Currently browsing posts about: FDA

The White House says it is taking steps to alleviate the nationwide shortage of infant formula.

House speaker Nancy Pelosi has written a letter to democrats demanding action.

Nationwide shortage of infant formula?

As CBS News explained,

At retailers across the U.S., 40% of the top-selling baby formula products were out of stock as of the week ending April 24…Prices of baby formula, which three-quarters of babies in the U.S. receive within their first six months, have also spiked…Supply-chain snarls related to COVID-19 are contributing to the shortage of formula around the U.S. They include manufacturers having more difficulty procuring key ingredients, packaging hangups and labor shortages…In addition, a major baby formula recall in January exacerbated shortages.

I wrote about the Abbott recall earlier, on February 22 and March 8.

Politico’s Helena Bottemiller Evich has been following this story closely in Politico.  You can find her articles here.

Her writing is getting action.

For example, Representative Rosa deLauro released a whistleblower report warning about food safety concerns months before infants died and the FDA investigated.

Food safety lawyer Bill Marler posted a link to the redacted  whistleblower report.

He says: Mr. Abbott, you are going to jail for manufacturing tainted infant formula.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.  For Abbott, at least 4 kids were sickened and of those two died, from drinking infant formula.

Here is the most recent inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

In the meantime, Bottemiller Evich keeps the focus on how hard this situation is for parents of infants with special nutritional needs.  She also has a Twitter thread on this “slow-moving train wreck.”  She reproduces this graphic from @erindataviz/@datasembly:

The Seattle Times has a particularly useful guide to what to do—and what not to do—if you can’t find the formula you need.

As to what this is really about, see:

The Morning.  This New York Times column attributes this particular shortage to general shortages, monopoly concentration in the formula business, bureaucratic inflexibility, and, most of all, American gerontocracy and overall indifference to the welfare of young children.

A blogger about the politics of monopoly, Matt Stoller, expands on these themes:  baby formula monopoly, FDA collusion, and USDA’s methods for dealing with infant formula in the WIC program (this last alone is reason to read this piece).  In response, the USDA says it is granting states flexibility in apply the WIC rules.

And the Cato Institute has an informative piece on trade restrictions that prevent import of formula from other countries, including the European Union; this pieces also discusses the WIC problem (Government is major buyer; Abbott is major supplier).

Comment: This is a really bad situation that is finally starting to get attention.  Babies are completely dependent on infant formula if they are not being breastfed.  It needs to contain all the right nutrients, but it also needs to be safe.

The FDA says it is taking steps to alleviate the formulat shortage.

Why hasn’t it acted more swiftly?  Perhaps because of what Bottemiller Evich wrote about previously?  See The FDA’s Food Failure.

Basically, we are seeing the results of unregulated monopolies and captured government.  With the most vulnerable members of society—and society’s future—at risk.

Additional links

• Letter from 8 Senators headed by Cory Booker to USDA Secretary Vilsack calling for greater formula competition
• Letter from USDA Secretary Vilsack calling on Abbott to provide rebates for competitive formula
• Politico: Senator Tammy Duckworth calls on the FTC to examine lack of competition in the formula market
• Center for Science in the Public Interest urges policymakers in Washington to deploy additional tools
• Congressional subcommittee to investigate shortages
• Background Press Call by Senior Administration Officials to Address Infant Formula Shortage
• Readout of President Biden’s Virtual Meetings with Retailers and Infant Formula Manufacturers
•  Associated Press — Parents swap, sell baby formula
• The New York Times — What Parents Need to Know
• USDA’s Q and A page about options for exchanging Abbott formula for other kinds 
• USDA’s page on the Abbott recall
• USDA’s guidance for keeping infants safe in the midst of formula shortages
• FDA’s details on Abbott product recalls
• CDC’s report on its Cronobacter investigations, now closed
• Wall Street Journal: What caused the baby formula shortage?
• Bill Marler: Abbott caused the infant formula crisi, but the FDA and public health enabled it
• Abbott and FDA agree on pathway to opening Sturgis MI plant
• Abbott denies its formulas were responsible in an 11-tweet Twitter thread

Additional links that came later

• The Washington Post – Biden invokes Defense Production Act to boost baby formula supply
• WhiteHouse.gov – Letter from President Biden to Secretary Xavier Becerra and Secretary Thomas Vilsack on addressing infant formula shortage  
• Fact sheet: President Biden announces new actions to address infant formula shortage
• Memorandum on the delegation of authority under the Defense Production Act to ensure an adequate supply of infant formula

In response to my post last week about problems at the FDA, I received an emailed note from Jerry Mande, whom I met years ago when he was at USDA, and is now a visiting fellow at the Harvard School of Public Health.

Terrific piece today, but you should have called for the need for FDA to focus much more on the chronic disease risks of food. It’s catastrophic that they have taken only one truly regulatory action (banning trans fat) to improve diet and health…Commissioner Califf needs to put the F back in FDA only 7% of CFSAN’s budget is used for improving diet quality and nutrition, which accounts for 99%+ of food related poor health…The bottom line, as you know better than anyone, is there are more deaths every day due to poor quality diets than in a year due to acute illnesses…I urge you to consider that when you write more on this topic. You could start by featuring our op-ed in your blog. Thx!

