by Marion Nestle

Currently browsing posts about: FDA

May 18 2011

FDA’s limited ability to regulate food imports

The congressional watchdog agency, the Government Accountability Office (GAO), has just published a new report comparing the way the FDA deals with inspections of imported foods to methods used by the European methods.  The title says it all: “FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources.”
GAO says:
FDA’s program is generally limited to enforcing the Hazard Analysis and Critical Control Point—the internationally recognized food safety management system—by conducting inspections of foreign seafood processors and importers each year.
These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms.
The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood.
Here are some of GAO’s more disturbing conclusions:
  • Aquaculture assessments have been limited by FDA’s lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country’s fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU.
  • FDA’s sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce.
  • FDA’s sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent.
  • In fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues.
  • FDA’s reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency’s use of resources.
  • FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years.

And Congress wants to cut FDA’s resources.  I have no doubt that the FDA could be more efficient but the scope of what it is expected to do with limited resources is beyond absurd.

From where I sit, the entire food safety system needs an overhaul and the problems with food imports are a good reason for doing that.

 

May 15 2011

Foods with benefits? Oh, please.

Sunday’s New York Times has not one but two articles about “functional foods,” those with something added over and above what’s in the food in the first place.

A front-page story, “Dessert, laid-back and legal,” describes brownies.  No, not brownies laced with marijuana.  This time they contain the sleep-inducing drug melatonin.

The brownies, according to the Times, contain just as much melatonin as are found in drug pills but are cheaper and can be purchased with food stamps (another reason for taking a look at the whole question of SNAP benefits?).

Since melatonin is a drug and not an approved food additive, the makers of these products are trying to get around the annoying FDA restrictions by marketing the brownies as “dietary supplements.”  Supplements, by order of Congress when it passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, do not have to meet FDA’s rigorous scientific criteria for safety or efficacy.

DSHEA applied to supplements, not foods, but the FDA has chosen to regulate foods containing such additives by the weaker rules applying to supplements and to deal with them as a regulatory gray area.   Is melatonin a drug, a supplement, or in brownie from a food?  The FDA is going to have to decide this, and fast.

A much longer story in the business section, “Foods with benefits, or so they say” (in which I am quoted) focuses on the entire point of functional foods: the ability to put something in a product that allows you to market it using health and wellness claims.  Health claims sell food products.  People like buying products with a “health aura,” no matter how poorly the health claim is supported by science.  Science is irrelevant here.  Marketing is what’s relevant.

As I discuss in my book, Food Politics, until the early 1990s, the FDA did not allow health claims on food products.  Claiming a specific health benefit for a food, said the FDA, meant that the food was being marketed as a drug.  If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

When Congress passed the Nutrition Labeling and Education Act in 1990, it struck a deal with the food industry.  The industry was objecting that because Nutrition Facts labels required them to say what was bad about their products, they ought to be allowed to say what was good about them.  Congress agreed, and forced the FDA to review the science linking certain food ingredients to health benefits as a basis for permitting health claims.

The FDA approved some claims but rejected others.  The rejected companies took the FDA to court, and the courts mostly ruled in favor of the companies on the grounds of the First Amendment.  The FDA stopped trying to control unsupported health claims and only recently has taken then on again.

But as sales soar, federal regulators worry that some packaged foods that scream healthy on their labels are in fact no healthier than many ordinary brands. Federal Trade Commission officials have been cracking down on products that, in their view, make dubious or exaggerated claims. Overwhelmed regulators concede that they are struggling to police this booming market, despite recent settlements with makers of brands like Kellogg’s Rice Krispies and Dannon’s Activia, which the authorities say oversold their health benefits.

To the distress of international food marketers, the U.S. currently has much looser regulations about health claims than are available in Europe.  The European Food Safety Authority has been reviewing thousands of petitions for health claims on food products and turning most of them down as scientifically unsubstantiated.  That doesn’t stop American food makers from loading on the claims.

From the ivory tower in which I sit, the remedy is easy: don’t allow health claims on processed foods at all.  The claims are all inherently misleading, as would be obvious if you gave it a minute’s thought.

But if they aren’t worth much to you, they are worth plenty to the marketers of processed foods.  And that’s what this is really about.

Apr 5 2011

FDA makes recalls transparent

The FDA has just revised its method for listing recalls online.  As explained by Food Production Daily, the FDA was required to do this by the food safety bill passed in January.

The new site is nifty.  It displays recalls in a neat, searchable, trackable table.

The most fun is in the details.  You can click on the links and see the original recall notice and photos of the product labels.

