USPlabs LLC is a dietary supplement manufacturer/distributor based in Dallas, Texas, that claims to offer a wide selection of safe and effective products to aid in weight loss and bodybuilding. Several of the company’s products have come under scrutiny in recent year, including OxyElite Pro and VERSA-1. In November of 2013, USPlabs “voluntarily” withdrew and recalled certain OxyElite Pro formulations after the product was implicated in numerous reported cases of serious liver dysfunction, including acute hepatitis, which resulted in at least one death, according to our OxyElite Pro recall lawyer.
The company received a letter from the FDA in advance of the recall in which the agency contends that OxyElite Pro contains an ingredient, Aegeline, which has not been shown to have a history of safe use when used in an extracted or concentrated form. OxyElite Pro, recently fell under the scrutiny of the FDA, CDA, and Hawaii Department of Health. These sources believe that OxyElite Pro could be associated with cases of acute hepatitis, liver disease, and one death.
According to the FDA, OxyElite Pro contains an ingredient called aegeline. In a recent letter to USPlabs, the FDA stated that the aegeline is a “new dietary ingredient… which lacks adequate information to provide reasonable assurance of safety.” A short time later, USPlabs discontinued distribution of OxyElite Pro and VERSA-1, another supplement containing aegeline.
OxyElite Pro Recall
On November 9, 2013, USPlabs agreed to recall the following OxyElite products:
OxyElite Pro Super Thermo capsules
- 180 count capsules UPC #094922447852
- 2 count capsules UPC #094922417275
- 10 count capsules UPC #094922417268
- 90 count capsules “Pink label” UPC #094922447906
- 10 count capsules UPC #094922417251
- 21 count capsules UPC #094922426604
- 90 count capsules UPC #094922395573
OxyElite Pro Ultra-Intense Thermo capsules
- 90 count capsules UPC #094922395627
- 3 count capsules UPC #094922447883
- 180 count capsules UPC #094922447869
- 3 count capsules UPC #094922447876
OxyElite Pro Super Thermo Powder
- Fruit Punch 4.6 oz UPC #094922426369
- Fruit Punch 0.15 oz UPC #094922417237
- Fruit Punch 0.15 oz UPC #094922447517
- Green Apple 4.6 oz. UPC #094922426499
- Blue Raspberry 4.6 oz UPC #094922426376
- Grape Bubblegum 4.6 oz UPC #094922447500
- Fruit Punch 5 oz. UPC #094922447487
The initial recall by USPlabs did not involve VERSA-1, another “dietary supplement” marketed by the company that contains Aegeline. However, FDA has recommended that consumers “discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1” while an investigation of Aegeline and the reported liver injury cases continues.
Past Lawsuits & Run-Ins with the FDA
The recall of OxyElite Pro is only one example of disputes between USPlabs and some of its officials and government regulators and law enforcement agencies in the United States an abroad. According to an expose about the company published in USA Today, USPlabs CEO Jacob Geissler, who serves on the board of the American Herbal Products Association, was indicted on a controlled substance charge involving possessing thousands of pills containing anabolic steroids in 2003. In 2011, a USPlabs product known as Jack3D was implicated in the deaths of four army soldiers who collapsed while exercising.
A department of defense investigation later concluded that Jack3D could not be definitively linked to the death, but the military nevertheless banned Jack3D and all other dietary supplements that contain the “natural” stimulant DMAA (methylhexanamine). In addition, in 2012-13, the FDA took action against USPlabs when it determined that DMAA was an illegal dietary supplement ingredient and threatened enforcement proceedings against the company if it continued to sell Jack3D or OxyElite Pro, which at the time contained the banned substance. USPlabs ultimately agreed to cease distribution of the product and to destroy all remaining DMAA-containing products at its manufacturing facility.
Consumers are Not Protected from Dangerous Dietary Supplements
Why have companies like USPlabs been allowed to manufacture and market dangerous and even illegal products? The answer lies in a huge loophole in federal regulations designed to protect consumers.
The FDA has the authority to require the makers of prescription drugs to prove that new drugs are both safe and effective before they can be marketed to consumers. Drugs must be carefully tested, first in animals, and then in human subjects, in controlled clinical experiments designed to determine whether new substances may be harmful.
Conversely, dietary supplement manufacturers are not required to obtain FDA approval to market their products. This is because the supplement industry was able to lobby Congress to pass very relaxed regulations on these products.
As a result, the safety profile of new supplement ingredients may be unknown until enough consumers are exposed and serious side effects are discovered. Complicating matters further is the fact that FDA’s recall authority is limited; it may take months or years before supplement manufacturers are forced to stop making dangerous products.
Moreover, consumers who are injured by these products often have no legal remedy because many dietary supplement companies are “fly-by-night” operations with few assets and little or no products liability insurance.
Related OxyElite Pro Information
- Senator Durbin’s letter to USPlabs, expressing his concern about OxyElite Pro
- An Alarming CDC Report regarding OxyElite Pro and 45+ case of liver illness
- Information about VERSA-1, another supplement containing aegeline
- More information about the specific products recalled by USPlabs LLC
Protect Yourself from Dangerous Supplements
How can you protect yourself and your family from dangerous products? First, you should question the claims made by supplement companies. Few supplement claims of health benefits are backed up by good science. Second, always consult your doctor before starting a supplement. Many products may be safe when taken by healthy individuals, but serious side effects may occur in people who have preexisting disorders such as heart and liver disease.
Contact The Senators Firm Today
If you or someone you love suffered severe liver damage or acute hepatitis while taking OxyElite Pro or VERSA-1, speak with our team of California defective drug attorneys today. The Senators Firm has years of experience representing people who have been injured by a variety of dietary supplements. We can rapidly evaluate your potential claim and help you achieve the maximum possible financial recovery. Contact us today.