If the FDA is now going after health claims (see yesterday’s post), will it also start going after dietary supplements? These, as I explained in my most recent column in the San Francisco Chronicle, get to make all kinds of unsubstantiated claims without the FDA being able to do much about them. More and more evidence is coming in suggesting that supplements can be harmful as well as ineffective. The latest example: antioxidant supplements are said to interfere with the beneficial effects of physical activity. Will such studies encourage the FDA to insist that manufacturers demonstrate safety and efficacy before they put supplements on the market? That would be a refreshing change, no?
It looks like the FDA is finally getting around to looking at the absurd health claims on boxes of breakfast cereals. And about time too, I’d say. For starters, the FDA picked on General Mills’ Cheerios. Cheerios boxes display banners claiming that if you eat this cereal, you will reduce your cholesterol by 4% is 6 weeks (see previous post on this). This, General Mills says, is “clinically proven.” Yes, but the trial on which General Mills bases this claim substitutes one serving of Cheerios for each of two meals a day. Hey – that ought to work!
In its warning letter, the FDA says that if Cheerios lowers cholesterol, it is claiming to work like a statin drug. If Cheerios acts like a drug, it has to be treated like a drug. Cheerios, says the FDA, “is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore…it may not be legally marketed with the above claims in the United States without an approved new drug application.”
So what’s going on here? I collect cereal boxes and I’m guessing that I bought the one shown here at least two years ago. The boxes have changed since then but similar claims appear on the Cheerios website. Maybe in this new administration the FDA can get a grip on silly and misleading health claims. Let’s hope.
Update May 18: Advertising Age advises marketers about how to avoid FDA interference: know the rules, don’t assume that breaking them is OK even if you have done so for a long time, follow the rules. Seems like good advice.
Update May 25: Europeans applaud this FDA action. They think we have gone much too far with health claims.
Update January 18, 2010: At a visit to the FDA last week, I saw a more recent Cheerios box that I somehow missed – lower your cholesterol by 10% in one month. This one disappeared quickly, but I found a good description of what happened on the Consumer World Mouse Print site. General Mills sponsored a study and rushed the box into print.
I’m still in awe of Melissa Clark’s “mature and restrained” recipe for Almond Birthday Cake with Sherry-Lemon Butter Cream. She says the recipe yields 8 servings. But she surely must mean 24.
I used the USDA’s handy food composition data base to add up the calories: 1,060 per slice!
Over the weekend, I received a letter from the American Society of Nutrition (ASN) nominating me to join the Board of Directors of the Smart Choices program. Smart Choices, you may recall from my previous posts on this program as well as on other such systems, is a food industry-initiated plan to put a check mark – a stamp of approval – on processed food products that meet certain nutritional criteria. Apparently, the ASN Board agreed to administer (and, implicitly, endorse) this program without discussing the matter with the membership. I think involvement of independent nutrition researchers with Smart Choices represents a conflict of interest and the ASN should not be involved in this effort. Here is what I told Katrina Dunn, the ASN Program Coordinator:
Thank you for inviting me to join the Board of Directors of the Smart Choices program. I regret that I cannot accept. Participating in Smart Choices represents a serious conflict of interest for nutrition educators who wish to maintain independence from the influence of the food industry on nutrition advice.
But participation also represents a serious conflict of interest for the American Society of Nutrition (ASN). I am dismayed that the ASN—an organization devoted to the highest standards of nutrition research–is involved in this project. I think the ASN should reconsider this involvement and withdraw immediately.
The ostensible purpose of Smart Choices is to guide the public to select more healthful foods. I am unaware of a research basis indicating that the program is likely to succeed in this goal.
Evidence does, however, support two additional goals of the program. The first is to provide a basis for marketing highly processed food products. I think we would all agree that highly processed foods are, in general, demonstrably nutritionally inferior to whole or minimally processed foods.
The second is to stave off federal regulations requiring a traffic-light food rating system such as that in use in the United Kingdom. Preliminary research indicates that consumers prefer this system to numerical scores and understand the colors to mean that they should choose green-lighted foods and avoid red-lighted foods.
The cut points selected for the Smart Choices program may meet criteria of the Dietary Guidelines, but their health benefits are debatable (the sodium cut point is particularly generous). Surely, a great deal more research is needed before ASN directly or indirectly endorses specific processed foods simply because they meet arbitrary nutrient cut points.
These concerns all address questions of intellectual conflict of interest. But I am also concerned about financial conflicts of interest. If ASN receives payment for its endorsement and administration of this program, the organization—and its members—risk losing intellectual independence.
I appreciate the invitation but I believe the entire program is ill advised and I urge ASN to extricate as quickly as possible.
Paulette Goddard Professor of Nutrition, Food Studies, and Public Health
New York University
According to the latest charts in the New York Times, countries in which people eat more quickly have faster growing economies than countries in which people linger over meals. The Gross National Product in such countries also suffered less severe declines last year. On the other hand, they exhibit higher rates of obesity. Coincidence? Maybe, but here’s another example of why food is such a powerful tool for examining major societal questions.
According to the Associated Press, Margaret Hamburg “breezed through” her Senate confirmation hearing yesterday. Great news, and I was pleased to hear that she thinks food safety is a top priority. So what’s the hold up? Everybody – even Senator Ted Kennedy – knows food safety is in crisis and needs strong leadership to get the system under control. Why can’t Congress approve her appointment right away and send her off to work? Don’t you think something is seriously wrong with a political system that holds food safety hostage to partisan politics? Let Congress know you want action in this area! Tell them to approve this appointment now!
This week, Eating Liberally’s kat wants to know what I think about Oprah’s free pass to KFC for adding grilled chicken to its fast food menu. Here’s what I told her. The moral: watch out for health auras!
The New York Times has an informative series of maps of the locations of the more than 10,000 organic farms in the U.S. And notice the increase in sales!
That number of organic farms may seem like a lot but it pales in comparison to the total 2.2 million farms. Most farms are East of the Mississippi and in the far West. The maps also show where most of the orchards, vegetable farms, and dairies tend to be. A big chunk of the country must have a hard time getting locally grown fruit and vegetables, let alone organics. Doesn’t this look like a growth opportunity?