by Marion Nestle

Currently browsing posts about: FDA

Nov 19 2012

Energy drinks, Cracker Jacks, and caffeine: enough already

People who consume caffeinated energy drinks may be dying right and left (Because of the caffeine?  The drinks?  Hard to say) but that isn’t stopping food manufacturers from adding it to everything: Cracker Jacks, jelly beans, Gummi Bears, brownies, mints, and maple syrup.

The FDA has just released its data on problems reported among users of three caffeinated energy drinks.

According to the New York Times,

The three products involved in the release — Rockstar Energy, 5-Hour Energy and Monster Energy — are all marketed as dietary supplements. Other energy drinks like Red Bull, NOS and AMP are marketed by their producers as beverages. There is not a mandatory reporting requirement for beverages, though makers can do so voluntarily.

In releasing the filings, the F.D.A. said it thought that even with the mandatory reporting requirement for dietary supplements, “only a small fraction of adverse events associated with any product is reported.”

…The records related to Monster Energy and 5-hour Energy came to light because they were released by the F.D.A. under the Freedom of Information Act.

The choice of labeling these products as foods or supplements deserves scrutiny.  By an act of Congress, dietary supplements do not have to meet the same standards for content and health claims as foods, and the FDA cannot do much to regulate them unless the products are demonstrably harmful.

Even though people died after drinking these products does not necessarily mean that the products caused the deaths.  Even this number of deaths could be a coincidence.

But earlier, the Times reported that

Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion….

Some lawmakers are calling on the F.D.A. to increase its regulation of the products and the New York State attorney general is investigating the practices of several producers.

I looked up the Supplement Facts label for 5-Hour Energy.

According to statements given to Beverage Daily, 5-Hour Energy says there isn’t any evidence that its products cause deaths.  Its shots contain no more caffeine than a cup of coffee, and do not contain herbal ingredients.

But the product label does not list caffeine content.  The FDA does not require companies to disclose caffeine levels.

It allows them to market the products as drinks or as dietary supplements. Monster Energy contains 240 mg caffeine in 24 ounces.  It has been associated with the deaths of five people so far.

The Times points out that healthy adults can consume large amounts of caffeine with no evidence of harm but that caffeine can be risky for people with underlying conditions like heart disorders.  How much is risky?  It’s hard to say.

Most adults know how much caffeine they can handle without getting shaky or sleep-deprived.  But kids don’t, necessarily.

Consumer Reports tested products and found that some energy drinks contained more than 240 mg per serving, but notes that packages sometimes contain more than one serving.

The FDA considers caffeine to be safe.  But in an opinion last updated in 2011, FDA’s Select Committee on GRAS Substances found that “it is inappropriate to include caffeine among the substances generally recognized as safe (GRAS). At current levels of consumption of cola-type beverages, the dose of caffeine can approximate that known to induce such pharmacological effects as central nervous system stimulation.”

The Times notes that sales of energy drinks in the U.S. are booming, growing by about 16% last year and bringing in nearly $9 billion.

What to do?  A lawyer for the parent of one of the teenagers who died after drinking Monster Energy is urging the FDA to ban the drinks to minors.

The FDA should investigate the cases, for sure.

And how about adding amounts of caffeine to labels.  That seems like a no brainer while the investigations are in progress.

Nov 7 2012

The election is over (whew): what’s next?

My post-hurricane Manhattan apartment still does not have telephone, internet, or television service, so I followed the election results on Twitter.

I knew that President Obama had been reelected when the Empire State Building turned on blue lights.

What’s ahead for food politics?

With the election out of the way, maybe the FDA can now:

  • Release final food safety rules (please!)
  • Issue proposed rules for front-of-package labels
  • Issue proposed rules for revising food labels
  • Require “added sugars” to be listed on labels
  • Define “natural”
  • Clarify “whole grain”
  • Release rules for menu labeling in fast-food restaurants

Maybe the USDA can

  • Release nutrition standards for competitive foods served in schools

And maybe Congress can pass the farm bill?

