Safety Aspects

Even though natural products or plant extracts have a long history of use in Ayurveda and other traditional medicinal systems, they are not altogether exempted from the quintessential safety evaluation.

Coleus forskohlii extracts and forskolin have shown an excellent safety profile and are generally considered safe, non-toxic and without any side effects at the recommended dosage. Prolonged topical application of forskolin is also well tolerated.

The safety of ForsLean® for use as a dietary supplement was established by means of detailed toxicological evaluation through in vitro, preclinical and clinical set ups.

  • Data from acute oral toxicity (to determined median lethal dose, LD50, the amount of a toxic agent that is sufficient to kill 50 percent of a population of animals usually within a certain time) (14 days), sub-acute oral toxicity (28 days) and chronic oral toxicity (180 days) revealed that ForsLean® did not produce any signs of toxicity.
  • Based on these findings, it was suggested that LD50 was found to be greater than 2000 mg/kg body weight. Additionally, no-observed-adverse-effect level (NOAEL) of ForsLean® administration over a period of 28 days and 180 days was found to be greater than 1000 mg/kg body weight
  • Bacterial Reverse Mutation Assay with an Independent Repeat Assay (AMES Test) also concluded that ForsLean® was non-mutagenic up to 5000 µg per plate
  • Repeated Insult Patch Test to assess dermal irritation or allergic contact sensitization by 2% w/w forskolin in 45 healthy volunteers of either sex suggested that the observations remained within the normal limits throughout the test interval