by Marion Nestle

Currently browsing posts about: FDA

Aug 11 2022

More FDA educational initiatives: Supplements this time

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?

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

Aug 10 2022

The FDA’s new pro GMO propaganda

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.

For More Information

Jul 20 2022

The Daily Harvest recall mystery: update

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:

We considered all possibilities, including processing issues or infection, and have ruled all of them out: Hepatitis A, Norovirus, a range of mycotoxins, including aflatoxins, food-borne pathogens including Listeria, E.Coli, Salmonella, Staphylococcus Aureus (Staph), B.Cereus, and Clostridium Species and major allergens including egg, soy, milk, and gluten. Testing also confirmed there are no pesticides or the presence of heavy metal levels that would have caused the reported adverse effects.

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.

Jul 19 2022

The failing FDA: What is to be done?

Everyone is worried about the FDA (or should be) and I’ve been collecting suggestions for how to fix it.  I have three so far.

I.  Move food safety out of FDA and into a new Food Safety Administration. 

This would be housed (as FDA is) in the Department of Health and Human Services (HHS).

Senators Durbin, Blumenthal, and DeLauro have proposed legislation to do this.  The bill text is here and a fact sheet here.

  • “In recent years, FDA has been plagued by one failure after another—from a failure to properly recognize the dangers of prescription opioids, to a failure to protect children from e-cigarette products, to a failure to properly ensure the safety of our nation’s food supply,” said Durbin. “The sad reality is that FDA seems unwilling or unable to use their authority to protect Americans from preventable illness and death.
  • “Americans deserve to know the food on their plates is safe to eat,” said Blumenthal. “By protecting consumers from foodborne illnesses and acting swiftly to respond to recalls, the Food Safety Administration will improve the safety of our nation’s vital food supply.”
  • “Food safety is currently a second-class citizen at the Food and Drug Administration,” said DeLauro. “Right now, there are no food policy experts in charge of food safety at the FDA.”

II.  Move all food functions out of FDA into a separate agency.

This is proposed by several public action groups:  Consumer Reports, STOP Foodborne illness, the Environmental Working Group, and Healthy Babies Bright Futures.

[The] groups discussed the need for congressional action to separate the food portion of the Food and Drug Administration into a separate agency under the Depart of Health and Human Services. The agency would be solely devoted to the food side of the FDA, which oversees 80 percent of the nation’s food supply.

These groups have not developed specific details about how this might work.

III.  Move FDA’s food functions into USDA.

This proposal comes from Jerry Mande, former FDA and USDA official:  “A Farm to Fork approach to Fixing FDA’s food program.”

USDA is best positioned to succeed due to its history and mission. Created by President Abraham Lincoln to be the “people’s department,” USDA has the comprehensive resources and authorities needed to succeed. These include its 15 nutrition assistance programs and their $175 billion budget, its farm executive directors in every state and its transformative extension agents in literally every county, and the nation’s leading food and nutrition research programs.

Specifically, we propose that the FDA’s Center for Food Safety and Nutrition (CFSAN) merge with USDA’s Food and Nutrition Service (FNS) and Food Safety and Inspection Service (FSIS) under one Food, Nutrition and Health mission area at the USDA.

The Government Accountability Office has been calling for a separate food safety agency since at least 1990.  Its idea would be to combine the food safety functions of FDA (generally, plant foods and food products), USDA (generally, animal foods), and other federal agencies.  From a food safety perspective, that makes sense.

But what about FDA’s other food functions, such as oversight of  food ingredients, labels, and health claims?

And what about food advertising (FTC), health risks (CDC), etc?

What’s good about this is that doing something to strengthen food regulation is on the agenda.

How best to do it?

Ultimately, it’s up to Congress.

Jul 7 2022

The latest food politics of CBD

Cannabidiol (CBD), the non-psychoactive component of marijuana, has made its way into the food supply in the form of CBD edibles, CBD water, and CBD pet and animal food.

The legal status of these products continues to be fraught with uncertainty, not least because CBD products sometimes contain the psychoactive components of marijuana hemp .  Some recent examples:

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Jun 8 2022

The FDA is not involved in approving most food chemicals, says Environmental Working Group

The watchdog Environmental Working Group has analyzed the approval process for new food chemicals.  Its disturbing conclusions:

Nearly 99 percent of all food chemicals introduced since 2000 were greenlighted for use by the food and chemical industry,…not by the Food and Drug Administration, the agency responsible for ensuring food is safe.

That’s because food and chemical companies exploited a loophole in the law allowing them to decide which chemicals are safe to consume, contrary to what Congress intended when it enacted food chemical laws in 1958….for 756 of 766 new food chemicals added to the food supply since [2000], or 98.7 percent, these companies have exploited a loophole for substances that are “generally recognized as safe,” or GRAS. The loophole lets them – not the FDA – decide a substance is safe.

The data:

Do we care?  I think we should.

EWG deserves thanks for keeping an eye on this issue.

Jun 6 2022

Oops: Sports supplements with doping drugs.

I am not much of a fan of dietary supplements and have to admit to confirmation bias; I collect studies that provide evidence for skepticism about how well they work.

So when a reader, Arya Afrashteh, sent this study, I gave it some attention.

The study:  Dietary Supplements as Source of Unintentional Doping.  Vanya Rangelov KozhuharovKalin Ivanov, and Stanislava Ivanova.  Biomed Res Int. 2022; 2022: 8387271. Published online 2022 Apr 22. doi: 10.1155/2022/8387271

The rationale:  Athletes are not supposed to take performance-enhancing drugs but they are permitted to take dietary supplements.  Are these safe?

Method: A review of the literature on unapproved substances found in dietary supplements.

Results: 875 of 3132 supplements contained undeclared substances.

Conclusion: ~28% of the analyzed dietary supplements pose a potential risk of unintentional doping.

Comment:  Between one-quarter and one-third of dietary supplements taken for performance enhancement contained unlabled substances that could test as unapproved drugs.

This is a result of the Dietary Supplement Health and Education Act of 1994 (DSHEA) that basically deregulated dietary supplements.  It took supplements out from under the control of the FDA.

All the FDA can do is write warning letters, which it occasionally does.

But unless the FDA is checking, you cannot be sure that what is in the supplements is accurately reflected by their labels.  Sports supplements, it seems, are prime examples of why this is a problem.

Caveat emptor.

 

May 17 2022

Infant formula: what’s the shortage really about?

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

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

Nationwide shortage of infant formula?

As CBS News explained,

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

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

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

Her writing is getting action.

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

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

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

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

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

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

 

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

As to what this is really about, see:

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

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

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

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

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

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

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

Additional links

Additional links that came later