Here, for example, is the most recent entry to give you an idea of how this works.  Click on the Details.  Enjoy!

Date Brand Name Product Description Reason/ Problem Company Details/ Photo
04/01/2011 Cottage Grove Farmhouse Bakery Bread Undeclared egg Cottage Grove Farmhouse Bakery Select to View Firm Press Release Select to View Image of Product Label
Apr 2 2011

FDA finally does proposed rules for calorie labeling

Federal agencies love releasing potentially controversial proposals on Friday afternoons when reporters and everyone else is heading for the weekend. So that’s when the FDA released its week-late proposed rules for calorie labeling in restaurants.   There are two sets of proposed rules, one for restaurants, and one for vending machines.

Most of the proposed rules are pretty much as expected. They will apply to restaurants and fast-food places, bakeries, groceries, convenience stores, and coffee shops that are part of chains with more than 20 locations nationwide.  They also will apply to vending machines from companies with more than 20.

But here’s an eyebrow-raiser. The rules will not apply to movie theaters, airplanes, bowling alleys, and other establishments whose primary purpose is not to sell food. Uh oh. Food is sold everywhere these days as anyone who has been to a drug store lately can attest.

An exemption for movie theaters seems like a bizarre oversight. If ever there was a place where calorie labeling might be useful, try movie theater supersized sodas, popcorn, and candy.

In FDA-speak, an outlet is defined as primarily in the food business if it says it is, or if more than half its floor space is used to sell food. I can’t wait to see those drug stores getting out their tape measures.

Fortunately, these are proposed rules and you are more than welcome to comment on whether you think these exempted places should be required to opt in (I vote yes).  The FDA press release in the link above gives information about how to comment.  Note that there are two codes, one for restaurants and one for vending machines.

A couple of other points caught my eye:

Ranges: “Calories for variable menu items, such as combination meals, would be displayed in ranges. An example of a combination meal could be a choice of sandwich, side dish and beverage.”

Like how? Chipotle, for example, is happy to post calories in absurdly large ranges (200 to 800, for example). Do such places get to keep doing this?

Preemption of state and local laws: these rules will take precedent except that “State and local governments can establish nutrition labeling requirements for establishments not covered by the new law or regulations.”

Does this mean like movie theaters?

Alcohol: the rules do not apply to alcohol beverages because FDA does not regulate alcohol.  Treasury does (go figure).

Take every opportunity to comment!  The comment period opens April 6.

Here are some press accounts of the proposed rules:

Lyndsey Layton in the Washington Post (I’m quoted)

William Neuman in the New York Times deals with the preemption issue.

But local governments would be free to create laws for establishments that were left outside the federal rules.  New York City’s labeling law already requires movie theater chains to post calorie information. It also requires calorie labeling for alcoholic beverages listed on menus at restaurant chains.

Mar 8 2011

Omega-3s in infant formula: time for a close look

The FDA just announced that it is planning to research health claims on infant formulas such as “supports brain and eye development.’’ The FDA wants to:

assess women’s understanding of and response to various statements on infant formula labels. The study results will be used to help the Agency to understand the role that certain types of statements on infant formula labels have in influencing formula choice….The study will focus on purchase choice, perceived similarity of the formula to breast milk, and perceived likelihood that the formula has certain health benefits.

Translation: the FDA thinks that claims for omega-3 fatty acids—DHA, in this case—on infant formulas mislead mothers into thinking the formulas are better than breast milk.

Despite lack of evidence for benefits, infant formula makers have been so successful in marketing the addition of these omega-3 fatty acids that you can hardly buy a formula without them.

I was in Ecuador a few months ago and saw this sign:

The idea?  Omega-3’s will make your kid smart.

My book, What to Eat, has a chapter on infant formula and baby food. Here are some relevant excerpts:

Infant formulas cause controversy and are endlessly contentious for three important reasons. Formulas are (1) largely unnecessary (most mothers can breast feed their infants), (2) not as perfect as breast milk for feeding babies, and (3) more expensive than breast feeding.

Breast milk is nutritionally superior to formula, but from a marketing standpoint it has one serious disadvantage: it is free. Beyond one-time purchases of breast pumps, storage bottles, or special clothing, nobody makes money from it.

For mothers who cannot, should not, or do not want to breast feed, formula is a socially and nutritionally acceptable substitute. But formula companies do not only promote formulas to mothers who must use formula. In subtle and not-so-subtle ways, they promote the use of formulas to all pregnant women and new mothers.

I go on to explain that because formula is the sole food for infants, its composition is highly regulated. Therefore, all infant formulas have the same composition, and all virtually indistinguishable.

