The Center for Science in the Public Interest (CSPI) is readying a class-action lawsuit against Frito-Lay in Massachusetts, which has some of the most friendly pro-consumer protection laws in the country.
It is accusing the company of deceptively marketing its "light" potato chips, after forwarding more than 3,700 consumer health complaints to the Food & Drug Administration over the last nine years, including 396 it filed last week.
The chips are made with olestra, a fat substitute in foods and in processing, including frying and baking. The Clinton-era FDA approved olestra in 1996, with the specification that U.S. labels for foods including olestra must state that the fat substitute may cause abdominal cramping and diarrhea (Olestra, which is manufactured by Proctor & Gamble under the trade name olean, is a molecule of table sugar linked to soybean or cottonseed oil that is too large for the body to absorb or digest.) The warning was reviewed and confirmed in 1998.
The science behind the warning didn't change after President Bush took office in 2001, and yet, the Bush-era FDA in 2003 agreed with a P&G petition and concluded that the latter label statement was no longer warranted.
Why? Because of the merging of several events:
-- Several years of lobbying by P&G, with help from various conservative "experts" and conservative media.
-- Significant campaign contributions to key Republicans, including the Bush campaign in 2000.
-- A Bush Administration that heavily leans toward removing obstacles for its corporate friends.
Forget the 3,700 health complaints. Forget the science. This was a case of you scratch my back, I'll scratch yours. Regardless of whether the lawsuit succeeds — and it faces a huge uphill battle — consumers should ask themselves: did the Bush Administration look out for consumers' best interests when it reversed earlier FDA decisions, or did it look out only for its corporate friends?
The answer should be clear. Corporate interests came first. Here's how it happened:
P&G and Frito-Lay, a subsidiary of PepsiCo, had a lot riding on the success of olestra. P&G had spent $200 million over 25 years developing the fat substitute, and with Frito-Lay constructed a $200 million olestra-making plant in Cincinnati.
In the mid-1990s, P&G asked scientists — some of whom had earlier been paid P&G consultants, to write letters of recommendation for olestra. It also underwriting a 1996 conference whose panelists included a P&G scientist and two P&G consultants, the results of which were later published as a bound volume in the Annals of the New York Academy of Science, which are distributed to more than 700 libraries. By doing so, it could point to industry-friendly research in peer-reviewed scientific journals.
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Article comments
— go to most recent comments1 - Temple Stark
Ok, I'll be on topic here after mentioning Olestra elsewhere:
Your Olestra post is relatively weak. I just felt my bowels opening at the mere mention. Stretching here, and I'm not talking me. This was much more opinion-laden than usual and should not have been labeled news (which I know is beyond your control).
Olestra is the shit. So to speak.
(I avoid it though if it's in fat-free Pringles that may explain a few things as I occassionally for a change of pace, eat those.)
2 - david r. mark
Temple, telling me it's weak but not saying why isn't helpful. Are you just trying to crack wise? Or are you seriously criticizing the post?
3 - sal m
i'm not a fan of food substitutes, but i have some problems with the argument laid out here.
for starters, while it sounds like a "WOW," 3700 consumer complaints over 9 years amounts to about 1 a day. and there is no indication as to what the nature of these complaints are.
if you are going to argue with science, you need to provide "science" to make your point. the kind of anecdotal evidence that is provided by these complaints really doesn't mean much.
if you REALLY want to go find out about how this process worked, visit this link and you'll learn way more about about loose stools and such than you'd ever really want to know.
http://www.cfsan.fda.gov/~lrd/fr030805.html
as an example of anecdotal evidence, there are "statistics" that say in one year as many as 56,000 people went to emergencies in the United States due to symptoms that are related to tylenol poisoning, and that 100 people in a year have died from tylenol poisoning. this sounds way more serious than the "threat" posed by olestra.
injecting politics into the mix also undermines your argument, as you can cherry pick the list of contributors to The Center for Science and Public Interest and make the case that THEY have a political agenda.
and looking at the other issues pursued by CSPI, they wanted to put warning lables on soda cans that dealt with a soda drinking/childhood obesity link despite the fact that studies found that there was no such link.
oh and the CSPI in their study of soda drinking, incorrectly doubled the amount of soda consumed by teens and had to issue a correction after their press release went out touting the "dangers" of soda.
a year ago CSPI filed a lawsuit to try to change the standards with regards to how much salt can be in packaged foods. when the lawsuit was ignored, they filed a petition with the FDA to get the status of salt, yes salt, changed have it removed from the list of "recognized as safe" substances.
i could go on, but you should get the point by now...provide science to back up your claims and don't mix politics and science, while you're at it.
