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FDA Sends Warning Letter to OxyElite Pro, VERSA-1 Manufacturer over Adulterated Ingredient

October 14, 2013 – Last week, the U.S. Food & Drug Administration (FDA) sent a warning letter to USPlabs, the company that makes OxyElite Pro and VERSA-1, because the supplements were found to contain an adultered ingredient called aegeline. USPlabs never submitted a notification to the FDA for aegeline, making the ingredient illegal to use in dietary supplements. OxyElite Pro has been the subject of much controversy in recent weeks, having been linked to nearly 30 cases of liver failure and acute hepatitis in Hawaii.

OxyElite Pro Lawsuit Update 4/16/14: Earlier this month, a panel of federal judges denied a motion by the makers of OxyElite Pro and Jack3d to transfer and consolidate a number of products liability lawsuits to federal court in Philadelphia. The litigation contends that the supplements contained altered ingredients that were unsafe and unapproved by the FDA, leading to a nationwide hepatitis outbreak. Click here to learn more.

Free VERSA-1 Lawsuit Evaluation: Schmidt & Clark, LLP, is currently investigating the potential for serious life-threatening injuries including liver failure related to the use of VERSA-1. If you or somebody you know has been injured by VERSA-1, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of VERSA-1 and we can help.

What’s the Problem?

In October 1994, Congress passed the Dietary Supplement Health and Education Act, which requires manufacturers to inform the FDA at least 75 days in advance of selling products with new ingredients. These companies must demonstrate that new ingredients are “reasonably safe” and not chemically altered. USPlabs never submitted a notification to the FDA for aegeline in OxyElite Pro and VERSA-1, making the ingredient adultered and illegal to use in dietary supplements.

In April 2012, the FDA sent a similar letter to USPlabs over OxyElite Pro, which at the time contained a controversial ingredient called 1,3-dimethylamylamine (DMAA). In both warning letters, the administration ordered USPLabs to discontinue the production and distribution of the supplements or face enforcement action. USPLabs argued unsuccessfully that DMAA was a natural geranium extract, and the company was forced to reformulate OxyElite Pro without the ingredient.

OxyElite Pro Linked to Hepatitis, Liver Failure

In October 2013, the Hawaii Department of Health (DOH) banned OxyElite Pro throughout the state after at least 24 cases of acute hepatitis and liver failure were linked to the supplement. Of these cases, 11 patients were hospitalized, two were forced to undergo liver transplants, and a 48-year-old mother of seven died as a direct result of her injuries. The FDA said it is attempting to determine whether counterfeit versions of OxyElite Pro, which are believed to be widely available in Hawaii and all around the country, caused any of the cases of hepatitis or liver failure.

VERSA-1 Class Action

USP Labs and GNC are offering rebates of up to $300 per customer under the terms of a settlement in an VERSA-1 Class Action Lawsuit. The complaint accused the companies of false and misleading claims relating to Oxy Elite Pro, Jack3d and VERSA-1. USP Labs and GNC have denied any wrongdoing but agreed to the settlement in order to avoid more costly litigation.

Do I have a VERSA-1 Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in VERSA-1 lawsuits. We are handling individual litigation nationwide and currently accepting new VERSA-1 cases in all 50 states.

Free VERSA-1 Lawsuit Evaluation: If you or a loved one has been injured by VERSA-1, you should contact our law firm immediately. You may be entitled to compensation by filing a VERSA-1 suit and we can help.

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