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Tuesday, May 31, 2011

Food Politics: The Food Pyramid to RIP

FOOD
Politics

MyPyramid R.I.P.


On May 26, the USDA announced that it will be releasing a new “food icon” to replace the foodless and useless 2005 MyPyramid:

The USDA’s press announcement explained:

The 2010 White House Child Obesity Task Force called for simple, actionable advice to equip consumers with information to help them make healthy food choices. As a result, USDA will be introducing the new food icon to replace the MyPyramid image as the government’s primary food group symbol. It will be an easy-to-understand visual cue to help consumers adopt healthy eating habits consistent with the 2010 Dietary Guidelines for Americans.

What will the new icon look like? The USDA isn’t saying, but William Neuman of the New York Times did some sleuthing. According to his account:

The circular plate, which will be unveiled Thursday, is meant to give consumers a fast, easily grasped reminder of the basics of a healthy diet. It consists of four colored sections, for fruits, vegetables, grains and protein, according to several people who have been briefed on the change. Beside the plate is a smaller circle for dairy, suggesting a glass of low-fat milk or perhaps a yogurt cup.

And WebMD scored an interview with Robert C. Post, PhD, deputy director of the USDA Center for Nutrition Policy and Promotion, who gave additional hints:

“There will be a ‘how-to’ that will resonate with individuals. That is the behavioral part that is needed. We need to transcend information — ‘here’s what the science says’ — and give people the tools and the opportunities to take action.”

He referred to six how-to messages to guide healthy eating that were released with the 2010 Dietary Guidelines, and which I enthusiastically posted when the Guidelines were released (I was disappointed that they weren’t actually part of the Guidelines):

Balancing Calories

• Enjoy your food, but eat less.

• Avoid oversized portions.

Foods to Increase

• Make half your plate fruits and vegetables.

• Switch to fat-free or low-fat (1%) milk.

Foods to Reduce

• Compare sodium in foods like soup, bread, and frozen meals—and choose the foods with lower numbers.

• Drink water instead of sugary drinks.

A bit of history:

From 1958 until 1979, the USDA’s food guide was sort of a rectangle illustrating four food groups: Dairy, meat, fruits and vegetables, breads and cereals. In 1979, USDA introduced a highly controversial design with food groups stacked on top of each other, with the plant-food groups at the top and the animal-food groups underneath (the producers of these foods did not like that).

Beginning in 1980, the USDA conducted an extensive research project to develop a new design—the pyramid—which it released in 1991 and withdrew immediately under pressure from meat producers.

In 1992, after a year of extraordinary controversy (recounted in my book Food Politics), the USDA released its highly controversial Food Guide Pyramid.

Why was it controversial? The food industry objected that the Pyramid make it look as if you were supposed to eat more foods from the bottom of the pyramid than the top (which, of course, was its point).

Nutritionists objected that it encouraged eating too many servings of grains and, therefore, encouraged obesity.

In 2005, the USDA replaced it with the unobjectionable MyPyramid. The food industry liked this one because it did not indicate hierarchies in food choices. Most nutritionists that I know hardly knew what to do with it. It required going online and playing with a website, and was unteachable in clinic settings.

I thought the 1992 pyramid had a lot going for it, particularly the idea that it’s better to eat some foods than others. But MyPyramid was a travesty–hopelessly complicated, impossible to teach, and requiring the use of a computer.

Given this situation, the new image is highly likely to be an improvement. If the new icon keeps the hierarchy, conveys concepts easily, and does not require online access, I will consider it a great step forward.

Fingers crossed.

Details about the release:

The announcement will be Thursday, June 2, 10:30 a.m. EDT. It will be live-streamed at www.usda.gov/live. All information will be posted at www.cnpp.usda.gov.

If you want to attend in person, it’s at USDA’s Jefferson Auditorium, USDA South Building (5th Wing Entrance), 1400 Independence Ave., S.W., Washington, D.C.

I’ll be there. Stay tuned.

FDA Accuses Supplement Manufacturers of…Selling Drugs?



FDA Accuses Supplement Manufacturers of…Selling Drugs?


May 17, 2011

supplement-label-150x150

Misleading claims vs. legitimate science—getting to the truth can be a minefield! Which is why the Free Speech about Science Act is so important.

The US Food and Drug Administration recently sent warning letters to manufacturers of a number of products—MedaVir, Herpaflor, Viruxo Anti-Viral Support, C-Cure, and Never an Outbreak—for making health claims about treating or preventing sexually transmitted diseases, including herpes.

According to the FDA press release, “While some of the companies market these products as dietary supplements, these products are all drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are offered for the treatment of disease. These drug products, which are offered for the treatment of STDs, may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).”

