Following on Hawaii liver injury reports, USPlabs issues national recall of OxyElite Pro

11-Nov-2013 - Last updated on 11-Nov-2013 at 16:48 GMT

"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 [...] The company agrees with FDA that a national recall is appropriate as a precautionary measure.” - USPLabs statement

Related tags Fda

Sports supplement manufacturer USPLabs has recalled lots of its OxyElite Pro products after receiving a letter directing the action from FDA motivated by reports of liver illnesses in Hawaii associated with the product. FDA also it directed the recall because of “a reasonable probability that the products are adulterated.”

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).

Epidemiological evidence

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.”

Counterfeit versions?

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.

Ingredient questions

Bael fruit — One of the ingredients in OxyElite Pro, aegeline, is said to come from the leaves of the bael tree. The fruit is shown here.

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.

PubMed

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.