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DMAA Supplement Makers Reformulate Products In Wake Of FDA Warnings | cialis online

DMAA Supplement Makers Reformulate Products In Wake Of FDA Warnings

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Following a warning letter issued by the U.S. Food & Drug Administration (FDA) regarding DMAA-containing supplements, makers of these products are beginning to reformulate the pre-workout products. Ten companies that manufacture and distribute dietary supplements containing dimethylamylamine, known as DMAA, were cited. The makers were warned for marketing products for which safety evidence was not submitted to the agency. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract and is often advertised as a “natural stimulant” in dietary supplements. Originally developed as a nasal decongestant, DMAA is now used in so-called “workout boosters” sold under brands including Lean Efx, Napalm, Nitric Blast, and Jack3D, explained NewsInferno. Last year, the Department of Defense banned sales of DMAA supplements at military base commissaries following two soldiers’ deaths which were linked to DMAA-containing products. “Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program. MuscleMeds, maker of Code Red, removed the product from its web site, noted CNBC. People answering its phones are also advising consumers that Code Red is being reformulated. Fahrenheit Nutrition indicated on its web site that its Lean EFX product no longer contains DMAA on the nutritional label. Both MuscleMeds and Fahrenheit Nutrition were among the 10 companies that received FDA warning letters, CNBC said. The FDA letter indicated that DMAA can narrow the blood vessels and arteries, which can raise blood pressure and may lead to cardiovascular events, including shortness of breath, tightening in the chest, and heart attack, said NewsInferno. To date, said the FDA, it has received 42 adverse reports on products containing DMAA, including psychiatric disorders and death. The letter stated that the agency had no evidence that DMAA should be classified as a dietary supplement, said CNBC. The firms involved must now prove DMAA should be classified as such. USP Labs, which received a letter, contends that

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DMAA is a dietary supplement because contains the geranium plant; however, at least seven current, published studies dispute that fact, said CNBC. This year, the American Herbal Products Association (AHPA), the only national trade association focused on herbs and herbal products, advised its members that DMAA should not be labeled as

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a product of geranium oil. Following a CNBC report this week, stopped direct sales of DMAA products; however, third-party sales continue, said CNBC. GNC Holdings Inc., which operates GNC health and wellness stores, disputed the FDA warning questioning DMAA dietary supplement safety. In a statement, GNC asserted that the FDA did not cite medical or scientific evidence indicating that DMAA is unsafe and maintains that, when used as directed, DMAA supplements have “the same effect on the body as drinking two cups of coffee.” GNC did not receive a warning letter; however, its stock fell following news of the warning. In February, GNC was one of several companies named in a California class action lawsuit accusing the defendants of making misleading claims about DMAA-containing Cellucor’s C-4 Extreme supplement and failing to disclose that DMAA is wholly synthetic, is manufactured, and is not a geranium plant derivative. If DMAA cannot be proved to be a derivative of the geranium plant, then the FDA can stop sales or seize products, said CNBC, which noted that DMAA has been banned in Canada since July when it was found that DMAA is not a dietary supplement and is a drug requiring approval.

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