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IMAGE SOURCE: Bayer Heart Advantage web site
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Drug maker Bayer is in hot water with the federal government.
Bayer is illegally marketing two aspirin products called Heart Advantage and Bayer Woman that have not been proven to work and mislead consumers, according to the Food and Drug Administration (FDA).
Bayer combines aspirin with a plant extract, phytosterois, calling the aspirin Heart Advantage and claiming it helps control cholesterol. Another aspirin formulation combined with calcium carbonate is called Bayer Woman’s and is labeled that it “fights” osteoporosis and strengthens bones.
In an FDA warning letter sent to the German conglomerate, the agency claims that Bayer has overstepped the restrictions on claiming that an over-the-counter can treat specific diseases.
"These statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used," the FDA wrote in an Oct. 27 warning letter.
Here is some of the language the FDA objects to in its letter:
"DIETARY SUPPLEMENTS OR FOOD CONTAINING AT LEAST 400MG PER SERVING OF FREE PHYTOSTEROLS, EATEN TWICE A DAY WITH MEALS FOR A DAILY TOTAL INTAKE OF AT LEAST 800 MG, AS PART OF A DIET LOW IN SATURATED FAT AND CHOLESTEROL, MAY REDUCE THE RISK OF HEART DISEASE BY LOWERING BLOOD CHOLESTEROL. EACH BAYER ASPIRIN WITH HEART ADVANTAGE DUO-CAP CONTAINS 400MG OF FREE PHYTOSTEROLS."
Generally drug makers are discouraged from repackaging supplements with drugs because it gives the impression both have had an FDA review. Supplements, vitamins and herbs do not have FDA approval because they do not have to prove they are safe before they are sold in the U.S.
The letters have no weight of law, but the FDA can take Bayer to court for attempting to circumvent the drug approval process.
The agency allows traditional over-the-counter pain relievers to be sold without review.
Both Reps John Dingell and Bart Stupak of Michigan brought the Bayer’s Heart Advantage to national focus when they asked the company to turn over research proving the Bayer products had a positive impact on cholesterol and osteoporosis.
"It's shameful that consumers have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns," Stupak said in a statement accompanying the letter to Bayer.
Meanwhile the American Herbal Products Association wants the FDA to issue guidelines on drug and supplement products, rather than just forbid them. #