Currently browsing posts about: FDA

Sep 2 2012

Regulations do change eating behavior

My monthly, first Sunday column in the San Francisco Chronicle:

Q: I still don’t get it. Why would a city government think that a food regulation would promote health when any one of them is so easy to evade?

A: Quick answer: because they work.

As I explained in my July discussion of Richmond’s proposed soda tax, regulations make it easier for people to eat healthfully without having to think about it. They make the default choice the healthy choice. Most people choose the default, no matter what it is.

Telling people cigarettes cause cancer hardly ever got anyone to stop. But regulations did. Taxing cigarettes, banning advertising, setting age limits for purchases, and restricting smoking in airplanes, workplaces, bars and restaurants made it easier for smokers to stop.

Economists say, obesity and its consequences cost our society $190 billion annually in health care and lost productivity, so health officials increasingly want to find equally effective strategies to discourage people from over-consuming sugary drinks and fast food.

Research backs up regulatory approaches. We know what makes us overeat: billions of dollars in advertising messages, food sold everywhere – in gas stations, vending machines, libraries and stores that sell clothing, books, office supplies, cosmetics and drugs – and huge portions of food at bargain prices.

Research also shows what sells food to kids: cartoons, celebrities, commercials on their favorite television programs, and toys in Happy Meals. This kind of marketing induces kids to want the products, pester their parents for them, and throw tantrums if parents say no. Marketing makes kids think they are supposed to eat advertised foods, and so undermines parental authority.

Public health officials look for ways to intervene, given their particular legislated mandates and authority. But much as they might like to, they can’t do much about marketing to children. Food and beverage companies invoke the First Amendment to protect their “right” to market junk foods to kids. They lobby Congress on this issue so effectively that they even managed to block the Federal Trade Commission‘s proposed nonbinding, voluntary nutrition standards for marketing food to kids.

Short of marketing restrictions, city officials are trying other options. They pass laws to require menu labeling for fast food, ban trans fats, prohibit toys in fast-food kids’ meals and restrict junk foods sold in schools. They propose taxes on sodas and caps on soda sizes.

Research demonstrating the value of regulatory approaches is now pouring in.

Studies of the effects of menu labeling show that not everyone pays attention, but those who do are more likely to reduce their calorie purchases. Menu labels certainly change my behavior. Do I really want a 600-calorie breakfast muffin? Not today, thanks.

New York City’s 2008 ban on use of hydrogenated oils containing trans fats means that New Yorkers get less trans fat with their fast food, even in low-income neighborhoods. Whether this reduction accounts for the recent decline in the city’s rates of heart disease remains to be demonstrated, but getting rid of trans fats certainly hasn’t hurt.

Canadian researchers report that kids are three times more likely to choose healthier meals if those meals come with a toy and the regular ones do not. When it comes to kids’ food choices, the meal with the toy is invariably the default.

A recent study in Pediatrics compared obesity rates in kids living in states with and without restrictions on the kinds of foods sold in schools. Guess what – the kids living in states where schools don’t sell junk food are not as overweight.

Circulation has just published an American Heart Association review of “evidence-based population approaches” to improving diets. It concludes that evidence supports the value of intense media campaigns, on-site educational programs in stores, subsidies for fruits and vegetables, taxes, school gardens, worksite wellness programs and restrictions on marketing to children.

The benefits of the approaches shown in these studies may appear small, but together they offer hope that current trends can be reversed.

Researchers also suggest other approaches, not yet tried. The Yale Rudd Center has just shown that color-coded food labels (“traffic lights”) encourage healthier food choices.

And Rand Corp. researchers propose initiatives like those that worked for alcoholic beverages: Limit the density of fast-food outlets, ban sales in places that are not food stores, insist that supermarkets put junk foods and sodas where they are hard to see, ban drive-through sales, restrict portion sizes and use warning labels.

