Warning: Cheerios is a drug says FDA :-) [modified]
-
I think this is a shake down of General Mills.... but thats just me. click[^] ...Unapproved New Drug Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label: ... (they can't even spell 'on' correctly) :doh: ---edit-- add link here fore Cheerios claim click[^]
modified on Friday, May 15, 2009 11:07 AM
-
I think this is a shake down of General Mills.... but thats just me. click[^] ...Unapproved New Drug Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label: ... (they can't even spell 'on' correctly) :doh: ---edit-- add link here fore Cheerios claim click[^]
modified on Friday, May 15, 2009 11:07 AM
<blockquote class="FQ"><div class="FQA">kmg365 wrote:</div>I think this is a shake down of General Mills.... but thats just me.</blockquote> Or, maybe manufacturers really shouldn't promote their product with misleading health claims that the average consumer isn't adequately equipped to or inclined to evaluate. I mean, seriously, your biggest take-home message from this seems to be that the FDA misspelled 'on' but they make some excellent points about the claims the box makes versus what the best evidence actually suggests about the role of fiber in preventing heart disease.
- F
-
<blockquote class="FQ"><div class="FQA">kmg365 wrote:</div>I think this is a shake down of General Mills.... but thats just me.</blockquote> Or, maybe manufacturers really shouldn't promote their product with misleading health claims that the average consumer isn't adequately equipped to or inclined to evaluate. I mean, seriously, your biggest take-home message from this seems to be that the FDA misspelled 'on' but they make some excellent points about the claims the box makes versus what the best evidence actually suggests about the role of fiber in preventing heart disease.
- F
-
Added link on first post for Cheerios claim; Do you think Cheerios claim is true? What if it is, should they still pull the ad since it falls under fda's classification of a drug?
I think GM is being exceptionally clever in their wording and that is misleading. Take this for example: Eating Cheerios each day, as part of a diet low in saturated fat and cholesterol, can help lower your cholesterol, and that could help reduce your risk of heart disease. The statement is technically true - because there is excellent evidence to suggest that more fiber = lower cholesterol. There is also excellent evidence that high cholesterol is implicated in a higher risk of heart disease - so if you have high cholesterol, and lower it, you're reducing your risk of heart disease. Hence the 'could.' However: 1) AFAIK, there is no good evidence that lowering cholesterol in the absence of hypercholesterolemia will reduce your risk of heart disease 2) There is no direct evidence that eating Cheerios reduces the risk of heart disease - essentially, they're making an argument based only on plausible speculation, which is something not generally allowed by the quintessential health claimants, drug companies. Because they're not addressing those two points, the text is misleading, and since they're straying into the avenue of health claims, they're being asked to put up or shut up, the FDA's motivation for this notwithstanding. My tinfoil hat would suggest that this is less of the FDA going after the GM as the pharmaceutical lobbies taking greater notice and crying foul. Does it really matter? I would say your average Joe without high cholesterol would read that text and assume that eating Cheerios would give him protection against heart disease - but that hasn't been adequately demonstrated. [edit/afterthought: to clarify point 2, it's possible (but unlikely) that Cheerios has an ingredient in it that actually raises the risk of heart disease which is why it's not sufficient to go on "it has fiber" because you could, for example, eat twelve bacon-fat-and-fiber sandwiches a day but you're probably not lowering your risk for cardiac disease ;P ]
- F
modified on Friday, May 15, 2009 12:10 PM
-
I think this is a shake down of General Mills.... but thats just me. click[^] ...Unapproved New Drug Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label: ... (they can't even spell 'on' correctly) :doh: ---edit-- add link here fore Cheerios claim click[^]
modified on Friday, May 15, 2009 11:07 AM
-
I think GM is being exceptionally clever in their wording and that is misleading. Take this for example: Eating Cheerios each day, as part of a diet low in saturated fat and cholesterol, can help lower your cholesterol, and that could help reduce your risk of heart disease. The statement is technically true - because there is excellent evidence to suggest that more fiber = lower cholesterol. There is also excellent evidence that high cholesterol is implicated in a higher risk of heart disease - so if you have high cholesterol, and lower it, you're reducing your risk of heart disease. Hence the 'could.' However: 1) AFAIK, there is no good evidence that lowering cholesterol in the absence of hypercholesterolemia will reduce your risk of heart disease 2) There is no direct evidence that eating Cheerios reduces the risk of heart disease - essentially, they're making an argument based only on plausible speculation, which is something not generally allowed by the quintessential health claimants, drug companies. Because they're not addressing those two points, the text is misleading, and since they're straying into the avenue of health claims, they're being asked to put up or shut up, the FDA's motivation for this notwithstanding. My tinfoil hat would suggest that this is less of the FDA going after the GM as the pharmaceutical lobbies taking greater notice and crying foul. Does it really matter? I would say your average Joe without high cholesterol would read that text and assume that eating Cheerios would give him protection against heart disease - but that hasn't been adequately demonstrated. [edit/afterthought: to clarify point 2, it's possible (but unlikely) that Cheerios has an ingredient in it that actually raises the risk of heart disease which is why it's not sufficient to go on "it has fiber" because you could, for example, eat twelve bacon-fat-and-fiber sandwiches a day but you're probably not lowering your risk for cardiac disease ;P ]
- F
modified on Friday, May 15, 2009 12:10 PM
Fisticuffs wrote:
My tinfoil hat would suggest that this is less of the FDA going after the GM as the pharmaceutical lobbies taking greater notice and crying foul.
GM could always work with the big pharms and say, "A diet of Cheerios, together with Rx..."