New study on FDA website casts doubt on qualified health claims

The Food and Drug Administration (FDA) recently posted to its web site a new study (.pdf) showing that FDA's own policy for permitting "qualified health claims" confuses consumers and fails to work as intended.

Qualified health claims are statements on the food label that are accompanied by an honest explanation of the limited scientific support for the statement. For example, the front of the label might say, "Pomegranate juice reduces your risk of heart disease*," with an asterisk. The disclaimer might say, "*This claim about pomegranate juice has not been scientifically proven, and is based on limited evidence from rats."

You may think it strange that such contradictory statements could end up on the food label, but the mixed messages reflect a genuine food policy conundrum. Until recently, FDA permitted only health claims that have "significant scientific agreement," such as the link between calcium and stronger bones. Food companies sued, however, claiming that this policy violated their freedom of speech and prevented them from sharing important health information whose scientific certainty fell slightly short of this legal standard. Court decisions forced FDA to begin permitting health claims based on somewhat weaker evidence.

The FDA website summarizes the various qualified health claims. I'd be interested to hear your comments about the health claims that do or do not appear on the FDA site. For example, although USDA strongly supports many millions of dollars in advertising of dairy weight loss claims, which are not endorsed in the Dietary Guidelines for Americans, I couldn't find such claims as having even qualified support on the FDA site.

The new FDA research study by Brenda M. Derby and Alan S. Levy, which does not reflect an official agency position, found that written qualifications expressing scientific uncertainty failed to significantly reduce consumer confidence in questionable health claims. By contrast, a "report card" style graphic may successfully communicate some distinctions in levels of scientific certainty. Unfortunately, however, a report card with a "B" or "C" rating seemed to increase consumer confidence in the health claim by comparison with no report card at all -- even though having no report card means the claim meets FDA's stronger standard of significant scientific agreement. The authors speculated that the qualified health claims report cards might work better if the graphic appeared on all products with health claims, even those that rate an "A."

The Center for Science in the Public Interest reported yesterday that FDA previously refused to make the new study public -- even to members of Congress! -- and finally posted the study to the agency website only after a Freedom of Information Act request from the consumer group. According to CSPI legal director Bruce Silverglade, "The FDA’s current policy allows companies to dupe consumers into thinking that this food or that food is the key to reducing the risk of cancer and heart disease.... The courts have made it clear that the First Amendment is not a license to practice quackery, but that is exactly what the Bush FDA policy sanctions."

The new report generally agrees with (but doesn't cite) the recent dissertation (large .pdf) by Ratapol Teratanavat, a clever student of Professor Neal Hooker at the Ohio State University. Teratanavat also finds that a report card graphic (see picture) strongly communicates differing levels of scientific certainty, while text qualifications seem to confuse the reader.



The research shows that qualified health claims work only if they include a graphic, like the "report card," which makes crystal clear to consumers that the health claim is unproven. In practice, report cards would probably never appear on real products with a "C" or "D" rating. The manufacturer would just decline to make the health claim. That seems to me a good outcome from the public interest and public health perspectives. The government is in a questionable position if it denies manufacturers their rights to speech, but it is in a strong position if it claims a bit of space on the food label to tell consumers when the manufacturer is lying.

Update 10/4/2005: Here's an interesting additional comment in July 2004 from a senior executive at the Ketchum public relations firm. It concludes,

Thus, the FDA’s support of qualified health claims will lead only to less informative, less instructional and less educational claims with less competitive value to marketers. Qualified health claims likely will add noise instead of clarity to the message stream, undermine the credibility and authority of regulatory statements and, potentially, even encourage retailers to place higher premiums on shelf space for products perceived to have more appealing claims. Here’s the bottom line: It is not “more information” but “more reliable sources of information” that impact consumer acceptance. The FDA should weigh these marketing issues carefully as it moves forward to establish a more definitive policy for allowing qualified health claims.

The 23rd post meme: "What is the government speech?"

Jennifer at Cookin' in the 'Cuse is a food weblogger and an Episcopal Priest. For several months, I have been following her eating adventures and her commentary on food politics, including such important issues as the recent controversies over redefining organic food. Jennifer invited me to play this game.

