FDA’s letter to Dallas, TX-based USPlabs said if the company did not initiate a voluntary recall, the agency could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. According to the agency, it is the second time FDA has exercised its recall authority under the Food Safety Modernization Act (FSMA).
In a statement on the recall, USPlabs said that “Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii. Investigations are ongoing into a potential causal relationship. The company agrees with FDA that a national recall is appropriate as a precautionary measure.”
USPlabs said the recalled products were distributed nationwide through retail stores, mail orders and direct delivery. The company said the following products and lot numbers were affected:
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.
Month long investigation
FDA began investigating the spate of liver injury reports in early October. In a statement given to NutraIngredients-USA at that time, the company said it was cooperating with FDA’s investigagtion and went on to say: "The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market.”
“Out of an abundance of caution, the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed. The company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii.”
According to the FDA, the company has also informed the Agency that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time. FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
In addition to the recall letter from FDA, USPlabs has also receved a high-profile inquiry from Sen. Dick Durbin, D-IL, seeking answers to questions on OxyElite Pro and its ingredients.
Questions have swirled around one of the ingredients in the formulation, aegeline, an alkaloid found in the leaves of the bael tree. At issue is the regulatory status of the ingredient. Mentions of the botanical can be founding the Herbs of Commerce reference book, meaning it could be construed to be an Old Dietray Ingredient under DSHEA, but whether this applies to purified forms of the compound is another matter. FDA has also questioned via a warning letter to USPLabs whether the ingredient is a lawful dietary ingredient in the first place, which would lead to the charges of adulteration.
A search on the PubMed database showed that eight papers have been published related to aegeline since 1965, with the majority being published since 2011 and referring to potential anti-adipogenic properties, as well as potential activity to control blood sugar and blood lipid levels.