Currently browsing posts about: FDA

I am late getting to the FDA’s July announcement of the release of its work plan for the next ten years, Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025.

The FDA organized the plan under goals for:

• Food safety
• Nutrition
• Animal health
• Organizational excellence

The FDA based the plan on basic principles:

1. Public health is the first priority
2. Partnerships are the key to success
3. Scientific expertise and research are the foundation
4. The program is committed to operating openly and transparently

Comments can be submitted on the strategic plan at any time.  Instructions for how to do so are here.

One possibility is to ask for further details.  The plan does not say how the FDA will accomplish the objectives, how much it will cost to achieve them, or whether it has adequate funding for everything it does (hint: it doesn’t).

Some of what it wants to do is puzzling.  For example, one Nutrition objective is this:

2.1: Provide and support accurate and useful nutrition information and education so consumers can choose healthier diets consistent with the Dietary Guidelines for Americans and other evidence-based recommendations.

I assume this refers to Nutrition Facts labels and menu labels, but one of its sub-objectives is:

Strategy 2.1d: Promote collaboration with stakeholders, including industry, consumer, and public health groups, to enhance consumer nutrition education directed towards age and demographic groups with specific needs.

I wish the report said more about this.  Surely the FDA is not suggesting that the food industry take responsibility for nutrition education?  I hope not.

The documents:

• Federal Register Notice
• FDA Home Page for the Plan
• The Strategic Plan for 2016-2015
• Blog: Charting a Path Forward on Food Safety, Nutrition and Animal Health

Presidential candidate Donald Trump gave a speech to the Economic Club of New York about his tax reform plan to “make America great again.”

The plan would eliminate some programs he finds annoying, the FDA’s food safety regulations among them.

The tax plan, including the FDA provisions, was posted on Trump’s website, but it is no longer there.

Fortunately, @nycsouthpaw did a screen capture and posted it on Twitter.  Among other things, Trump would like to eliminate:

Food safety lawyer Bill Marler, who begs producers of unsafe food to “put me out of business” is getting his wish and notes how well the new food safety rules are working.  He says Trump must love him: Killing the FDA is good for business:

How did “The Donald” know that my business has dropped over the last few years as the regulatory work of our governmental agencies have kicked into gear.

Who knew that food safety would be an issue in this year’s election, let alone Skittles.

The FDA has announced its Final Rule on Substances Generally Recognized as Safe (GRAS).

The FDA explains:

Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives…The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.

Uh oh.  “Appropriate qualified experts?”  Like those selected by the companies themselves?  The FDA has failed the public on this one.

Consumers Union (CU) says

FDA missed a major opportunity to clean up the food system… Companies will still be able to introduce novel substances into food in secret, without having to show they are safe.  The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients. That is unacceptable and deeply disappointing [CU should know.  It filed comments on the FDA’s proposed GRAS rules in 2011].

Senator Ed Markey (Dem-MA) says

FDA’s Final Rule On Food Safety Process Is A Missed Opportunity…The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take home exam that industry doesn’t even have to hand in…I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply [Sen. Markey sent FDA a letter in April asking if the agency needs statutory authority to ensure the safety of GRAS substances and encouraging the FDA to issue guidance on how to prevent conflicts of interest for outside experts evaluating GRAS substances.

The backstory

The FDA’s final GRAS rule is the result of a settlement agreement following a 2014 lawsuit filed by the Center for Food Safety. The basic issue: GRAS substances are not subject to FDA premarket approvals required for food additives.  Manufacturers are allowed to decide for themselves whether their additives are GRAS without informing the FDA. The new rules confirm this self-managed GRAS notification procedure.

I wrote about this issue in an editorial for JAMA Internal Medicine in 2013 when I commented on a study by Tom Neltner and his colleagues on the blatant conflicts of interest in FDA approval of GRAS substances.

Their study examined conflicts of interest among scientific experts serving on panels deciding whether food additives–substances that preserve, flavor, blend, and thicken food—should be deemed generally recognized as safe (GRAS) and exempt from Food and Drug Administration (FDA) premarket approval requirements.  Their findings are alarming. An astonishing 100 percent of the members of 290 expert panels included in their review worked directly or indirectly for the companies that manufactured the additive in question.  Even more alarming, the experts on these panels form a tight professional cadre.  Although 850 people served on the panels, 10 experts served on 27 panels or more, and one of these ten participated in three-quarters of the panels.

