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

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 products

show more

Replacement Isn't the Future. Variety Is.

Replacement Isn't the Future. Variety Is.

Content provided by ADM | 22-Mar-2024 | White Paper

Successfully navigating the intersection of food and technology can help your business meet evolving consumer demands.

Consumer Attitudes on Ultra-Processed Foods Revealed

Consumer Attitudes on Ultra-Processed Foods Revealed

Content provided by Ayana Bio | 12-Jan-2024 | White Paper

Ayana Bio conducted the Ultra-Processed Food (UPF) Pulse survey, offering insight into consumers’ willingness to consume UPFs, as well as the variables...

Future Food-Tech San Francisco, March 21-22, 2024

Future Food-Tech San Francisco, March 21-22, 2024

Content provided by Rethink Events Ltd | 11-Jan-2024 | Event Programme

Future Food-Tech is the go-to meeting place for the food-tech industry to collaborate towards a healthier food system for people and planet.

Palate Predictions: Top Flavor Trends for 2024

Palate Predictions: Top Flavor Trends for 2024

Content provided by T. Hasegawa USA | 08-Jan-2024 | Application Note

As consumers seek increased value and experience from food and beverages, the industry relies on research to predict category trends. Studying trends that...

Related suppliers

Follow us

Products

View more

Webinars