Sabinsa selenium gets GRAS
food and beverage manufacturers in the US, following a recent GRAS
(generally recognized as safe) certification.
GRAS status is the standard set by the US Food and Drug Administration (FDA) for ingredients to be approved for use in foods and beverages.
Companies can either apply to FDA for GRAS affirmation, or they can self-affirm their products as GRAS by conducting all relevant safety and quality evaluations.
Sabinsa's Selenium SeLECT is the latest dietary supplement ingredient that has become available for use in foods and beverages following a GRAS affirmation.
The company announced the self-affirmed GRAS status after an independent panel of scientists reviewed safety and toxicology data.
Benefits Selenium is a trace mineral that is found naturally in soil.
When consumed, selenium enters the body to form selenoproteins and glutathione, the body's antioxidant immune system detoxifier, Sabinsa explained.
FDA has approved a qualified health claim linking consumption of selenium to a reduced risk of certain cancers, including breast, prostate and colon.
Other research has indicated that it can help prevent stroke and heart disease, and provide greater resistance to the polio virus.
According to Sabinsa, its branded L-(+)-Selenomethionine compound could be used in products including yogurt, flavored milk, pudding, bread, cookies, pasta, cereal, oils, candies, water, beverages and tea.
"As consumers continue to embrace functional foods and beverages as a major component of a healthy lifestyle, manufacturers are searching for safe and efficacious ingredients to improve the nutritional profile of their finished products," said Dr Muhammed Majeed, managing director and CEO, Sabinsa.
"Given the increasing number of ineffective and sometimes dangerous products on the market today, the proven safety and efficacy of Selenium SeLECT, as exemplified by its clinical research and GRAS status, makes it ideal for inclusion in a full array of food and beverage offerings."
Quality and science Sabinsa claims its Selenium ingredient is the most bioavailable, pure and safe form of selenium available on the marketplace.
The company said the global quality standard or United States Pharmacopeia (USP) monograph for selenomethionine is based on Selenium SeLECT.
The ingredient, which is manufactured in Sabinsa's plant in India, has also been certified by the certification agency NSF.
Selenium SeLECT is currently being used by the National Cancer Institute in a 12-year study into the role of selenium and vitamin E (both separately and together) in the prevention of prostate cancer.
NCI is also conducting a trial using Selenium SeLECT to examine the role of selenium and vitamin E in preventing memory damage with age, including Alzheimer's and other diseases that can affect the brain.
In 2005, Sabinsa lowered the heavy metal limits for its Selenium SeLECT in the face of tightening regulations in the European Union.
Its ingredient is said to contain less than one part per million (ppm) lead, less than 0.5 ppm arsenic, less than 0.5 ppm cadmium, and less than 0.5 ppm mercury.
Although they are naturally occurring, when consumed in large enough quantities heavy metals can be toxic to humans.
The USP limits are 20ppm for heavy metals and 10ppm for lead.
