by Marion Nestle

Currently browsing posts about: FDA

Apr 19 2024

Weekend reading: Eric Schlosser on our cartel food system

In the Atlantic (to which I subscribe), Eric Schlosser writes: Do We Really Want a Food Cartel?

Mergers and acquisitions have created food oligopolies that are inefficient, barely regulated, unfair, and even dangerous.

He begins with the Federal Trade Commission’s report on what happened to the US food supply during the COVID-19 pandemic: Feeding America in a Time of Crisis: FTC Staff Report on The United States Grocery Supply Chain and the COVID-19 Pandemic. This report focuses on the hazards of corporate consolidation for workers and consumers.

We see the effects in the grocery store. Prices are up and executive compensation even more so.

As Schlosser puts it,

When four companies gain a combined market share that is greater than 40 percent, an oligopoly has formed. The prices offered to suppliers, the prices charged to consumers, and the wages paid to workers are no longer determined mainly by market forces. Further, the power these corporations exert within their industries and the economy as a whole leads to a well-documented dynamic: Effective government regulation becomes difficult, whether because state and federal agencies are “captive” or because they are outmatched in terms of resources and personnel.

This brings us back to my post this week about the FDA. Schlosser describes the agency as “Poorly managed and notoriously reluctant to confront major food companies,” as shown by its inability to get on top of infant formula shortages.

Read his piece and see if he makes the case for his conclusion:

the fight against oligopolies and monopolies won’t be easy. A small number of corporations have tremendous political influence, expensive attorneys, and great skill at rigging markets in ways the public just can’t see.

We all need to pay close attention.

Tags: FDA, Food-industry

Apr 16 2024

What is the FDA’s food regulatory role anyway?

The keynote address at the Consumer Federation of America’s annual food policy conference was given by the FDA’s new Deputy Commissioner for Human Foods, James “Jim” Jones.

He talked about his priorities and what he’s hoping the FDA will do. Fine.

But in the Q and A, he was pushed repeatedly by Mike Jacobson (former head of CSPI) to say what the FDA would be doing to pressure the food industry to reduce salt in the food supply, something the FDA has promised to do for years with little progress.

In response, Jones said: “…I wouldn’t say pressure. Pressure is not our statutory authority…isn’t to pressure….it is to help manage the food supply in a way that makes it healthier for Americans.”

Oh dear.

Pressuring the food industry most certainly is in the FDA’s authority. I can think of lots of things the FDA has done that directly oppose food industry interests despite plenty of industry pushback: food labels in general and trans fat and sugar labeling in particular, restrictions on health claims, food safety regulations, and anything else the agency has done to force food companies to behave in the interest of public health.

Food companies will act in the public interest, only when they have to. Jones’ statement, if that’s what he meant, is an alarming indication of agency capture.

The FDA is a regulatory agency and part of the Public Health Service. It’s not supposed to win popularity contests. It’s not supposed to be an arm of the food industry.

It’s supposed to take whatever tough steps are needed to keep the food supply safe and healthy so as to improve the overall health of Americans.

Yes, the FDA should be pressuring food companies about salt (and sugar, for that matter), and as strongly as possible.

Maybe I am misunderstanding what he said. I hope so.

Here’s the video of the session. Jacobson’s questions begin at 19:30. Watch and decide for yourself.

Tags: FDA, Salt

Mar 12 2024

FDA allows health claim on yogurts, sugary and not

The FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes.

FDA intends to consider exercising its enforcement discretion for the following qualified health claims:

“Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.”

“Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”

FDA intends to consider exercising enforcement discretion for the above qualified health claims for when all other factors for enforcement discretion identified in Section IV of this letter are met.

All I can do is laugh. As I told CNN,

Qualified Health Claims are ridiculous on their face.

Why would any sensible person think that all you have to do to prevent type 2 diabetes is eat 2 cups of yogurt a week?…All we can hope is that the yogurt is at least unsweetened, but since it’s really hard to find unsweetened yogurt [in small cups], this is telling people who want to avoid type 2 diabetes that sweetened yogurts are good for them…According to the FDA’s review of the studies, the amount of sugar in the yogurt made no difference to the results…Therefore, according to the FDA, sugar is a non-issue.”

