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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.

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.