FDA issues warning about MMS use
ROCKVILLE, Md. The Food and Drug Administration on Friday issued a warning to consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”
The product, when used as directed, produces an industrial bleach that can cause serious harm to health.
The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.
Consumers who have MMS should stop immediately using it and throw it away.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.
The product instructs consumers to mix the 28% sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea and symptoms of severe dehydration.
MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.
The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.
The FDA advises consumers who have experienced any negative side effects from MMS to consult a healthcare professional as soon as possible and to discard the product.
Bayer Diabetes Care updates devices under National Glycohemoglobin Standardization Program
TARRYTOWN, N.Y. Bayer Diabetes Care has successfully completed certification of its A1CNow+ and A1CNow Selfcheck devices under a tighter performance certification standard that went into effect Jan. 1.
The new performance certification standards applicable to devices that measure A1C (or glycated hemoglobin) as set by the National Glycohemoglobin Standardization Program (NGSP) changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.
Bayer received a new NGSP certificate valid from July 1, 2010 through July 1, 2011. The previous criteria for last year’s NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range.
FDA issues warning letter to Abbott Diabetes Care manufacturing plant
ROCKVILLE, Md. The Food and Drug Administration earlier this week posted a July 2 warning letter addressing quality concerns at an Abbott Diabetes Care manufacturing plant.
The warning letter outlined some of the specific violations of good manufacturing practices for the manufacturer of the FreeStyle blood glucose meter, including not following through on reports concerning empty blister packs being produced on the Noack Blister Packer at one of Abbott’s establishments. Similarly, an exception report initiated on April 8, 2008, for scratches on FreeStyle Lite strips was closed with no corrective action or effectiveness check, the agency stated.
Abbott is working with the FDA to address the agency’s concerns.