Currently browsing posts about: FDA

I don’t know what to say about acrylamide.  Acrylamide is the powerful carcinogen that gets formed when carbohydrates and proteins are cooked together at high temperature, as in dark toast, French fries, and potato chips.    I just can’t figure out how bad it is, and I like my toast well toasted.  But:

Canada recently added acrylamide to its list of toxic substances.  The European Union has just listed it as a hazardous chemical “of high concern.”

The FDA, trying to figure out what to say about acrylamide, is asking for public comment:

The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels. FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

The FDA offers an information page on acrylamide.  This comes with a Q and A and information about avoiding acrylamide when eating or cooking.

How serious a problem is acrylamide?  Nobody knows, really, and the research is mixed. According to recent reports, Dutch investigators say that acrylamide has no relationship to brain or lung cancer.  So that’s some relief.

Update, September 3: No surprise, but surveys show the public doesn’t know much about acrylamide.  With so much uncertainty, this is a particularly tough one to deal with.

Update, September 5: Food Production Daily has produced a nifty interactive timeline of events in the history of troubles with acrylamide, since it was first suspected of being a problem in 2002.

You may recall my previous posts about the new Smart Choices program.  This program was developed by food processors to identify products that are ostensibly “better for you”  because they supposedly contain more good nutrients and fewer bad ones.  This program is about marketing processed foods and I wouldn’t ordinarily take it seriously except that several nutrition professional associations are involved in this program and the American Society of Nutrition is managing it.  In effect, this means that nutritionists are endorsing products that bear the Smart Choices logo.

So what products are nutritionists endorsing?  I went grocery shopping last week and bought my first Smart Choice product: Froot Loops!

Froot Loops

Look for the check mark in the upper right of the package.  Frosted Flakes also qualifies for this logo, and do take a look at what else is on the approved list.

A close look a the Nutrition Facts label of Froot Loops shows that it has 12 grams of added sugars in a 110-calorie serving.  That’s 44% of the calories (12 times 4 calories per gram divided by 110).  The usual program maximum for sugar is 25% of calories but it makes an exception for sugary breakfast cereals.  Note that the fiber content is less than one gram per serving, which makes this an especially low-fiber cereal.

OK.  I understand that companies want to market their processed foods, but I cannot understand why nutrition societies thought it would be a good idea to get involved with this marketing scheme.  It isn’t.  The American Society of Nutrition gets paid to manage this program.  It should not be doing this.

But, you may well ask, where is the FDA in regulating what goes on package labels?

Good news: I am happy to report that our new FDA is on the job!  FDA officials have written a letter to the manager of the program.  Although the letter is worded gently, I interpret its language as putting the program on high alert:

FDA and FSIS would be concerned if any FOP [Front of Package] labeling systems used criteria that were not stringent enough to protect consumers against misleading claims; were inconsistent with the Dietary Guidelines for Americans; or had the effect of encouraging consumers to choose highly processed foods and refined grains instead of fruits, vegetables, and whole grains [my emphasis].

Update August 25: I received an interesting e-mail message from a member of the Keystone group that developed the Smart Choices program.  The message confirms that this program is a scheme to make junk foods look healthy.  It says:

Glad to see your posting about Froot Loops! The negotiations over criteria were interesting. Lots of good debate on various points, but when the companies put their foot down, that was it; end of discussion. And sugar in cereals was one such point. Others included the non-necessity for breads, etc. to contain half or more whole grains and the acceptance of fortification to meet the nutrient requirement.

In other words, some people in the group argued that breads needed to contain at least half a serving of whole grains to quality and that added vitamins and minerals should not count toward qualification.  Too bad for them.  I guess the companies put down feet.  But why didn’t they speak up then?  And why aren’t they speaking up now?

You will recall that the FDA’s 1994 stance on labeling of genetically modified (GM) foods was that labeling foods as GM or non-GM would be misleading  because the foods are no different.  Despite overwhelming evidence that the public wants to know whether foods are GM or not, GM foods do not have to be labeled.  Worse, those that are labeled non-GM have to include a disclaimer that this makes no difference (I explain how all this happened in Safe Food).

At present, there is no way to know whether GM foods that have been approved by FDA (such as potatoes, tomatoes, squash, papayas) are actually in the produce section of supermarkets.  When I was writing What to Eat, I paid to have some papayas tested.  Most were not GM.  But you have no way of knowing that.

The GM industry (translation: Monsanto) has opposed labeling from the very beginning, no doubt because of fears that people will reject GM foods.  The makers of processed foods object to labeling because practically everything they make contains GM ingredients: about 90% of the soybeans and 50% of the corn grown in America is GM.  Ingredients made from these foods – corn and soy oils, proteins, and sweeteners – are widely used in processed foods.