The reason for my amusement? Limited evidence. Translation: if you want to believe this, go ahead, but it’s not on the basis of compelling evidence.

Take a look at the Danone petition. The company asked for—and got—the qualified claim on the basis of observational evidence along with consumption data indicating that Americans currently do not eat much yogurt.

Given this low consumption, such a QHC is important to encourage food companies to increase yogurt in the food supply and inform consumers of current evidence in order to help them make informed choices.

It’s not that the FDA is ignoring the sugar issue despite its allowing the claim no matter how much sugar the yogurt contains. In its letter of acceptance of Danone’s petition, the FDA said,

we are concerned that the use of a qualified health claim on yogurts that contain a significant amount of added sugars could contribute empty calories to the diet. The Dietary Guidelines for Americans, 2020-2025 recommend limiting added sugars to less than 10 percent of total calories and note that added sugars account on average for almost 270 calories, or more than 13 percent of total calories per day in the U.S. population.

…Consequently, while there is currently no disqualifying level for added sugars, given that Americans are exceeding recommended limits on added sugars, and some yogurts on the market are high in added sugars, FDA encourages careful consideration of whether to use the claim on products that could contribute significant amounts of added sugars to the diet.

Is this a warning to Danone to avoid using the claim on sugary yogurts? We shall have to wait and see.

In the meantime, Danone is delighted: Danone North America Announces the FDA’s Decision on Their Petition for the First-Ever Qualified Health Claim for Yogurt, Linking This Dairy Aisle Staple to a Reduced Risk of Type 2 Diabetes

In response to efforts led by Danone North America, the new claim states that “eating yogurt regularly, at least 2 cups (3 servings) per week” may reduce the risk of developing type 2 diabetes, a condition 1.4 million Americans are diagnosed with every year.

Qualified Health Claims are about selling food products, not science.

Tags: Danone, FDA, Health-claims, Yogurt

Jan 9 2024

The FDA’s somewhat good news on antibiotic use in farm animals (if we believe it)

The FDA issued its most recent report on antibiotics late last year: 2022 Summary Report On Antimicrobials Sold or Distributed for Use in Food-Producing Animals, along with Antimicrobial Sales and Distribution Data 2013-2022.

It did this in response to public concerns about antibiotic use in food animals: if antibiotics are used at subtherapeutic doses, they might induce microbial resistance to drugs used to treat diseases in humans.

This is not a theoretical concern. It’s a real problem.

It’s also a problem because the vast majority of antibiotics were used as growth promoters or to prevent infections in animals crowded together—not to treat disease.

In 2014 or so, the FDA ruled that medically important antibiotics could no longer be used as growth promoters in farm animals. That rule went into effect in 2017.

The FDA’s good news: the amounts of antibiotics used in farm animals has declined since then.

Are medically important antibiotics still used for non-therapeutic purposes?

The report says that since 2017, zero antibiotics are administered for growth promotion.

If you wonder whether this is really true (as I do), consider that $11.2 million kilograms of antibiotics were used in food animals in 2022. This is a decrease from the 15.6 million kg used in 2015, but still a lot.

Of these drugs, 63% are administered in feed, and 31% in water.

All antibiotics still used as growth promoters are supposed to be drugs not used in human medicine.

I’m not the only skeptic on this one. See:

I. The Bureau of Investigative Journalism’s Antibiotics in agriculture: The blurred line between growth promotion and disease prevention.

In an investigation published today, the Bureau revealed how US farm animals are still being dosed with antibiotics vital to human health, despite efforts to curtail such usage and combat the spread of deadly superbugs. We also found that a regulatory loophole means that using antibiotics to make animals fatter – a process known as growth promotion – is technically still possible, despite this practice being banned in January 2017.

II. Nature: Antibiotic use in farming set to soar despite drug-resistance fears. Analysis finds antimicrobial drug use in agriculture is much higher than reported.

III. Vox: Big Meat just can’t quit antibiotics: Meat production is making lifesaving drugs less effective. Where’s the FDA?

