Gencor’s Slimaluma gets FDA no objection to GRAS

Gencor’s Slimaluma gets FDA no objection to GRAS

Patented extract of Caralluma fimbriata is on the market as a supplement ingredient and is effective for weight management.

Slimaluma, a patented extract of Caralluma fimbriata offered by Gencor, has received notification from the ­Food and Drug Administration (FDA) of no objection to it being considered GRAS (Generally Recognized as Safe) for use in meal replacement products. 

Gencor is offering Slimaluma for use as an ingredient in meal replacement products such as baked goods, bars, soups, drinks and shakes, at levels up to 350 milligrams per serving (700 milligrams per day). Slimaluma is currently in the market as an ingredient in dietary supplements and is effective in reducing waist circumference and suppressing appetite, when combined with healthy diet and exercise.

Slimaluma has been affirmed safe by six toxicity studies, including two in vitro genotoxicity assays, acute and repeated dose oral toxicity studies, and a developmental study in rats. A toxicological assessment supporting the safety of the repeated oral consumption of Slimaluma was also published recently in the International Journal of Toxicology (2013; 32(5):385-94). 

Both human and animal clinical studies have been conducted on the effectiveness and safety of Slimaluma. These include an eight-week human clinical trial which showed clinically significant results for decrease of waist circumference and for appetite suppression (when combined with a healthy diet and exercise), and a 12-week human clinical study which also showed a clinically significant reduction in waist circumference as well as a decline in waist-to-hip ratio, among other factors. Both human clinical studies were double-blind, randomized and placebo-controlled.

On the basis of independent and collective critical evaluation of the available information on Slimaluma, an expert panel concluded that Slimaluma produced in accordance with current GMP standards and meeting specifications is safe for its intended use. Notification of this GRAS finding was filed with FDA without objection, and is designated GRN 500. This project was handled by AIBMR Life Sciences for Gencor. 

Slimaluma is certified Kosher and Halal and available as certified USDA organic. Slimaluma is a 90% water-soluble free-flowing powder and offers heat, acidic and alkaline stability. It is suitable for use in beverages, smoothies, capsules and tablets, meal-replacements and chocolates. 


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