. Canadian health officials have also issued a recall warning.

Helena Bottemiller Evich, writing in Politico, is right on top of this situation.

The FDA first received a report of a foodborne illness suspected to be linked to infant formula in September — four months before issuing a recall of three major brands this week after four babies were hospitalized and one died, according to a state agency.

The [recall]…comes after reports of illnesses came to FDA and the Centers for Disease Control and Prevention between September and January. The Minnesota Department of Health investigated a case of an infant who was sickened by Cronobacter sakazakii in September 2021, the state agency told POLITICO.

She also Tweeted:

I’ve gotten a bunch of reports that the formula recall includes these (often unsolicited) packs that formula companies send new parents. So check those, too!

Warning to parents: if you are using any Abbott formula products, check the labels.  Do not feed recalled products to your infant.

Comment: Anything wrong with infant formula is a terrible problem because that’s all infants are fed and they are completely dependent on those products.  We will have to wait and see why the FDA:

• Did not push Abbott to recall these products four months ago.
• Did not mention the gift pack of formula given to new mothers.

And Bill Marler writes: “I have some questions about the Cronobacter and Salmonella infant formula outbreak: Why are illnesses not universally reportable and why was there a two year gap in FDA inspections at plant?”

Also worrying is that the FDA still does not have the authority to demand immediate recalls of potentially harmful products.

The Food Safety Modernization Act gave the FDA recall authority, but tied its hands.

FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met. The FDA can use its mandatory recall authority when the FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA.

You will be amused to know that SAHCODHA stands for Serious Adverse Health Consequences or Death to Humans or Animals.

If you want to know what preoccupies the FDA, takes up its time, and keeps it from giving food safety the attention it needs, try this for a burning issue: Revocation of the Standard of Identity for French dressing.

Why would the FDA go to all this bother (and it looks like a lot of bother?

Because it was petitioned to do so by the Association for Dressings and Sauces (ADS).

If, like me, you had never heard of this trade association,

it represents manufacturers of salad dressing, mayonnaise and condiment sauces and suppliers of raw materials, packaging and equipment to this segment of the food industry.

Background: Standards of Identity

These date back to the Federal Food, Drug, and Cosmetic Act of 1938. They say what a food product must contain, in what proportions, and, sometimes, how it must be manufactured. Foods called things like ‘milk chocolate,’ ‘bread’ and ‘ketchup’ have standards of identity.  Because some of these standards date back 80 years, the FDA has called for comments on modernizing them.

When the FDA extended the comment period, it explained the goals for updating Standards of Identity:

• Protect consumers against economic adulteration;
• Maintain the basic nature, essential characteristics and nutritional integrity of food; and
• Promote industry innovation by giving manufacturers the flexibility to produce healthier foods.

The French Dressing standards

Check this for level of effort over more than 70 years.

In the Federal Register of August 12, 1950 (15 FR 5227), we established a standard of identity for French dressing. We later amended that standard of identity in the Federal Registers of May 10, 1961 (26 FR 4012), February 12, 1964 (29 FR 2382), February 1, 1967 (32 FR 1127 at 1128), May 18, 1971 (36 FR 9010), and November 8, 1974 (39 FR 39554), to allow the use of certain ingredients in French dressing. We also re-designated the French dressing standard of identity as § 169.115 (21 CFR 169.115) (42 FR 14481, March 15, 1977).

The Association for Dressings and Sauces complained—in its January 1998 petition— that nonstandardized pourable salad dressings such as Italian, Ranch, cheese, fruit, and peppercorn, have proliferated as have those reduced in fat, “light,” and fat-free. Because of this variation, and because consumers now expect French dressing to contain tomato-derived ingredients, be reddish-orange color, and sweet, the French dressing standard of identity “no longer serves honesty and fair dealing in the interest of consumers.”

It took more than 20 years, but the FDA now agrees.

Commentary

Ted Kyle of ConscienceHealth.org, who always has thoughtful and interesting things to say about food issues (even when we disagree), asks a good question: Does Anybody Care What’s in French Dressing?  He points out that standards protect the integrity of real as opposed to ultra-processed foods.

The New York Times quotes food historian Ken Albala:

“I can picture the people at Kraft sitting down at a board meeting and the chief marketing guy saying, ‘Do you know the sales of French dressing have dropped off by x and y?’ ” Professor Albala said that the change could allow food companies to revamp their recipes for French dressing as a way to try to boost sales.

 The Times also noted:

In response to the F.D.A.’s announcement of the change on Twitter, some people mocked the agency on Wednesday and said that it should concentrate more on its regulatory role in the coronavirus pandemic. The agency said in the newly published rule that it had received at least one comment as part of its review that questioned its priorities.

My point precisely.

In a press release, the USDA says it is going to take action against Salmonella contamination of poultry in order to get closer to the national target of a 25% reduction in Salmonella illnesses.