Competition for market share explains why formula companies want to put distinctive nutrients in their formulas–especially nutrients considered “conditional.” A conditional nutrient is one that might have some benefits under some circumstances. Even if the health benefits are minimal or questionable, they can be used in advertising.

That is the principal reason why so many formulas now have fatty acids added—omega 6 arachidonic acid (ARA) and omega-3 docosahexaenoic acid —the same one that is in fish oil. These two fatty acids are normally present in breast milk, and there is some evidence, weak and questionable as it may be, that they support infant brain development and vision.

Formula makers got the FDA to agree that ARA and DHA are normal components of food (which they are) and, therefore, are Generally Recognized As Safe (GRAS). This means that companies could add ARA and DHA to infant formulas without having to prove that either of them really did anything useful or beneficial.

I then explain that the FDA apparently agreed to the GRAS petition with some reluctance, as indicated by its answer to the question, “What is the evidence that addition of DHA and ARA to infant formulas is beneficial?”

The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.

My interpretation of the proposed research study is that the FDA thinks the addition of ARA and DHA may discourage mothers from breastfeeding and may unnecessarily cause them to buy more expensive formula.

If you agree, tell the FDA you think the study is a great idea, and the sooner it gets going, the better.

You can file comments at http://www.regulations.gov.  Refer to Docket No. FDA–2011–N–0098]

Mar 2 2011

Way to go GAO! A single food safety agency

Thanks to FoodSafetyNews for the heads up on the latest Government Accountability Office(GAO) attempt to get Congress to consolidate federal food safety functions on one agency.

The GAO’s latest 345-page report on how the federal government can save money lists its proposals in alphabetical order by area.  Agriculture comes first and, therefore, so does food safety.  You have to love the way GAO titles its sections: “Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.”

GAO has been saying this for 20 years.  In 1990, for example, it published reports on who does what in the federal government about food safety and the inconsistencies in oversight.

As I wrote in Safe Food: The Politics of Food Safety (2010),

Today, an inventory of federal food safety activities reveals a system breathtaking in its irrationality: 35 separate laws administered by 12 agencies housed in six cabinet-level departments….

At best, a structure as fragmented as this one would require extraordinary efforts to achieve communication let alone coordination, and more than 50 interagency agreements govern such efforts.

Among the six agencies with the broadest mandates, all conduct inspections and collect and analyze samples, and at least three–though not necessarily the same ones–have something to do with regulating dairy products, eggs and egg products, fruits and vegetables, grains, and meat and poultry.

Until recently, the system had no mission statement (for whatever such statements are worth) and it still does not have consistent rules, clear lines of authority, a rational allocation of resources, or standards against which to measure success.

With such a system, some issues–such as use of animal manure to fertilize food crops—inevitably fall between the cracks and are governed by no rules whatsoever.

Not much has changed in the subsequent 20 years, as this new report attests.  As is inevitably the case, some of the areas of overlap are simply absurd:

The 2008 Farm Bill assigned USDA responsibility for catfish, thus splitting seafood oversight between USDA and FDA. In September 2009, GAO also identified gaps in food safety agencies’ enforcement and collaboration on imported food.

Specifically, the import screening system used by the Department of Homeland Security’s Customs and Border Protection (CBP) does not notify FDA’s or FSIS’s systems when imported food shipments arrive at U.S. ports.

But the worst is the situation with shell eggs, seemingly unfixable, given the 2010 recall of 500 million eggs:

FDA is generally responsible for ensuring that shell eggs, including eggs at farms such as those where the outbreak occurred, are safe, wholesome, and properly labeled and FSIS [USDA] is responsible for the safety of eggs processed into egg products.

In addition, while USDA’s Agricultural Marketing Service sets quality and grade standards for the eggs, such as Grade A, it does not test the eggs for microbes such as Salmonella.

Further, USDA’s Animal and Plant Health Inspection Service helps ensure the health of the young chicks that are supplied to egg farms, but FDA oversees the safety of the feed they eat.

I repeat.  This is not a new issue.  The hope was that the food safety act passed in January would pave the way to establish a single food safety agency.  The GAO report, while urging its creation, doubts that it will cut costs.

But it might save lives.

Feb 28 2011

Should the FDA allow HFCS to be renamed “corn sugar”? I vote no.

A colleague pointed out to me today that I am listed nine times on the Corn Refiners Association website as supporting its petition to the FDA to change the name of High Fructose Corn Syrup (HFCS) to corn sugar.

