Posts dated: August2012

I’ve written previously about the holdup on implementation of the FDA Food Safety Modernization Act by the White House Office of Management and Budget, reportedly because anything regulatory is likely to be a campaign issue in this especially contentious election year.

To get things moving, The Center for Food Safety and the Center for Environmental Health have sued the FDA to implement the rules on the grounds that the law requires federal agencies to conclude matters presented to them “within a reasonable amount of time.”

The suit complains that the FDA is failing to meet required deadlines for at least seven new food regulations and that nine more are coming due in 2013.  It asks the court to order the agency to enforce the law right now.

In several instances, the FDA has attempted to make FSMA’s deadlines only to have its work held up at the White House Office of Management and Budget. FDA reported sending its proposed Foreign Supplier Verification Program to the OMB in November and its proposed produce safety standards in December, though the OMB has yet to release either regulation. Both were required by FSMA on Jan. 4.

FSMA also required FDA to establish standards for analyzing and documenting hazards and implementing preventative measures by July 4 of this year, the suit recounts.

The plaintiffs are especially alarmed that the FDA is not enforcing policies that are “self-executing,” meaning the new preventive standards for example.

From where I sit, the preventive standards are the critical factor in stopping outbreaks of foodborne illness before they happen.

While we are waiting for politics to resolve, the CDC keeps adding new outbreak home pages.

• Multistate Outbreak of Salmonella Braenderup Infections Associated with Mangoes is the latest.
• Multistate Outbreak of Salmonella Typhimurium Infections Linked to Cantaloupe isn’t over yet.

Would implementation of preventive standards help?  Yes it would, especially if the problem is in the packing houses (packing houses can be cleaned).

The New York Times front page today has a report of a long-term study at NIH of severe calorie restriction in Rhesus monkeys.  It found that calorie restriction did not extend the monkeys’ lifespan.

I’m not at all surprised.  My co-author and I reviewed the literature on calorie restriction for a chapter in our book, Why Calories Count.

The new study makes news because it contradicts a study done in Wisconsin showing that severe calorie restriction extends life.  Severe means 25% to 30% fewer calories per day that are needed to maintain normal body weight.  I’d call this a starvation diet.

An editorial accompanying the report of the study in Nature attributes the difference between the results of this NIH trial and the Wisconsin study to a difference in dietary composition, suggesting that calories differ in their effects.

Not necessarily.  The Wisconsin study allowed the control monkeys to eat a lot of junk food and they were fatter than normal.  The NIH study restricted calorie intake in its control monkeys so they maintained normal weight and were healthier.  This is the simplest explanation of the difference.

Studies in rats, mice, and many other animals show that calorie restriction extends life.

But what about primates?

Starvation can hardly be good for health.  It causes weight loss, of course, but also a host of physiological and psychological problems.  These were extensively documented in humans during World War II in Ancel Keys’ Starvation studies.

The relationship between BMI and human longevity has been examined in several recent studies, all of which show similar results: Longevity is best associated with BMIs in the range considered normal or slightly overweight.  Above that range—but also below it—mortality increases.  

Being underweight is associated with higher mortality.

A Canadian study provides this example:

And one from the National Cancer Institute provides another:

The bottom line?  Eat a healthy diet and balance calories to maintain a healthy weight within that range.

California’s ballot initiative to label GMO’s has caused quite a stir.

Food biotechnology companies are spending millions to defeat the initiative.

The Yes on 37 California Right to Know people don’t have nearly as much money, but they are doing what they can.  They have a new video ad, well worth a look: “Agent Orange is harmless.”

And another: “Vote Yes for Labeling GMOs.”

But the “don’t miss” has to be this fast-paced rap taking a broad look at the issues: “OMG GMOs!” 

The polls say voters approve GMO labeling by a very wide margin: 65% to 24%.

Will they vote this way in November?  Or will outspending by opponents prevail?

Stay tuned. 

A blog post from Fernando Quintero on the Berkeley Media Studies Group’s site alerted me to PepsiCo’s latest example of corporate social responsibility: an additional $50,000 donation for scholarships and internships to the National Association of Hispanic Journalists bringing the total to $100,000.

