OxyElite Pro is a dietary supplement sold as a “super thermogenic fat burner.” Various formulations have been linked to heart attacks, liver failure, and death. In 2015, the FDA found Prozac (fluoxetine) in OxyElite Pro. Now, our class action representatives are evaluating cases on behalf of anyone who purchased this product.
Do I Have an OxyElite Pro Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one bought OxyElite Pro Super Thermogenic or developed side effects, you should contact our lawyers immediately. You may be entitled to compensation by filing an OxyElite Pro lawsuit or joining a class action.
UPDATE: SK Labs Stays Open Despite Making OxyElite Pro
September 27, 2016 — With dozens of lawsuits filed over the deadly supplement OxyElite Pro, a Dallas judge has ruled that SK Laboratories will stay open despite making the product for Dallas-based USPLabs. Click here to read more.
November 18, 2015 — Federal officials arrested six executives of USPLabs as part of a crackdown involving OxyElite Pro, a supplement that contained synthetic amphetamine-like stimulants made in a chemical factory in China. Click here to read more.
March 2, 2015 — The FDA is warning consumers not to buy or use OxyElite Pro Super Thermogenic because it contains fluoxetine, the active ingredient in the antidepressant Prozac. Click here to read more.
January 16, 2015 — The FDA has opened a criminal mail fraud investigation of USPlabs over misleading statements about its sports supplements, such as OxyElite Pro. Click here to read more.
November 13, 2014 — USPlabs, LLC has agreed to pay $2 million to settle another false-advertising class action lawsuit in Florida, Velasquez v. USPlabs, LLC, and offer reimbursements to people who bought OxyElite Pro, Jack3D, and Versa-1. Click here to read more.
September 24, 2014 — Law360.com reports that USPLabs and GNC have agreed to pay $2 million to settle a class action lawsuit in Florida involving OxyElite Pro and Jack3D. Click here to read more.
September 17, 2014 — Hawaii News Now reports that dozens of lawsuits have been filed by people who took OxyElite Pro and developed liver damage in the last couple months. Of the 17 lawsuits involving 46 plaintiffs, at least 38 plaintiffs are from Hawaii. Click here to read more.
September 16, 2014 — USPLabs, LLC has filed a second motion (PDF) to centralize dozens of lawsuits involving OxyElite Pro and Jack3D supplements in a MDL. They were hit with another 12 lawsuits involving 40 new plaintiffs in the last few months. Click here to read more.
April 8, 2014 — Federal judges have decided against centralizing lawsuits and class actions involving OxyElite Pro and Jack3D into a Multi-District Litigation (MDL). Click here to read more.
April 7, 2014 — Experts are calling on the FDA to improve the safety of dietary supplements. According to CDC data, OxyElite Pro has been linked to 97 cases of non-viral hepatitis (non-contagious liver inflammation) in at 16 states, resulting in 47 hospitalizations, three liver transplantations, and one death. Click here to read more.
February 26, 2014 — 40 OxyElite Pro lawsuits have been filed in federal court, and new victims continue to come forward to report liver damage. Click here to read more.
February 19, 2014 — A putative OxyElite Pro class action lawsuit has been filed in New Jersey. The plaintiff was not injured but alleges that he never would have purchased OxyElite Pro if he had known about the risks. Click here to read more.
January 22, 2014 — USPLabs requests the centralization of OxyElite Pro lawsuits in a federal Multi-District Litigation (MDL), consolidating 9 lawsuits and 3 class actions involving 30 plaintiffs. Click here to read more.
November 22, 2013 — Two more lawsuits have been filed by Hawaiians who developed severe liver injuries after taking OxyElite Pro. Click here to read more.
November 19, 2013 — OxyElite Pro recall expanded to include Raspberry Lemonade OxyELITE Pro Super Thermo Powder.
November 18, 2013 — In a Consumer Update, the FDA announced that they will oversee the destruction of $22 million worth of OxyElite Pro. Click here to read more.
November 18, 2013 — 56 cases of liver damage from OxyElite Pro have been reported in 13 states, including California, Ohio, and Hawaii. Click here to read more.
November 10, 2013 — USPLabs LLC has voluntarily recalled OxyElite Pro after the FDA threatened to force a recall. Click here to read more.
Products included in OxyElite Pro recall:
- OxyElite Pro Super Thermo Powder
- OxyElite Pro Super Thermo Capsules
- OxyElite Pro Ultra-Intense Thermo Capsules
November 8, 2013 — The CDC has confirmed 56 cases of liver damage from OxyElite Pro. Most cases have been reported in Hawaii, but other cases have been confirmed on the mainland U.S. Click here to read more.
November 8, 2013 — USPLabs has agreed to re-fomulate OxyElite Pro to remove aegeline, an unapproved ingredient that the FDA has warned is illegal. Click here to read more.
October 18, 2013 — One case of liver damage in Hong Kong has been linked to OxyElite Pro. Yohimbine, a prescription drug, was also found in OxyElite Pro purchased over the internet by Singapore health authorities. Click here to read more.