These regulatory approaches are worth trying. If research continues to demonstrate their value, cities will have even more reason to use them. If the research becomes compelling enough, the federal government might need to act.

In the meantime, cities are leading the way, Richmond among them. Their initiatives are well worth trying, testing and supporting.

**Marion Nestle is the author of “Why Calories Count: From Science to Politics,” as well as “Food Politics” and “What to Eat,” among other books. She is a professor in the nutrition, food studies and public health department at New York University, and blogs at foodpolitics.com. E-mail: food@sfchronicle.com

Aug 31 2012

Advocacy groups sue FDA to get busy on safety standards

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.

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

Aug 23 2012

FDA proposes study of consumer attitudes to fortified snack foods

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.
Aug 21 2012

The FDA tries again on egg safety

We Americans like our eggs.

American egg producers provide us with about 76 billion eggs a year, which averages out to 242 eggs per capita.

But their safety can be iffy for two reasons: Salmonella and cholesterol.

Since the 1980s, more and more eggs have gotten contaminated with pathogenic Salmonella enteriditis, in part because of the increasing size of egg farms, and in part because of long delays in safety rules.

Salmonella is a preventable problem.

Producers must use clean food and water, probiotics to prevent development of pathogenic bacteria in hen intestines, and vaccines as necessary.  They also must keep eggs cold.

I discussed all this in my book What to Eat, in a chapter I called “Eggs and the Salmonella Problem.”  In it, I reviewed some history:

  •  1997     Center for Science in the Public Interest petitions the FDA to do insist that egg farms follow standard food safety procedur.
  • 1999     The FDA requires Safe Handling labels on egg cartons and refrigeration during storage and transport.
  • 2004    The FDA proposes safety rules for on-farm egg production.
  • 2009    The FDA issues rules to be implemented in 2010 for egg producers with 50,000 or more hens, and 2012 for producers with 3,000 or more.

Yesterday, the FDA issued Guidance for Industry:  Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.

And it updated its Egg Safety home page.

Still to come: rules for producers of organic eggs that allow hens access to the outdoors.

But maybe we shouldn’t be eating so many eggs anyway?

A recent Canadian study associates eating egg yolks with formation of plaques in coronary arteries.

The egg industry doesn’t like this study much.

Eggs have been shown to have a wide range of health benefits, providing 13 essential vitamins and minerals, high-quality protein and antioxidants, all for just 70 calories.

It cites other studies giving different results.

These findings are surprising and contradict more than 40 years of research demonstrating that healthy adults can enjoy eggs without significantly impacting their risk of heart disease.

I like eggs.  I vote for everything in moderation on this one.  But having seen industrial egg facilities, I’m buying them from farmers’ markets these days—for reasons of food safety, animal welfare, and taste.

Jul 19 2012

What’s holding up the new food safety regulations?

A full-page ad in Tuesday’s New York Times (July 17) alerts readers to the astonishing 18-month delay in issuing food safety rules authorized by the Food Safety Modernization Act passed by Congress at the end of 2010.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The sponsor of the ad, Make Our Food Safe, is a coalition of highly respected public health and advocacy groups working on food safety issues.

According to the New York Times report, they are baffled by the delay.

But the F.D.A. rules that are needed to carry out the law have been under review by the Office of Management and Budget in the White House since December, and consumer health advocates say there has been no explanation for what they describe as a lengthy delay.

….Before the rules become official, the F.D.A. still has to circulate them for public comment, adding more months to the process. The rules for importers were expected in January and for domestic food processors in July, advocates said.

Could the delay be due to election-year politics?  Advocates wonder if

Democrats may want to avoid the impression that government regulation is growing, a popular cause for attacks by Republicans.

The Office of Management and Budget denies this.

Moira Mack, a spokeswoman for the Office of Management and Budget, said that the agency coordinates suggestions from many institutions across the federal government, and that it is not unusual for the review process to take months. A regulation last year on dangerous snakes, for example, took about 10 months to clear, she said.