Despite consistent reductions in the occurrence of Salmonella in poultry products, more than 1 million consumer illnesses due to Salmonella occur annually, and it is estimated (PDF, 1.4 MB) that over 23% of those illnesses are due to consumption of chicken and turkey…USDA intends to seek stakeholder feedback on specific Salmonella control and measurement strategies, including pilot projects, in poultry slaughter and processing establishments. A key component of this approach is encouraging preharvest controls to reduce Salmonella contamination coming into the slaughterhouse.

The North American Meat Institute says its members are happy to assist (Salmonella is a problem for poultry, not beef).

The National Chicken Council also pledged to assist with the pilot projects, but then put the onus of responsibility squarely on you.

Even with very low levels of pathogens, there is still the possibility of illness if a raw product is improperly handled or cooked. Increased consumer education about proper handling and cooking of raw meat must be part of any framework moving forward. Proper handling and cooking of poultry is the one thing that will eliminate any risk of foodborne illness. All bacteria potentially found on raw chicken, regardless of strain, are fully destroyed by handling the product properly and cooking it to an internal temperature of 165°.

The newly formed Coalition for Poultry Food Safety Reform, led by Center for Science in the Public Interest, welcomes the USDA’s announcement, but insists that USDA’s food safety oversight needs to extend from farm to fork.

Comment: The USDA’s jurisdiction starts at the slaughterhouse, but chickens coming into the plant are already contaminated with Salmonella.  This means prevention has to start on the farm, and poultry producers would have to institute procedures to keep their flocks free of Salmonella. They would much rather you cooked your chicken properly.

The latest big Salmonella outbreak is due to onions, an FDA-regulated food.

FDA’s traceback investigation is ongoing but has identified ProSource Produce, LLC (also known as ProSource Inc.) of Hailey, Idaho, and Keeler Family Farms of Deming, New Mexico, as suppliers of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico.

Keeler Family Farms issued a voluntary recall.   ProSource Produce LLC also issued a voluntary recall.

The CDC has the statistics:

Comment: I wrote about a previous onion recall last year.   Food safety lawyer Bill Marler asks: What did we learn – or not – from the 2020 Salmonella Outbreak linked to onions?  That investigation, as he emphasizes, identified probable causes:

• potentially contaminated sources of irrigation water;
• sheep grazing on adjacent land;
• signs of animal intrusion, including scat (fecal droppings), and large flocks of birds that may spread contamination; and
• food contact surfaces that had not been inspected, maintained, or cleaned as frequently as necessary to protect against the contamination of produce.

The FDA lists all the products that have been recalled so far.  It also displays their labels.  If you have onions from these companies, treat them like biosafety hazards.  If you can’t bear to throw them out, at least boil them and sterilize everything they could have contacted.

As I mentioned yesterday, the American Beverage Association represents the interests of soft drink companies that use sugars and artificial sweeteners in their products.  Its goal: to make you think both are just fine for your health.

Today, let’s take a look at a related, but different trade association, this one The Sugar Association.  Its goal: to make you not worry about sugars and to think that they are better for you than artificial sweeteners.

Here, for example, is a press release from this Association from this past summer: New Research Shows Large Majority of Consumers Understand Real Sugar Comes from Plants & That it Can Be Part of a Healthy Diet; Data reveals significant shift in perceptions of sugar and artificial sweeteners.

And here is its infographic showing data on public suspicions of artificial sweeteners.

Now, we have a new campaign from The Sugar Association: The Campaign for Sweetener Transparency.

More than 10,000 consumers across the United States have joined the fight for sweeping reform of the government’s labeling regulations covering the use of alternative sweeteners in packaged food by signing an online petition urging the U.S. Food & Drug Administration (FDA) to require food companies to place clear, complete and accurate information on food labels…it’s virtually impossible for shoppers to know what alternative sweeteners are in which packaged foods because the FDA only requires food companies to list the chemical names of sugar substitutes on food ingredient labels. So, consumers only see names like Xylitol, Hydrogenated Starch Hydrolysates, Saccharin, Acesulfame Potassium, Neotame, Isomalt and Lactitol on ingredients lists without even knowing what they are and why they are used.

The Sugar Association wants artificial sweeteners clearly labeled so customers will switch to products that have sugars instead.

• Products containing artificial sweeteners fall in the category of ultra-processed—foods that should be avoided or eaten in small amounts.
• Products containing added sugars also should be avoided or eaten in small amounts.

That’s why this campaign is about market share, not health.

For a basic guide to what to do about sugars, see this resource guide from Hunter’s Food Policy Center.

Thanks to Tufts Professor Sheldon Krimsky for sending me this gem.

Residues of glyphosate in food and dietary exposure.  John L. Vicini,Pamela K. Jensen,Bruce M. Young,John T. Swarthout, Comprehensive Reviews in Food Science and Food Safety.  First published: 16 August 2021.

