Currently browsing posts about: FDA

Last week I did a post on the FDA’s reorganization.   I should have made one other point: the long-standing inadequacy of FDA funding.  For decades, Congress has assigned tasks to the FDA but provided inadequate funding to do those tasks adequately (hence 1% of imported foods are inspected).  Congress also assigns the funding for specific purposes.

Yes, FDA ought to be doing more, but it is not up to the agency to decide how to deploy its funds.

One more point: For long-standing historical reasons, FDA funding comes from congressional Agriculture committees, even though it is an agency of the Public Health Service.  That is one reason why USDA’s food safety programs are funded at so much higher a level than FDA’s.

With that said, the FDA has come out with some recent initiatives of interest.

I.  Front-of-Package labels.  The FDA is proposing to research a front-of-package symbol: “an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretive with respect to the levels of added sugars, sodium, and saturated fat per serving.”

It is doing this in response to a petition from the Center for Science in the Public Interest.

The comments that have come in so far are here.

It is examining the use of front-of-pack symbols in other countries.

It also plans to conduct research on consumer understanding of multiple designs.  Here are the prototype packages on which the designs will be tested.

None of these is likely to be as effective as the ones used in other countries.

Here is one of the better options, in my opinion.

To file comments, go here.  It’s important to do this because the Consumer Brand Association (formerly the Grocery Manufacturers Association) and other industry groups are unlikely to accept any labeling scheme that might discourage you from buying a product.

II.  Qualified health claim: cocoa flavanols.  The FDA has approved a qualified health claim for cocoa flavanols and reduced risk of cardiovascular disease.

This was in response to a petition from the Swiss chocolate company, Barry Callebaut.

Here’s what the FDA will allow.  Yes, this is absurd (look at what the FDA has to go through to get to this), but companies must think statements like this will sell their products.

• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”

III.  GRAS panels.  The FDA has issued final guidance on best practices for panels deciding which ingredients can be Generally Recognized as Safe.

This lays out the guidelines for

• Identifying GRAS panel members who have appropriate and balanced expertise.
• Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
• Limiting the data and information provided to a GRAS panel to publicly available information.

A lot of this is headache-inducing.  FDA rulemaking takes forever.  Can’t wait to see how all this turns out.

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Last week, the FDA announced its proposed Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.   You can also watch this announcement on video.

This action comes in the wake of:

• The infant formula crisis [Contaminated formula made babies sick. The FDA was warned about food safety concerns at an Abbott plant but took no action.  Abbott recalled formulas,shut down the plant.  This led to empty shelves.  Abbott is now under criminal investigation].
• The FDA’s evaluation of its performance during the crisis [this didn’t say much about accountability]
• The evaluation of the FDA by the Reagan-Udall Foundation [it called for major structural changes]
• The resignation of Frank Yiannas, deputy FDA commissioner [which made clear needed changes were not going to happen]
• Bipartisan pressure from members of Congress to enact major reforms
• Pressure from Senators DeLauro and Durbin to enact reforms
• The Washington Post editorial calling for breaking up the FDA
• Pressure from food safety lawyer Bill Marler to put food back into the FDA and to make fundamental changes

The FDA proposal comes with a vision of how the redesign would work.

The complaints and pressures argued for appointing a senior FDA official in charge of all FDA food programs and units.  Instead, the FDA proposes to create a Human Foods Program encompassing some, but not all, FDA food units.

Most prominently missing is the Center for Veterinary Medicine which deals with food for farm animals and pets.  These, however, fully participate in the food system for humans; they eat most of US corn production and loads of byproducts of human food production.  The systems for humans and animals are inextricably linked.

The organizational chart will look like this.  It splits the food units and connects them with dotted lines.  Good luck with that.  That was precisely the problem with the previous organization.

This looks better than the previous organization chart but falls far short of the authority needed to solve the nation’s food safety problem.

What’s needed?

• Unification of food safety under a central authority that unites the functions of USDA and FDA (the Government Accountability Organization has been calling for that for decades).
• Short of that, high-level FDA authority over the entire food supply under its jurisdiction.
• And much more FDA attention to its public health as well as its safety functions.  It should be taking the lead on actions to prevent diet-influenced chronic diseases.

Hey, I can dream.

In the meantime, let’s see how the FDA’s new structure goes and who it hires into that key position in charge of human foods.

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Last week, the Washington Post editorial board gave its Opinion :  For the nation’s health, break up the Food and Drug Administration.

