Pharmachem bean extract granted GRAS
bean-derived carb-blocker is generally recognised as safe (GRAS) -
news that is expected to speed the launch of the first foods and
drinks containing the ingredient.
Marketed under the name StarchLite, the ingredients is an extract of the common white bean (Phaseolus vulgaris). It works by binding temporarily to alpha-amylase, the enzyme responsible for digesting complex carbohydrates, thereby delaying the absorption of carbohydrates and potentially promoting weight loss.
The New Jersey-based company has previously offered white-bean Phase 2 Neutraliser as a dietary supplement ingredient, as well as in a consumer product to be sprinkled directly over starchy foods called Carb Counters.
It signalled its intention to enter the foods arena in April, with the new StarchLite line to enable manufacturers to deliver products with a lower calorie-count or glycemic index.
Study results released earlier this year also showed that StarchLite has the potential to significantly reduce the glycemic index of white bread by 20.23 points, or 39.07 percent.
It is suitable for use in all food and beverage products that normally have a heavy carbohydrate load, including cereals, frozen foods, packaged meals, pasta, pizza crust, soups and confectionary. The GRAS conclusion is applicable for consumption of up to six grams per day.
The company has conducted a number of studies to support the safety of Phase 2, including a 28-day rat study that is yet to be published.
"The results of pivotal nonclinical safety studies indicate that Phase 2 and dietary supplements containing Phase 2 is of low toxicological concern," said an expert opinion statement.
The statement also drew on supportive evidence from studies designed to ascertain efficacy, two of which specifically included tests for hematology, clinical chemistry and/or urinalysis.
The GRAS affirmation was issued by Cantox US, the research firm that organized the expert panel and scientific review.
The statement said that the "experts unanimously agreed that the long-time presence of Phaseolus vulgaris in the human diet and its digestion by normal physiological pathways is supporting evidence of the safety of phase 2. Also supportive is its current widespread use in dietary supplements, with no known adverse effects."
Director of new product development Mitch Skop said that the GRAS designation is important "for the assurance of our customers, particularly as we move into many new, exciting food applications."
It is not expected that it will be long before the first products containing StarchLite are launched: developments are already underway with a speciality baker and a pasta-maker.
Company spokesperson Tom McCartney told NutraIngredients-USA.com that the ingredient has the potential to be "huge".
Whilst on the one-hand it might be used to make such products not-so-unhealthy, it might also be used in products aimed at people who are actively trying to manage their weight or blood glucose levels.
