by Marion Nestle

Currently browsing posts about: FDA

Apr 6 2022

The FDA says it’s working on “healthy”—symbol and rules

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?

The FDA issued its final rules for the Nutrition Facts panels, but now I want to know: What ever happened to its front-of-package (FOP) initiatives?

The New York Times editorial on the new food label raised this very question.

But the labels, which most food companies will have to use by July 2018, still have serious limitations. They require busy shoppers to absorb a lot of facts, not all of which are equally important, and then do the math themselves while standing in the grocery aisle. And the labels are on the back of the package, where only the most motivated shoppers will look.

The editorial refers to the FDA’s front-of-package initiatives early in the Obama administration.  These involved two reports from the Institute of Medicine.  The first, released in 2010, examined about 20 existing front-of-package schemes cluttering up the labels of processed foods and evaluated their strengths and weaknesses.  It recommended that FOP labels deal only with calories, saturated fat, trans fat, and sodium.  My question at the time: why not sugars?  The committee’s answer: calories took care of it.

But the IOM’s second report in 2011 included sugars and recommended a point system for evaluating the amounts of it and those nutrients in processed foods.  Packages would get zero stars if their saturated and trans fat, sodium, or sugars exceeded certain cut points.

The Times editorial explained what happened next:

the Grocery Manufacturers Association [GMA] called the Institute of Medicine’s recommendation “untested” and “interpretive.” Along with the Food Marketing Institute, it developed its own front-of-package labeling system, which includes some useful information, but is more complex and less helpful than the institute’s version.

As I stated at the time, the FDA let the GMA get away with this and has said not one more word about front-of-package labels.

According to the Times, the FDA is still studying the matter.

it’s not clear when or if the agency will require front-of-package labels. The food industry, of course, wants to make its products appear as healthy as possible. The F.D.A. would serve consumers best by taking the Institute of Medicine’s good advice and putting clear and concise nutrition labels right where most shoppers will see them.

It certainly would.  It’s time to take those IOM reports out of the drawer and get busy writing rules for them.

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

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

Mar 8 2022

The Abbott infant formula recall: an update

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).
Feb 22 2022

Urgent! Recall of infant formula: check those product numbers now

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.

Jan 18 2022

FDA’s big accomplishment: revoking standard of identity for French dressing

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.

Oct 26 2021

USDA says it will try to reduce Salmonella in poultry. What about FDA-regulated onions?

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.

Oct 12 2021

The Sugar Association vs. Artificial Sweeteners

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.

Oct 4 2021

Industry-sponsored study of the week: glyphosate (Roundup) in food

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.”

Conflicts of interest:  “The authors are all employees of Bayer Crop Science, a major manufacturer of glyphosate.”
Comment: Glyphosate is used to kill weeds on fields of genetically modified crops, most notably corn and soybeans, but also other crops engineered to resist its action.  US farmers use a lot of it—300 million pounds a year on average.  Glyphosate has been linked to cases of non-Hodgkin lymphoma in people exposed to large amounts.  Its maker, Bayer Crop Science, settled these cases for billions of dollars last year.  It also said it would stop selling glyphosate for home use.  Bayer wants you to stop worrying about glyphosate residues in your food.  Hence, this publication.
Here’s what the FDA says about what it’s doing to protect us from glyphosate in food.
Here’s what a law firm says about which foods have glyphosate residues.
What can you do to avoid glyphosate?
  • Don’t use it in your garden or around your house.
  • Eat a wide variety of minimally processed whole foods; most are unlikely to have been sprayed directly.
  • Minimize intake of highly processed foods made with soy and corn ingredients.

And encourage the EPA to set firm standards and the FDA to continue to monitor foods for glyphosate residues.  Its last report was in 2017.

Jun 2 2021

The latest complaints about the FDA’s non-action on GRAS ingredients

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.

The FDA has announced its Final Rule on Substances Generally Recognized as Safe (GRAS).

The FDA explains: “Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives…The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.”

Uh oh.  “Appropriate qualified experts?”  Like those selected by the companies themselves?  The FDA has failed the public on this one.

In my 2016 post, I explained the complicated backstory of the FDA’s non-action on GRAS ingredients.

The FDA’s final GRAS rule is the result of a settlement agreement following a 2014 lawsuit filed by the Center for Food Safety. The basic issue: GRAS substances are not subject to FDA premarket approvals required for food additives.  Manufacturers are allowed to decide for themselves whether their additives are GRAS without informing the FDA. The new rules confirm this self-managed GRAS notification procedure.

I wrote about this issue in an editorial for JAMA Internal Medicine in 2013 when I commented on a study by Tom Neltner and his colleagues on the blatant conflicts of interest in FDA approval of GRAS substances…My editorial reviewed the lengthy history of FDA’s dithering about the GRAS process.  None of this would matter if all food additives were safe.  But some are not…The FDA’s decision is a loss for public health.

As I said then, this constitutes yet another reason not to eat ultra-processed food products with long lists of additive ingredients.

Tom Neltner, the director of chemicals policy for the Environmental Defense Fund (EDF), suggests 10 ways new FDA head should protect people from toxic chemicals in food.  He lists first:

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” (GRAS) loophole.
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