Currently browsing posts about: FDA

Keeping up with BPA is a headache.  BPA, you may recall from previous posts, is an endocrine disrupter increasingly associated with developmental disorders in experimental animals and with heart disease and diabetes in humans.  Is it OK to feed infants out of plastic bottles or not?

A new study out of Harvard says that BPA leaches out of plastic bottles even when what is in them is cold.  This, according to the investigators, means that even more BPA will get out when bottles are heated, as is typical of infant formulas.

But European and British Food Standards Agencies say they see no reason to review their previous decision that BPA is safe at current usage levels.

In contrast, the FDA has just announced that it intends to take another look at its previous judgment that BPA is safe.  This action is viewed as evidence that the new FDA Commissioner, Margaret Hamburg, means it when she says the agency’s decisions will henceforth be based on science, not politics.

As for the politics: the chemical industry says Chicago’s ban on plastic baby bottles and sippy cups is scientifically absurd.  And another industry group firmly denies that it was involved in a disinformation campaign using pregnant women to promote the safety of BPA.

Expect more of the same while waiting for the results of the FDA’s ongoing research review.  And in the meantime, why not switch to glass bottles for infant feeding (or breast feed for that matter)?

If the FDA is now going after health claims (see yesterday’s post), will it also start going after dietary supplements?  These, as I explained in my most recent column in the San Francisco Chronicle, get to make all kinds of unsubstantiated claims without the FDA being able to do much about them.  More and more evidence is coming in suggesting that supplements can be harmful as well as ineffective.   The latest example: antioxidant supplements are said to interfere with the beneficial effects of physical activity.    Will such studies encourage the FDA to insist that manufacturers demonstrate safety and efficacy before they put supplements on the market?  That would be a refreshing change, no?

It looks like the FDA is finally getting around to looking at the absurd health claims on boxes of breakfast cereals.  And about time too, I’d say.  For starters, the FDA picked on General Mills’ Cheerios.  Cheerios boxes display banners claiming that if you eat this cereal, you will reduce your cholesterol by 4% is 6 weeks (see previous post on this).  This, General Mills says, is “clinically proven.”  Yes, but the trial on which General Mills bases this claim substitutes one serving of Cheerios for each of two meals a day.  Hey – that ought to work!

In its warning letter, the FDA says that if Cheerios lowers cholesterol, it is claiming to work like a statin drug.  If Cheerios acts like a drug, it has to be treated like a drug.  Cheerios, says the FDA, “is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore…it may not be legally marketed with the above claims in the United States without an approved new drug application.”

So what’s going on here?  I collect cereal boxes and I’m guessing that I bought the one shown here at least two years ago.  The boxes have changed since then but similar claims appear on the Cheerios website.  Maybe in this new administration the FDA can get a grip on silly and misleading health claims.  Let’s hope.

Update May 18: Advertising Age advises marketers about how to avoid FDA interference: know the rules, don’t assume that breaking them is OK even if you have done so for a long time, follow the rules.  Seems like good advice.

Update May 25: Europeans applaud this FDA action. They think we have gone much too far with health claims.

Update January 18, 2010: At a visit to the FDA last week, I saw a more recent Cheerios box that I somehow missed – lower your cholesterol by 10% in one month.  This one disappeared quickly, but I found a good description of what happened on the Consumer World Mouse Print site.  General Mills sponsored a study and rushed the box into print.

According to the Associated Press, Margaret Hamburg “breezed through” her Senate confirmation hearing yesterday.  Great news, and I was pleased to hear that she thinks food safety is a top priority. So what’s the hold up?  Everybody – even Senator Ted Kennedy – knows food safety is in crisis and needs strong leadership to get the system under control.  Why can’t Congress approve her appointment right away and send her off to work?  Don’t you think something is seriously wrong with a political system that holds food safety hostage to partisan politics? Let Congress know you want action in this area!  Tell them to approve this appointment now!

Confronted with the proliferation of symbols on food labels ostensibly designed to alert customers to “better choices” of packaged foods (see my previous posts on this topic), the FDA held a hearing.  It has now followed up with a memo on what it plans to do about them.  The agency posed many sensible questions about the criteria, use, and interpretation of such symbols at the hearing, but heard “little evidence.”   The FDA wants more research before deciding what to do.

