Why assess safety?
Dietary/Food supplements contain active ingredients that have biological effects in the body. As ingredient manufacturers, we are responsible for making sure our products are safe for the final consumer.
Thus, as we developed this new highly bioavailable turmeric extract formulation to achieve significant pharmacological outcomes, it was crucial for us to ensure full safety of a higher level of curcuminoids in the blood as well as the innocuity of our additional ingredients to guarantee compliance and consumer safety (for all markets – dietary/food supplements as well as food & beverages).
Best in class safety program – What sets us apart?
Because we believe that safety is central, we hold ourselves to the highest standards, which include:
- Conducting the first and only clinical safety trial in healthy volunteers to evaluate the innocuity of our formula while providing a higher dose of curcuminoids in blood
- Testing curcuminoids’ long term impact by assessing a chronic consumption of 5 weeks in healthy subjects
- Following the gold standard process developed by numerous external regulatory authorities worldwide
In vitro and in vivo safety
Because of the ingredient’s increased bioavailability, a single 300 mg serving delivers the same amount of curcuminoids to the blood as 1,922 mg of standard turmeric (containing 95% curcuminoids), allowing food and beverage manufacturers to ensure that consumers receive an effective dose.
Safety of this innovative formulation was evaluated using the standard OCDE in vitro genotoxicity tests and in vivo repeated-dose (28‐ and 90‐day) oral toxicity studies in rats (Phipps et al, 2020). In conclusion, the negative results in the in vitro genotoxicity tests, in addition to the absence of any test item‐related adverse effects in the 90‐day study at doses up to 3000 mg/kg body weight/day, support the safe use of Turmipure Gold® in foods and beverages for the general population.
Clinical safety study
To complement our in vitro and in vivo results, we chose to go further by performing a unique clinical study in human subjects.
Thus, we conducted, in France, a safety study to assess the innocuity and tolerance of long-term administration of a high dose of Turmipure Gold® (1000mg, hence three times the recommended dose).
Our study was designed as a double-blind randomized placebo-controlled clinical trial to evaluate the chronic safety and tolerance of Turmipure Gold® in healthy subjects during 5 weeks. Sixty healthy volunteers (24 male and 36 female) were enrolled.
Because of the potential effect of high curcuminoid dosage on the gastrointestinal tract, our study specifically assessed the gastrointestinal tolerance of Turmipure Gold®. The primary outcome was a composite score of gastrointestinal tolerance (combined scores for bloating, abdominal cramping, stomach noises, flatulence, and frequency and consistency of stools); secondary outcomes included individual gastrointestinal symptoms and Gastrointestinal Quality of Life (GIQLI), hematology, clinical biochemistry and urinalysis, and a record of adverse events (AEs). There were no statistically significant differences in gastrointestinal tolerance scores or GIQLI. Clinical pathology parameters, vital signs or physical examinations were unaffected by Turmipure Gold® consumption, and the incidence and severity of AEs were similar in both groups. In conclusion, daily oral consumption of Turmipure Gold® (1000 mg) for 5 weeks was well tolerated and safe in healthy adults.
GRAS stands for Generally Recognized as Safe. GRAS status is the standard set by the United States Food and Drug Administration (USFDA) for the acceptance of food and beverage ingredients.
Customer safety is imperative. That is why, all ingredients must undergo safety evaluations by qualified experts to achieve approval for use in food and beverages.
In January 2020, Naturex obtained the Self-Affirmed GRAS designation for our highly bioavailable natural turmeric extract, Turmipure Gold®. The expert panel unanimously concluded that Turmipure Gold® is recognized as safe under the conditions of intended use in a wide range of food categories including beverages at both intuitive and effective doses.
This Expert Panel decision means that Turmipure Gold® can be safely used in a wide range of US food and beverage applications for turmeric extract standardized in curcumin. The ingredient is now authorized in categories that include beverage and beverage bases, confectionery products, dairy and dairy analogs.