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FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled Oxy
October 11, 2013
The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.
FDA advises consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 because these products contain an ingredient, aegeline, for which the manufacturer has not provided adequate evidence of safety.
In a warning letter issued to USP Labs LLC of Dallas Texas on October 11, 2013, the FDA informed the company that the dietary supplements OxyElite Pro and VERSA-1 are deemed to be adulterated, and that failure to immediately cease distribution of these products may result in enforcement action by the FDA.
The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling) which lacks adequate information to provide reasonable assurance of safety.
Specifically, USP Labs failed to provide the FDA with evidence, as required by law, that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was safe for use in its dietary supplements.
Additionally, in the warning letter, the FDA relayed findings suggesting that a causal connection may exist between the use of a product labeled as OxyElite Pro and a number of liver illnesses reported in Hawaii.
On October 8, 2013, the FDA posted a statement on its website advising consumers of an ongoing investigation related to a growing number of reports of acute non-viral hepatitis in Hawaii and further advised consumers not to use the dietary supplement product labeled OxyElite Pro while the investigation is still ongoing. Today the FDA is advising consumers not to use an additional product produced by USP Labs labeled VERSA-1.
The FDA continues to work with its federal, state, and local partners in this investigation.
FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro
October 11, 2013
The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.
FDA advises consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 because these products contain an ingredient, aegeline, for which the manufacturer has not provided adequate evidence of safety.
In a warning letter issued to USP Labs LLC of Dallas Texas on October 11, 2013, the FDA informed the company that the dietary supplements OxyElite Pro and VERSA-1 are deemed to be adulterated, and that failure to immediately cease distribution of these products may result in enforcement action by the FDA.
The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling) which lacks adequate information to provide reasonable assurance of safety.
Specifically, USP Labs failed to provide the FDA with evidence, as required by law, that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was safe for use in its dietary supplements.
Additionally, in the warning letter, the FDA relayed findings suggesting that a causal connection may exist between the use of a product labeled as OxyElite Pro and a number of liver illnesses reported in Hawaii.
On October 8, 2013, the FDA posted a statement on its website advising consumers of an ongoing investigation related to a growing number of reports of acute non-viral hepatitis in Hawaii and further advised consumers not to use the dietary supplement product labeled OxyElite Pro while the investigation is still ongoing. Today the FDA is advising consumers not to use an additional product produced by USP Labs labeled VERSA-1.
The FDA continues to work with its federal, state, and local partners in this investigation.
FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro
