Currently browsing posts about: FDA

Ah those British.  So ahead of us in so many ways.  A professor in Aberdeen had the nerve to suggest that supplements don’t make healthy people healthier.  The industry reacted accordingly. More interesting is the expectation that sales of vitamin and mineral supplements are expected to drop by 50% in the near future.  Imagine: the British don’t think they do much good.

But maybe Americans don’t either?  The September issue of Nutrition Business Journal (NBJ) is full of doom and gloom.  The FDA wants to regulate supplements.  Congress is rethinking the Dietary Supplement Health and Education Act of 1994 (DSHEA) – the one that deregulated the industry.  Today’s New York Times discusses congressional hearings about problems with sports supplements that contain steroids but don’t say so.

So maybe DSHEA wasn’t such a great idea.  Sports supplements and those for weight loss are getting bad press for the harm they cause.   Coupled with the economic downturn, none of this is helping sales.  NBJ says last year’s 5% growth in supplement sales is the lowest since 1997 and predicts that next year will be worse.

Why?  As NBJ explains, it gets letters from doctors saying things like this: “I’ve become stronger in my conviction that taking supplements is nothing more than a giant crapshoot.”

This, I argue, is the entirely predictable result of deregulation.  The supplement industry worked relentlessly to get itself deregulated.  It even wrote the language of the bill that Congress eventually passed (I describe this history in detail in Food Politics).  This industry is now facing the consequences of its own actions.

How ironic that supplement makers will be begging the FDA for regulation if for no other reason than to gain some trust.

I like yogurt.  But do probiotics – those “friendly” bacteria in yogurt and  increasingly added to other foods – do anything for you beyond making yogurt taste good?  I wrote about probiotics in What to Eat at some length.  Tara Parker-Pope has a quick summary of the state of the research in today’s New York Times.

The quick answer is mixed.  It includes a lot of  “maybe” or “probably,” always a sign that whatever probiotics might do isn’t going to be much.  The answer is probably yes for infant diarrhea and, maybe, irritable bowel syndrome, and maybe or no for just about everything else.

In the absence of FDA action to regulate misleading health claims, lawyers have jumped into the breach.  They have just won a large class-action settlement – $35 million – against Dannon for claiming that Activia yogurt promotes immunity.   According to one news account, Dannon spent $100 million marketing the immunity-promoting effects of Activia ignoring the results of its own company-sponsored research which inconveniently showed few benefits.  (Did they not pay enough for the research?).

Dannon is working hard to get an approved health claim from the European Standards Agency which annoyingly wants to see some science behind health claims before approving them.  Dannon has now added a tomato extract to its yogurts with the idea that this substance, which appears to help deal with diarrhea, will strengthen its bid for a health claim.

Probiotics are another reason why the FDA needs to set better standards for health claims.  If it were up to me, food packages would have no claims on them: none at all.  Foods are not drugs.

And here’s another reason why:

Will Cocoa Krispies  be the next target of those pesky lawyers?

FDA: get to work!

Three items on the Smart Choices front (make that four – see below):

1.  Let’s start with the great video by ABC News [if the link doesn’t work, go to the ABC News site and search for Food Label Fight].  It features an incredulous Mark Bittman pulling check-marked products off supermarket shelves, along with Richard Kahn defending the program.  Kahn, as I discussed in What to Eat, defended the American Diabetes Association’s (ADA) implied endorsement of Post sugary cereals.  When Jane Brody wrote about this in the New York Times, the Association promised to remove its logo from the products and did so after a bit.

2.  The letter-writing campaign organized by Change.org has had the same effect: “Victory: Change.org Members Force Health Organizations to Back Away from Food Labeling Ploy.”

The new marketing program, called “Smart Choices,” is a front-of-the-package nutrition-labeling program designed in theory to help shoppers make smarter food choices.

But as the New York Times exposed last week, the selections are anything but healthy. One of the selections is Froot Loops, which was chosen, according to one board member, because “it’s better for you than donuts.” (No, we’re not kidding. We couldn’t make this up.)

Despite the program’s dubious standards, it maintained the appearance of legitimacy because researchers associated with three reputable organizations – American Diabetes Association, American Dietetic Association, and Tufts University – were on its board.

In response, thousands of Change.org members sent letters to the presidents of these three major research institutions urging them to remove their name from the program.

The result? All three organizations responded to the pressure this week by publicly distancing themselves from the food labeling scheme and officially asking Smart Choices to remove their name from its website and marketing materials – thereby publicly embarrassing and discrediting the program.

Fine, but this one isn’t over until the American Society of Nutrition (ASN) also extricates from its commitment to manage the program – a clear conflict of interest.

3.  The Institute of Medicine (IOM) is asking for nominations to a committee to study front-of-package labeling (what follows is edited from the request letter):

The IOM is searching for experts in the scientific, technical, and medical professions to be considered for a study committee titled Examination of Front of Package Nutrition Rating Systems and Symbols (Phase I). The sponsors are the CDC and FDA.   The Phase I committee will undertake a review of front-of-package nutrition rating systems and symbols…[and] will also plan for a Phase II.

Phase I will (a) identify front-of-package systems being used, (b) consider their purpose and overall merits, (c) identify the criteria underlying the systems and evaluate their scientific basis, (d) consider advantages and disadvantages, (e) plan Phase II which will consider the potential benefits of a single, standardized front-of-package food guidance system regulated by FDA (my emphasis).

Send the names of candidates to front-of-pack@nas.edu by October 5, 2009. You do not need to contact the individuals you nominate.

This is great news but I’m way too impatient.  This two-phase process will take years. Is the FDA really going to have to wait that long to take action on front-of-package labels such as Smart Choices?

FDA: How about issuing a moratorium on all front-of-package labels until the committees do their work?

4.  Update, September 24: On that very issue, Congresswoman Rosa de Lauro has asked the FDA to do an investigatation of the Smart Choices program.  Excellent idea!

The FDA just announced in the Federal Register that it plans to take a good hard look at public understanding of what’s currently on food labels.  It says it will do an Internet survey of 43,000 people to:

• Identify attitudes and beliefs to do with health, diet and label usage
• Determine relationships between these attitudes and beliefs, demographics, and actual label use
• Look at the relevance of these attitudes
• Identify barriers to label use

I hope they ask me!

What is this about?  Let me take a wild guess: Health claims?  Smart Choices labels?  Anything that makes people think highly processed foods are good for them?  Or distracts from the Nutrition Facts panel?

The FDA is required to allow 60 days for comment.   Tell the FDA you think the more research it does on food labels, the better!

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.