Hispanic populations in the United States have higher than average rates of obesity, type 2 diabetes, and other chronic conditions associated with overconsumption of sodas and snacks.

Such generosity raises questions about what Pepsi is buying from this group.

The NAHJ says:

We are thrilled to have PepsiCo as a new partner committed to building a stronger Latino community,” said Ivan Roman, Executive Director for NAHJ. “The company’s support as we get more Hispanics into journalism to tell our stories is key to making sure our communities are represented fairly in the news media, while giving them a louder voice in the civic dialogue.

Why do I think that journalists in this Association are unlikely to be telling stories like these:

• The relationship of soda and snack consumption to obesity and type 2 diabetes in Hispanic communities
• The relationship of soda and snack consumption to Hispanic childhood obesity
• How soda intake among Hispanic children leads to dental decay
• Soda company marketing practices in Hispanic communities
• The effects of soda and snack marketing on dietary practices and health in countries in Latin America

Pepsi says:

As part of La Promesa de PepsiCo, the company is building relationships with the community, strengthening its strategic partnerships, and sponsoring national Hispanic organizations like: CHCI (Congressional Hispanic Caucus Institute), HACR (Hispanic Association on Corporate Responsibility), LULAC (League of United Latin American Citizens), NAHJ (National Association of Hispanic Journalists), and NCLR (National Council of La Raza) among others.

A page from the tobacco-industry playbook, no?

The costs of obesity are personal, but also societal.

Economists love trying to figure out how to quantify such things.

The most widely used estimate for the United States is from Cawley and Meyerhoefer’s 2012 article in the Journal of Health Economics: $190 billion annually for health care and lost productivity (their 2010 working paper may be easier to access at the National Bureau of Economic Research site).

Now the Campaign to End Obesity has published its own analysis of these costs.

• $44.7 billion, for inpatient services.
• $45.2 billion, for non-inpatient services.
• $69.3 billion, for pharmaceutical services.
• $146.6 billion, across all services.

As the Campaign puts it:

the total economic cost of overweight and obesity in the United States and Canada caused by medical costs, excess mortality and disability is approximately $300 billion per year. The portion of this total due to overweight is approximately $80 billion, and approximately $220 billion is due to obesity. The portion of the total in the United States is approximately 90 percent of the total for the United States and Canada.

I don’t know what to make of such estimates.  They are always based on assumptions that may or may not be valid. 

One thing is clear: obesity is expensive, personally, economically, and politically.

That’s why it’s a good idea to support public health initiatives to make it easier for people to maintain a healthy weight.

Providing healthier food in schools, getting junk food out of schools, soda taxes, soda caps, and restrictions on marketing to kids are the kinds of ideas that are worth supporting.  

Now. 

Kelly Brownell and Mark Gold.  Food and Addiction: A Comprehensive Handbook.  Oxford, 2012

I blurbed this one:

Brownell and Gold have produced an instant classic.  Food and Addiction presents a comprehensive, authoritative, and compelling case for considering whether food is addictive.  Its chapters raise serious questions about our current laissez-faire attitude toward food marketing, especially to children.  This book is a must read for everyone who cares about the causes and consequences of obesity and the need for food policies that better promote health.  It is a game changer.  Readers will never look at food the same way again.

The book is a collection of edited pieces by a variety of authors with distinctly different approaches and viewpoints, ranging from the seriously scientific (“is food addiction real?” to to the thoroughly anecdotal (“I am a food addict”).  The editors deserve much praise for casting so wide a net and for their cautious interpretation of the available science.  Is food addictive in ways similar to alcohol or cocaine?  In some ways yes, maybe, and no.  Read it and decide for yourself.

Martha Rosenberg.  Born with a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health.  Prometheus, 2012.

This book is better than it’s flashy, misleading title would suggest.  It doesn’t seem to be at all about McDonald’s or soft drinks.  Instead, the first half is about Big Pharma and the marketing of drugs that don’t do much good but cause plenty of harm.  The second half is devoted to the same kind of analysis of Big Food, but mostly focuses on animal agriculture: bovine growth hormone, antibiotic resistance, salmon farming, mad cow, and the safety of animal foods.  I liked the cartoon illustrations by the author.