The op-ed is indeed worth a read.

But, in fact, this topic has been on my mind since Politico’s Helena Bottemiller Evich wrote Diet-related diseases pose a major risk for Covid-19.  But the U.S. overlooks them, back in October.

Her article, which focused on the lack of government attention to the risks posed by obesity for chronic disease and COVID-19, inspired me to write an editorial for the American Journal of Public Health.  I’m told it’s going online tonight (if it does, I will post it tomorrow).

Politico’s Helena Bottemiller Evich has produced a blockbuster exposé of the FDA.

If you’ve been worried that the FDA is not doing its job, you are not alone.  This is an astonishing piece of in-depth reporting on the current status of this agency, which in addition to regulating drugs is responsible for the safety and labeling of three-quarters of the food we eat.

I have long complained that the FDA has two structural handicaps:

1. The FDA Commissioner is not even close to being a cabinet-level appointment; it is at least two steps down the reporting ladder, meaning lots of reporting requirements and authority.
2. FDA gets its funding from congressional agriculture committees, even though it is an agency of the Public Health Service.  This result of history puts it secondary to USDA in committee funding priority.

I also have long believed that it would be better all the way around if the FDA strongly regulated the food industry.  Strong regulatory agencies are essential for:

• Trust in science
• Trust in government
• Trust in the food supply
• Establishing a level playing field for the food industry

Here’s what Bottemiller Evich found when she looked into FDA’s delays in getting regulations into place:

Many consumers would be surprised to learn this anemic, slow response is typical for an agency that oversees nearly 80 percent of the American food supply, but slow is what insiders in Washington have come to expect from FDA, regardless of administration.

A monthslong POLITICO investigation found that regulating food is simply not a high priority at the agency, where drugs and other medical products dominate, both in budget and bandwidth – a dynamic that’s only been exacerbated during the pandemic.

Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems in interviews.

Her investigation comes in five parts:

1. “It’s a struture that’s designed to fail.” This part deals with leadership challenges.
2. “A bit of a black hole.”   Why the FDA took so long to get out standards for regulating irrigation water, and weak ones at that.
3. The rage of a million parents.  The FDA’s failure to take vigorous action to remove toxic metals from baby food and ensure the safety of infant formula.
4. “Our food is making us sicker” Why the FDA has been so lax about getting sodium reduced in the food supply.
5. “They ignore everyone.” The agency, which seems excessively responsive to industry, doesn’t consult its leaders adequately.

Bottemiller Evich says:

• Read the four major findings from our investigation.
• Have you complained to the FDA about the Similac recall or another infant formula problem? We want to hear from you.

Every bit of this is worth reading and pondering.  We need a strong, active FDA, unafraid to take unpopular stances to protect public health.

The FDA needs an overhaul.  I hope it comes soon.

Maybe this article will get everyone thinking about how best to get this?

Congressional reactions: Lawmakers demand answers from FDA after investigation on food failures

• Sen. Patty Murray (D-Wa.), who leads the Senate Committee on Health, Education, Labor and Pensions, sent a strongly-worded letter to FDA Commissioner Robert Califf Monday afternoon seeking “immediate action to ensure the FDA is doing all it can to fulfill all aspects of its mission to protect the health and safety of the American people.”
• Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, tweeted Monday that he is requesting a briefing from the agency.
• House Appropriations Chair Rosa DeLauro (D-Conn.) also tweeted criticism over the weekend: “The ‘F’ in FDA has come to mean ‘failure’ on food safety,” she wrote. “We must greatly intensify the pressure to get the FDA to do its job and to keep the American people safe and alive.

Bill Marler’s: FDA’s failures have consequences – real people – here is one story – there are countless others

The FDA’s?  The agency has not released a statement but by coincidence it is holding a webinar tomorrow on one aspect of Politico’s investigation.  An opportunity to ask questions?

Please join the U.S. Food and Drug Administration (FDA) for a webinaron April 13, 2022 at 2 p.m. on the Foodborne Outbreak Response Improvement Plan that the agency released in early December 2021.

Michael Taylor on the need for a separate food safety agency or better direction for food within FDA.

The FDA is issuing yet another notice about consumer research on a symbol for “healthy.”

The U.S. Food and Drug Administration is issuing a 30-day procedural notice on the preliminary quantitative consumer research it plans to conduct on voluntary symbols that could be used in the future to convey the nutrient content claim “healthy”…while at the same time developing a proposed rule that would update when manufacturers may use the “healthy” nutrient content claim on food packages.

It’s déjà vu all over again.

I went right back to what I wrote on  January 1, 2016.

**** Here’s what I said back then:

FDA: What is happening with front-of-package labels?

****So here we are six years later:

• Procedural Notice on Consumer Research on “Healthy” Symbol (May 2021)
• Use of the Term Healthy on Food Labeling
• Food Labeling & Nutrition

I can’t wait to see what this symbol is going to look like.  The mind boggles.

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.