The company began life selling herbal ingredients to the dietary supplements industry but in the past 3-4 years has been taking an increasing interest in functional foods and beverages markets.
Food and Drug Administration GRAS (generally recognized as safe) approval is not required for dietary supplement ingredients as a different authorization system is in place.
But it is required for the food supply. Companies can also self-affirm GRAS, whereby the regulator will only become involved if some kind of event draws attention to the ingredient’s safety claims.
With this in mind, BI Nutraceuticals decided to call in the auditors to scrutinize just how many of its offerings had GRAS approval and had met requirements for safe use in foods, as its dietary supplements focus meant it did not have all this information to hand.
GRAS or not GRAS
It found 298 were GRAS, out of its entire inventory of 470. Many of those that had not been GRAS-approved by either the FDA or the Flavors and Extracts Manufacturers Association (FEMA) which is also authorised to approve GRAS claims, were in the food supply as self-affirmed because no safety issue surrounded them.
Panax ginseng and goji were examples, vice president of sales and marketing, Walter Postelwait, told NutraIngredients-USA.com.
He said the audit had made it clear which of its ingredients required toxicology studies if they were to attain GRAS status.
In a statement he said: "We plan to continually update and refine this database to ensure its accuracy and are now able to provide critical regulatory information in addition to lending our expertise in product formulation."
He said many food and beverage makers were not up to speed with the latest developments in GRAS approvals and so the audit clarified exactly where any potential deal stood in relation to GRAS.
Postelwait added: "This database allows BI to provide accurate regulatory guidance to our customer base surrounding the use of our botanical powders and extracts in functional food and beverage applications."
BI’s 298 ingredients are used in frozen dairy, milk products, snack foods, imitation dairy products, chewing gum, instant tea and coffee and soups.