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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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The FDA has announced a proposed rule for a “healthy” claim on food packages.

It proposes to align “healthy” with the Dietary Guidelines for Americans, 2020-2025 and the Nutrition Facts label.

The proposal has two requirements for the “healthy” claim.  To make the claim, products must:

1. “Contain a certain meaningful amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetable, dairy, etc.) recommended by the Dietary Guidelines.”
2. “Adhere to specific limits for certain nutrients, such as saturated fat, sodium and added sugars. The threshold for the limits is based on a percent of the Daily Value (DV) for the nutrient and varies depending on the food and food group. The limit for sodium is 10% of the DV per serving (230 milligrams per serving).?

Food comes first!  What a concept!  The FDA will only allow a “healthy” claim on foods, not ingredients.  It also will only allow the claim on foods that are quite low in saturated fat, salt, and sugars (with exceptions for real foods).

The press release gave an example.  To qualify,

A cereal would need to contain ¾ ounces of whole grains and contain no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars.

The FDA is also researching a symbol to illustrate the “healthy” claim.  In March, it proposed research to develop this symbol.  The proposal did not illustrate prototypes, but some examples were published by a law firm.  ConscienHealth also published them under the heading of “A new roadmap for marketing healthy-ish food”

I see several things going on here.

1.  Positive, not negative.  This says foods are healthy.  Choose this!
2.  It adds sugars to disqualifying ingredients.
3.  It heads off warning labels—“high in fat, sugar, salt”—like those in Chile, Brazil, and Israel (see, for example, a previous post).  Avoid those!
4.  It heads off ultra-processed warnings (although this will exclude most, if not all, ultra-processed products).
5.  It supersedes the FDA’s efforts in 2010 and 2011 to put zero, one, two, or three stars or check marks on products.

I love Ted Kyle’s “Healthy-ish.”  As I keep saying, health claims are not about health; they are about marketing.

Companies love health claims; they sell food products.  Everyone falls for them; it takes serious critical thinking to resist them.

The FDA’s proposal will make “healthy” claims difficult for many products currently marketed with a health aura (Antioxidants! Gluten-free! No carrageenan!).

The time for comments is now.  I can’t wait to see the ones from companies making ultra-processed foods.

Next from FDA: a definition of “Natural?”

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The New York Times article on drug industry user fee payments to the FDA reminded me of my first meeting as a newly appointed member of the FDA’s Science Board in the late 1990s.  Here’s how it went:

FDA staff: We want to get your advice on user fees for inspection of food production facilties.

Me, appalled (oh no.  Not this at my very first meeting):  You mean food companies would pay the FDA’s expenses for inspecting their facilities?

FDA: Yes, what’s wrong with that?

Me: It’s causes a conflict of interest.  It puts the FDA under financial pressure to stay on good terms with the companies and not find problems.

FDA: But NIH does it.

Me: NIH is not a regulatory agency; FDA is.

I did not last long on that committee.  I was nominated for it again a year or so ago but never heard another word about it.

The Times article is about the drug industry.  Here are some excerpts:

• The pharmaceutical industry funding alone has become so dominant that last year it accounted for three-quarters — or $1.1 billion — of the agency’s drug division budget.
• Senator Bernie Sanders,…suggested that the pharmaceutical companies’ tendency to charge “outrageous” prices was related to their significant role in funding and advancing policy goals of the F.D.A.’s drug division. “So the industry, in a sense, is regulating itself,” Mr. Sanders said…May make sense to somebody — but not to me.”
• …the high costs of the program limit opportunity for small businesses; new-drug application fees are $1.5 million to $3.1 million.
• Over the years, the program’s scope and funding grew. Annual “performance reports” detail the F.D.A.’s efforts to make quick decisions, hold routine meetings with drug companies and approve products under fast-track pathways.
• …user fee negotiations in 1997 led to reducing the number of clinical trials for drug approval to one, from the longtime standard of two trials.

So does the FDA charge food companies for regulating them?  Yes.