My editorial reviewed the lengthy history of FDA’s dithering about the GRAS process.  None of this would matter if all food additives were safe.  But some are not.  I also pointed out:

The problems created by conflicts of interest for the FDA go well beyond those related to food additives and GRAS exemptions.  A recent analysis of requests for waivers by people serving on FDA advisory committees views conflicts of interest as a severe threat to scientific integrity.  As Neltner et al. argue, the lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, particularly the additives that the FDA does not even know about. It also raises questions about conflicts of interest in other regulatory matters.

The FDA’s decision is a loss for public health.

It constitutes yet another reason not to eat products with long lists of additive ingredients.

Addition, August 16

The Environmental Working Group also issued a statement.

EWG is disappointed the FDA has decided to once again ignore its legal obligation to ensure the safety of our nation’s food supply…The so-called “GRAS loophole” – originally intended to only allow known ingredients proven safe to skip regulatory approval – has swallowed the law, permitting novel chemicals to be added to food without government oversight.

A couple of weeks ago, Politico reported that six former commissioners of the FDA agreed that this agency needed to become independent of its present location in government.

The FDA is presently one of eight agencies in the Public Health Service of the Department of Health and Human Services.

The former commisioners think the FDA would be better off having

either Cabinet-level powers or the autonomy of agencies like the Federal Trade Commission or the Securities and Exchange Commission. They argued that the FDA, which regulates more than a quarter of the economy and deals with critical food and drug safety, is harmed by bureaucracy, meddling politicians and confusing budgetary lines in Congress.

Politico quotes former commissioner David Kessler: “The micromanagement from on top has probably gotten to the point where an independent agency is necessary.”

Every decision made by FDA officials must be cleared not only through the FDA bureaucracy, but also through that of HHS—and the White House Office of Management and Budget.

This explains why the FDA appears to—and does—move at pre-climate change glacial speed.

But that’s not the only structural problem that impedes the work of this agency.  The other big one is how it gets funded.

The FDA is a public health agency housed in the health department.

BUT: it gets its congressional funding from House and Senate Agricultural committees.

These can hardly be expected to be sympathetic to the FDA’s regulatory mission to keep foods safe and labeled accurately.

This happened for reasons of history.  In its earlier incarnations, the FDA was part of the USDA.  It moved, but its funding didn’t.

These calls raise issues about the structure of food regulation at the federal level.  I’ve written about calls for a single food agency often on this site.  This may be a good time to consider how best to deal with food policy in the next few years.  We badly need:

• Food policy linked to health policy
• Better linkage of the FDA’s and the USDA’s food safety regulation
• Better coordination of food and nutrition policy overall

It’s great that the commissioners started this conversation.  It’s one well worth continuing.

The Senate just voted to reverse a decision of Congress last year to remove catfish inspection from the FDA (which is usually in charge of regulating seafood) and give it to the USDA (which usually regulates meat and poultry).

Why did the 2008 and 2012 farm bills say that catfish inspection should be given to USDA?

It depends on whom you ask.

• Defenders say it’s because USDA has the resources to protect us against unsafe Vietnamese catfish.
• Critics said it’s to protect the Mississippi catfish industry against the food safety hazards of cheap imported catfish from Vietnam.

Indeed, the USDA inspection program is finding antibiotics and other unapproved carcinogens in catfish imported from Vietnam.

This issue, however, is a sticking point in US negotiations with Vietnam over the Trans Pacific Partnership trade agreement.

Vietnam wants the USDA catfish inspection removed as an unfair barrier to trade.

As I wrote about this issue in 2013,

What is this about?  Not fish safety, really.  It’s about protecting catfish farmers in the South and setting up “more rigorous” safety criteria that will exclude competitive foreign catfish imports, especially from Vietnam.

Food retailers and retail trade associations are for reverting inspection to FDA. They say USDA’s catfish inspection program will take years to allow imports from Vietnam, thereby causing the cost of domestic catfish to rise.

But today, Politico Morning Agriculture reports that more than 100 House Republicans are urging repeal of the USDA’s catfish inspection program, pointing out that

The Government Accountability Office (GAO) has 10 times stated that this program is “duplicative” and at “high risk” for fraud, waste, abuse, and mismanagement…This is not a food safety issue.  USDA acknowledges that catfish, regardless of where it comes from, is considered a “low risk food.”

When I wrote this issue previously, I got comments that I needed to better appreciate the superiority of USDA’s import safety program.  As I said in response:

It’s not surprising if USDA’s import safety system is better than the FDA’s.  USDA gets $14 million a year to run its currently non-operating catfish inspection system.  The FDA gets $700,000 and, according to the Government Accountability Office, has managed pretty well with it.

My conclusion then and now:

If the political fuss over catfish inspection reveals anything, it is why we so badly need a single food safety agency—one that combines and integrates the food safety functions of USDA and FDA—to ensure the safety of the American food supply.