On their websites, the supplement manufacturers make a wide variety of claims. Some of the claims are supported by varying degrees of science; some seem wildly overreaching. But all health- or disease-related claims are currently illegal. And that is precisely the problem: there is no mechanism in place for citing the legitimate science behind a food or supplement’s effectiveness. Many Americans are trying to take charge of their health, and they are desperate for information, so some supplement manufacturers are filling that void by violating current law and making health claims—which makes it even more difficult for consumers to judge a misleading claim from a scientifically valid one.

MedaVir’s website says that research about the product’s ingredients effectiveness has been published in national medical journals, though they don’t link to that research. The website also says MedaVir has been proven effective by an official FDA phase 2 double-blind clinical trial, as well as research at Proctor and Gamble’s laboratories for medical testing and the Cincinnati Children’s Hospital Infectious Diseases Division. Why would FDA warn a manufacturer over health claims when a FDA clinical trial has proven that the product is effective?

Here’s why. The sad truth is, whether the products are effective or not, or whether they have good science to back up their claims or not, is utterly irrelevant to the FDA. Dietary supplements cannot treat or prevent STDs like herpes—only FDA-approved, prescription-only medications can do that. That’s because, as you’ll note above in the FDA’s own words, any product that is offered as a treatment for disease is by definition a “drug product,” and without an NDA, said drug product cannot be sold.

Sadder still, natural substances can be powerful healers, but most of the public will never hear about them. As we have reported in previous newsletters, there are excellent natural treatments for diseases like herpes: vitamin C, selenium, lysine, and especially the powerhouse of the vitamin world, vitamin D. But the FDA says that making a health or disease claim for a supplement instantly and magically transforms it into a drug. It must therefore go through the FDA drug approval process or it cannot be sold. Alternatively, it can be sold, but you can’t tell anyone about its health benefits!

The difficulty, as we have noted many times, is that naturally occurring substances cannot be patented, and without patent protection, few manufacturers will pay the millions—and occasionally billions—of dollars to do the double-blind studies necessary to bring a new product through the FDA new drug approval process.

The long and short of it is this: the current health claim regulation system is broken, and the FDA is exploiting it.

This is why we so desperately need the Free Speech about Science Act of 2011 (FSAS). Passing this bill into law would make a food’s or product’s scientific studies and their implications more transparent and understandable to consumers.

Under FSAS, dietary supplement manufacturers will be able to make well-substantiated disease or health-related claims, based on legitimate scientific research. Because food and supplement manufacturers cannot legally make health claims, it becomes even harder for consumers to make informed and healthy decisions—and consumers are missing out on valuable information. FSAS creates a standard that would weed out junk science and misleading claims, and would provide health-conscious consumers with access to much-needed credible scientific information behind natural products.

We mentioned MedaVir earlier, but some of the other companies targeted by the FDA warning letter also cite scientific evidence to support their claims. The Herpaflor website, for example, cited science behind each of the product’s seventeen different ingredients (or did, before the FDA warning letter made them remove the citations, though we have a PDF of the page in question), supporting the claim that Herpaflor’s ingredients help prevent and treat herpes outbreaks as well as help alleviate some of the side effects such as pain and discomfort. They listed twenty reputable scientific sources for their claims, ranging from NIH studies, The Journal of Dermatology Treatment, The Journal of Medical Sciences Research, and The Journal of Antimicrobial Chemotherapy—though they also listed a number of sources that are not peer-reviewed, like BBC News and Answers.com.

ANH-USA does not, of course, support manufacturers’ misleading or fraudulent claims! We do support, however, the right of consumers to have access to credible, peer-reviewed scientific information about food and dietary supplements. It is difficult for consumers to differentiate what is credible information and what isn’t—because there is no standard in place for citing science for natural products. FSAS would help correct this.

The great irony here is that FDA and FTC absolutely allow egregiously misleading claims—with impunity—so long as they’re made by the major pharmaceutical manufacturers! For example, a full page ad for Astrazenica’s acid blocker drug Prilosec OTC in People magazine says in large type, ZERO HEARTBURN**. If you follow the asterisks down to the bottom of the page, it says in tiny type, “It’s possible while taking Prilosec OTC.” So the actual message is that zero heartburn is possible while taking this drug. Of course, zero heartburn is possible for any other product under the sun! Manufacturers of acid blockers are very careful to avoid saying that their product cures heartburn—because there is no evidence it does. There is abundant evidence, however, that it leads to more infection, pneumonia, bone problems, and a failure to absorb minerals. There is also evidence that it actually makes heartburn worse over time. Yet the FDA and FTC have no trouble with these claims.

Consumers have the right to access this information, and the FDA’s method of barring access to this information in untenable. There must be a system that allows consumers access to credible scientific data, through legislation like FSAS. If you have not already done so, please see our Action Alert and ask Congress to support the Free Speech about Science Act!