The FDA can charge user fees for:

• The cost of reinspecting domestic food facilities, U.S. agents for foreign facilities, and food importers.  Fees cover “all expenses, including administrative expenses incurred in connection with arranging, conducting, and evaluating the results of the reinspection.”
• Expenses related to companies that do not comply with food recall orders, “including technical assistance, follow-up effectiveness checks, and public notifications. “
• Expedited review and import entry of human and animal food into the United States for participating importers.”

Food user fees are less conflicted than for drugs, and only about 1% of the cost of FDA’s food inspections comes from user fees.

But this is a bad system overall.  FDA is a regulatory agency.  It requires absolute independence in order to do its work honestly.  It should be taxpayer supported entirely so it can work entirely in the public interrest.

See:

• FDA User Fee Programs
• Fees under FSMA
• Guidance for industry on user fees under FSMA
• Why is the FDA Funded in Part by the Companies It Regulates?

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Coming soon!  My memoir, October 4.

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The FDA’s food operations are under siege over problems with infant formula, the Fresh Harvest recall, and all its other food safety and regulatory problems.

As you saw yesterday, it has plenty of time for educational initiatives.

This one is called “Supplement Your Knowledge.”  Its purpose is to help inform health care professionals, consumers, and educators about the hazards of dietary supplements.

How is the FDA helping with this?

• For consumers: Public education videos and fact sheets.
• For educators: Curriculum guide, Science and Our Food Supply: Examining Dietary Supplements (2021 Edition).
• For healthcare professionals: In collaboration with the American Medical Association (AMA), a continuing medical education (CME) program, free.  This includes three videos and companion education materials available on the FDA’s Healthcare Professionals website.  Physicians should go to the AMA Ed Hub^TM

The FDA is worried about harm from thousands of products that are largely unregulated, thanks to the Dietary Supplement Health and Education Act of 1994 (DSHEA).  This act took the FDA out of the business of regulating supplements, allowed supplement manufacturers to claim pretty much anything they want about supplements (regardless of evidence), and left ghe matter of what’s actually in the bottles as a matter of faith.

More than half of American adults take supplements of one kind or another, despite lack of evidence that they do any good at all for reasonably healthy people.  Fortunately, most are harmless.

The FDA wants to encourage supplement users to report adverse effects from the ones that aren’t.

I’m guessing the AMA wants to discourage physicians from inappropriately suggesting supplements and encourage them to recognize adverse events when they see them.

Congress passed DSHEA.  It will take another act of Congress to  protect the public from supplements that contain what they shouldn’t, don’t contain what they should, and otherwise mislead the public about what they can do.

Related Information

• To report a problem: the Safety Reporting Portal.
• Dietary Supplements Social Media Toolkit
• Additional information on dietary supplements:  www.fda.gov/dietarysupplements.
• Constituent Update 
• Dietary Supplements Education Initiative  
• Information for Consumers on Using Dietary Supplements
• Dietary Supplements

You would think the beleaguered FDA would have better things to do.

It sent out a press release announcing new “Feed Your Mind” materials to increase public and professional understanding of GMOs, in partnershipwith USDA and EPA.

My first question: Who paid for this?

The answer:

Funding for the “Feed Your Mind” initiative was provided by Congress in the Consolidated Appropriations Act of 2017 to conduct “consumer outreach and education regarding agricultural biotechnology and biotechnology derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed.”  More funds were provided through 2018 and 2019 Appropriations bills.

How’s that for effective lobbying by the food biotechnology industry!

Why do I think this is pro-GMO propaganda?

I started with the Discussion Guide for Health Educators.  It has just a few questions and answers.  For example:

Q.  Are GMO’s safe to eat?

A.  Yes…they are just as safe to eat as non-GMO foods.

Q.  Is here a link between GMOs and cancer?

A.  No.  GMO crops are not changed in ways that would increase the risk of cancer for humans or animals.

I don’t think these answers are necessarily wrong.  They just don’t tell the whole story.

