Search results: single food agency

As it promised in response to a petition from the KIND fruit-and-nut bar company (as I discussed in a previous post), the FDA is now asking for public comment on what “healthy” means on food package labels.

You might think that any food minimally processed from the plant, tree, animal, bird, or fish would qualify.

But “healthy” is a marketing term for processed food products (not foods).  

As Politico Morning Agriculture reminds us, things got complicated when KIND, which makes products from whole nuts, said its bars deserved to be called “healthy.”

In 2015, KIND received a warning letter from FDA arguing the company violated federal rules by using “healthy” on its packages. KIND then petitioned the agency, and, after an exchange about why the current definition is outdated, FDA decided to reverse course. For example, it requires that a food be low-fat to be labeled “healthy,” a standard that a nut-based bar doesn’t meet, while products like fat-free puddings do.

The FDA’s rules now say:

The term “healthy” and related terms (“health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily” and “healthiness”) may be used if the food meets the following requirements: 21 CFR 101.65(d)(2)

OK.  I know you can’t read this (you can look for it here). The point is that to qualify as “healthy,” a product has to be low in fat, saturated fat, and cholesterol; relatively low in sodium; and contain at least 10% of the Daily Value per serving for vitamins A or C, calcium, iron, protein, or fiber (with some exceptions).  There are also rules for levels of nutrients added in fortification.

The FDA wants input on whether all of this makes sense in the light of the 2015 Dietary Guidelines and the KIND petition.

In its inimitable FDA-speak:

While FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. FDA is also issuing a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

If I correctly understand the meaning of “does not intend to enforce the regulatory requirements,” the FDA, while waiting for your comments, will allow manufacturers to call products “healthy” as long as the products:

(1) Predominantly contain mono and polyunsaturated fats regardless of total fat content; or

(2) Contain at least ten percent of the Daily Value (DV) per serving of potassium or vitamin D.

In other words, if your food product is made with a low saturated fat oil and contains potassium or vitamin D, it is by definition “healthy.”

Correction, September 29: An FDA official wrote to say that I didn’t quite get this right.  

Actually, if a food exceeds the low fat requirement currently in our definition, we will not take any enforcement or compliance action as long as the food meets all of the other requirements in the definition, namely that it is low in saturated fat, cannot exceed the specified levels of cholesterol and sodium, and contains at least 10 percent of the daily value for beneficial nutrients.  

Second, we are not saying that foods must contain potassium or vitamin D to be labeled as “healthy.”  We are simply indicating that potassium and vitamin D can be substituted for the beneficial nutrients now listed in the current regulations, in line with the new Nutrition Facts label regulations.

My apologies to the FDA for misunderstanding the notice.

The FDA’s request is good news for KIND bars.

But it smacks of “nutritionism”—the use of these two single nutrients (as well as others on the short list of beneficial nutrients) as indicators of quality in processed food products (and don’t get me started on vitamin D, which is a hormone, not a vitamin, and best obtained by getting outside in the sun once in a while).

Understand: this effort is not about semantics; it is about marketing.

Would you like to weigh in on what you think qualifies a food as “healthy?”  Here’s how:

• Federal Register Notice for the Guidance for Industry 
• Federal Register Notice for the Request for Information
• Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
• Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages
• “Healthy” on Food Labeling 

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 Government Accountability Office has just released a new report.

Much of the report is about the need for better coordination of the food safety oversight responsibilities of the USDA (meat and poultry) and those of the FDA (everything else), not to mention the 13 other agencies that deal with aspects of food safety (the report provides a handy summary chart).

This report points out that both agencies

have mechanisms in place to facilitate interagency coordination on food safety that focus on specific issues, but none provides for broad-based, centralized collaboration…[Existing]mechanisms do not allow FDA, FSIS [USDA], and other agencies to look across their individual programs and determine how they all contribute to federal food safety goals. Nearly all the experts GAO interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The Food Safety Working Group (FSWG) served
as a centralized mechanism for broad-based food safety collaboration and resulted in a number of accomplishments, including improved coordination. However, the FSWG is no longer meeting…Without a centralized collaborative mechanism on food safety, there is no forum for agencies to reach agreement on a set of broad-based food safety goals and objectives.

The GAO complains that “for more than a decade, we have reported on the fragmented nature of federal food safety oversight.”

Actually, its complaints go back longer than that but here’s one from 1999:

I will have to go through my files but as I recall, the GAO started arguing for a single food safety agency sometime in the early 1990s.  Political realities make that idea impossible.  Instead, we have the Food Safety Working Group which seems to have stopped meeting.

It’s good the GAO is still on the case.  We need better food safety oversight.