4 - david r. mark
It's hard not to inject politics when you see how it came to be that the earlier FDA decisions were reversed. The politics are pretty obvious to me, given who was recruited to advocate for the change, and who actually made the change, and what kinds of lobbying and campaign contributions occurred during the period of change.
This isn't an article about science. I state that two P&G studies offered the science, and two earlier FDA decisions were made in part using the P&G science. The science hasn't changed. The formula for olestra hasn't changed, and there haven't been any additional non-industry (non-partisan) studies to suggest the effect on people has changed.
All that's changed is the politics.
CSPI has faults? Sure. That's not really the point, though. If the lawsuit is without merit, it won't go anywhere. They are planning a lawsuit, though, for seemingly legitimate reasons. My goal was to provide some history so the issue -- a history that to the best of my knowledge is factually accurate and well-attributed.
5 - gonzo marx
why is this particulat INstance so fascinating?
well two words...words that were REQUIRED to be on the original warning label by the FDA
"anal leakage"
now, try marketing somthing with THAT on the label
nuff said?
Excelsior!
6 - Matthew T. Sussman
I must forcibly disagree Gonzo. Ashlee Simpson's first album went triple platinum.
7 - Dave Nalle
for starters, while it sounds like a "WOW," 3700 consumer complaints over 9 years amounts to about 1 a day. and there is no indication as to what the nature of these complaints are.
In fact, given all the publicity that Olestra got for causing 'anal leakage' the fact that there were this few people who complained is truly miraculous. The anal leakage scare alone could easily have generated this many hypochodriac panics.
But what really makes this article even worse than David Mark's usual biased twaddle is that the fundamental premise of this article is ridiculous. All we're taking about here is a name change for marketing purposes, not some grand conspiracy or an effort to defraud the public. If there's a problem with Olestra the blame falls not on Bush, but on the Clinton administration's FDA which approved the creepy stuff in the first place back in 1996.
As for "A Bush Administration that heavily leans toward removing obstacles for its corporate friends." That's utter bullshit in this case as well, though it may certainly be true as a general practice in the administration of supporting and encouraging business - which BTW is NOT a bad thing.
But in the case of Olestra and the FDA, the situatiojn is entirely different. Consumer groups have been screaming for years that the FDA was taking too long to approve new products, especially drugs. Bush is just responding to that demand. The tenuous suggestion of bribery in the article is completely unsupported and once again this is just a lame attempt at a smear.
Dave
8 - david r. mark
If there's a problem with Olestra the blame falls not on Bush, but on the Clinton administration's FDA which approved the creepy stuff in the first place back in 1996.
>>
The Clinton-era FDA approved it with the warning label. It then reviewed and maintained the label in 1998. It was the Bush FDA that decided it didn't need the label. So that's why the Bush FDA should be blamed.
Consumer groups have been screaming for years that the FDA was taking too long to approve new products, especially drugs. Bush is just responding to that demand.>>
olestra isn't a drug, so I don't see this as apples for apples.
And it's laughable to say that Bush is responding to demand for quicker drug approval by removing a warning label on a product. What kind of logic is that?
If the Clinton FDA had refused olestra, and the Bush FDA had supported it, maybe your argument would make sense.
But you are basically ignoring a host of facts. I assume that's because you can't refute them.
-- P&G lobbied hard, and incrasingly lobbied and contributed to Republicans to try to reverse the 1998 FDA decision.
-- P&G used junk science to try to defend itself, and found a willing accomplice in pro-business conservatives.
-- The science hasn't changed regarding olestra. The formula is the same since the P&G studies in 1993 and 1995, which supported the need for the warning label -- and were in fact a component of the original FDA decision.
9 - david r. mark
By the way, CSPI wasn't the only forwarding complaints of intestinal distress to the FDA. So the 3,700 number might be misleading -- much lower than the true number.
Check out this CSPI release.
10 - sal m
when you look at the reason the warning label was put on the packaging in the first place this conspiratorial, "blame bush and the conservative businessmen" argument becomes even more specious.
The warning label was NOT put on the packaging as a warning to tell people olestra was dangerous. here is an excerpt from the report from the Federal Register,
"In comments to the 1996 final rule, CSPI and an individual consumer
requested that the label statement be placed on restaurant menus so
that diners will not unknowingly consume olestra at a restaurant.