According to an analysis published in September by the Natural Resources Defense Council and One Health Trust, medically important antibiotics are increasingly going to livestock instead of humans. In 2017, the meat industry purchased 62 percent of the US supply. By 2020, it rose to 69 percent.

Does the FDA check? It has guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, but this guidance is non-binding.

Obviously, the FDA needs to do more. Its officials told Vox:

Veterinarians are on the front lines and as prescribers, they’re in the best position to ensure that both medically important and non-medically important antimicrobials are being used appropriately…We cannot effectively monitor antimicrobial use without first putting a system in place for determining [a] baseline and assessing trends over time.

Vox reports: “The agency right now only collects sales data, and it’s been exploring a voluntary public-private approach to collect and report real-world use data.”

This is not reassuring. The use of antibiotics in animal agriculture is a long-standing issue. It requires political will, big time.

Tags: Animals, Antibiotics, FDA

Oct 18 2023

California’s new food additive law: groundbreaking!

California’s AB 418, the California Food Safety Act, is now law.

Commencing January 1, 2027, a person or entity shall not manufacture, sell, deliver, distribute, hold, or offer for sale, in commerce a food product for human consumption that contains any of the following substances:

Brominated vegetable oil [Emulsifies citrus-flavored drinks, but can cause heart lesions and fatty liver in children and headaches, dizziness, and memory loss among other problems in adults]

Potassium bromate [Used as a dough conditioner, but is a possible human carcinogen]

Propylparaben [A preservative but disrupts endocrine function]

Red dye 3 [Banned in cosmetics because of its carcinogenic potential]

The bill addresses additives banned in Europe on the basis of various health concerns. Originally it also included titanium dioxide, but that got dropped when candy makers protested and framed the bill as a “Skittles ban.” Fighting words, apparently.

In his statement on signing the bill, Governor Newsom implied that the ban is temporary, pending the FDA’s setting safe levels for these additives. He also said the ban would not need to be implemented until 2027.https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/

These additives—and titanium dioxide—have been the subject of heath concerns for years. The Center for Science in the Public Interest has been pushing for bans for decades. It reviewed some of this history in a statment:

The FDA learned Red 3 was a carcinogen in the 1980s and declared it as such in 1990. For that reason, the agency eliminated Red 3 from cosmetics and drugs applied to the skin. That same year, the FDA said it would “take steps” to ban the use of Red 3 in foods, ingested drugs, and dietary supplements. With inaction in the intervening decades, the Center for Science in the Public Interest last year petitioned the FDA to finally eliminate the carcinogenic dye from the food supply. CSPI says it hopes the California legislation will inspire similar efforts around the country and prompt the FDA to eliminate the four additives.

According to Bakery & Snacks, the ban could affect 12,000 products. A ban in California is a call for reformulation with with safer substances.

It’s now time for the FDA to act, and the sooner the better.

Of course, not everyone agrees. Take the National Confectioners Association, the trade association for candy makers, for example. It issued a statement, “California is once again making decisions based on soundbite rather than science,” and also wrote the FDA to protest.

The gist of the letter is that candy makers have limited alternatives to the banned additives and “the cost of reformulation will be substantial and ultimately passed on to consumers in the form of higher prices.”

Really? These additives are banned in Europe yet the last time I looked there was still plenty of candy on sale.

You might think candy makers would be proud to replace potentially harmful additives with healthier alternatives and advertise accordingly, but that’s not how the system works, alas.

As I keep saying, food companies are not public health or social service agencies. They are businesses prioritizing profits to stockholders and compensation to executives. Ther job is to sell you candy, lots of it, and at the lowest possible cost. [Oops. A reader points out I should have said at the highest possible cost. Of course. I stand corrected].

Note: we are talking candy here, not health foods.

Tags: Additives, FDA

Aug 4 2023

Weekend reading: FDA’s curricula for middle and high school teachers

I started out my careeer as an instructor in a university biology department teaching cell and molecular biology. I got handed a nutrition course to teach and quickly discovered it was the best way to engage students in learning biology. I’ve never looked back.

Now the FDA has made the same discovery:

What captures the interest of students? FOOD! Yes, food can be used to engage students in inquiry-based science — really!