The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula. The baby formula fiasco was the latest in a long line of food crises that the agency was slow to catch and handle. But the deaths of babies and the desperation of parents trying to find enough food for their newborns shocked Congress, the public and the world into realizing just how broken the U.S. food-monitoring system had become.

The editorial cited:

• Helena Bottemiller Evich’s investigation in Politico, which found the FDA’s food-safety operations to be so slow as to be “practically in its own league.”
• A 2017 inspector general report finding the food recall system to be “dangerously sluggish.“
• Reports from the Government Accountability Office which have “repeatedly called out ‘high risk’ problems, including an urgent need for a national food-safety strategy and ‘high-level sustained leadership.'”

Bottemiller Evich is now doing her own invaluable newsletter, Food Fix (subscribe here, and  follow Food Fix on Twitter and LinkedIn).

In it, she says, “The FDA is not working if…”

• it takes a years-long struggle to set even interim, voluntary limits for heavy metals and other neurotoxins in baby food.
• its public health mission is to improve nutrition, but diet-related diseases continue to worsen unabated, driving massive human and health care costs.
• it takes more than a decade to address agricultural water safety…sparking deadly outbreaks year after year.
• it routinely fails to get to the bottom of serious food poisoning incidents – like last summer, when hundreds of people were sickened and more than 130 were hospitalized after eating Daily Harvest frozen crumbles.
• it is conducting fewer and fewer food safety inspections, even as Congress has given the agency more resources over the years to do more inspections.

The FDA says it is taking all this seriously and will come up with a plan to address these failings.  I can’t wait to see it.

Other comments

• Jerold Mande in the Washington Post: Food is making us sick. The FDA can do something about it.  
• Bill Marler asks: Hey FDA, its been over a month, are you going to do anything with the Reagan-Udall Foundation reccomendations?  Note: I discussed the Reagan-Udall report here.

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President Biden signed H.R. 2617, the Consolidated Appropriations Act, 2023.  

I’m interested in what the $1.7 trillion , 1600-page bill does for food issues.  It mentions the word “food” 786 times.  It mentions “agriculture” 213 times.  Fortunately, most of this is in Division A.  Even so, one longs for summaries. For whatever they are worth, here are a few I’ve collected.

• Senate Appropriations committee summary
• Sen. Patrick Leahy’s bill highlights
• Sen. Patrick Leahy’s highlights for USDA and FDA funding 
• Rep. Sanford Bishop’s summary for USDA and FDA funding 
• Rep. Sanford Bishop’s fact sheet 
• Congressional explanation of intent about Division A funding

Let me see if I can make some sense of this.

USDA highlights

• $25.48 billion in discretionary spending (more than last year, less than what Biden asked for).
• $3.7 billion for research ($1.74 billion for the Agricultural Reseach Service and $1.7 billion for the National Institute of Food and Agriculture
• $1.17 billion for Animal and Plant Health Inspection Service (APHIS), more than $60 million above last year’s.
• $1.15 billion for the Food Safety and Inspection Service, including funding to reduce user fees and to retain veterinarians.
• Nutrition programs: $154 billion for SNAP; $6 billion for WIC; an increase of $6.6 million for commodities; an increase of $11 million for emergency food assistance.
• International food assistance: $1.75 billion for Food for Peace grants (an increase), and $243 million for the McGovern-Dole education program (an increase).

FDA 

• $6.56 billion for everything (but this includes a large percentage to be derived from food, drug, and tobacco user fee revenues).  These include increases for food safety and  some core functions.

The bill does some other things worth mentioning.  It includes: funds to:

• Expand the Summer EBT program and makes it permanent as of 2024.
• Addresses SNAP EBT skimming (stealing benefits across state lines).
• Test for testing for per- and polyfluoroalkyl substances (PFAS—forever chemicals)
• Make sure lobster and crab fisheries are in compliance with rules about whales.

It takes a lot of expertise to analyze all of this.  Here are two reactions.

Heritage Action: This omnibus package represents the very worst of Washington: back-room deals, $1.85 trillion dollar spending bills full of pet projects and partisan priorities, and an Establishment more interested in their own power than the wellbeing of the American people. The GOP must stand united in their opposition to this bill.

The Center on Budget and Policy Priorities: The biggest disappointment of the year-end bill by far is the failure to expand the Child Tax Credit. The American Rescue Plan’s expanded credit and other relief measures drove the child poverty rate to a record low of 5.2 percent in 2021. But with the expansion’s expiration, that record progress in reducing child poverty in 2021 has sharply reversed.

There are lots of other criticisms of this bill floating around, mainly having to do with what the Biden Administration asked for but did not get, and concerns about inadequate funding of FDA for food safety.

