Posted October 18, 2012

Natural Product Manufacturer Warned For GMP Violations, Misbranding, Unapproved Devices and Drug Claims

On August 28, 2012, the FDA issued a warning letter to Creation's Garden Natural Products, Inc. following an inspection of the company's manufacturing facility, which found violations of Current Good Manufacturing Practices (CGMPs) for dietary supplements. These violations cause the company's products to be adulterated because they were prepared, packed or held under conditions which do not meet regulations for dietary supplement manufacturing.

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'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.

See's Reviews of Garlic Supplements and Flaxseed Oil Supplements for tests of products that contain some of these ingredients.

For more information about this warning letter, use the link below.