The FDA Takes On Cheerios !

The FDA Takes On Cheerios!

                                                                           May 5, 2009

FDA WARNING LETTER

18

Ken Powell 
Chairman of the Board and CEO 
General Mills  

“The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) ...

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 on 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.”

------------------------------------------

The FDA, purportedly, is a consumer protection agency. It is part of the Agency of the U.S. Department of Health and Human Services. It inspects, tests, approves, and sets safety standards for foods and food additives, prescription and over-the-counter drugs, chemicals, cosmetics, and household and medical devices and labeling of such.

Not a bad mission. However, in this case absurd and revealing.

According to the FDA:

“The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading. If a (food) / dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the (food) / dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.”

Talk about false claims!

This circular thinking and FDA ‘Act’ is an incredible boon to the medical/pharmaceutical industry and a blow that undermines and threatens the natural foods/health and wellness industry.

If only a drug can “diagnose, treat, cure or prevent disease” then:

1. The reality of achieving true health through personal responsibility and lifestyle change is minimized, secondary to taking drugs, at best. This further promotes our perverted definition of health; as being on some medication to control some condition (cholesterol, blood pressure, blood sugar, anxiety, etc).

2. As this FDA warning letter proves, any/all, natural food or supplement that can prevent, treat or cure diseases can be labeled as a drug to be prescribed only by a medical doctor.

If this sounds like far-fetched science fiction, then you need to read about The Codex Alimentarius. (to be discussed in a future blog entry)

Since PDUFA (Prescription Drug User Fee Act) passed in 1992, most of the FDA's funding comes directly from the Pharmaceutical Industry. This is a conflict of interests that favors the drug industry and has seriously compromised the consumer protection role of the FDA.

Following the enactment of PDUFA, the time period for new drugs to be approved has dropped significantly while the number of new drugs approved has soared. This has had the predicable consequence of increased adverse-events; including, all too frequently, death; the ultimate adverse-event.

While a single FDA approved drug, Vioxx caused an estimated 140,000 people to have heart attacks and more than 55,000 deaths, no-one has ever been reported to suffer a single adverse-event from eating Whole Grain Oat Cheerios, even if they over-dosed.

The FDA, with its limited resources, should be targeting pharmaceutical companies with warning letters, not cereal manufacturers’ claims that “Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

This epitomizes an industry-subservient, through the looking glass, bureaucracy.