FDA disagrees with these comments. FDA concluded in the 1996 final
rule that the use of olestra in savory snacks meets the safety standard
for food additives, reasonable certainty of no harm (61 FR 3118 at
3167). The label statement required by the 1996 final rule was never
intended to prevent illness or warn against conditions of use that may
be harmful as the agency concluded in 1996 that olestra is safe for its
intended use in savory snacks even without the label statement. FDA
required that olestra-containing foods bear the label statement to
provide information about the presence of the vitamins listed in the
ingredient statement and about potential nutrient and GI effects of
olestra. FDA determined that these statements were necessary at the
time to ensure that olestra-containing foods are not misbranded within
the meaning of the act (61 FR 3118 at 3168)."
11 - david r. mark
On January 24, 1996, the FDA approved olestra for use in savory snacks such as chips, crackers, and tortilla chips. There were conditions: though olestra had been determined to be safe, all snacks containing olestra would have to carry a label that stated:
This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added.
A second condition of FDA approval was a requirement that Procter & Gamble, which makes the fat, and Frito-Lay, which manufacturers and sells the chips, report on any adverse health effects.
-- “Advisers Consider Label Change for Chips Made With Phony Fat,” Associated Press, June 17, 1998
12 - david r. mark
I don't believe I said the warning was menat to say the product was dangerous. I stated what the warning said, and why (it was supported by P&G's own studies, in 1993 and 1995.)
13 - Dave Nalle
So is your argument now that there are adverse health effects? 3700 complaints in 9 years out of hundreds of thousands of people who have eaten the chips and probably billions of instances of consumption? That's not even statistically significant.
Dave
14 - sal m
and one more thing, if the CSPI was so concerned with the public health issue of GI distress - and the associated problems it brings about - they should pursue the cause of putting warning labels on containers of milk to protect those of us who are lactose-intolerant.
given the prevalence of us "L-I'ers" our plight is much more of a problem than those of the people who can't tolerate olestra.
15% or caucasians, 50% of mediterranians, 75% of african-americans and 95%(!) of asians are lactose intolerant...these are the folks that need the help of the CSPI! especially when you consider that left unaddressed, people who continue to consume lactose-laden products are prone to malnutrition and weight loss, we have a real need for help here.
15 - david r. mark
Sal, I'm sure there are lots of things that CSPI could focus on. But that doesn't make its case against olestra -- which it has fought against since 1996 -- any less worthy.
16 - david r. mark
Dave, as I said in comment #9, the 3,700 number may be understating the number of complaints filed with the FDA.
my argument is that there has always been a health issue, but that the Bush-era FDA -- siding with corporate friends instead of consumer protection -- reversed two earlier Clinton-era FDA decisions. There was no science to back that up -- except for the industry-backed science P&G whipped up. The thing that changed was that P&G's campaign contributions and other lobbying efforts -- which increasingly went to Republicans after the second FDA ruling, in 1998 -- paid off when the GOP took over the White House.
17 - Dave Nalle
So 3700 is just your guess? Does the FDA not post figures on this? To be more accurate, the number the FDA claims is 800 complaints. CSPI has gone out looking for complaints and has managed to trump up more than 15,000 additional complaints. How valid they are is anyone's guess.
Here's another figure. In the first 2 years it was available 150 million bags of chips were sold which had been fried in Olestra. Sales dropped off some after that, but at this point a reasonable estimate would be total sales of 500 million bags.
So let's take the high figure of 15,000 complaints and divide it into 500 million bags. That's 1 complaint per 33,333 bags sold or .003% of the bags produced a complaint.
Compare that with complaint rates for other products. For example, Vioxx. 100 million prescriptions, with estimates as high as 50,000 deaths associated with the drug. Frankly, I think most of the claims are spurious, but it's still a fair comparison. That's a .05% rate of 'complaint', 17 times as high as Olestra, and here we're talking about people dying, not just a bad taste or some 'anal leakage'. I have yet to hear of a claim of death associated with Olestra, except for one claim in the case of one person who already had life-threatening medical/digestive problems.
More people get sick every year from hundreds of drugs and food additives which no one is considering banning. I'm no fan of Olestra - wouldn't touch it with Sharks lips. But nonetheless, this kind of crusade is totally out of proportion to any real problem that might exist.
Dave
18 - david r. mark
The 3,700 figure is from the CSPI press release from Wednesday. The 20,000 figure is from a 2002 press release, and factors in complaints about olestra generated for the FDA by P&G.
I didn't make up anything.
