Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted October 18, 2012
Natural Product Manufacturer Warned For GMP Violations, Misbranding, Unapproved Devices and Drug Claims
The FDA also determined that several of Creation's Garden's products were misbranded, unapproved, or promoted as drugs.
The company's pediatric electrolyte solution was found to be misbranded because testing found there was less sodium and potassium than claimed on the label. The product also contained sucralose, sodium benzoate and potassium sorbate, but these ingredients were not listed on the label with a description of their purpose, as required.
LunaSX Women's Intimate product was found to be misbranded and adulterated because it contained undeclared DHEA. This product, along with Personal Lubricant Jelly, Gel Lubricant, Silicone Lubricant and Liquid Lubricant were promoted as "condom compatible" and "latex compatible," and were determined to be unapproved devices because they lack the appropriate marketing authorization.
(See ConsumerLab.com's Review of DHEA Supplements for tests of products containing this ingredient.)
The company's Bowel & Parasite Cleanse and Parasite Cleanse were found to be unapproved drugs because the product names imply treatment for infection with parasites. These products were also found to be misbranded due to inadequate directions for use. Each contained a blend of herbs including garlic, flaxseed and wormwood.
For more information about this warning letter, use the link below.