The Science and Our Food Supply Teacher Guides are challenging hands-on, minds-on activities that empower students to make informed choices about food safety, nutrition, biotechnology, and dietary supplements. They are crafted in a teacher-friendly modular format that easily fit into science, health, and other classes.

I. Food Safety: Science and Our Food Supply: Investigating Food Safety from Farm to Table (2014)

Resources

II. Nutrition: Science and Our Food Supply: Using the Nutrition Facts Label to Make Healthy Food Choices (2022)

III. Biotechnology: Science and Our Food Supply: Exploring Food Agriculture and Biotechnology (2020)

IV. Dietary Supplements: Science and Our Food Supply: Examining Dietary Supplements (2021)

Dietary Supplements High School Guide

COMMENT

I think these are pretty good and could make teaching these topics easy for teachers and fun for students. They are written intelligently and do not talk down. All of them provide useful sections on how to decide whether information sources are reliable. For that alone!

The curricula provide plenty to work with, even though they are decidedly non-controversail. You would never know from reading the one on biotechnology, for example, that the topic caused much in the way of debate.

Tags: FDA, Food-safety, GMOs, Labels, Supplements

Aug 1 2023

Letter to FDA on front-of-package labels

I signed a letter organized by the Center for Science in the Public Interest calling on the FDA to do more to research front-of-package labels.

This is in response to the FDA’s announcement of what it plans to test in developing a front-of-package labeling scheme.

We asked the FDA for specific additions to the research proposals, among them this one:

Consider testing additional High In scheme designs with attention-grabbing features like these:

We noted that the FDA states three goals for the research:

Participants’ ability to correctly interpret the nutritional profile of the product
The speed at which participants make their decisions
Whether or not participants search for more information to answer the question (i.e., whether they click a link to view the Nutrition Facts label)

We argued that

Of the three outcomes, we believe that participants’ ability to correctly interpret the nutritional profile of the product is the most important [because it is the only one that is independently and objectively desirable. In contrast, the desirability of faster decision-making is dependent on whether the decision is correct, and it is unclear what would be the more desirable outcome with respect to searching for the Nutrition Facts label. Searching for the Nutrition Facts label could be positive (if the labeling scheme spurs consumers to learn more about the product’s nutrition information and ingredients) or negative (if the labeling scheme is not noticeable or confusing and thus participants need to seek more information).

Front-of-package labeling has been in the works for a long time. It’s great the FDA is getting to it.

Tags: C, CSPI(Center for Science in the Public Interest), FDA, FOP(Front-of-Package)Labels, Labels

Jul 5 2023

Comment now on FDA’s front-of-package label proposals

The FDA is asking for public feedback on an updated research study to decide which front-of-package labeling design will work best to help the public choose healthy fpackaged foods.

To submit comments, go here. They are due by July 17.

I’ve written about this issue previously.

The FDA tried to do this a decade ago. But the Grocery Manufacturers Association (now Consumer Brands Association) did an end run and volunteered to use Facts Up Front/Guideline Daily Amounts, which nobody understands or pays attention to. The FDA caved in and let that happen.

Now countries all over the world are putting warning labels on foods high in calories, fat, salt, and sugar, most of them ultra-processed.

The FDA says it will test 8 front-of-package label designs to see which work best in conveying healthfulness. The study materials are here and here.

Earlier, if those links don’t work, it proposed to test all of these designs.

I don’t think any of the choices is as compelling as Chile’s warning labels, which can be understood easily by children and people who cannot read.

Among the FDA’s choices, here’s my preference (it’s most like the labels from Canada and Brazil).

This still requires people to figure out what it means if the colors differ, as they do here, but surely everyone will understand that the more red boxes, the worse.

One other complaint: Since this effort started, the concept of ultra-processed has become much more prominent and is backed up by a tremendous amount of research.

Avoiding ultra-processed foods is the key message needed now.

The FDA’s proposals will take care of most ultra-processed foods, but miss the point. Whatever the FDA chooses will be out of date no matter when it appears.

Never mind. This is a step in the right direction. Food industry opposition to any of it is strong.

It’s important to tell the FDA to get busy on this, and to strengthen the warning.

Write the FDA NOW!

Tags: FDA, FOP(Front-of-Package

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