by Marion Nestle

Currently browsing posts about: FDA

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. 

May 16 2012

Follow-up on sushi tuna scrape: it’s supposed to be cooked!

In response to my post on tuna scrape, Professor Alan Reilly, Chief Executive, Food Safety Authority of Ireland (the equivalent of our FDA) sent this photograph of an actual tuna scrape label.

 

After I forwarded it to Bill Marler, he noticed that it is one of several photographs posted on the FDA’s tuna scrape recall web page).

The type is too small to read so I’ve done some cropping:

Professor Reilly asks:

What is puzzling me is why this product “minced tuna” was used in sushi products. The label (copy attached) clearly states that the product must be cooked before consumption and it is for industrial uses only (labelled not for retail).

Those are good questions, but here’s another, equally alarming.  What’s that strangely formatted Nutrition Facts label? It does not precisely follow FDA design or content requirements.

This is a red flag.  If the company is not following labeling rules, it might not be  following other rules either—safety, for example.

Safety?  Uh oh.

Bill Marler reports that the FDA “483 Inspection Report” on the Indian tuna processing facility is now available.  Read these quotes and shudder:

  • Tanks used for storage of process waters have apparent visible debris, filth and microbiological contamination.
  • There is no laboratory analysis for water used in ice manufacturing at the [redacted] facility to show the water used to make ice is potable.
  • Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment.
  • Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

I draw several lessons from this episode:

  • Food is safer when cooked.
  • Labels need to be read—and followed—carefully.
  • Raw sushi is a high risk product, especially if it doesn’t cost much.
  • The FDA needs to be doing a lot more inspecting of overseas facilities, and before they cause problems.

All of this means that we need a better food safety system, one that can address the enormous proportion of our food supply that comes to us from countries with weaker food safety standards.

Addition, May 17: Ben Embarek, a food safety scientist at the World Health Organization notes that the 483 report reveals that Moon’s HACCP plan did not list appropriate critical control points.  Anyone auditing the plan should have picked up the problems on paper, which is easier and less expensive to do than an on-site inspection.  But the FDA does not pre-audit international HACCP plans.  They are supposed to be cleared by exporting companies registered by FDA.  Comment: it’s hard to imagine that the current system can work, and it clearly does not.

May 11 2012

FDA panel recommends approval of another iffy weight-loss drug

I was riveted by an article in today’s New York Times about the latest decision of an FDA drug advisory panel.

The panel voted to approve a new weight-loss drug, lorcaserin.  The vote was mixed: 18 for approval, 4 against, and 1 abstention. The majority felt that the benefits outweighed the risks and that even if there were risks, “new tools are needed to treat a major health problem.”

The benefits are worth a look.

  • People taking the drug lost an average of  5.8% of their body weight in a year, compared to 2.5% for people taking a placebo.  This difference is below the FDA’s standard for approval which requires a 5% difference.
  • Among those taking the drug, 47% lost at least 5 percent of their weight after a year, whereas only 23% of those taking the placebo did so.  This meets a second FDA standard for approval.

What about the risks?  The drug:

  • Causes tumors in rats (although perhaps at higher doses than might be taken by people).
  • Damages heart valves (in the same way the withdrawn drug, Fen-Phen, did).

Also in the Times is a piece by Dr. Danielle Ofri on her experience with patients who want weight-loss drugs.

She quotes from an essay called “Lemons for Obesity” by Dr. Michael S. Lauer, who was a minority voter on the FDA panel that approved the weight-loss drug Qnexa earlier this year.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Shares of the maker of the drug nearly doubled after the decision.  The Times reported that “Arguments by investors have been passionate.”

People who cannot easily lose weight are desperate for help.

But is it ethical to put them at this kind of risk?

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