FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro
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November 20, 2013
On November 19, 2013, USPLabs added a product to the recall of OxyElite Pro dietary supplement products that was originally announced on November 9. The product added was Raspberry Lemonade OxyElite Pro Super Thermo Powder in 4.6 oz. containers with UPC #094922447494.
The FDA along with the Centers for Disease Control and Prevention (CDC) and state and local health officials are investigating more than 50 cases of acute non-viral hepatitis. As of October 31, 2013, 56 cases had been identified. Among these cases, 22 people have been hospitalized, two people have received liver transplants, and one person has died.
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.
By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.
In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.
The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.
On November 9, 2013, USPlabs LLC, of Dallas, Texas, recalled certain OxyElite Pro dietary supplement products that the company markets. The products involved in the recall include:
OxyElite Pro Super Thermo capsules
2 count capsules UPC #094922417275
10 count capsules UPC #094922417251
10 count capsules UPC #094922417268
21 count capsules UPC #094922426604
90 count capsules UPC #094922395573
90 count capsules "Pink label" UPC #094922447906
180 count capsules UPC #094922447852
OxyElite Pro Ultra-Intense Thermo capsules
3 count capsules UPC #094922447883
3 count capsules UPC #094922447876
90 count capsules UPC #094922395627
180 count capsules UPC #094922447869
OxyElite Pro Super Thermo Powder
Fruit Punch 0.15 oz UPC #094922417237
Fruit Punch 0.15 oz UPC #094922447517
Fruit Punch 4.6 oz UPC #094922426369
Fruit Punch 5 oz. UPC #094922447487
Blue Raspberry 4.6 oz UPC #094922426376
Grape Bubblegum 4.6 oz UPC #094922447500
Green Apple 4.6 oz. UPC #094922426499
On November 19, 2013, USPLabs added a product to the recall of OxyElite Pro dietary supplement products that was originally announced on November 9. The product added was Raspberry Lemonade OxyElite Pro Super Thermo Powder in 4.6 oz. containers with UPC #094922447494. Images of the labels of recalled products can be found here.
In the interest of protecting public health, we are moving quickly to learn as much as possible. We recognize that people will be concerned about these illnesses, and we will provide updates as the investigation develops.
Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.
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 retail stores, mail orders and direct delivery.
Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 am - 5 pm EST) or by e-mail at email@example.com<mailto:firstname.lastname@example.org>.
Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.
If you think you have suffered a serious harmful effect or illness from a dietary supplement, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or report online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.
Consumers may also report an adverse event or illness they believe to be related to the use of a dietary supplement by calling FDA at 1-800-FDA-1088 or online. FDA would like to know when a product may be related to a medical problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
For more information:
- FDA: USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
- FDA: FDA Investigates Acute Hepatitis Illnesses Potentially Linked to OxyElite Pro
- FDA: Dietary Supplements – Adverse Event Reporting
- FDA: New Dietary Ingredient Notification Process