On this last point, let me again say that the perennially underfunded FDA gets its appropriations from agriculture committees, even though it is an agency of the public health service.  Agriculture subcommittees could not care less about FDA.  FDA needs a mandated home in Congress and much better support than it now gets.

Happy new year.

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Food Safety News hosted an opinion piece by Sarah Gallo, vice president of product policy for the Consumer Brands Association (formerly the Grocery Manufacturers of America, an industry organization I’ve written about frequently, most recently about its name change).

Ms. Gallo joins consumer food advocates in arguing that the FDA needs reform (see Helena Bottemiller Evich’s account here).

The FDA is released its internal review yesterday (see my post), with insiders doing the reviewing (see Helena Bottemiller Evich’s account here).

Here’s what the food industry says it wants (my selection from Ms. Gallo’s list):

• Quicker reviews of new foods and ingredients.
• Tailored inspections.
• Updated recall processes.
• Flexible food labeling.
• Improved industry collaboration.
• “A transparent regulatory agenda for chemicals in packaging.”
• Better IT systems.

It’s hard to argue with some of these, and I won’t.

Yesterday’s report recommends some of these, not all (see my post on it).

The Coonsumer Brand Association liked the report.  Here’s why:

The FDA is a public health agency; it is part of the US Public Health Service.

I want to see it put public health first in everything it does.

If this means coming up against the food and beverage industry, so be it.  That’s its job.

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The Expert Committee tasked with evaluating the FDA’s human foods program has released its report.

The Committee begins by pointing out that to do its job, the FDA needs adequate resources, sufficient authority, and a structure and culture that breeds success.

In its judgment, the FDA has none of those.  Instead, it is an agency in “constant turmoil.”

The report focuses on lack of leadership.

A leadership skill set, it says, should include:

• Expertise and knowledge in food safety and/or nutrition
• Ability to make decisions in a complex regulatory environment
• Ability to lead in a complex work environment
• Strong demonstrated management capability
• Superb communication skills
• Ability to identify and nurture talent

Instead, the FDA is risk averse, which it admits is “not surprising in a program subject to significant external criticism.”

The committee makes many (too many) recommendations:

Identify vision and mission.

Change the agency’s culture.

Give it more resources.  Food programs are under-resourced; budget and staffing have been flat for at least a decade.

Expand user fees.  [Uh oh.  Bad idea.  The committee even explains why, but ignores the hazard.]

There is also significant skepticism in the public interest community about the potential for “industry capture” of the Human Foods Program if FDA is overly reliant on industry fees.  Efforts to establish structures to secure additional industry funding, such as enhanced registration fees, may address these concerns. While the Panel acknowledges these concerns, the Panel recommends that FDA explore whether common ground can be found on this issue.

Reinstate the Food Advisory Committee.  [I was on the first one in the early 1990s, but our job was to react to decisions the agnecy had already made, not advise it about tough issues].

Reorganize the agency to give the food programs more visibility, integrate them, and give them clear lines of authority [Note: one big weakness of this project is that the committee was instructed not to include the Center for Veterinary Medicine, as if food for pets and food animals has nothing to do with the human food supply, which of course it does].

The report gives five options for reorganization, all of them complicated and undoubtedly politically difficult.  It lists their strengths and weaknesses, but does not state a preference.

• Create a separate food administration within HHS
• Create a Deputy Commissioner for Foods
• Put CFSAN in charge of human food programs
• Puts Commissioner in charge of human food programs
• Create a Deputy Commissioner for Foods

Do more about nutrition labeling, research on consumer behavior.  [Really?  That’s all?]

Comment: The committee only had a couple of months to pull this together and was required to leave out the Center for Veterinary Medicine.  Even so, the report makes it clear that the FDA is in serious trouble, so much so that the committee did not even get into what the FDA ought to be doing about about taking steps to prevent diet-influenced chronic disease.  This, of course, would require it to take on the food industry—an unlikely scenario given everything else that’s not happening.

The next step is to see what the Commissioner does with the report, if anything.  And whether Congress will appropriate more funding.

The report did not say a word about what I see as a major political handicap for the FDA; it’s funding comes from congressional agriculture committees, not health committees, even though FDA is an agency of the public health service.   That too needs to change.