As for lessons learned:

  • The food industry has proven that it can defeat consumer initiatives by spending lots of money: $45 to $50 million on California’s Proposition 37 (GMO labeling), $4 million on soda tax initiatives in Richmond and El Monte.
  • But if enough such initiatives get started, food companies might get the message?
The election leaves plenty of work to do.  Get busy!
Oct 9 2012

Big Soda to put calorie labels on vending machines in city offices in Chicago and San Antonio

Yesterday, Beverage Digest announced that the American Beverage Association (ABA) and its Big Soda members—PepsiCo, Coca-Cola, and Dr Pepper/Snapple—were starting a “new vending machine program to help combat obesity.”

The new “Calories Count Vending Program” starts in 2013 in city buildings in Chicago and San Antonio.

This, Beverage Digest says, “is what can happen when the industry and mayors work together, collaboratively.”   It quotes an executive from Dr Pepper Snapple: “this program is yet another example of how the beverage industry is providing meaningful solutions to help reduce obesity.”

Really?  If these companies really wanted to help reduce obesity, they might start by eliminating sugary drinks.  But never mind.  This is about politics, not health.

For one thing, calorie labels are going to have to go on most vending machines anyway, as soon as the FDA gets around to writing the regulations for them.

For another, this move heads off any attempt to introduce (horrors!) taxes on sodas or caps on bottle size in those two cities.

Chicago Mayor Rahm Emanuel is quite clear about that.  He says his approach to the health issue “is better because it emphasizes personal responsibility.”

He prefers to have Chicago city workers compete with those from San Antonio for a $5 million grant from the ABA.  The ABA has also agreed to pay $1,000 to workers who meet health goals to be determined.

Although this might look like a bribe, Emanuel denies that the program is a payoff:

I believe firmly in personal responsibility,” the mayor said at a City Hall news conference with the pop company executives. “I believe in competition, and I believe in cash rewards for people that actually make progress in managing their health care.”

According to the New York Times, Mayor Emanuel actively sought the ABA grant.

If only personal responsibility worked, alas.  So much evidence now shows that it’s not enough to change behavior.  It is also necessary to create a food environment more favorable to making healthful choices.

That’s the public health approach taken by New York City Mayor Michael Bloomberg .  His approach is to make the food environment more conducive to healthful choices without anyone having to consciously think about them.  This approach is more likely to reduce soda consumption, which is why the ABA wants to head off taxes and caps.

Oh well.  Education is always a good thing, and here’s what the ABA says the vending machines will look like.

Oct 4 2012

FTC issues advice on “eco” claims

The Federal Trade Commission (FTC), which is responsible for regulating advertising, has just revised its “Green Guide” to eco-labeling.

The FTC warns that

  • Explanations of specific attributes, even when true and substantiated, will not adequately qualify general environmental marketing claims if an advertisement’s context implies other deceptive claims.
  • Marketers [are] not to imply that any specific benefit is significant if it is, in fact, negligible.
  • If a qualified general claim conveys that a product is more environmentally beneficial overall because of the particular touted benefit, marketers should analyze trade-offs resulting from the benefit to substantiate this claim.

The FTC did this, according to the New York Times, to reduce the confusion caused by the proliferation of eco-labels.

In surveying consumers, the F.T.C. found that products that were promoted as “environmentally friendly” were perceived by consumers to have “specific and far-reaching” benefits, which, the government says, they often did not have.

“Very few products, if any, have all the attributes consumers seem to perceive from such claims, making these claims nearly impossible to substantiate,” the commission said.

No wonder the public is confused.  The Consumer Reports Greener Choices index of eco-labels goes on for pages, and the international EcoLabel index currently lists 432 icons and programs.

But the FTC guide says nothing about claims that a product is natural, organic, or sustainable.

“Natural” still has no regulatory definition.  Of Natural, the FDA says:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

“Organic” is defined by the USDA through its National Organic Program.

“Sustainable” has no regulatory definition.

Will the FTC’s guide help alleviate confusion?  Perhaps, if companies follow it.

 

 

 

 

 

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.

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