by Marion Nestle

Currently browsing posts about: GAO(Government Accountability Office)

Jan 18 2011

GAO takes on health claims. Yes!

Let’s hear it for the Government Accountability Office, the congressional watchdog agency that has still managed to remain independent of the more corrupt aspects of Washington food politics.  In its most recent investigation, the GAO took a tough look at the inability of the FDA to hold health claims on food packages to reasonable scientific standards.

The new GAO report, Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims, appeared on January 14.

The report reviews the history of health claims on food labels.  By law, these must be supported by “significant scientific agreement,” but court decisions in 2002 led the FDA to allow “qualified health claims.”  These claims have less—and, sometimes, no—scientific support.

Parke Wilde, who writes the U.S. Food Policy Blog, brilliantly parses the categories of health claims now allowed by the FDA:

  • Health claims — aka REAL health claims — which must have evidence that meets a standard called “significant scientific agreement”
  • Qualified health claims — aka WISHFUL health claims — which can meet a weaker standard of evidence, so long as the company admits the weaker evidence on the label.
  • Structure / function claims — aka STEALTHY health claims — which purport not to be health claims (for example, a high-fiber product that “keeps your bowels moving” without explicitly claiming to “treat constipation”; or a high-calcium product that “builds strong bones” without explicitly claiming to “prevent osteoporosis”)

The GAO reviews evidence that consumers can’t tell the difference between one kind of health claim and another (I could have told them that).

Food companies take advantage of this confusion and increasingly use the stealth structure/function claims, which the FDA pretty much ignores.

The FDA has to ignore them.  It doesn’t have much choice.  The FDA has no authority to require companies to submit evidence of scientific substantiation.  The FDA is permitted to ask for the information, but it has no legal authority to force companies to provide it.

GAO says this situation does not sufficiently protect the public from unscrupulous marketers.  It says the FDA should:

  • Ask Congress to grant it the authority to access companies’ evidence for the scientific support of potentially false or misleading structure/function claims on foods.
  • Provide guidance to industry on the evidence it needs to support such claims.
  • Provide direction to FDA inspectors to help identify claims for further review.

FDA: Do this, please, and right away.  Congress: Pay attention and act.

Imagine: health claims on food packages that actually have some science behind them.  What a concept!


Jul 8 2010

The news in food nanotechnology

Nanotechnology involves the ability to control matter at the scale of a nanometer—one billionth of a meter. The world market for products that contain nanomaterials is expected to reach $2.6 trillion by 2015.

So says a report from the Government Accountability Office (GAO): Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk. GAO-10-549, May 25, 2010.

GAO identified a variety of products that currently incorporate nanomaterials already available in commerce…[in] food and agriculture….The extent to which nanomaterials present a risk to human health and the environment depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials. Although the body of research related to nanomaterials is growing, the current understanding of the risks posed by these materials is limited.

The effects of nanotechnology on the environment are regulated by the EPA (Environmental Protection Agency), which is why this report targets recommendations to EPA.

Shouldn’t some of those recommendations be directed toward FDA, the agency that regulates food safety?  Maybe GAO needs to do another report?

In the meantime, the European Food Safety Authority is preoccupied with issues related to the safety of food nanotechnology.

The risk assessment framework for nanotechnology in Europe – like so much else connected to the technology – appears to be in its infancy but developing at a rapid pace…. Nano knowledge gaps have led some to call for a ban on the use of nanomaterials in food products until their safety has been fully established. One area of concern is whether nanoparticles can migrate from packaging materials into foods.

In seeking to assess nanomaterials, the food safety body repeatedly used phrases such as “specific uncertainties”, “limited knowledge” and…“difficult to characterise, detect and measure” in relation to toxicokinetics and toxicology in food. Likely usage and exposure levels are also largely a mystery.

The European Food Safety Authority says that lack of knowledge means that risk assessment of risk assessments must be done on a “cautious case-by-case approach.”

Last April, the European Parliament’s environment committee said nanotech products should be withdrawn from the market until more is known about their safety.  In June, that committee added that nanotech foods should be assessed for safety before they are approved for use and labeled.

Doesn’t that sound reasonable?  Let’s hope it’s not too late to put such constraints in place, and in the U.S. too.

Apr 10 2010

GAO on FDA and USDA: irradiation, food safety, and humane treatment of animals

It’s the weekend and I’m cleaning out my e-files.  The Government Accountability Office (GAO), the congressional watchdog agency, has just released a bunch of reports complaining about the way the FDA and USDA do business:

Food Irradiation: FDA Could Improve Its Documentation and Communication of Key Decisions on Food Irradiation Petitions (GAO-10-309R, February 16, 2010, 23 pages).

labels on food products subject to FDA jurisdiction do not have to be reviewed and preapproved by FDA before marketing. Rather, the processor is responsible for properly labeling its products. In fact, FDA officials told us that they do not collect information on how irradiated foods are labeled and marketed. In contrast, USDA reviews and preapproves all labels before use on meat and poultry products and has denied label submissions that do not meet its requirements…FDA does not require the product’s ingredient list to disclose that a particular ingredient has been irradiated, while USDA generally does.

Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (GAO-10-246, February 3, 2010, 69 pages).

FDA only reviews those GRAS determinations that companies submit to the agency’s voluntary notification program…the agency has not systematically reconsidered GRAS substances since the 1980s… FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008…FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA’s knowledge. In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.

Food safety note #1: This arrives in the middle of the latest set of FDA recalls, this time of nearly 100 products made with a flavor enhancer, hydrolyzed vegetable protein, contaminated with Salmonella.

Food safety note #2: the Produce Safety Project at Georgetown University has estimated the cost of foodborne illness:  $152 billion annually, of which $39 billion is due to leafy greens and other vegetables.