October 14, 2013 — U.S. Marine Corps leads the way in banning OxyElite Pro on military bases. Click here to read more.
October 14, 2013 — FDA issues warning letter for aegeline, unapproved ingredient in OxyElite Pro and VERSA-1 that may be linked to liver injuries in Hawaii. Click here to read more.
October 11, 2013 — Central Texas health experts weigh in on OxyElite Pro removal request. An emergency room physician in Texas warns, “buyer beware” when it comes to using dietary supplements like OxyElite Pro for weight loss. Click here to read more.
October 10, 2013 — Counterfeit OxyElite Pro may be to blame for liver injuries in Hawaii. The FDA is investigating. User reports of fake OxyElite Pro and “bad batches” go back to at least 2010. Click here to read more.
October 9, 2013 — USPLabs has issued a statement on the liver injury epidemic linked to OxyElite Pro, calling it a “complete mystery” and cautioning that counterfeit products may be responsible. Click here to read more.
October 8, 2013 – OxyElite Pro will be removed from store shelves nationwide. USPLabs has agreed to stop selling the product until the CDC completes their investigation. Click here to read more.
October 8, 2013 – The FDA has issued a Drug Safety Communication to warn about the outbreak of non-viral hepatitis — 24 out of 29 people report using OxyElite Pro.Click here to read more.
October 3, 2013 — The Hawaii Department of Health has reported a cluster of at least 30 liver injuries have been associated with OxyElite Pro. At least one person has had a liver transplant, and many more are on a waiting list or are being evaluated for a transplant. Click here to read more.
Hawaii News Now Exclusive Reports
Hawaii News Now has been reporting on the sudden outbreak of liver failure cases linked to the use of OxyElite Pro in Hawaii. Below are links to the video library:
- Hawaii embargoes shipments of OxyElite Pro
- UPDATE:Woman who took diet pills dies of liver failure
- Dying woman’s family says she took diet pills before getting sick
- More cases of liver failure linked to diet supplement
- Gov’t shutdown impeding investigation into liver injury epidemic
- Hawaii State Department of Health – Hawaii Department of Health Oxyelite Pro Weightloss Supplement Pill Liver Failure Hepatitis Outbreak
- Centers for Disease Control and Prevention — Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building
- OxyElite Pro Liver Damage — Case Definition and Overview
- OxyElite Pro Recall — Information on Market Withdrawal
- OxyElite Pro Class Action — $2 million settlement in Jack3D/OxyElite Pro class action
UPDATE: $8 Million of OxyElite Pro, Jack3d Destroyed
July 16, 2013 –– Prosecutors from the Justice Department, on behalf of the FDA, have requested permission to seize 3,200 cases of DMAA products (Jack3D and OxyElite Pro) from warehouses owned by GNC in Pennsylvania and South Carolina. Click here to read more.
July 2, 2013 — The FDA has announced that USPLabs has voluntarily destroyed about $8 million worth Jack3D and OxyElite Pro stored at a facility in Dallas, Texas. Click here to read more.
April 16, 2013 — New FDA warning for DMAA. Click here to read more.
January 23, 2013 — USPLabs has agreed to settle a DMAA class action lawsuit for $2 million. Click here to read more.
April 27, 2012 — USP Labs, the manufacturer of OxyElite Pro, has been sent a Warning Letter from the U.S. Food and Drug Administration (FDA). The FDA has concluded that “synthetically-produced DMAA is not a ‘dietary ingredient’ and, therefore, is not eligible to be used as an active ingredient in a dietary supplement.” The company is being specifically cited for failing to provide the FDA with a New Dietary Ingredient (NDI) notification. By law, all supplements that contain ingredients introduced after 1994 must provide the FDA with an NDI with evidence of the safety of the ingredient. Because manufacturers have never provided the FDA with this information, supplements containing DMAA are adulterated. Furthermore, the FDA warns that DMAA side effects include blood vessel constriction, which can elevate blood pressure and increase the risk of deadly heart attacks.
August 2006 — The Washington Post reports that DMAA was first marketed as a supplement by Patrick Arnold, a chemist who served federal prison time for his role in the BALCO / Barry Bonds sports-doping scandal. Click here to read more.
OxyElite Pro Overview
OxyElite Pro is one of the most popular dietary supplements in the United States. It is mostly marketed toward people who work out a lot and are looking for extra weight-loss, an energy boost, or performance enhancement. It is sold by the Dallas-based USPlabs.
The label on OxyElite Pro claims that it is a “super thermogenic fat burner.” Thermogenic drugs, like caffeine and ephedrine, stimulate a person’s metabolism to produce more heat, which burns more calories. Thermogenic drugs can also cause a person to overheat and dehydrate, which can contribute to lethal exhaustion or other deadly cardiovascular side effects, especially during extended physical exercises.
OxyElite Pro contains DMAA, which is listed on the product label as “1,3-Dimethylamylamine (Geranium [stem]).” The evidence linking DMAA to the geranium plant, or any natural source, is very weak. Most experts do not believe that DMAA is a naturally occurring substance, and is actually a synthetic drug.