Of course, not everyone with a problem complains to the FDA. I don't know where you got your 500 million bags of chips figure, so it's hard for me to comment on it.
And yes, there are other things to complain about. Maybe you can write articles about them. I'm writing about this because CSPI announced it's planning a lawsuit -- and I think it has a legitimate beef. I also think that the Bush-era FDA failed consumers with its pro-industry decision. I think its a reflection of P&G's hefty contributions to Republicans in the late 1990s, and the amount of money it spent trying to pass off junk science as legitimate.
I hope the lawsuit is successful, although I doubt it will be.
19 - Dave Nalle
The 500 million bags of chips is from a P&G 1998 press release.
For the record, I've already written on similar topics, like the Vioxx lawsuits and weight loss pills.
My concern here is about issues like the extreme and gratuitous litigiousness of our society and of course your suspect motivation for promoting this issue way out of proportion to its actual significance. We're talking about a tiny number of people adversely effected by this product in very minor ways.
Hundreds, perhaps thousands of food additives, 'dietary supplements' and actual foods have far worse effects and are sold with no warnings at all. You're not taking issue with them. In fact, the only discernable reason why you're raising this issue at all is that it serves your anti-corporate, anti-Republican interests to bring it up and try to make something trivial into a manufactured scandal.
Hey, you want a crusade? How about going after the various democratic administrations of the past (Wilson, Roosevelt, Johnson) which gave away free cigarettes to soldiers on behalf of the tobacco industry to addict generations of Americans and ultimately cause millions of deaths. That's a real issue.
Dave
20 - Andy Marsh
How come there's no warning on cucumbers..they give me gas...or cabbage for that matter! How come there's no warning on the exceptible way to eat a banana? or an ice cream cone? I do so love to watch a good lookin woman eat an ice cream cone!!! Maybe that's why...
Now you know folks...when you're in the elevator and the guy next to you lets that green cloud go...it's Bush's fault! and all along you thought that tsunami he caused was bad.
Dammit, I want to know when something I'm eating is gonna create an uncomfortable environment for my family! Damn that George Bush!
21 - gonzo marx
Andy...are you off yer meds again?
just curious
as fer bananas, cucumbers and cabbages...yer supposed ta EAT them...NOT "insert" them
i guess some folks DO need warning labels
{8^P~~~~~~~~~~~~~~~~~~
ah well...
Excelsior!
22 - david r. mark
Again, these other things may all be worthy of a good fight. But that doesn't take away from the importance of the Olestra issue.
The problem is not just the health concerns over olestra. Those are well documented, and haven't changed in more than a decade, since P&G's last study.
The concern is
a) the Bush Administration placing corporate interests above consumer protection, for no real reason other than to help out a campaign contributor.
and b) Frito-Lay being able to deceive consumers into thinking they aren't eating olestra. If the Bush Administration hadn't allowed Frito-Lay to remove the warning label, then Frito-Lay changing the product name wouldn't have been important.
But because of the favorable 2003 FDA decision, Frito-Lay was able to change the brand name, remove the warning label, and in effect trick consumers into eating a product that apparently causes some of them intestinal discomfort, diarrhea, and/or anal leakage.
And that's what has the CSPI upset, and that's why I thought it was worthy of writing about.
23 - Andy Marsh
I can't even imagine a cabbage...but anyway!
gonzo - this guy is getting all worked up because the FDA took a warning off a product informing people that it may make them fart!
Come on, we're not talking about the warnings on cigarettes here. We're talking about a product that generates about a complaint a day for the last almost 10 years! Holy fuck! Is everything Bush's fault? You read this guy and the sun setting is Bush's fault! I'm waiting for the next story of his "Bush makes sun disappear from sky!"
He gets called out on his bullshit and then he says, as in comment #9, that his original story "may be a bit misleading". Everything this guy writes belongs under opinion...and BC actually needs to start another section called BULLSHIT...then he could file all his stories under the opinion section of the BULLSHIT section!
24 - Dave Nalle
Andy, I wouldn't label David's writing 'bullshit'. It's mostly true. I'd have it labeled 'propaganda', because while the factual information is correct, the conclusions and implications he pulls out of those facts are wild distortions.
This article is a perfect example, as you point out. He's taken a completely trivial issue which makes no difference to anyone and presents it as if it's a terrible scandal with the Bush administration intentionally victimizing and deceiving the American People. Totally blown out of proportion.
Dave
25 - Mark Saleski
while the factual information is correct, the conclusions and implications he pulls out of those facts are wild distortions
look into the mirror.