These materials have nothing to say about:

• Consolidation in the biotechnology industry
• Corporate control of commodity agriculture
• Glyphosate, the herbicide used with GMOs and considered carcinogenic by international health agencies and US courts
• How GMO crops have taken over, driving out everyone else
• How pesticides used on GMO crops contaminate organic production
• The ways GMO companies harrass independent farmers by enforcing intellectual property rights
• How the Farm Bill subsidizes GMO corn and soybeans, causing them to be overproduced and corn to be used for ethanol
• Congress’s absurd Bioengineered labeling, widely ignored.
• The consequent lack of transparency in the supermarket

No wonder so many people look for Non-GMO labels on food products.

Take a look at these materials and judge for yourself (I particularly recommend the video for consumers).  It and the rest are quite short.

• A video and infographic for consumers:
  • Video: “GMOs, Farm to Table”
  • Infographic: “Where Can You Find GMOs?”
• A video and discussion guide for health educators:
  • Video: “GMOs and Food Safety: A Guide for Health Educators”
  • Discussion Guide: “A Question of GMOs”
• A video and factsheet developed in partnership with the Academy of Nutrition and Dietetics for registered dietitians (RDs)/registered dietitian nutritionists (RDNs) and nutrition and dietetics technicians, registered (NDTRs). Interested RDs/RDNs and NDTRs can earn free continuing education units through the Academy of Nutrition and Dietetics’ EatRight® Store.
  • Video: “Understanding GMOs”
  • Factsheet: “Understanding GMOs”

For More Information

• Feed Your Mind – Agricultural Biotechnology Initiative
• Resources for Healthcare Professionals
• FDA Releases New “Feed Your Mind” Consumer Education Materials (September 2020)

Breaking news: The ingredient that caused the illnesses among people who consumed Daily Harvest’s French Lentil + Leek Crumbles has been identified, sort of.  As suspected, it’s the tara flour.  But what’s the toxin in the tara flour?  That, we still don’t know.

As Rachel Drori, the CEO of Daily Harvest, explains in her latest update (all are here).

At this time, we have identified tara flour as the cause of the issue. Our extensive investigation has involved many experts analyzing data from all sources. We have only used this ingredient in French Lentil + Leek Crumbles and we are no longer sourcing from this producer who does not provide any ingredients for our 140+ other items. This was the first and only time we’ve used tara flour, which has been available and used in the North American market as a plant-based source of protein prior to our use. Our investigation team will continue working with the FDA, the tara flour producer and others to help determine what specifically made people sick.

To review: Daily Harvest is a company that makes and ships preprepared vegan frozen meals, one of which, French Lentil + Leek Crumbles, has been recalled after several hundred people who ate it developed serious problems with their livers and gall bladders.

The big question: what caused these problems?

As Drori says:

The FDA is on the case.  Its most recent accounting gives these figures:

Total Adverse Illness Events: 277*
Hospitalizations: 96*
Deaths: 0
Last illness onset: July 9, 2022*
States with Adverse Illness Events: AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, MD, MA, MN, MI, MO, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CAERs reports received by the FDA

The FDA’s previous update noted that the company shipped about 28,000 of these specific meals between April 28 and June 17.

Food safety lawyer Bill Marler, who represents many of the afflicted (and is filing lawsuits), says:

We have filed lawsuits in both state and federal court to more effectively push discovery against both Daily Harvest and the manufacturer of the product, Stone Gate. We need to know what is the likely common ingredient and who supplied it. We need to understand all food safety protocols and what went wrong. We need to know when these companies first were aware of the “Adverse Illness Events” and what was done with that information.

Marler’s latest summary is here.

ABC News reporter Melanie Woodrow (@Melanie Woodrow) spoke with some of the victims and their lawyers (not Bill Marler)  She Tweeted:

Spoke w/ two attorneys today who say #DailyHarvest has filed motions compelling their clients to arbitrate, meaning cases would play out in conference room not court. @DlyHarvest says customers agreed to terms that included an arbitration clause.

I truly do not understand why the toxin has not yet been identified.

This situation reminds me of how hard it was to identify melamine as the toxin in the massive pet food recalls of 2006.  I ended up writing a book about this case: Pet Food Politics: The Chihuahua in the Coal Mine.

While waiting for answers, let’s all wish the victims a speedy recovery.