Oh come on.  These rules are about protecting the public from dangerous microbes.  They need to move.

The Make Our Food Safe website makes it easy to write President Obama to release the FDA’s proposed rules.    Add your voice!

Jul 11 2012

The Ad Council on food safety: buy a meat thermometer

Yesterday’s international edition of USA Today (I picked it up at Heathrow) carried a full-page ad from the Ad Council, which donates its services to worthy causes every now and then.  This one, entirely in grey and white, displays logos from the Ad Council, USDA, and the Department of Health and Human Services (DHHS), the parent agency of FDA.

In inch-high letters, all caps: DO YOU WANT THAT SAFE OR MEDIUM-SAFE?

In quarter-inch letters, also caps: USE A FOOD THERMOMETER TO MAKE SURE YOU COOK RAW MEAT AND POULTRY TO A BACTERIA-KILLING TEMPERATURE.

The ad also displays the Cook, Clean, Chill, Separate logo and the admonition to “Keep your family safer from food poisoning.  Check your steps at foodsafety.gov.”

Mind you, I’m highly in favor of following food safety procedures at home.

But most food safety problems are not due to the failure of home cooks to use thermometers.

They are caused by failures to observe food safety procedures during commercial production and preparation.

Shouldn’t meat and poultry be safe when you buy it in the supermarket?

This ad implies that the principal responsibility for food safety lies with the end user—you.

If you get sick it’s your fault because you didn’t use a meat thermometer?

USDA and DHHS:  how about getting the Ad Council to encourage meat and poultry producers to make sure their products are safe in the first place.

May 31 2012

FDA says HFCS is HFCS; it is not corn sugar

Cheers to the FDA.  It just said a firm no to the Corn Refiners’ petition to be allowed to call High Fructose Corn Syrup (HFCS) “corn sugar.”

The FDA’ s rationale:

  • Sugar is solid, dried, and crystallized.  Syrup is liquid.  HFCS is liquid.  Therefore, it is syrup, not sugar.
  • Corn sugar already has a regulatory definition: dextrose (glucose).  HFCS contains fructose as well as glucose.  Therefore, it is not corn sugar.

As I mentioned earlier, I filed comments to the FDA on the Corn Refiners’ petition:

The [Corn Refiners'] website quotes comments I have made to the effect that HFCS is biochemically equivalent to sucrose. It is. But I do not believe that biochemical equivalence is a good reason for the FDA to agree to a name change at this point.

It is highly unlikely that public misunderstanding of nutritional biochemistry and the differential physiological effects of glucose vs. fructose will be addressed and corrected by changing the name of HFCS to corn sugar.

…the name change is not in the public interest. Its only purpose is to further the commercial interests of members of the Corn Refiners, and that is not one the FDA should be concerned about.

I was referring here to the legal and public relations wrangling between the Sugar Association, which represents the growers of cane and beet sugar (sucrose), and the Corn Refiners.

I have complained previously about the in-your-face behavior of the Corn Refiners in attempting to protect its share of the sweetener market: its strange advertisements; its use of my quotes (they told me the quotes are in the public domain and if I don’t like it I can sue them); its aggressive lobbying; its stated intention to use the term “corn sugar” whether the FDA approves it or not.

The Sugar Association’s behavior is not much better.  It has taken the Corn Refiners to court over the naming issue.

I was amused to receive two e-mails this week from its public relations firm complaining about the Corn Refiners’ clumsy PR response to a UCLA  study ostensibly showing that HFCS makes rats “fat and stupid.”  This study, however, did not compare the effects of sucrose and HFCS and its results, even if confirmed, could apply to any source of fructose.

The second e-mail sent links to the FDA’s decision and the Sugar Association’s response.

