Undisclosed prescription ingredients found in weight-loss or sexual enhancement pills are not behind the latest dietary supplement recall – instead, it's knife blades found in energy and whey protein drinks manufactured by Protica, Inc.
However, the firm marketing the New Whey brand protein drinks, IDS of Oviedo, Fla., says it recalled two lots of the product in February after a blade was discovered during a routine quality assurance inspection at its warehouse. FDA did not contact the firm and the agency's July 5 recall announcement "came out of left field," a company spokesman said.
Golden, Colo.-based iSatori Technologies distributes the recalled energy drinks also manufactured by Protica, Hardcore Energize Bullet. ISatori could not be reached to comment.
FDA said a utility knife blade was found in one 2.9-ounce container each of New Whey, which is marketed in the U.S. and Canada, and Hardcore Energize Bullet, which is available in Canada. No injuries linked to the products have been reported.
IDS worked with Protica to ensure that customers returned possibly tampered-with containers of New Whey. IDS "fired" Protica in February and has not had any reports of foreign objects in products provided by the firm's new manufacturing partner.
The firm's attorneys have contacted FDA to ask that it revise its July 5 release, according to the spokesman. Meanwhile, IDS will work on informing customers that the recall FDA announced was already conducted and no additional products should be returned.
Protica did not respond to a request for comment. FDA said the Whitehall, Pa.-based firm is investigating the suspected tampering,
Both products are sold in test tube-like vials. Hardcore Energize Bullet is available in two flavors, Blue Rage and Black Rush, and New Whey is available in Fruit Punch 25g and Blue Raspberry 42g varieties, FDA says here.
These recalls follow the recent guilty plea by an Arizona businessman on charges -- as FDA says here ---- linked to the sale of an herbal supplement containing sildenafil citrate, the active ingredient in Pfizer's erectile dysfunction drug Viagra, and they come as FDA continues an investigation of weight-loss supplements containing Rx ingredients.
The supplement industry has long pushed FDA and other regulatory authorities to crack down on sales of supplements – notably sexual enhancement and diet pills – suspected of containing Rx ingredients, as "The Tan Sheet" reports here and here.
However, the reports of a knife blade found in an energy drink and a liquid whey protein product – both marketed as nutritional supplements – could have the supplement industry answering questions about lax manufacturing standards and about firms' control over their production and packaging operations.
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-- Katie Stevenson (k.stevenson@elsevier.com) and Malcolm Spicer (m.spicer@elsevier.com)
