Posted August 16, 2013

Maker of Energy, Weight Loss, Sleep and Vitamin D Supplements Warned for Manufacturing Violations

On July 22, 2013, the FDA issued a warning letter to N.V.E. Pharmaceuticals, Inc. following a facility inspection which found the company's products, including Stacker 2, Stacker 2 XPLC, Black Jax, Yellow Hornet, Extra Strength Xtra Energy Shot, Extra Strength 6 Hour Energy Shot, Extra Strength Extreme Energy Shot, Stacker 3 and Stacker 3 XPLC, DIET APPULOSS, 7-Phenyl Stack Diet and Energy, Extreme Energy Kickin Classic Zero, SLEEP EASE Shot and Vitamin D3 Shot, to be adulterated because they were packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish dietary supplement specifications for identity, purity, strength, failure to establish required specifications for certain steps in the manufacturing process, and failure to use sanitary handling procedures during filling, packaging, and labeling operations.

The FDA also noted that N.V.E.'s established procedure for product complaints is inadequate because it lacks details and directions for documenting and following up on product complaints.

Between October 2011 and June 2012, the company received 29 health related complaints - including a complaint of a heart attack, a possible allergic reaction, jittery, sick feeling, and a rash, associated with the use of Stacker 2, Stacker 2 XPLC, Black Jax, Yellow Hornet, Extra Strength Xtra Energy Shot, Extra Strength 6 Hour Energy Shot, Extra Strength Extreme Energy Shot, Stacker 3 and Stacker 3 XPLC - but was unable to provide sufficient information about these complaints to the FDA.

(See ConsumerLab.com's Reviews of Energy Supplements, Weight Loss Supplements and Vitamin D Supplements for tests of related products.)

In addition, Stacker 2, Stacker 2 XPLC, Black Jax, Yellow Hornet, Extra Strength Xtra Energy Shot, Extra Strength 6 Hour Energy Shot, Extra Strength Extreme Energy Shot, Stacker 3 and Stacker 3 XPLC, DIET APPULOSS, 7-Phenyl Stack Diet and Energy, Extreme Energy Kickin Classic Zero, SLEEP EASE Shot and Vitamin D3 Shot were found to be misbranded because the labels did not provide information required by federal regulations.

To read the FDA's warning, use the link below.