Other safety alerts
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| The United States: FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro |
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The US 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.
The FDA advises consumers to discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1 while the investigation continues. OxyElite Pro and VERSA-1 are distributed by USPlabs LLC of Dallas, Texas, and are sold nationwide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. Consumers who believe they have been harmed by using a dietary supplement should contact their healthcare practitioner.
Please refer to the following website in FDA for details:
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/../ucm370849.htm#problem
In Hong Kong, the above products are not registered pharmaceutical products. News regarding OxyELITE Pro has been released by FDA and was posted on the Drug Office website on 9 October 2013. A press release was issued to appeal the public not to buy or use oral product labelled as OxyELITE Pro on the same day.
Ends/ Tuesday, October 15, 2013
Issued at HKT 15:00 |
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