Fine, but in the meantime how about a moratorium on the use of all such symbols?  Just asking.

The April 26 New York Times Magazine carried a seductive ad on page 15 for PepsiCo’s “Trop50 orange juice goodness with 50% less calories and sugar…And no artificial sweeteners”  PepsiCo performs this miracle by diluting the juice by half with water (really, you could do this at home).  But in case the result isn’t sweet enough for you, Trop50 adds the sweetener, Stevia.

PepsiCo can get away with claiming that its juice drink has no artificial sweeteners.  Because Stevia is isolated from leaves of the Stevia plant, the FDA lets companies claim it is “natural.”

We can debate whether a chemical sweetener isolated from Stevia leaves is really “natural” but here’s another problem: Stevia doesn’t taste like sugar.  Companies have to fuss with it to cover up its off taste.  And, they must do so “without detracting from the perceived benefits of its natural status.”  Flavor companies are working like mad to find substances that block Stevia’s bitter taste, mask its off flavors, and extend its sweetness, while staying within the scope of what the FDA allows as “natural.”

Yesterday, I received an e-mail from a Stevia PR representative eager for me to see the company’s website.  “Naturally delicious” anyone?

Among the many publications that flood my snail mailbox is the trade magazine, Pacific Fishing. I’m not sure why it gets sent to me but I do look at it since it covers a world I know little about.   The May issue has several articles about banned pesticides in Chilean farmed salmon.  I had completely missed this story, even though the New York Times discussed the problem on February 5.  That was the day the Pew Environmental Group revealed the results of its FOIA (Freedom of Information Act) request to the FDA.  The otherwise undisclosed documents say farmed fish from Chile contains residues of pesticides banned by the FDA since 2007.

But Chile is not alone in using banned pesticides.  British Columbia salmon farmers use SLICE, a pesticide that kills sea lice.  Because such pesticides are toxic, it is not surprising that they also seem to be killing local prawns and other invertebrates along the Canadian West Coast.

A Pacific Fishing reporter, Don McManman, went to great pains to find out what the FDA was doing about all this.  His interview makes entertaining reading.  The FDA’s final answer?  Looking into it, apparently.

I’m wondering why the Pew Group had to file a FOIA request to get information that the FDA should be releasing to the public.  The lack of disclosure makes it appear that the FDA cares more about protecting the salmon farming industry than consumers, especially now that the public has the right to choose.  Seafood has Country-of-Origin labeling (COOL).  With COOL , you can see whether farmed salmon comes from Chile or British Columbia and decide for yourself whether you want to eat fish raised on pellets containing banned pesticides.

Want to check out the documents?  Go to the Pacific Fishing website, then Resources. Scroll down and look for “Insecticides–It’s What’s for Dinner,” “Chile Salmon Report,” and “Chilean Contamination History.”

According to press reports, investigators from a Mt. Sinai School of Medicine project funded by the Environmental Protection Agency (EPA), “Growing Up Healthy in East Harlem,” find higher levels of endocrine disrupters, mostly phthlates and bisphenol A, among obese girls (age six to eight) in East Harlem, as compared to girls who are not obese.   The actual research does not appear to be published yet – I can’t find it on the Epidemiology website – but the EPA’s site provides the latest report on the project.

Endocrine disrupters are widely used in food and beverage packaging materials, as well as things such as cosmetics, shampoos, lubricants, and paint. As I explained in earlier posts, federal agencies have been taking a hard look at such substances, particularly bisphenol A.  Their interim conclusion: such chemicals pose no harm at current levels of intake.

While waiting for more research or regulatory action, a group called As You Sow has asked food companies what they are doing about bisphenol A.  Its report, Seeking Safer Packaging, concludes that the companies it surveyed generally aren’t doing nearly enough.  A few companies – notably Hain Celestial, Heinz, and Nestle (no relation) do have plans to phase out these chemicals eventually.

Why isn’t there more research on endocrine disrupter chemicals?  Without it, we have only two choices: precaution or do nothing and see what happens.  In this instance, it looks like the evidence favors precaution.  Glass bottles, everybody!