Wednesday, May 13, 2009

Your Cereals are on Drugs!!

Uhh oh... Here we go again. The Food and Drug Administration has sent a threatening letter to General Mills warning them that Cheerios are a new unapproved new drug. 

You didnt misread that, no, the FDA is now stating that a breakfast cereal invented in 1941 is an Unapproved New Drug. 

Heres an excerpt:

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:

• "you can Lower Your Cholesterol 4% in 6 weeks" " 
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 
1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. 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.

Followed shortly by the allegation that the box is mislabeled because it makes the inappropriate,  untested and unproved claim that eating healthy is good for you. 

Your Cheerios ® product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because it bears unauthorized health claims in its labeling. We have determined that your website is labeling for your Cheerios® product under section 201(m) of the Act [21 U.S.C. § 321 (m)] because the website address appears on the product label. This website bears the following unauthorized health claims:

  • "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."

Jebus. is there anyone out there (other than my dear friend Bilgeman) who still thinks the FDA is a regulatory agency tasked with guarding public health, and not a part of a huge Pharmaceutical Cartel Protection Racket tasked with dismantling and destroying anything that might threaten Drug Company profits by so much as hinting that you dont need to take handfulls of patented pills to be healthy? Red Yeast, Vitamins, Fish, and now Cheerios?

The FDA has grown in size 1,000% since 1955, and in the same time period, the time to bring a new life saving drug to market has tripled. The FY 2008 budget was 2,300 million dollars, and is set to expand this year, not to provide more regulation to protect the public health, but to more effectively provide the protectionism that the american medical industry requires to maintain profits in such an unbalanced market.

As i said in Confronting the Cost of Addiction:
The FDA is the reason most of the people i know travel out of their home country to buy the medicine they need to ensure their health, when the other countries have similar regulations, but the drugs are cheaper, because their parasitic regulator cartels haven't yet grown as fat, and without such massive parasitism and protectionism, the general cost of health care would be a fraction of what it is today, as evidenced by the market of "medical tourism", a sad state of affairs if ever Ive seen one.
This rising cost is felt across the board, and now, might even effect your breakfast.

1 comment:

chris horton said...

They will never stop over-reaching will they? (ALL of them)