Ingredient spurs firm to recall two sports supplements

5:53 AM, Nov 22, 2013   |    comments
Physique Enhancing Science is recalling certain lots of Enhanced, a pre-workout supplement, because the company says it contains the "unapproved" dietary ingredient aegeline. (Photo: Physique Enhancing Science)
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(USATODAY.com) - Another sports supplement company is recalling products containing an ingredient flagged by federal regulators as lacking evidence of safety.

Physique Enhancing Science, also called PES, this week launched a recall of certain lots of Enhanced, a pre-workout supplement, and Alphamine, which is sold as a fat burner.

Both products contain aegeline, an ingredient flagged by the U.S. Food and Drug Administration during its investigation of an outbreak of dozens of liver injuries linked to a weight-loss supplement made by a different company: USPlabs' OxyElite Pro. Health officials have said it's not clear whether aegeline or something else in OxyElite Pro is the culprit. USPlabs launched a product recallthis month.

PES officials have not responded to USA TODAY's repeated requests for interviews since Nov. 14 about the company's use of aegeline in its products. PES' website last week said Enhanced was "currently under reformulation" with a new formula expected in January. After the newspaper's calls, the Enhanced webpage was changed to say: "This product has been discontinued."

In the recall notice posted on the PES website, the company said it's requesting customers return certain lots of Enhanced distributed between Feb. 4 and Nov. 5, and certain lots of Alphamine distributed between Sept. 9 and Nov. 12. Details are on the company's website:pescience.com/recall.

"PES has received no serious adverse events from either of these products, but out of an abundance of caution we are requesting their return," the notice says.

The company says the recall is happening because the products contain aegeline, "an unapproved New Dietary Ingredient according to the FDA."

It is unclear whether the FDA played a role in the PES recall, given no notice of it has appeared on the agency's website. FDA officials were not immediately available for comment.

The PES recall notice is dated Tuesday but wasn't posted on the firm's website until sometime late Wednesday.

The products are sold through a variety of online retailers.

"GNC has received and issued the recall of the Alphamine and Enhanced products per the vendor's instructions. Any further questions concerning these products or their recall should be addressed to the vendor," GNC spokeswoman Laura Brophy said in an e-mail after USA TODAY inquired about the recall Wednesday morning.

The FDA sent a warning letter last month to USPlabs notifying the Dallas-based company that it deemed OxyElite Pro and another supplement, VERSA-1, to be adulterated because they included aegeline as an ingredient. The FDA said it considers aegeline, a compound found in an Asian tree, to be a new dietary ingredient that lacks a history of use or other evidence of safety in the United States prior to 1994, a key regulatory date.

USPlabs has said that aegeline has been consumed safely for centuries. Still, the company told the FDA in a Nov. 4 letter that it was discontinuing use of the ingredient in the United States because of the negative publicity and that it had destroyed its distribution center inventory of supplements containing it.

To report adverse events involving dietary supplements, call the FDA at: 800-332-1088.

To read more articles in USA TODAY's "Supplement Shell Game" series, go tosupplements.usatoday.com.

Follow USA TODAY investigative reporter Alison Young on Twitter: @alisonannyoung

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