Currently browsing posts about: FDA

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.

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:

• FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.
• Fruit snack or edible? Study finds some cannabis products look like popular snacks. Some cannabis edibles look remarkably like popular snack foods and may be easily confused for them, finds a new study led by researchers at NYU School of Global Public Health published in Drug and Alcohol Dependence.  These “copycat” edibles also have levels of tetrahydrocannabinol or THC—the main psychoactive compound in cannabis—that far exceed the limits set by state cannabis regulations.
• Majority of CBD products tested in [a German] study found to have at least some THC.  A new study that sampled dozens of commercially available CBD products found detectable THC levels in 64% of them. Some levels were high enough to approach therapeutic thresholds or to potentially trigger drug test failures….Read more
• [A Kentucky] Study: Many CBD products would trigger doping bans.  Almost a third of 23 tested CBD products contained traces of banned cannabinoids at levels that would have provoked doping infringements, according to a just-published study….Read more
• StatNews: THC ingestion by young kids highlights the need to tighten inadequate packaging regulations.  Tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana, is finding its way into the hands and mouths of young children via products packaged and labeled in ways that bear striking resemblance to famous candy and other snack products known to appeal to children.
• CBD: The ultimate celebrity side hustleWhether they’re an investor, founder or spokesperson, public figures such as athletes and actors are benefitting from CBD’s therapeutic properties –and its ability to bring in the dough…. Read more

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.

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 Kozhuharov, Kalin 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.

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

• Letter from 8 Senators headed by Cory Booker to USDA Secretary Vilsack calling for greater formula competition
• Letter from USDA Secretary Vilsack calling on Abbott to provide rebates for competitive formula
• Politico: Senator Tammy Duckworth calls on the FTC to examine lack of competition in the formula market
• Center for Science in the Public Interest urges policymakers in Washington to deploy additional tools
• Congressional subcommittee to investigate shortages
• Background Press Call by Senior Administration Officials to Address Infant Formula Shortage
• Readout of President Biden’s Virtual Meetings with Retailers and Infant Formula Manufacturers
•  Associated Press — Parents swap, sell baby formula
• The New York Times — What Parents Need to Know
• USDA’s Q and A page about options for exchanging Abbott formula for other kinds 
• USDA’s page on the Abbott recall
• USDA’s guidance for keeping infants safe in the midst of formula shortages
• FDA’s details on Abbott product recalls
• CDC’s report on its Cronobacter investigations, now closed
• Wall Street Journal: What caused the baby formula shortage?
• Bill Marler: Abbott caused the infant formula crisi, but the FDA and public health enabled it
• Abbott and FDA agree on pathway to opening Sturgis MI plant
• Abbott denies its formulas were responsible in an 11-tweet Twitter thread

Additional links that came later

• The Washington Post – Biden invokes Defense Production Act to boost baby formula supply
• WhiteHouse.gov – Letter from President Biden to Secretary Xavier Becerra and Secretary Thomas Vilsack on addressing infant formula shortage  
• Fact sheet: President Biden announces new actions to address infant formula shortage
• Memorandum on the delegation of authority under the Defense Production Act to ensure an adequate supply of infant formula

In response to my post last week about problems at the FDA, I received an emailed note from Jerry Mande, whom I met years ago when he was at USDA, and is now a visiting fellow at the Harvard School of Public Health.

Terrific piece today, but you should have called for the need for FDA to focus much more on the chronic disease risks of food. It’s catastrophic that they have taken only one truly regulatory action (banning trans fat) to improve diet and health…Commissioner Califf needs to put the F back in FDA only 7% of CFSAN’s budget is used for improving diet quality and nutrition, which accounts for 99%+ of food related poor health…The bottom line, as you know better than anyone, is there are more deaths every day due to poor quality diets than in a year due to acute illnesses…I urge you to consider that when you write more on this topic. You could start by featuring our op-ed in your blog. Thx!

The op-ed is indeed worth a read.

But, in fact, this topic has been on my mind since Politico’s Helena Bottemiller Evich wrote Diet-related diseases pose a major risk for Covid-19.  But the U.S. overlooks them, back in October.

Her article, which focused on the lack of government attention to the risks posed by obesity for chronic disease and COVID-19, inspired me to write an editorial for the American Journal of Public Health.  I’m told it’s going online tonight (if it does, I will post it tomorrow).