Tomorrow’s example: Caramel apples.

The food and chemical industries are lobbying hard against what is expected to be a tough report from the Environmental Protection Agency (EPA).

The report will set an upper limit for safe consumption of dioxins.

Most Americans consume dioxins at levels higher than this standard, mostly from food.

About 90% of dioxins come from foods, particularly high-fat animal foods.

Dioxins mainly enter the food chain as by-products of industrial processes.  To a lesser extent, they also come from natural processes such as volcanoes and forest fires.  They contaminate land and sea, are consumed in feed, move up the food chain, and end up in the fatty parts of meat, dairy products, and seafood.

Dioxins accumulate in fatty tissues.  They increase the risk of human cancer more than any other industrial chemical.

The EPA is expected to recommend an intake limit of 0.7 picograms of dioxin per kilogram body weight per day.  A picogram is one trillionth of a gram.  The World Health Organization and European Union limit is higher—from 1 to 4 picograms per kilogram per day.

The food and chemical industries argue that the proposed EPA limit is too low.

The EPA thinks less is better.  Dioxins are toxic and Americans typically consume amounts within the European range.   A single hot dog can contain more dioxin than the proposed limit for a 2-year-old.

Dioxin levels in the United States have been declining for the last 30 years due to reductions in man-made sources. But they break down slowly and persist for a long time in the environment.

How to avoid them?  The best way is to eat less high-fat meats, dairy foods, and seafood.

No wonder the food industry is alarmed.

A “Food Industry Dioxin Working Group” of trade associations such as the International Dairy Foods Association, the American Frozen Food Institute, and the National Chicken Council wrote to the White House:

Under EPA’s proposal…nearly every American – particularly young children – could easily exceed the daily RfD [reference dose] after consuming a single meal or heavy snack…The implications of this action are chilling.

Since the agency contends the primary route of human exposure to dioxin is through food, this could not only mislead and frighten consumers about the safety of their diets, but could have a significant negative economic impact on all US food producers.

These groups singled out the media for particular blame:

The media will inevitably report on this change and in all likelihood misinterpret the RFD as a ‘safe limit’. As a result, consumers may try to avoid any foods ‘identified’ as containing or likely to contain any dioxin.

Eat more fruits and vegetables anyone?

Congressman Ed Markey (Dem-MA) is urging the EPA to get busy and release its report:

The American public has been waiting for the completion of this dioxin study since 1985 and cannot afford any further delays…A baby born on the day the EPA completed its first draft health assessment would be 27 years old today. I’d like to see the final EPA analysis before it turns 28.

Let’s hope the EPA does not cave in to industry pressure and releases the report this month as promised.

Technical note:

“Dioxins” collectively refers to hundreds of chemical compounds that share certain structures and biological characteristics. They fall into three closely related groups: the chlorinated dibenzo-p-dioxins (CDDs), chlorinated dibenzofurans (CDFs) and certain polychlorinated biphenyls (PCBs). The most studied is 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).  PCBs are no longer produced in the U.S.

References:

• EPA
• FDA
• Food Safety News
• Food Quality News

In preparation for the holiday season, Secretary of Health and Human Services Kathleen Sebelius and Agriculture Secretary Thomas Vilsack held a press conference  to promote the departments’ efforts on food safety.

They announced release of the administration’s progress report from its Food Safety Working Group.

They also highlighted additional places to get government information about food safety at home:

• Food Safety Blog
• FoodSafety.gov 
• Tips on Holiday Food Safety

I didn’t pay much attention to these announcements until I read the slightly snarky account in Food Chemical News (December 22). 

The Obama administration patted itself on the back today with a new report that both lists the accomplishments over the past three years of its Food Safety Working Group (FSWG) and identifies the group’s top priorities for the coming year.

Released just minutes before a short media call that served as more of a pep rally, The Federal Food Safety Working Group Progress Report, a 31-page document, summarizes for stakeholders a host of activities that have taken place at government agencies over the past three years related to detecting foodborne pathogens, enhancing surveillance, responding to food safety problems, improving food safety at the retail level and educating consumers.

The list of the administration’s food safety accomplishments is long and detailed, and many are impressive.

But what the report does not say is telling.  Neither the USDA nor FDA have the resources or power to require the industries they supposedly regulate to produce safe food.

As Mark Bittman explains in his Opinionator column in the New York Times, politics defeats even the most rational and thoroughly science-based safety measures, leaving the FDA unable to do much more than politely request “voluntary guidance” of industry.

Bittman focuses on the political barriers to doing what the FDA has been asking for since 1977:  a ban on the use of antibiotics for non-therapeutic purposes, in this case to make food animals grow faster.   The result: “Bacteria 1, FDA 0.”