The Europeans are faced with the same problem but insist on labeling GM.  Guess what?  No problem.  Hershey’s Reese’s NutRageous candy bars in the U.K. disclose the GM ingredients in exactly the way our products disclose allergens: “Contains: Peanuts, Genetically Modified Sugar, Soya and Corn.”

Here’s the label (borrowed from Mike Grenville at flickr.com/photos):

Hershey is an American company.  If labeling in the U.K. is this simple, we ought to be able to do this here, no?  Here’s a chance for the FDA to fix an old mistake and give consumers a real choice.

The FDA must be in a bit of a quandary as it waits to see what Congress orders it to do about food safety (see previous post).  But it is not sitting around doing nothing.  Instead, it seems to be unblocking regulations that have been in the works for a long time.

On July 9, the FDA announced a final rule for prevention of Salmonella Enteriditis contamination of shell eggs during production, storage, and transportation.  This might seem unremarkable except for two points: (1) it requires science-based food safety procedures – with pathogen testing – from farm to table (an all-time first), and (2) it was first proposed in 2004 and has been stuck ever since (that’s politics for you).

On July 31, the FDA proposed safety guidance for melons, tomatoes, and leafy greens that would apply to everyone involved in the supply chains for these foods – growers, packers, processors, transporters, retailers, and others.  Guidance, alas, is just that: voluntary.  But this puts the producers of such foods on alert that the guidance could swiftly turn into rules  if Congress gets busy and does what it ought to be doing about food safety.  The guidance is open for comment but it is designed to be implemented within two years.  This is quick in FDA regulatory time.

And now the FDA announces that it is speeding up its system for issuing warning notices to companies in violation of safety regulations.  This is a good step, although it falls far short of recall authority.  For that, Congress must act.

Applaud the FDA and keep fingers crossed that no new outbreaks occur while Congress takes its own sweet time to act.

I don’t track legislation very carefully because bills change so much between the time they are proposed and actually pass.  But I keep getting asked about the bills that seem to have the best chance this year,  H.R. 2749 (which has just been passed by the House) and its equivalent in the Senate, S. 510 (still in the works).  The bills are quite similar.  Both aim to fix the FDA.   Neither aims to fix the system, so forget about combining the food safety functions of USDA and FDA into one agency.  The bills bring the FDA’s rules closer to those of USDA, as they propose science-based food safety standards (much like HACCP) from farm to table.  Best, they give the FDA recall authority as well as a few other goodies.

The bills themselves are miserable to read and it is hard to believe that anyone in government does.  That is why the Congressional Research Service (CRS) does summaries that even legislators can understand.  CRS researchers have now produced blessedly short and hopefully accurate summaries of the House bill as well as the Senate bill.

As my contribution to the cause of clarity, I have done a quick edit of the CRS summaries, with comments in Italics.  The links above are to the original bills so you can plow your way through them to see if this does them justice.   Enjoy!

THE HOUSE BILL, H.R. 2749, requires each food facility to:

(1) Conduct a hazard analysis, (2) Implement preventive controls, and (3) Implement a food safety plan. [This sounds like HACCP, although they aren’t calling it that. I vote yes]

Requires FDA to:

(1) Issue science-based performance standards to minimize the hazards from foodborne contaminants [this means HACCP or its equivalent, and about time too],

(2) Establish science-based standards for raw agricultural commodities [this means some version of farm-t0-table HACCP, long awaited],

(3) Inspect facilities at a frequency determined pursuant to a risk-based schedule [this is an admission that the FDA can’t handle the work load; it will focus on products most likely to be contaminated]

(4) Establish a food tracing system [this will help identify where foods come from]

(5) Assess fees relating to food facility reinspection and food recall [make companies pay for all this, I hope in a way that avoids conflicts of interest],

(6) Establish a program for accreditation of laboratories that perform analytical testing of food for import or export [can’t believe we don’t already have this, but that’s why we need this legislation].

Authorizes FDA to:

(1) Order an immediate cessation of distribution, or a recall, of food [recall authority at last!]

(2) Establish an importer verification program [accountability for importers, at last!]

(3) Quarantine food in any geographic area within the United States [they can’t do this now?].

Defines the term “color additive” to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood [this will have to meet food additive regulations].

Requires country of origin labeling on food, and annual registration of importers [Yes!].

Provides for unique identifiers for food facilities and food importers [so FDA actually knows who they are].

Deems a food to be adulterated if an inspection is delayed or refused [Yes!].

Requires FDA to establish a corps of inspectors dedicated to inspections of foreign food facilities [Amazing that we don’t already have this].

Reorganizes the FDA field laboratories and district offices [Could this possibly be a euphemism for closing some?].

Gives the FDA Commissioner subpoena authority [Yes!].

Establishes whistleblower protections [OK].

