Gencor’s Slimaluma gets letter of no objection from FDA for GRAS status

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Slimaluma is positioned as an appetite-suppressant by Gencor Pacific
Slimaluma is positioned as an appetite-suppressant by Gencor Pacific

Related tags: Toxicology

The US Food and Drug Administration has issued a letter of no objection to Gencor for its branded Caralluma fimbriata extract called Slimaluma for use in meal replacement products.

The ingredient can be used in products such as baked goods, bars, soups, drinks and shakes, at levels up to 350 milligrams per serving (700 milligrams per day). 

Slimaluma is positioned as an appetite-suppressant by Gencor Pacific, and was released into the US market back in 2006. The ingredient is a patented extract of C. Fimbriata, a cactus-like plant that has a long history of use in India, where it is grown as a vegetable and used as an ingredient in curries and chutneys. According to Gencor, it was also traditionally used by local tribes to ward off hunger when going into the hills or woods for long stretches of time.

The appetite-suppressing effects of C. Fimbriata were reported in a clinical trial with 50 Indian men and women in Appetite​ in 2007 (Vol. 48, pp. 338–344). A daily one gram dose of Slimaluma for 60 days was associated with appetite suppression and a reduction in waist circumference, compared to placebo.

Slimaluma has been affirmed safe by six toxicity studies, said the company, 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).

The GRAS affirmation was filed with FDA by AIBMR Life Sciences for Gencor​.

Related topics: Suppliers, Botanicals, Weight management

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