Politico’s Helena Bottemiller Evich has produced a blockbuster exposé of the FDA.

If you’ve been worried that the FDA is not doing its job, you are not alone.  This is an astonishing piece of in-depth reporting on the current status of this agency, which in addition to regulating drugs is responsible for the safety and labeling of three-quarters of the food we eat.

I have long complained that the FDA has two structural handicaps:

1. The FDA Commissioner is not even close to being a cabinet-level appointment; it is at least two steps down the reporting ladder, meaning lots of reporting requirements and authority.
2. FDA gets its funding from congressional agriculture committees, even though it is an agency of the Public Health Service.  This result of history puts it secondary to USDA in committee funding priority.

I also have long believed that it would be better all the way around if the FDA strongly regulated the food industry.  Strong regulatory agencies are essential for:

• Trust in science
• Trust in government
• Trust in the food supply
• Establishing a level playing field for the food industry

Here’s what Bottemiller Evich found when she looked into FDA’s delays in getting regulations into place:

Many consumers would be surprised to learn this anemic, slow response is typical for an agency that oversees nearly 80 percent of the American food supply, but slow is what insiders in Washington have come to expect from FDA, regardless of administration.

A monthslong POLITICO investigation found that regulating food is simply not a high priority at the agency, where drugs and other medical products dominate, both in budget and bandwidth – a dynamic that’s only been exacerbated during the pandemic.

Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems in interviews.

Her investigation comes in five parts:

1. “It’s a struture that’s designed to fail.” This part deals with leadership challenges.
2. “A bit of a black hole.”   Why the FDA took so long to get out standards for regulating irrigation water, and weak ones at that.
3. The rage of a million parents.  The FDA’s failure to take vigorous action to remove toxic metals from baby food and ensure the safety of infant formula.
4. “Our food is making us sicker” Why the FDA has been so lax about getting sodium reduced in the food supply.
5. “They ignore everyone.” The agency, which seems excessively responsive to industry, doesn’t consult its leaders adequately.

Bottemiller Evich says:

• Read the four major findings from our investigation.
• Have you complained to the FDA about the Similac recall or another infant formula problem? We want to hear from you.

Every bit of this is worth reading and pondering.  We need a strong, active FDA, unafraid to take unpopular stances to protect public health.

The FDA needs an overhaul.  I hope it comes soon.

Maybe this article will get everyone thinking about how best to get this?

Congressional reactions: Lawmakers demand answers from FDA after investigation on food failures

• Sen. Patty Murray (D-Wa.), who leads the Senate Committee on Health, Education, Labor and Pensions, sent a strongly-worded letter to FDA Commissioner Robert Califf Monday afternoon seeking “immediate action to ensure the FDA is doing all it can to fulfill all aspects of its mission to protect the health and safety of the American people.”
• Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, tweeted Monday that he is requesting a briefing from the agency.
• House Appropriations Chair Rosa DeLauro (D-Conn.) also tweeted criticism over the weekend: “The ‘F’ in FDA has come to mean ‘failure’ on food safety,” she wrote. “We must greatly intensify the pressure to get the FDA to do its job and to keep the American people safe and alive.

Bill Marler’s: FDA’s failures have consequences – real people – here is one story – there are countless others

The FDA’s?  The agency has not released a statement but by coincidence it is holding a webinar tomorrow on one aspect of Politico’s investigation.  An opportunity to ask questions?

Please join the U.S. Food and Drug Administration (FDA) for a webinaron April 13, 2022 at 2 p.m. on the Foodborne Outbreak Response Improvement Plan that the agency released in early December 2021.

Michael Taylor on the need for a separate food safety agency or better direction for food within FDA.

The FDA is issuing yet another notice about consumer research on a symbol for “healthy.”

The U.S. Food and Drug Administration is issuing a 30-day procedural notice on the preliminary quantitative consumer research it plans to conduct on voluntary symbols that could be used in the future to convey the nutrient content claim “healthy”…while at the same time developing a proposed rule that would update when manufacturers may use the “healthy” nutrient content claim on food packages.

It’s déjà vu all over again.

I went right back to what I wrote on  January 1, 2016.

**** Here’s what I said back then:

FDA: What is happening with front-of-package labels?

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

• Procedural Notice on Consumer Research on “Healthy” Symbol (May 2021)
• Use of the Term Healthy on Food Labeling
• Food Labeling & Nutrition

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