What the press is saying:

• Washington Post: Scathing report recommends major changes at FDA, including possibly breaking up agency
• Bloomberg:  FDA’s Food Program Needs Strong Leader, Outside Reviewers Find
• USA Today:  Report finds FDA’s food regulatory agency lacks leadership, is in ‘constant turmoil’
• Politico:  ‘Constant turmoil’ at FDA’s food regulatory agency, report says

Anda quote from a colleague:

“While we appreciate the Panel’s thoughtful attempt to dig into complicated food issues and their recommendation to elevate nutrition/chronic food illness, creating a seperate, unfunded, nutrition center would have the opposite effect. That’s unacceptable.” Jerold Mande CEO Nourish Science

My book talk today:  Online with NYU’s Fales Library in conversation with Clark Wolf.  5:00-6:00 p.m.  Registration is HERE.

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The FDA has come under heavy criticism this year for its failure to handle the infant formula crisis adequately and for its internal disorganization and lack of leadership.

To deal with this, the FDA commissioned the Reagan Udall Foundation for the FDA to do an operational evaluation of its human foods and tobacco programs.  This Foundation is “an independent 501(c)(3) organization created by Congress ‘to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.’”

As announced on July 19, 2022, the Reagan-Udall Foundation will facilitate, via two Independent Expert Panels, operational evaluations of FDA’s human foods and tobacco programs. Each evaluation will yield a report with operational recommendations to the FDA: one for human foods and the other for tobacco. Each evaluation, and therefore report delivery, is on its own 60-business-day timeline. Both reports will be delivered to the FDA Commissioner and made available to the public.

The Foundation began its work by

• Appointing a committee to oversee the evaluation
• Opening a stakeholder portal where you can file anonymous comments
• Holding hearings: Agenda

The two-day hearings were held right after the White House Conference on Hunger.  Videos are posted on YouTube

• First day
• Second day

As far as I can tell, no reporter covered these hearings except for Helena Bottemiller Evich at Food Fix, which is what makes her newsletter an invaluable resource and essential to subscribe to (at least for me).

Her overview:

Wow, were people honest in their assessment of shortfalls at the agency.

There was a strong consensus among the nearly three-dozen experts who spoke that things are not working very well and serious changes are needed. The panel got an earful about problems with leadership structure, culture, inadequate funding and staffing, poor oversight of inspections and a lack of responsiveness to the public and Capitol Hill – as well as plenty of complaints about how painfully long it takes to get anything done.

If all of this sounds familiar, that’s because it is. I’m sure you are all tired of me referencing this, but I did an investigative piece on FDA earlier this year, based on more than 50 interviews, that found many of the same things.

Her piece goes into the details.  Subscribe and you can read them.

More complaints

• One criticism of this entire procedure is that the Center for Veterinary Medicine (CVM) was excluded from the review.  This is a serious oversight, as noted by a letter from several groups to the FDA.
• Senator Richard Burr says in a letter to the FDA that he won’t support funding until the agency cleans up its ac

We only have one food supply: it serves people and animals inextricably (an issue discussed in my books Feed Your Pet Right and Pet Food Politics).

In the meantime I want to know:  Why aren’t more journalists covering this issue?

The FDA is responsible for regulating the safety and health of 80% of the foods we eat.  If we want foods to be safe and healthy, we need a strong, vigilant FDA willing to stand up to lobbying and industry pressure.

This needs press attention.

The Reagan Udall Foundation has to issue reports within the next couple of months.  Let’s see how well those reports reflect what was said at the hearings.

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Last week, STAT News asked if I would write something about the FDA’s definition of “Healthy” for them.  I agreed because I was planning a blog post on it anyway (posted here).

I wrote a draft and had a great time working with a STAT editor, Patrick Skerritt, to fill in some missing pieces.  Here’s how it came out (with a couple of after-the-fact embellishments).

First Opinion: FDA’s plan to define ‘healthy’ for food packaging: Better than the existing labeling anarchy, but do we really need it?   STATNews, Oct. 7, 2022

The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” The proposed rules are a lot better than the labeling anarchy that currently exists. But here’s my bottom line: health claims are not about health. They are about selling food products.

The FDA says that a “healthy” product must meet two requirements: It must contain a meaningful amount of food, and it must not contain more than certain upper limits for saturated fat, sodium, and added sugars.

To illustrate the “healthy” claim, the FDA is also researching a symbol that food makers can use, and might be testing examples like these.

[Source: https://www.regulations.gov/document/FDA-2021-N-0336-0003]

Doing all this, the FDA says, would align “healthy” with the 2020-2025 Dietary Guidelines for Americans and with the Nutrition Facts label that is printed on food packages.

