I heard this one on the radio a week or so ago. I have a tough time with this one. The FDA is letting some medications walk out the front door without even a passing glance and causing heart attacks a suicidal tendencies. They can't stop these mega huge prescription drug companies so they need to go and beat up on General Mills for Cheerios? If this isn't a case of fighting the fights you think you can win, I don't know what is.
This really aggravates me. The FDA is supposed to protect us from dangerous drugs and bogus claims, but all I've seen them do recently is protect the pharmaceutical companies from non drug alternatives. I have no doubt that Cheerios lower cholesterol any more than oranges treat scurvy, but if you claim even that today you are asking for trouble. I'm just waiting for a drug to treat obesity to be released then the FDA can start going after exercise equipment manufacturers and health food producers.
I understand the arguments of both sides. I wonder if they changed the methods to something like "Foods high in soluble fiber, like Cheerios, have been shown to reduce cholesterol levels" rather than advertising the product itself as the drug. A statement that can be backed up by science, while not making a claim that Cheerios is doing something different from other Wheat O's off brands or other fibrous breakfast products.
I assume GM would then say "well that ruins our whole campaign!"
But then again, who is requiring them to show proof of that claim at all? Through in the qualifier "may" and all of a sudden all responsibility goes out the window. The FOOD and drug admin should be handling this. I know it seems like they're picking on Cheerios, but you need to have a big enough case to make your point that it should be regulated.
I'm firmly under the belief that ANY product that claims a health benefit AT ALL should be required to prove it through trials and tests before being allowed to use it as part of the products marketing.
I can understand they argument against allowing companies to make any claim they wish, but if I'm not mistaken that isn't the problem. If I own a company and we do a study showing that our food product has certain health benefits, and then if I use that for marketing the FDA can turn around and classify my product as a drug and then require clinical trials for me to market it. The FDA is not supportive of the consumer anymore they support the drug companies in a sort of sick symbiotic relationship. If a natural plant was found to cure cancer there would be no way for anyone to market it as such unless it went through clinical trials, and there are no companies that would pay the cost for something that anyone can produce. So these days, unless it is a drug it can't be marketed to treat anything, even if it actually does treat something.
On the other hand you can have drugs that barely escape the placebo effect in trials, but are marketed to treat conditions.
The end result is drugs that are expensive to research and produce, and widely available alternatives that cannot be marketed as such. I don't like snake oil medicine, but what we have now is laughable and the consumer loses the most.
Theres a similar row going on with the FDA and plastic cigarettes (nicotine inhalers)
If you say they are to help people quit smoking they become a medical treatment and the FDA ban them - if you advertise them as just another way of smoking then the FDA don't care.
So the FDA is busy banning a popular way of quitting smoking for the good of people's health.
What bothers me is that due to legislation about 10 years ago, the suppliment companies are exempt from the type of treatment Cheerios got. Cheerios don't kill people, yet they get in trouble with the FDA, while many suppliments do kill people, yet are exempt, by law, from oversight.
Sports Illustrated just had a lengthy article about just how bad the suppliment industry is and how easy it is for anyone to make and market their own suppliment.
Those are my sentiments exactly as I read this thread.
Maybe it's just a matter of HOW Cheerios says what they say though. Instead of saying "Cheerios reduces cholesterol," say, "Cheerios are recommended as part of a cholesterol-reducing diet." Because, realistically, just adding Cheerios to your diet isn't going to reduce your cholesterol if you keep eating the 20 oz steak every night and have a couple of eggs fried up in butter with the Cheerios in the morning. The cholesterol reducing part is to substitute high-cholesterol foods with high fiber and low cholesterol foods.
I suppose the best interpretation of the FDA having no authority over herbal supplements is that they are neither food nor drug, therefore should not be considered fit for human consumption.
This sort of thing makes my blood boil:
In September of 2005, Council for Responsible Nutrition (CRN) senior vice president of scientific and international affairs, John Hathcock, PhD, wrote a letter to the FDA stating that “Pyridoxamine is unequivocally a dietary ingredient because it is one of the three primary natural forms of vitamin B6, and it is one of the two predominant forms in animal products used as human foods.”
But now, thanks to a petition filed with the FDA by Biostratum, the North Carolina-based manufacturer of a pyridoxamine-based drug called Pyridorin, which is designed to prevent the progression of diabetic nephropathy (kidney disease), on January 12 the FDA announced that pyridoxamine dihydrochloride was a “new drug.” This means that the FDA has now effectively prevented any substance containing pyridoxamine from being marketed as a dietary supplement. Never mind that the fish on your lunch salad and the chicken on your dinner table both contain pyridoxamine, as does brewer’s yeast!
The status of pyridoxamine has been debated by Biostratum and the Council on Responsible Nutrition (CRN) via FDA petitions since July, 2005. The issue was whether pyridoxamine was protected by DSHEA, the law protecting supplements passed in 1994.