Jen of Life Begins at Thirty, who tagged Jennifer and was herself tagged by Jeanne of World on a Plate (all fascinating weblogs and residents of the sidebar), explained the game's rules in an earlier post.

Meme Instructions

1. Delve into your blog archive.

2. Find your 23rd post (or closest to).

3. Find the fifth sentence (or closest to).

4. Post the text of the sentence in your blog along with these instructions. Ponder it for meaning, subtext or hidden agendas...

5. Tag five people to do the same.

The fifth sentence in my 23rd post is a quote from Justice Ruth Bader Ginsburg last January:

"What is the government speech?"

This sentence is spot-on perfect as a representative question for U.S. Food Policy. I had to double-check my counting twice, because it seemed to good too be true. You can confirm my counting using the archives. "Government speech" is a technical legal term (see here and here [.pfd] for more on the Supreme Court case from whence it comes). But in the spirit of this meme, we can read the question more broadly. What does the government in our fine democracy have to say on the issues of the day in food policy? Does it say "eat in moderation" or "eat as much as you can"? For whom does the government speak?

Here's my invitation to five weblogs, only a small fraction of the fine ones I might have mentioned. Come play a game.

1. Bitter Greens Journal

2. Accidental Hedonist

3. Tigers and Strawberries

4. Fork and Bottle

5. Calorie Lab

Child nutrition programs around the world

Britain will ban junk food from school meals and in-school vending machines beginning next September, the BBC reported yesterday.

In related coverage, the BBC last spring had reporters around the world describe local school meals programs. From France:

In a country where food is virtually the national religion, school meals are naturally a subject of intense interest, not least as the nation worries about the rising obesity rate among its children, especially the under-15s.

Many schools already employ their own nutritionist, who works with a parents' committee to ensure lunches provide a healthy, balanced diet.

Much more is spent per meal than in Britain, with a French school lunch costing anything from £1.50 to £4 a head, depending on region. Poorer parents pay only a portion of the total.

And there's no pandering to children's love of pizzas, burgers or chips; these are adult menus served in child-size portions, as the French believe good eating habits start early.

From the United States:

Walk into almost any school cafeteria in the United States and the students will be grousing about the "mystery meat" and the pile of green stuff on their plates that once in a former life was spinach.

Students don't like the food, which means as soon as they can drive, they head off campus to the nearest fast food franchise.

And critics say that school lunches contribute to the fattening of the United States.

The humble school lunch has had more than its fair share of controversy in the US. Attempts to limit the amount of fat by limiting the servings of French fries have only been met by student rebellion.

Post Hurricane Katrina statement on budget and nutrition programs

The Food Research and Action Center, a leading national advocacy group for low-income Americans, has organized a lobbying coalition on the premise that the month after Katrina would be the wrong time to cut food stamps. Here is the coalition's statement distributed recently to legislators in the national capital.

TO: Senators, Members of the House of Representatives

The attached letter strongly opposing Food Stamp Program cuts in the reconciliation process and strongly opposing structural changes that would weaken the program was signed by more than 1,000 organizations and sent to Congressional leaders before Hurricane Katrina hit the Gulf Coast. The success of the food stamp program and USDA’s fast and effective response since Hurricane Katrina in reaching people from the four affected states has shown once again that the food stamp program is fundamentally sound.

Yesterday and today representatives of more than 30 state-based anti-hunger organizations at a meeting in Washington D.C. discussed how Katrina has affected the food stamp and other anti-hunger programs and the needs of poor Americans. Based on that discussion we are writing you to:

1. restate, but with renewed vigor and urgency, our opposition to cuts and structural changes in the Food Stamp Program;
   
2. restate our deep opposition to proposed tax cuts and tax cut extensions that will disproportionately benefit wealthy Americans at a time of great need in our country;
   
3. urge you in passing legislation in the weeks ahead to help Katrina’s victims to buttress the already effective ability of the food stamp, WIC, and child nutrition programs to respond; and
   
4. move quickly, effectively, and fundamentally in the months and years ahead to address the problems of poverty, hunger, deprivation and inequality that Hurricane Katrina exposed.

The more than 20 million food stamp recipients just in our states – and the millions more in other states, and millions of poor, hungry, food insecure, unemployed, disabled, and others in this country who need but can not access food stamps – urge you to commit to take these four steps. We are confident that after Hurricane Katrina Congress can build on proven successful programs, Congress can reject proposals to reduce such programs and weaken the government’s fiscal position through tax cuts, and Congress can respond to the basic human needs Katrina has revealed.

