On May 8, 2013, the FDA issued a warning letter to Entrenet Nutritionals, Inc., following a facility inspection which found the company’s products, including Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme, Your Harmony Plus, Your Arthri-Attack , Big Mo Momentum Grande, Immune Force , Your Natural Ease Plus, Purifying Cleanse I, Purifying Cleanse II and Seven Flowers BP to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
These violations include failure to establish and follow written procedures for the responsibilities of the quality control operations, failure to establish and follow written procedures relating to the review and investigation of product complaints, and failure to make and keep written procedures for holding and distributing operations.
The FDA also stated that Entrenet’s response to the agency regarding these violations to be inadequate.
In addition, statements made on product labels for Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme were found to be drug claims.
Gone was promoted with statements such as “Gone is an all-natural herbal supplement known to reduce pain and inflammation.”
Arthri-Attack was promoted with statements such as “MSM and Glucosamine…while helping the body protect against inflammation and damage.”
(See ConsumerLab.com’s Reviews of Glucosamine, Chondroitin, and MSM Supplements for Joint Health and Turmeric and Curcumin Supplements for tests of related products.)
Cardio Rescue was promoted with statements such as “It may help…arterial debris to be dissolved quickly,” and “This product is designed to melt down deposits.”
Complete Food Supreme was promoted with statements such as “support for…people at high risk of cardiovascular disease and those with cardiovascular disease.”
(See ConsumerLab.com’s Reviews of Cholesterol-Lowering Supplements and Greens and Whole Foods Powders.)
Your Natural Ease Plus, Purifying Cleanse I, Purifying Cleanse II, Gone, Cardio Cleanse, Cardio Repair, and Seven Flowers BP, Pro Plus Gold, Your Arthri-Attack, Big Mo Momentum Grande, Your Harmony Plus, Immune Force and Powerzyme were also found to be misbranded because the labels did not provide information required by federal regulations.
To read the FDA’s warning, use the red link below.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm351662.htm