Marketing pyridoxamine as a dietary ingredient is fully supported by the science behind this form of vitamin B6. The CRN statement warns that a precedent could be established in which the status of other ingredients is challenged as well. Companies have to keep long-term records to make sure they can substantiate that an ingredient has in fact been marketed previously as a dietary supplement. A key vitamin form that is presently at risk is P5P, the natural form of B-6 that can be used directly by the body without conversion. Because some people have difficulty converting synthetic B-6 to P5P, elimination of P5P could make them entirely dependent on drugs for survival (human beings cannot live without B-6). Yet another drug company petition has asked the FDA to ban P5P just as it has banned pyridoxamine. If you have not already sent a message to the FDA against banning P5P, please do so now.
This action by the FDA speaks to the fundamental need for reform of the agency. AAHF believes the FDA needs complete reform and restructuring in order to rebuild the American healthcare system and make it once again the envy of the world. Visit www.ReformFDA.org[/URL] to sign the petition and learn more.
In 1998, the FDA tried to ban a product (Cholestin) containing red yeast rice extract but the U.S. district court in Utah allowed the product to be sold without restriction. This was reversed on appeal. (Moore, 2001) (see ref.: PDRhealth). Cholestin as a product continues to be marketed but no longer contains red yeast rice (RYR). Other companies sell red yeast rice products but most of them use a different strain of yeast or different growing conditions, resulting in RYR with a negligible statin content. The labeling on these new products often says nothing about cholesterol lowering. As late as August 2007, FDA noted supplements being sold containing significant lovastatin levels.(FDA, 2007)
The simple answer is that the FDA should have the authority to regulate anything that is consumed by humans: food, drugs, supplements, vitamins, etc. Then they can write their own definitions rather than be constrained by the definitions the lawmakers have forced them to work under.
It just seems that the FDA too readily capitulates to the industry it's supposed to regulate. Are they going to pull vitamins off the shelf because they are "tainted with pharmaceuticals"? They're supposed to protect the consumer, not the pharmaceutical company's collective wallet.
I apologize for the rant, it's just beyond belief, the government is banning vitamins now!
Well, I do wish they DID regulate all the vitamins on the shelves. Afterall, if you buy a bottle of vitamin tablets, wouldn't you like to be sure you're getting something that really is safe to consume, and doesn't include any other harmful inactive ingredients, forms of the vitamin that can't be absorbed, and includes the dose of vitamin it says it includes?
Amen! Unregulated vitamins and "food supplements" can harm a lot of people who might otherwise have been better off choosing a healthier diet.
That's a totally different topic. B6 isn't getting scrutiny because it's dangerous, it's getting scrutiny because someone decided to use it as an active ingredient in a pharmaceutical. Again, just to clarify: my beef is with regulating substances because the pharmaceutical companies asked them too.
They do regulate vitamins. There is a list with the dose of each vitamin included with DRV, the forms of different vitamins that are absorbable are debatable, and what constitutes a 'harmful inactive ingredient'? Sure they don't give vitamins the same scrutiny that prescription medicines have, but c'mon do you want them giving that kind of scrutiny to everything they have domain over? Are we someday going to need a prescription to eat a cheeseburger?
I really don't know where you are getting this. Yes some diet supplements have this problems, but they are all stimulants. You don't see the FDA cracking down on coffee or alcohol which can both cause a lot of harm if taken excessively. Sure a healthier diet would be nice, but we have lost huge amounts of some vitamins from our food supply due to mass production.
I quite like the system of government where we decide what authority the government has in our live not the opposite. If people were dying from B vitamin complexes or overdosing on Cheerios I might agree with you, but most of this push to get rid of anything that claims to have health benefits is from the pharmaceutical companies. If we continue down this path the treatment for scurvy will be prescription "scurvex" instead of an orange and you better believe it will cost more.
There's a small trade war at the moment between the FDA and India over 'bio-piracy'. A couple of US pharma-companies and the University of Mississipi are claiming that India is not upholding their patent on using tumeric to clean wounds.
The Indian claim for prior art was rejected, apparently the Indians who started using it a couple of thousand years ago forgot to file the claim with the USPTO.
I'm waiting for the Luxor to sue Egypt for copying it's pyramid shape.
I did decide! I decided I want the government to regulate product safety. All product safety.
Cheerios isn't in trouble for what they have in their food, they are in trouble for how they are advertising it. You're reacting to a problem that doesn't exist.
I don't know for sure, but I suspect that the current way it works with the FDA is a result of backlash against that suppliment law. They've been so restricted from common sense powers that they go after whatever they can.
Too bad they aren't regulating red yeast rice, vitamin B6, etc. due to safety concerns, they're doing it because the pharmaceutical companies are telling them too. It's ludicrous.
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