I can hardly believe it but is the FDA really proposing to test consumer understanding of food industry evasions of the “Jelly Bean Rule?”

The FDA established this “rule” (a principle, actually) in 1994 to prevent food companies from adding vitamins to junk foods in order to allow them to be marketed as healthy.

The FDA said that just because a food is low in fat, cholesterol, and sodium—like a jelly bean—the manufacturer cannot make a health claim for it unless it contains at least 10% of the Daily Value of vitamin A, vitamin C, calcium, protein, fiber, or iron.

But, the FDA also said, companies could not fortify foods with these nutrients for the sole purpose of making health claims.

This is explained in the FDA’s policy on food fortification, given in 21 CFR 104.20(a).

The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply.

However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply.

It could also result in deceptive or misleading claims for certain foods.

The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.

Now the FDA announces that it wants to study consumer responses to health claims on fortified snack products:

The FDA has an interest in the American public achieving and maintaining diets with optimal levels of nutritional quality, wherein healthy diets are composed of foods from a variety of nutrient sources.

The FDA does not encourage the addition of nutrients to certain food products (including sugars or snack foods such as [cookies] candies, and carbonated beverages).

FDA is interested in studying whether fortification of these foods could cause consumers to believe that substituting fortified snack foods for more nutritious foods would ensure a nutritionally sound diet.

The makers of fortified junk foods and drinks must be trembling in their boots.  Health claims sell food products.  Health claims are practically the only things that sell food products these days.

And companies will have plenty of time to lobby.

Like all FDA processes, this one is required to move at glacial speed.  It must give 60 days to allow people to comment on the proposal and get their lobbying acts together.

Then, the FDA will have to review the comments and, presumably, include them when it submits its request to do the study to the White House Office of Management and Budget.

No point in holding breath for this one.  The OMB has been sitting on FDA proposals for months.

My prediction: if the FDA ever gets to do the study, it will show that consumers interpret health claims as government guarantees that the products are healthy and, probably, have fewer calories than they actually do.

The makers of such products would prefer that the FDA not have this information confirmed.  Watch the lobbying begin!

If you want to comment, do so by October 15.  Here’s how:

• File electronic comments here for Docket No. FDA–2012–N–0871.
• Submit written comments to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Use Docket No. FDA–2012–N–0871.

I consider the results of studies showing remarkable health benefits attributed to single foods or single nutrients to be “nutrifluff”—fun, but not necessarily meaningful unless you are eating a healthy diet anyway.

Here are four recent examples:

Dark chocolate reduces heart disease risk: Everybody loves this one—an excuse to eat chocolate (but only the dark, bitter kind, alas).  This comes from a Cochrane meta-analysis of studies on the role of flavonols in blood pressure.  It concludes that chocolate eating is associated with a small reduction in blood pressure of 2 to 3 mm Hg—but only in short-term trials.  How many of the studies were sponsored by chocolate companies?  The report doesn’t say.

Apple peel extracts reduce blood pressure: Apples also have flavonols.  These were test-tube studies.  Note: Eating fruits and vegetables in general is associated with lower blood pressure.

Walnuts boost semen quality: Here’s a fun one.  Eat 75 grams of walnuts a day, and you improve your sperm vitality, motility, and morphology, at least if you are age 21 to 35 (and male).  This one was sponsored by the California Walnut Commission.  One report on this study has the best title ever: “Nuts for your nuts.”

Goji berries promote immune function in the elderly: This one, done by researchers working for Nestlé  (no relation), tested daily supplements of “lacto-wolfberry” on immune responses to influenza vaccine.  I’m assuming Nestlé must be planning to market this supplement.

What does all this tell us?  These kinds of studies confirm that eating fruits and vegetables is good for health (I think we might have known that already).

But the main (perhaps only) reason for doing such studies is for marketing purposes, which is why food companies sponsor them.