When the idea first came up, I didn’t think it mattered much.  But as I had to add more and more postscripts to my post on the issue, and as I read the comments on it, I was persuaded otherwise.   On balance, the arguments against changing the name outweigh the idea that it doesn’t matter (it matters to the Corn Refiners of course).

The FDA is collecting comments on the name change on its website.  I filed this comment today:

The FDA should deny the Corn Refiners petition to change the name of High Fructose Corn Syrup (HFCS) to corn sugar.

I understand that the Corn Refiners Association uses my comments on its website to support its position. The website quotes comments I have made to the effect that HFCS is biochemically equivalent to sucrose. It is. But I do not believe that biochemical equivalence is a good reason for the FDA to agree to a name change at this point.

It is highly unlikely that public misunderstanding of nutritional biochemistry and the differential physiological effects of glucose vs. fructose will be addressed and corrected by changing the name of HFCS to corn sugar.

Therefore, the name change is not in the public interest. Its only purpose is to further the commercial interests of members of the Corn Refiners, and that is not one the FDA should be concerned about.

If you have thoughts about the petition, nothing could be easier than telling the FDA what you think:

1. Click on this link.

2. Look on the left side of the page “Results,” “Corn Refiners Association – Citizens Petition,” and on the right side a link that says “Submit a Comment.”

3. Click on “Submit a Comment.”  Fill out the form with your name and affiliation.  Type in your comment.  If a box comes up saying that you are taking too long, click OK and it will give you more time.

My understanding is that there is no particular deadline but rumors are that the FDA will consider all comments submitted by the end of this week.

1. Click on the following link:

http://www.regulations.gov/#!searchResults;dct=O;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-P-0491

2. You will see on the left side of the page “Results,” “Corn Refiners Association – Citizens Petition,” and on the right side a link that says “Submit a Comment.”

3. Just hit the “Submit a Comment” link, and then you just enter your name and affiliation, etc., type in your comment.

There is no formal comment deadline, but as usual, the sooner a comment is submitted, the more likely FDA will consider it. The best information I have is that FDA will consider all comments submitted by the end of this week.

1. Click on the following link:

http://www.regulations.gov/#!searchResults;dct=O;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-P-0491

2.  You will see on the left side of the page “Results,”  “Corn Refiners Association – Citizens Petition,” and on the right side a link that says “Submit a Comment.”

3.  Just hit the “Submit a Comment” link, and then you just enter your name and affiliation, etc., type in your comment.

There is no formal comment deadline, but as usual, the sooner a comment is submitted, the more likely FDA will consider it.  The best information I have is that FDA will consider all comments submitted by the end of this week.

1. Click on the following link:

http://www.regulations.gov/#!searchResults;dct=O;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-P-0491

2. You will see on the left side of the page “Results,” “Corn Refiners Association – Citizens Petition,” and on the right side a link that says “Submit a Comment.”

3. Just hit the “Submit a Comment” link, and then you just enter your name and affiliation, etc., type in your comment.

There is no formal comment deadline, but as usual, the sooner a comment is submitted, the more likely FDA will consider it. The best information I have is that FDA will consider all comments submitted by the end of this week.

Feb 18 2011

Michael Taylor goes international

Michael Taylor, the FDA’s Deputy Commissioner for Foods, gave a talk in London yesterday at a meeting of the Global Food Safety Initiative (GSFI).

GSFI, for the policy wonks among you, is a project of the Paris-based Consumer Goods Forum (formerly CIES), which brings together CEO-level food industry executives to discuss topics of mutual interest—a World Economic Forum for food companies, as it were.

I’ve given several talks at these meetings over the years, presumably because the organizers like to stir up some controversy once in a while.

Mr. Taylor’s speech, which you can read here in its entirety, does not seem particularly controversial—unless you think that making business responsible for ensuring food safety is controversial:

For those of you who live and work in the European Union countries, imported food is a fact of daily life.

And many emerging economies recognize that food exports can help drive their economic growth.

It is for these reasons – high public expectations and expanding trade in food – that the effort to improve food safety and to build prevention in from farm to table is a global movement…and is good business.

It is a global movement that, very importantly, recognizes that the primary responsibility for prevention rests with business – with those who produce, process, import, and market food.

Consumers certainly have a role to play as food handlers and preparers.

And, of course, government plays a vital role in providing scientific leadership, setting standards for effective prevention of food safety problems, and ensuring through inspection and other means that those standards are understood and met.

But everything we do to improve food safety rests on the foundation of the food industry fulfilling its duty to do everything it reasonably can to make food safe.

FoodSafetyNews has more details on what the meeting was about.   Taylor’s speech is a sign that the FDA is on the job.

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