The FDA’s ruling represents a victory for American consumers,” said Dan Callister, an attorney for the plaintiffs in the ongoing litigation. “It reaffirms what most consumer advocates, health experts and policy officials have been saying all along: only sugar is sugar. HFCS is not sugar. The next step is for the federal court to end the CRA’s misleading propaganda campaign.

Sugars, plural, are sugars.  Sucrose is glucose and fructose.  So is HFCS.

Everyone would be better off eating a lot less of both.

And that brings me to New York City Mayor Michael Bloomberg’s latest attempt to promote the health of his constituents: banning any sugary drink larger than 16 ounces from restaurants, movie theaters, and street carts.

I can’t wait to see how the Beverage Association deals with this one.

Addition June 1: Rosie Mestel of the L.A. Times has an excellent account of this in which she quotes from these comments.  Her story is accompanied by a PR photo from the Corn Refiners Association.  What are these people thinking?

Ad campaign by the Corn Refiners Assn.

May 29 2012

The latest battle in the supplement wars: FDA v. DMAA

Welcome to the largely unregulated universe of dietary supplement marketing, in this case of DMAA, a.k.a. 1,3-dimethylamylamine, methylhexanamine, or geranium extract (from which it is supposedly isolated).
DMAA is supposed to stimulate athletic performance.
In April, the FDA sent letters warning ten DMAA distributors that it considered their products adulterated because:
  • DMAA does not naturally come from a food.
  • Most of it is produced synthetically
  • It might not be safe.
The FDA received 42 complaints of adverse events associated with taking DMAA supplements.  Although the reports do not prove that DMAA caused the problems, these are serious: cardiac disorders, nervous system disorders, psychiatric disorders, and death.The FDA says:

dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).

One FDA warning letter went to a company called Muscle Warfare for its DMAA supplement “Napalm” which “produces intense sensations of power, drive, energy, focus, motivation, and awareness.  Enormous strength, speed and endurance increases may result.”

Here’s how the company says Napalm works:

Upon ingestion, energy is almost instantly kicked in with Air Strike while core body heat is dramatically supported. This extra body heat may then dramatically support the release of heat shock proteins, during your workout by way of our patent pending Thermobraic Heat Shock Protein Deployment System via Myobolic-SERMS/1&2….Muscle Pumps are fueled via a remarkable creatine free, Plasma Scorch Muscle Engorgement Agent….

Just pure power and dry hard size. Anabolism is kicked in by your ultra-intense workout coupled with our powerful mTOR pathways inducing Vaso-Anabolic Branched Chain Amino Acid Blend. Further hormonal anabolic support is induced by our patent pending NMDA™ hormonal support agent. NMDA™ specifically targets growth hormone, testosterone, IGF-1 and IGF-2 release and has been scientifically shown to provide dramatic support!

As I keep saying, you can’t make this stuff up.

The supplement industry, ever eager to find an athletic supplement that everyone will want to take has reacted with outrage to the FDA’s warning letters (see NutraIntredients-USA.com for a series of articles on DMAA).

Since Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, the supplement industry has gotten a virtually free pass on regulation and its less scrupulous members push the limits of marketing to the point where the FDA has no choice but to act.

DMAA supplement marketers now argue that if DMAA comes from geraniums, synthetic DMAA should be legal. 

I had no idea people were eating geraniums, but never mind.  The flowers may not contain DMAA anyway.

According to NutraIngredients, most DMAA is synthetic (hence: not natural):

There is only one study repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85) – which analytical testing experts contacted by NutraIngredients-USA say is “not scientifically defensible“.

The supplement industry views the warning letters as signs that the FDA is going to start giving its products greater scrutiny.

That would be a step in the right direction, but maybe the FDA won’t have to.  The warning letters elicited a flood of  class action lawsuits against DMAA.

If the FDA won’t or can’t act, lawyers will take up the burden of regulating potentially unsafe and misleadingly marketed supplements.

Update, June 29:  Oops.  Investigators fail to find DMAA in geranium extracts or oils. 

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