• Dentistry,  Food and Drug Administration

    Why is the FDA to Review Science Behind Ruling on Mercury in Dental Fillings?

    Existing fillings sometimes need to be replaced due to wear, chipping, or cracking. Many people use this opportunity to replace their silver amalgam fillings with natural, tooth-colored composites. Their reasons may be aesthetic, or concern over the safety of amalgam filings, which contain mercury.

    Food and Drug Administration (FDA) to review science behind ruling on mercury in dental fillings.

    Less than 18 months after concluding that mercury in dental fillings was not harmful to patients, the Food and Drug Administration is reviewing the scientific basis for its decision.

    A panel of outside experts will meet next week to consider challenges from four consumer and dental groups to the analysis that FDA used to justify its conclusion that mercury released from dental amalgam fillings is too low to cause harm.

    Agency officials said Thursday there’s no new evidence contradicting that assessment, and that “at this time FDA is not modifying its existing guidance.”

    The FDA’s position is supported by the American Dental Assn., which says that treatment decisions should be left to patients and their dentists.

    Opponents say FDA used flawed science in setting the safe level for mercury exposure too high, especially for pregnant women and children.

    They want dental amalgam either banned or subject to extensive testing to prove safety.

    The advisory committee will not vote on specific recommendations, but will discuss a series of technical questions about how exposure to mercury is measured, whether safe levels of exposure have been set correctly and the reliability of studies of mercury on humans.

    This is political payback by the Obama Administration to the “Holistic Dentistry” quacks who want to outlaw dental amalgam.

    Earth to FDA – most dentists are no longer using amalgam in restorations because of patient demand and the availability of better tooth-colored materials.

    Should dental amalgam be banned only the poor children who receive these long lasting and LESS EXPENSIVE restorations as a result of Medicaid or other government programs will be harmed.

    So, do your study again, waste more public money and come to the same conclusions.

  • Cheerios,  Food and Drug Administration,  General Mills

    Food and Drug Administration Warns General Mills: Cheerios Is a Drug

    cheerios

    The Obama Food and Drug Administration (FDA) has warned General Mills, the makers of Cheerios, that the labeling on Cheerios boxes is in “serious violation” of federal rules.

    The letter is here.

    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. 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, General Mills responded that it’s flap with the FDA is a miscommunication on their packaging.

    The science is not in question … the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution.”

    Ok, you would think the FDA would work with General Mills (which is a large food corporation) in formulating better language in compliance with the law rather than issuing a caustic legal missive which demands a fifteen day response.

    Wouldn’t cooperation and compliance be better for the American people than confrontation and gotcha?


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