Documents

• The Senate resolution
• USDA’s catfish inspection program

The CDC has started a page on the E. coli O121 (STEC O121) outbreak linked to General Mills flour:

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Sixteen (76%) of 21 people reported that they or someone in their household used flour in the week before they became ill. Nine (41%) of 22 people reported eating or tasting raw homemade dough or batter. Twelve (55%) of 22 people reported using Gold Medal brand flour. Three ill people reported eating or playing with raw dough at restaurants.

The CDC’s “At A Glance”

• Case Count: 38
• States: 20
• Deaths: 0
• Hospitalizations: 10
• Recall: Yes

It looks like cases are—or were—popping up one at a time.  There is always a reporting lag.

While waiting for more information, the CDC recommends:

• Do not use, serve, or sell the recalled flours.
• Do not eat raw dough or batter, whether made from recalled flour or any other flour.
• Bake items made with raw dough or batter before eating them.
• Do not taste raw dough or batter.
• Do not serve raw dough to customers or allow children and other guests to play with raw dough.

But really. Gold Medal flour?  If flour is used for cooking or baking, the bacteria would be killed.

OK.  I totally get eating raw cookie dough.  I did plenty of that back in the day when I baked cookies for my kids, and they helped clean the bowl.  Eating raw cookie dough may sound disgusting, but the mix is truly delicious.

If you’ve never tried it, now is not a good time to start.  In 2009, there was a really nasty E. coli outbreak from eating pre-packaged raw cookie dough.

But eating or playing with raw dough in restaurants?   Is this common practice?  News to me.

Documents

• Recall list and advice to Consumers, Restaurants, and Retailers
• FDA announcement and investigation
• Shiga toxin-producing Escherichia coli O121 (STEC O121) infection
• Signs & Symptoms
• Key Resources

The Center for Science in the Public Interest (CSPI) has sued the FDA for ignoring its 2012 petition to prevent illnesses and deaths caused by eating raw oysters from the Gulf of Mexico contaminated with toxic Vibrio vulnificus.

The lawsuit, filed jointly with Public Citizen, asks the FDA to set standards to make sure these bacteria are “nondetectable in oysters and other molluscan shellfish sold for raw consumption.”

The FDA is supposed to respond to the complaint by July 25.

This issue goes back a long way.  I wrote about it in 2011 in the context of a Government Accountability Office (GAO) report, Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

Vibrio vulnificus bacteria are considered “flesh-eating;” they kill half the 30 or so people who eat contaminated raw oysters.   Treating the raw oysters before allowing them to be sold kills the bacteria.  California requires this and nobody eating California oysters gets sick from Vibrio.  As I wrote in 2011:

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups. If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

So what happened?  Late in 2009, the FDA said it would issue rules, but backed off under pressure from the oyster industry and friendly state officials.

Despite years of warnings and promises that it obviously has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for 15 years at the cost of about 15 preventable deaths a year.

CSPI and Public Citizen are trying the legal route.  I hope it works.

Food Chemical News reports that the Senate Appropriations bill comes with report language instructing the FDA to:

• Conduct a risk assessment to see how harmful it really is to eat Listeria-tainted frozen vegetables [these, presumably, would be cooked before eating].  CRF Frozen Foods had to recall of 358 organic products after 7 people became ill.
• Release no sodium guidelines before the National Academies of Science has a chance to update the Daily Reference Intake (DRI) for sodium [which will take years].  The report says “it is “imperative that any guidance be issued using the latest sound science…based upon an updated DRI report.”  House directives said the same thing.  [The FDA has just released voluntary sodium guidelines for public comment].
• Release its overdue report on food traceability systems: “The Committee directs the FDA to collaborate with science-based international and industry-led food traceability initiatives of the type recommended by the pilot projects…[and] to make publicly available information on FDA’s efforts to encourage…traceability initiatives.”
• Reconsider its E. coli standard.  The Senate views this standard as too stringent and disruptive of raw milk cheese businesses.
• Actively engage stakeholders in best practice standards for medical foods. “They should work together on “forming a framework for a distinct regulatory pathway for medical foods that does not encumber its progress towards approval for patient use.”
• Better enforce standards for antibiotics in shrimp imports.
• Sample olive oil bottles at retail to determine if they are adulterated, and report findings to Congress.
• Report on efforts to implement regulations for the growing commercial human milk industry.

Some of these directives would improve food safety, but some would not.

All make more work for the FDA.

Does the Senate also plan to appropriate sufficient funds for the FDA to do all this in addition to what it is already doing?  Want to take bets?