THE SENATE BILL, S. 510, is pretty much the same except that it addresses food bioterrorism [fortunately, a rare event so far]. In addition to most of what is in the House bill, it requires HHS and USDA to prepare the National Agriculture and Food Defense Strategy [If this is done right, it ought to promote the safety of domestic foods and imports].

It also requires FDA to:

(1) Identify preventive programs and practices to promote the safety and security of food [worries about food bioterrorism again];

(2) Promulgate regulations on sanitary food transportation practices [good idea];

(3) Develop a policy to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs [I’m not sure how this got in here]

Requires FDA and CDC to enhance foodborne illness surveillance systems [Good idea].

Requires EPA to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency [in the military sense of food security].

There is much, much more in these bills.  Bill Marler, who has actually read the bills, has produced his own summary, which includes definitions and more.  If you are wondering what implementation of these bills might cost, the Congressional Budget Office has done an analysis: a mere $2 billion.

It’s hard to know how seriously to take all this until we see what Congress actually does when it gets back to work.  Stay tuned.

There is so much wrong with bottled water that it’s hard to know where to begin (read Elizabeth Royte’s Bottlemania, for starters).  But let’s start with the fact that bottled water is the most brilliantly marketed product ever invented.  The companies get it practically free out of a tap and charge you a dollar or more – sometimes a lot more – for a quart or less).  The plastic bottles pollute the environment.  Worst of all, drinking bottled water makes people less apt to be vigilant about protecting public water supplies.

And it isn’t even regulated very well, or so says a report from the Government Accountability Office.  The title says it all: “Bottled water: FDA safety and consumer protections are often less stringent than comparable EPA protections for tap water.”  The report was released in time for congressional hearings on the topic.   Reporters had a lot of fun with the self-interested statements of industry people who testified.

None of this gets into the additional question of bisphenol A and other endocrine disrupters in plastic bottles that are sometimes used for water.  The Canadians are now saying that bisphenol A is safe at amounts commonly used, and so is a California expert committee.  The American Chemistry Council is pleased with these decisions.

Where does that leave us?  Defend tap water!  As for endocrine disrupters, stay tuned but why use bisphenol A when other alternatives are so readily available.

July 24 update: The International Bottled Water Association is suing a maker of steel water bottles for false advertising.  The bottle maker’s ads apparently suggested that plastic water bottles leak synthetic estrogens.   Bisphenol A must be causing serious problems for the bottled water industry, along with all those pesky enviromental concerns.

On Monday this week, Michael Taylor began his new job as special assistant to the FDA Commissioner for food safety.  He will be in charge of implementing whatever food safety laws Congress finally decides to pass.

I know that what I am about to say will surprise, if not shock, many of you, but I think he’s an excellent choice for this job. Yes, I know he worked for Monsanto, not only once (indirectly) but twice (directly). And yes, he’s the first person whose name is mentioned when anyone talks about the “revolving door” between the food industry and government. And yes, he signed off on the FDA’s consumer-unfriendly policies on labeling genetically modified foods.

But before you decide that I must have drunk the Kool Aid on this one, hear me out.  He really is a good choice for this job.  Why?  Because he managed to get USDA to institute HACCP (science-based food safety regulations) for meat and poultry against the full opposition of the meat industry — a truly heroic accomplishment.  His position on food safety has been strong and consistent for years.  He favors a single food agency, HACCP for all foods, and accountability and enforcement.  We need this for FDA-regulated foods (we also need enforcement for USDA-regulated foods, but he won’t be able to touch that unless Congress says so).  So he’s the person most likely to be able to get decent regulations in place and get them enforced.

Legislators in the new administration are working on food laws.  Here is a quick sample:

Calorie labeling: it looks like we have bipartisan support for national menu labeling.  If passed, calories will have to be disclosed on menu boards of fast food and vending machine chains throughout the country – and not just in New York City and the few states that have passed their own laws.   Lots of health organizations are backing this proposal.

Food safety: the House just passed its version of a bill that will overhaul some aspects of the present food safety system.  This bill still has a long way to go but is a hopeful sign that Congress might actually do something to fix the FDA.  What the bill does not do is deal with fixing the system.  It exempts meat, poultry, and eggs under USDA jurisdiction.

Produce safety: The new head of the FDA, Margaret Hamburg, says her agency is going to put special efforts into ensuring the safety of high-risk produce. To do that, she will need Congress to pass laws that, among other things, give the FDA the authority to order recalls and a lot more money to carry out its work.

Organics: The U.S. and Canada have agreed to coordinate their organic standards, so foods certified organic in Canada can be sold here and vice versa.  Let’s hope the most stringent standards prevail.

These are (somewhat) hopeful signs.  Let’s hope Congress manages to keep at this and tries to get it right.