Gencors Slimaluma Receives GRAS Status

IRVINE, Calif.—Gencor’s Caralluma fimbriata extract, Slimaluma, has received notification that the FDA considers it GRAS (generally recognized as safe) for use in meal replacement products.

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 (Int J Toxicol 2013 Sep-Oct; 32(5):385-94).

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 mg per serving (700 mg/d).  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.

Both human and animal clinical studies have been conducted on the effectiveness and safety of Slimaluma. These include an eight-week human clinical trial that 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.

Slimaluma is certified Kosher and Halal, and available as certified USDA organic. Slimaluma is a 90-percent 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.

Earlier this year, Gencor introduced its Gynostemma pentaphyllum extract ActivAMP at Engredea.