That's right -- a warning letter from the FDA for Cheeerios.
What's next? A black box-top?
I spoke with senior officials at the agency yesterday who were incensed that the Minneapolis field office sent out this letter. Just another example of the right hand not knowing what the left is doing. Interpret that as you like.
First sponsored Google links, now this. Is the FDA saying people should stop eating cholesterol-lowering cereals? Isn't that exactly the opposite of what the FDA wants people to do? Whatever happened to "Better Health Through Better Nutrition?"
My favorite part of the letter reads thus:
"Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application."
And voila, a new potential marketing opportunity -- follow-on cereals!
What's next? A black box-top?
I spoke with senior officials at the agency yesterday who were incensed that the Minneapolis field office sent out this letter. Just another example of the right hand not knowing what the left is doing. Interpret that as you like.
First sponsored Google links, now this. Is the FDA saying people should stop eating cholesterol-lowering cereals? Isn't that exactly the opposite of what the FDA wants people to do? Whatever happened to "Better Health Through Better Nutrition?"
My favorite part of the letter reads thus:
"Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application."
And voila, a new potential marketing opportunity -- follow-on cereals!