Here’s the nut: The F.D.A. has no money to spare, but the corporations that control the food industry have all they need, along with the political power it buys.

That’s why we can say this without equivocation: public health, the quality of our food, and animal welfare  are all sacrificed to the profits that can be made by raising animals in factories….Animals move from farm to refrigerator case in record time; banning prophylactic drugs would slow this process down, and with it the meat industry’s rate of profit.

Lawmakers beholden to corporate money are not about to let that happen, at least not without a fight.

For more than 20 years, the Government Accountability Office has called for creation of a single food safety agency that unites the safety oversight functions of the FDA and USDA and has the authority to require food to be produced safely.

In this Congress?  Hopeless.

But Congress can be changed—and that’s a worthy thought for the new year.

Just a couple of weeks ago, the Government Accountability Office (GAO), the congressional watchdog agency, issued a report calling for a single food safety agency (see my post on this). 

The GAO is working hard on this issue.  It has just issued yet another report, this one called FEDERAL FOOD SAFETY OVERSIGHT: Food Safety Working Group Is a Positive First Step but Governmentwide Planning Is Needed to Address Fragmentation.

The report points out some of the alternatives it has suggested in the past:

• A single food safety agency
• A food safety inspection agency
• A data collection and risk analysis center
• A coordination mechanism led by a central chair

GAO says:

GAO and other organizations have regularly paired proposals for alternative food safety organizations with calls for comprehensive, unified, risk-based food safety legislation.

New food safety legislation that was signed into law in January 2011 strengthens a major part of the food safety system; however, it does not apply to the federal food safety system as a whole or create a new risk-based food safety structure.

GAO recommends that the Director of OMB, in consultation with the federal food safety agencies, develop a governmentwide performance plan for food safety that includes results oriented goals and performance measures for food safety oversight and a discussion about strategies and resources.

As I have mentioned in previous posts, GAO has been making these kinds of recommendations for 20 years.  Does anyone in government listen?  This report notes that the Office of Management and Budget declined to respond to its recommendations.

Responsive government anyone?  This seems like a reorganization well worth trying.  We only have one food supply.  We should not need two agencies to manage its safety risks.

 Bill Marler, the food safety lawyer in Seattle, is asking for responses to the question, “if you had a magic wand, how would you fix the food safety system?” 

I’ve been mulling over his question in light of the recent enactment of the food safety bill, as yet unfunded.  Magic wand in hand, here’s what I’d do:

Create a single food safety agency: the new law is designed to fix the FDA.  It does nothing to fix the USDA’s food safety functions.  These remain divided between the two agencies, with USDA responsible for the safety of meat and poultry, and FDA responsible for everything else.  This division pretends that animal wastes have nothing to do with the safety of fruits and vegetables which, alas, they do. 

Require safety control systems for all foods.  Everyone who produces food should do it safely using proven methods for identifying where hazards can occur, taking steps to prevent those hazards, monitoring to make sure the steps were taken, and—when appropriate— testing to make sure the system is working. 

Apply safety controls from farm to table.  The new law does this for FDA-regulated foods.  But USDA safety regulations begin at the slaughterhouse after animals have already been contaminated in feedlots or in transport.  Everyone involved in food production, even farmers large and small, should be actively engaged in food safety efforts.

Fund food safety through congressional health committees.  For irrational reasons of history, the FDA gets its funding through agricultural committees, not health—even though FDA is an agency of the Public Health Service within the Department of Health and Human Services.   As a consequence, the FDA is at the mercy of appropriations committees whose mandate is to protect agricultural interests.  This anomaly explains why 80% of food safety funding goes to USDA, and only20% to FDA.  The new chair of the House agricultural appropriations committee has made it clear that he does not believe FDA needs any more funding.   Health appropriations committees might view FDA’s role in food safety in a more favorable light.

Fund food safety adequately.  To protect the domestic food supply—and to ensure the safety of imported foods—more money is needed to pay for inspection, testing, and research. 

Give the food agency cabinet-level status.  Everyone eats.  Food safety affects everyone.  Food has critically important economic and food security dimensions, domestically and internationally.   

Require election campaigns to be publicly funded, with no loopholes. This is the only way we will be able to remove corruption from our political system and elect officials who care more about public health than corporate health.

Require Wall Street to rate corporations on long-term sustainability.  Wall Street pressures on corporations to report growth every quarter are at the root of corner-cutting on food safety.  Food corporations should be valued for excellent food safety records and for maintaining high ethical standards in every aspect of their business.

Even a magic wand may not be enough to do this.  It will take more than a magic wand to do this, I fear.  Hey, I can dream.