Tag Archives: regulation

FDA Says Cheerios Is an Unapproved Drug

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A box of Cheerios breakfast cereal.

Hey, General Mills: If you want to say Cheerios is “clinically proven to lower cholesterol,” you better get your whole-grain Os approved as a new drug by the FDA.

That’s what the FDA told the company in this letter, which says the labeling on Cheerios boxes is in “serious violation” of federal rules. The letter continues:

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.

What’s more, the letter says, Cheerios “may not be legally marketed with the above claims in the United States without an approved new drug application.” (WSJ).

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No Legal Shield in Drug Labeling, Justices Rule

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Very disappointing to Big Pharma, which of course only accepts greater regulation in hopes it will protect it.

“The court, by a 6-to-3 vote, upheld a jury verdict of $6.7 million in favor of a musician from Vermont whose arm had to be amputated after she was injected with an antinausea drug. The drug’s manufacturer, Wyeth, had argued that its compliance with the Food and Drug Administration’s labeling requirements should immunize it from lawsuits.” via NYTimes.com.

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The Maggots in Your Mushrooms

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Making the Peanut Butter and Jelly Sandwich

“The Georgia peanut company at the center of one of our nation’s worst food-contamination scares has officially reached a revolting new low: a recent inspection by the Food and Drug Administration discovered that the salmonella-tainted plant was also home to mold and roaches.

You may be grossed out, but insects and mold in our food are not new. The F.D.A. actually condones a certain percentage of “natural contaminants” in our food supply — meaning, among other things, bugs, mold, rodent hairs and maggots.

In its (falsely) reassuringly subtitled booklet “The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Foods That Present No Health Hazards for Humans,” the F.D.A.’s Center for Food Safety and Applied Nutrition establishes acceptable levels of such “defects” for a range of foods products, from allspice to peanut butter.” — EJ Levy via NYTimes op ed.