The study: A review of existing data on amounts of glyphosate residues in foods as compared to maximum limits or tolerances set by European or American regulatory agencies.  The study also reviewed data on levels of glyphosate in urine samples.

Conclusion: “Exposures to glyphosate from food are well below the amount that can be ingested daily over a lifetime with a reasonable certainty of no harm.”

NutraIngredients.com had an intriguing (to me, at least) article about the latest complaints about FDA’s lack of action on GRAS ingredients—those Generally Recognized As Safe.

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make changes, the authors found.”

The article referred to a this paper, Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

The starting point for this paper is a study done by the Government Accountability Office (GAO) ten years ago: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS)

The new paper argues that ten years later, the FDA has done little to address the GAO’s concerns.

Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. …most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers…FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

This took me right back to a blog post I did in 2016: The FDA’s unfortunate ruling on GRAS regulations.

Bettina Siegel’s Lunch Tray blog had an item recently about a new report on the effects of food dyes on children’s behavior (her blog is behind a Substack paywall, but well worth the subscription).

This report makes it time to talk about food dyes again.  For starters, they have only one purpose: to sell ultra-processed (junk) foods.  Research shows that brightly colored candy, snacks, and sodas are perceived as tasting better than the grey alternatives.  The food industry needs cosmetic food dyes.  We don’t, especially if they are harmful.

The 311-page peer-reviewed report, from the California Environmental Protection Agency’s Office of Environmental Health Hazards Assessment (OEHHA), is a meta-analysis of animal studies and 27 human clinical trials dealing with the neurobehavioral effects of seven synthetic food dyes on children.

Its conclusion:

The scientific literature indicates that synthetic food dyes can impact neurobehavior in some children… current ADIs [FDA’s Acceptable Daily Intakes] may not provide adequate protection from neurobehavioral impacts in children. For some of the dyes… updated safe levels of exposure would be much lower.

The idea that synthetic food dyes are associated with adverse neurobehavioral outcomes in children, but that children vary in their sensitivity to these dyes, is hardly new information.

In the mid-1970s, the physician Ben Feingold associated food dyes with hyperactivity in children and developed the Feingold Diet to improve kids’ behavior.

Much of the evidence for the “Feingold hypothesis” rested on anecdotal reports by parents,

Scientists’ attempts to study the effects of food dyes gave mixed results.  For example, as I wrote in a blog post on March 31, 2011, consider two studies published by Science magazine in 1980:

• Researchers gave pills containing a mix of food additives to 40 children, 20 diagnosed as hyperactive and 20 not.  The children diagnosed with hyperactivity reacted to the food additive challenge but the other children did not (Science 1980;207:1485-87).  But this study used pills rather than foods, mixed additives, and used questionable methods for evaluating hyperactive behavior.
• Researchers attempted to correct for such problems by using two drinks that looked and tasted the same—one contained seven food colors while the other did not.   The study was designed carefully such that neither the kids, parents, or observers knew what the kids were drinking.  The result:  Twenty of the 22 kids showed no reaction to the dyes.  One child reacted to the dyes every time (Science 1980;207:1487-89).

The interpretation?  Some kids may react to food dyes.

This gave the FDA an excuse to do nothing.  But then,

• In 2007, a study in England associating food dyes with hyperactivity revived the issue.
• In 2008, the Center for Science in the Public Interest (CSPI) petitioned the FDA to bad food dyes associated with behavioral problems in children.
• In 2009, CSPI updated its Diet, ADHD & Behavior: A Quarter-Century Review
• In 2010, CSPI published Food Dyes: A Rainbow of Risks.
• In 2016, CSPI published Seeing Red: Time for Action on Food Dyes.

Today, the FDA says this about color additives in food:

FDA on color additives in food (2007):

So how safe are they? “Color additives are very safe when used properly…There is no such thing as absolute safety of any substance. In the case of a new color additive, FDA determines if there is ‘a reasonable certainty of no harm’ under the color additive’s proposed conditions of use.”

FDA on whether color additives are safe to eat (2018):

Yes, color additives are safe when they are used in accordance with with FDA regulations…our regulations specify:

• the types of foods in which it can be used,
• any maximum amounts allowed to be used, and
• how the color additive should be identified on the food label.

FDA on whether color additives affect the behavior of children (2018)

The FDA has reviewed and will continue to examine the effects of color additives on children’s behavior. The totality of scientific evidence indicates that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them…Parents who wish to limit the amount of color additives in their children’s diet may check the food ingredient list on labels. Parents should also discuss any concerns with their family physician.

Well good luck with that.  The FDA can and should do better.

The bottom line: Food dyes have no health benefits.  Kids don’t need to be eating ultra-processed foods anyway.  They will not be harmed by avoiding food dyes.

CSPI has produced a lengthy and comprehensive comment on the new report. 

Given all of this, it’s surely time for the FDA to take some action.