This action is the latest in the FDA’s attempts to simplify food label information so it’s easier for consumers to identify healthier food choices. It is also an attempt to head off what food companies most definitely do not want: warning labels like those used in Chile, Brazil, and several other countries. These have been shown to discourage purchases of ultra-processed “junk” foods, just as they were supposed to, a message understood even by children or adults who cannot read. No wonder food manufacturers will do anything to prevent their use.

If we must have health claims on food packages, the FDA’s proposals are pretty good. They require any product labeled “healthy” to contain some real food (as opposed to a collection of chemical ingredients or, as author Michael Pollan calls them, “food-like objects”), and for the first time they include limits on sugars.

Here’s an example given by the FDA: To qualify for the “healthy” claim, a breakfast cereal serving would need to contain at least three-quarters of an ounce of whole grains and could contain no more than one gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars.

These proposed rules would exclude almost all cereals marketed to children.

But do Americans really need health claims on food products? You might think that any relatively unprocessed food from a plant or animal ought to qualify as healthy without needing FDA approval, and you would be right. But health claims aren’t about health. They are meant to get people to buy food products, not real foods like fruit, vegetables, grains, nuts, meat, poultry, dairy, eggs, or fish.

Food companies love the term “healthy” because it gets people to buy food products.

The history of “healthy”

How did we get to where the FDA needs to require a product to contain real food to be considered “healthy”? Blame KIND bars.

In 2015, KIND (then a small private company, but now owned by Mars) advertised its bars as healthy because they contained whole foods like grains and nuts. But nuts have more fat than the FDA allowed at the time for products to be labeled as “healthy.” The FDA warned KIND that its bars violated the rules for health claims.

KIND fought back. It filed a citizens’ petition arguing that even though nuts are higher in fat than the FDA allowed, they are healthy. The FDA could hardly argue otherwise — of course nuts are healthy — and it backed off. It permitted KIND to use the term and said it would revisit its long-standing definition of “healthy.” That was good news for KIND.

At the time, the FDA’s definition of “healthy” set upper limits for fat, saturated fat, sodium, and cholesterol; required at least minimal amounts of one or more vitamins or minerals; and said nothing about sugars. So the new FDA proposals break new ground in simplifying the nutritional criteria and in putting a limit on sugars.

Front-of-package symbols

These, too, have a long history with the FDA. In the early 1990s, when the agency was writing the rules for Nutrition Facts labels on food products, it tested public understanding of several prototype designs. As it happened, nobody could understand any of the samples very well, so the FDA picked the one that was the least poorly understood. Soon afterward, food companies and health organizations developed symbols that would allow buyers to recognize at a glance which products were supposed to be good for them.

By 2010, more than 20 such symbols were on food packages. The FDA commissioned the Institute of Medicine to do studies of front-of-package labeling. The Institute’s first report on the subject examined the strengths and weaknesses of all of the symbols cluttering up the labels of processed foods, and recommended that the FDA develop a single symbol that would cover just calories, saturated fat, trans fat, and sodium. Why not sugars too? The Institute said calories took care of them.

But the Institute’s second report did include sugars. It recommended a front-of-package labeling system that would give food products zero, one, two, or three stars (or check marks) depending on how little they had of the undesirable nutrients.

This idea so alarmed food manufacturers that they quickly developed the Facts Up Front labeling system in use today.

This, in my view, is so obfuscating that nobody pays any attention to it. But this scheme, coupled with industry pushback, was all it took to get the FDA to drop the entire idea of a symbol that would tell people what not to eat.

Here we are a decade later with the FDA’s current proposal. This plan is strong enough to exclude huge swaths of supermarket products from self-identifying as “healthy.” Products bearing the “healthy” symbol will have to contain real food and be low in saturated fat, salt, and sugar, as called for by federal dietary guidelines.

The new rules won’t stop “healthy” products from being loaded with additives and artificial sweeteners. And the FDA won’t require warning labels for unhealthy products, which work better than other symbols. But these proposals are a marked improvement over the current situation.

And the FDA might do more. It could look into the idea of warning labels. It already promises to make a decision about the other ambiguous marketing term, “natural.” A decision on that one can’t come soon enough.

As for “healthy,” the FDA is seeking feedback on its proposals. Instructions for filing comments, which can be made until Dec. 28, 2022, are at Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.”

I can’t wait to see what companies wanting to sell ultra-processed food products as “healthy” will have to say about this.

Marion Nestle is professor emerita of nutrition, food studies, and public health at New York University, author of the Food Politics blog, and author of the new memoir, “Slow Cooked: An Unexpected Life in Food Politics” (University of California Press, October 2022).

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