News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
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Sunday, November 10, 2013
USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
From the FDA this weekend:
The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.
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.
“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”
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
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.
In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.
In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.
If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it 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 can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or email@example.com.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.