Food and Drug Administration: Opportunities Exist to Better Address Management Challenges. (GAO-10-279, February 19, 2010, 54 pages).

Through reviewing reports…GAO determined that FDA’s management challenges include recruiting, retaining, and developing its workforce; modernizing its information systems; coordinating internally and externally; communicating with the public; and keeping up with scientific advances…While FDA has taken steps to align its activities and resources to strategic goals, these efforts in its centers and offices are not clear, making it difficult to connect the agency’s use of resources to the achievement of its goals.

If you feel gossipy (or want to interpret the raw data for yourself), you can read what FDA staff actually told GAO interviewers.

Humane Methods of Slaughter Act: Actions Are Needed to Strengthen Enforcement (GAO-10-203, February 19, 2010, 60 pages). [The actual survey responses are here.  And a shorter version given as testimony is here.]

The guidance does not clearly indicate when certain enforcement actions should be taken for an egregious act–one that is cruel to animals or a condition that is ignored and leads to the harming of animals. A noted humane handling expert has stated that FSIS inspectors need clear directives to improve consistency of HMSA enforcement. According to GAO’s survey, FSIS’s training may be insufficient.

This, one can only assume, is an understatement.

The GAO does important work, no?  Now if only government agencies would listen to it.

Aug 13 2009

Increasing concentration in agriculture: a problem?

The Government Accountability Office (GAO), which does research in response to questions from members of Congress (in this case, Charles Grassley, Rep-Iowa),  has just released a report on agricultural concentration and food prices.  Concentration, for this purpose, has a specific meaning: the share of sales held by the four largest companies.

Grassley wanted to know: is increasing concentration in the food sector responsible for the recent rise in food prices.  The GAO says no, but check out its findings about what’s happening in the food industry.  Examples:

  • Less than 2% of farms accounted for 50% of farm sales in 2007 (See Table on page 10).
  • The top four concentration in grocery chains more than doubled from 1982 to 2005, from 16% to 36% (page 12).
  • The concentration in meat also has nearly doubled.  Beef concentration went from 41% to 79%, pork went from 36% to 63%, and poultry went from 27% to 57% (page 18).

Only two sectors have become less concentrated: Wet corn milling (translation: high fructose corn syrup) from 74% to 69%, and breakfast cereals (86% to 78%).  No wonder the Big Four Breakfast Cereals (General Mills, Kellogg, Post, Quaker) are so desperately pushing their wares these days.

And do take a look at the figure on page 19, which illustrates the steady decline since 1980 of the proportion of the food dollar that goes to the farmer (from 30% to less than 20%), and the steady increase in the proportion going to food marketing (from 70% to more than 80%).

The USDA must be really worried about all this.  Thanks to Maya for telling me that USDA has teamed up with the Justice Department to take a look at legal ramifications of increasing agricultural concentration.  Why?  America does best with “a fair and competitive marketplace that benefits agriculture, rural economies and American consumers,” says the USDA Secretary.

The Justice Department has its own interests in this matter: the anti-trust implications of food sector concentration.

I’m guessing that Senator Grassley wanted GAO to demonstrate that agricultural concentration does not affect prices and, therefore, is good for consumers.  Instead, the GAO report focuses attention on just how concentrated agriculture had become.  Let’s keep a close eye on this one.

Mar 7 2009

Dietary supplements: GAO says FDA needs to do better

The Government Accountability Office, the agency that keeps a close eye on government integrity, says the FDA ought to be doing a much better job of regulating dietary supplements.  It grants that the FDA has taken “some” or “limited” action to go after potentially unsafe products,  of which, apparently, there are plenty.  The agency, it says, cannot do its job because it lacks resources and recall authority and gives supplements too low a priority.

This is old news, but the report provides an excellent summary of the history and current status of the dietary supplement industry and its regulation.  As is typical of GAO reports, the clarity of presentation is exceptional.  Here’s  what the New York Times reporter says about it.

Jan 10 2009

GAO says oversight of GM crops could be better

The Government Accountability Office has just produced a report looking at the way the federal agencies regulate (or don’t regulate) genetically modified crops.  At issue is the escape of unauthorized modified genes into supposedly non-GM crops, animals, or the environment.  The report notes six such incidents.  These, it says, caused not harm to human or animal health but did result in “lost trade opportunities.”  The report documents long-standing gaps in coordination and direction among the three regulatory agencies involved: FDA, USDA, and EPA. If I count right, it’s been nearly 15 years since the FDA approved the first genetically modified food (bovine growth hormone, quickly followed by tomatoes) and the government still can’t figure out what to do about them.

It’s interesting that this report comes just as Monsanto is asking the FDA to approve the company’s new supposedly drought-tolerant.  If this corn really does what it is claimed to, it could fulfill what biotechnology companies have long promised.  We will have to wait and see on this one.

Dec 6 2008

GAO says GM foods need better regulation

In a new report, the watchdog Government Accountability Office reviews six incidents in which genetically modified foods got into places they weren’t supposed to be.  GAO concludes that when it comes to GM foods, the USDA, FDA, and EPA need to do a better job of communicating, coordinating, and acting more transparently.  Will this report do any good?  Let’s hope.

Nov 11 2008

GAO says Obama should fix food safety

The Government Accountability Office says fixing the food safety system should be a high priority for the new administration.  Specifically, it asks the new President to:

  • Reconvene the President’s Council on Food Safety right away, and develop longer term structures to promote interagency coordination on food safety.
  • Develop a “governmentwide performance plan” for agencies to ensure that goals are complementary and resource allocations are balanced.
  • Encourage Congress to assign the National Academy of Sciences to analyze alternative food safety organizational structures.
  • Encourage Congress to pass “comprehensive, uniform, and risk-based food safety legislation.”
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