Sincerely,

Atlanta Community Food Bank, Association for Arizona Food Banks, California Association of Food Banks, California Food Policy AdvocatesCenter for Civil Justice, Center for Public Policy Priorities, Children’s AllianceChildren’s Hunger Alliance, Colorado Anti-Hunger Network, Connecticut Association for Human Services, DC Hunger Solutions, End Hunger Connecticut!, Federation of Virginia Food Banks, Food Bank of Central & Eastern North Carolina, Food Bank of Central New York, Food Bank of Iowa, Food Research and Action Center, FoodChange, Greater Minneapolis Area Council of Churches, Greater Pittsburgh Community Food Bank, Health & Welfare Council of Long Island, Hunger Solutions Minnesota, Illinois Hunger Coalition, Kentucky Task Force on Hunger, MANNA Tennessee, Milwaukee Hunger Task Force, Nebraska Appleseed, Center for Law in the Public Interest, New Jersey Statewide Emergency Food Network, Nutrition Consortium of NYSNYC, Coalition Against Hunger, Oregon Food Bank, Oregon Hunger Relief Task Force, Partners in Ending Hunger, Pennsylvania Hunger Action Center, Project Bread/The Walk for Hunger, Public Policy Center of Mississippi, Second Harvest Food Bank of Middle Tennessee, Southern New Hampshire Services, Inc., Texas Association of Community Action Agencies, Vermont Campaign to End Childhood Hunger

FDA chief Lester Crawford resigns suddenly

FDA Commissioner Lester Crawford resigned Friday. According to the Associated Press (AP):

Crawford's surprise resignation, submitted Friday and effective immediately, gave no specific reason for his departure. "It is time at the age of 67, to step aside," he wrote in his resignation letter.

Crawford's tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics than in its mission to protect consumers.....

Crawford's time at the agency included more than a year as acting commissioner during a lengthy confirmation process. He won the Senate's backing in July only after telling senators the agency would make a final decision on legalizing Plan B for over-the-counter sales by Sept. 1.

Then in August word came of another delay, prompting intense criticism from proponents of Plan B and leading to the resignation of the FDA's top woman's health official.

Only days before his resignation, speaking at the Consumer Federation of America's annual food policy conference in Washington, Crawford gave little hint of an impending departure. A veterinarian by training, Crawford led USDA's Food Safety and Inspection Service in the early 1990s. The newsletter I edited then, the Community Nutrition Institute's Nutrition Week, frequently criticized FSIS' food safety regulatory decisions during Crawford's tenure there.

Environmental regulation of agriculture

Juliet Eilperin writes in the Washington Post today about the public policy of environmental regulation for agriculture:

Agriculture does not occupy a prominent place in America's environmental policy debates, but farming has arguably more of an impact on the land, air and water than any other sector in the U.S. economy, environmental and industry experts say. In addition to producing airborne emissions, farms take up nearly half of the nation's land, and nutrient-laden runoff from farms affects such waterways as local streams and the Gulf of Mexico.

The most interesting parts of the article explain how Bush administration officials ordered the Environmental Protection Agency "to stop investigating farm emissions in 2001":

But the EPA's amnesty for major livestock producers may amount to a temporary reprieve as even farmers' most loyal political allies are sensing a shift in public sentiment. Calvin M. Dooley, a former central California farmer who served in the House for 14 years, said local attitudes hardened during his time in office, which ended this year.

"There's a different political environment in the Central Valley today," said Dooley, a Democrat who now heads the Food Products Association. "More and more people have become increasingly concerned about the health and environmental consequences of our air quality."

National Association of Farmers' Market Nutrition Programs (NAFMNP) conference

The National Association of Farmers' Market Nutrition Programs (NAFMNP) will hold its annual conference October 26-29 in Plymouth, MA. Speakers include USDA's Under Secretary Eric Bost, and Wil Bullock, Jr. , with the Food Project, a 24-year-old food advocate from Boston. This association has roots in the work of the School of Nutrition at Tufts in the 1980s (before the Friedman School was named) and the Massachusetts state government.