OxyElite Pro is sold for around $30-40, both online and by major dietary supplement stores such as GNC, which claims to have sold 440 million doses of DMAA products since 2007.
What is DMAA?
DMAA is a chemical that was first sold on the internet in 2006, by a chemist who bragged that he supplied steroids to BALCO. You may remember that BALCO was the company behind the Barry Bonds steroid scandal in 2002. The company gained fame producing “designer” stimulant drugs to professional athletes that would not be detected by drug tests, even at the Olympic level.
DMAA is banned by the World Anti-Doping Agency, which drug-tests professional athletes. It has also been banned by the Canadian and New Zealand government, following deaths and other adverse events.
DMAA appears on product labels under many names, including:
- Geranamine, Geranium oil, extract, or any part of the geranium plant
- methylhexaneamine (MHA)
Products containing DMAA include:
- USPlabs Jack3d (Tropical Fruit and Lemon Lime)
- USPlabs Oxy Elite Pro
- Nutrex Lipo 6 Black Caps (his and hers)
- Nutrex Lipo 6 Black Ultra Concentrated (his and hers)
- Nutrex Hemo Rage Black Powder (Punch and Berry)
- Isatori PWR
- Muscletech Neurocore
- Muscletech Hydroxyslim
- Fahrenheit Nutrition Lean EFX
- Muscle Warfare Napalm
- All American Efx K-Otic
- SNI Nitric Blast
- BIORhythm SSIN Juice
- Muscle Meds Code Red
- SEI MethylHex (4 and 2)
- Grenade (universal) Grenade
- M.A.P. (iovate) Arson
- Gaspari Nutrition Spirodex
Military Bans DMAA and OxyElite Pro on Military Bases
Following the deaths of two soldiers on the same base in the American Southwest, the U.S. Department of Defense has banned the sale of DMAA and products containing DMAA on military bases. The two soldiers who died both suffered fatal heart attacks. The first was a 22 year-old who collapsed during a training run. The second was a 32 year-old who collapsed during a physical fitness test, and died one month later in the hospital. Both men had DMAA in their bloodstream and were participating in difficult, high-endurance physical tests in the summer in the Southwest.
The military also received reports that other soldiers had suffered liver and kidney failure, seizures, loss of consciousness, and rapid heartbeat after taking DMAA.
DMAA and the Geranium Plant
Though the manufacturers of OxyElite Pro claim that the active ingredient in their product comes from the geranium plant, the evidence linking DMAA to a natural source is weak. It is based on a report in a Chinese technical journal from 1996. The people who produced the report took dried leaves of the geranium plant and ran them through a gas-spectrometer, which used an automated system to assign identities to 40 compounds it found in the leaves.
The results of this report have never been duplicated. No independent scientist has ever been provided with the cut and dried botanical samples that supposedly are behind DMAA.
Synthetic DMAA was first mass-produced by the drug company Eli Lilly in 1940. The company produced a nasal decongestant spray under the brand-name Forthane. Though Forthane never became popular, scientists studied the effects of DMAA in animals. A study published in 1950 found that DMAA was more potent than ephedrine, a similar drug. Ephedrine was once popular as a dietary supplement, but was banned after it was linked to deadly heart attacks.
OxyElite Pro Side Effects
Is OxyElite Pro safe to use? The reality is, no one really knows if DMAA is safe to use. Because it is sold as a “dietary supplement” instead of a drug, the manufacturers have never needed to submit safety data to a government agency. The FDA has never reviewed DMAA to determine whether it is safe or effective.
If you go to the website of USPlabs, you can find a list of seven studies of DMAA. With lots of bold writing, underlines, and links, it might appear that the company is providing solid evidence that DMAA and OxyElite Pro are safe and effective for weight-loss. The results of the studies are far from conclusive, however. Only 98 people participated in all seven studies, and many were taking a placebo. The results of these studies were “published” in an online journal, and the results were reviewed by volunteers. The journal is not affiliated with a major university or hospital.
Many people who take OxyElite Pro and other DMAA products use them “at their own risk.” If you read forums, comments, and other website regarding the safety of this drug, you may have seen people advocate “cycling” on and off the drug. It is important to know that some drugs actually become far more dangerous when a user is starting or stopping a drug. This is not a proven method for protecting yourself from the potential side effects of DMAA.
Other users advocate using “common sense” and only using “reasonable” amounts. However, there is very little scientific evidence regarding what a “reasonable” amount of DMAA is. Furthermore, a sample size of only 98 people is not enough to get a solid idea what adverse events may be caused by DMAA. Though the manufacturers claim that millions of people have used DMAA with no problem, the reality is, no one is keeping track of adverse events. Dietary supplement manufacturers are not legally required to keep track of adverse events, issue safety warnings, or report events to any government agency or authorities.
Health risks linked to the use of OxyElite Pro include:
- Cold sweats
- Increased blood pressure
- Liver and kidney failure
- Loss of consciousness
- Racing heartbeat
- Heart Attack
- Lethal exhaustion
Do I have an OxyElite Pro Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free OxyElite Pro lawsuit review.