Cypress selenium gets GRAS for use in foods

By Lorraine Heller

- Last updated on GMT

Related tags Selenium Dietary supplement Food Food and drug administration

Ingredient firm Cypress Systems has received FDA-reviewed GRAS status for its selenium yeast product, opening up the use of the ingredient in foods and beverages targeting a range of health conditions, including cancer risk reduction.

Selenium is the only mineral that qualifies for an FDA-approved qualified health claim for general cancer reduction incidence.

Cypress Systems said its SelenoExcell High Selenium Yeast product, which has been available on the market as a dietary supplement ingredient for a number of years, now has extra backing for its use in selected food categories, further to a review of the safety dossier for the ingredient by the US Food and Drug Administration.

According to the company, its branded product could help reduce lung, colon and prostate cancer incidence by 50 – 63 percent, as demonstrated by a clinical trial published in the Journal of the American Medical Association (JAMA).

However, Cypress founder and CEO Paul Willis, said most of the food manufacturers that the company is in negotiations with are primarily interested in the ingredient for its antioxidant properties. These, he said, are thought to be at the route of most of selenium’s reported health benefits, which include immune health, anti-aging, cognitive function and heart health.

What is selenium?

Selenium is a trace element that occurs naturally in the soil and is absorbed by plants and crops, from where it enters the human food chain - either directly or through consumption of meat and other products from grazing animals. However different regions have different levels of selenium in their soils.

North American soil is naturally rich in selenium, meaning grains like wheat that are grown there have a higher content of the nutrient. Wheat grown in selenium-poor Europe, on the other hand, has lower selenium levels.

Selenium may not have made as much of an impression on consumer consciousness as other minerals such as calcium, for instance, but the science has shown it plays an important role in health maintenance - and particularly in cancer prevention. It is included in between 50 and 100 different proteins in the body, with multifarious roles including building heart muscles and healthy sperm.

Cancer prevention

FDA has approved a qualified health claim for use with dietary supplements containing selenium at levels of at least 14 micrograms (20 percent of the daily recommended value), and not exceeding the tolerable upper intake level of 400 micrograms.

The claim reads: Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”

To access FDA’s qualified health claim guidance for selenium, click here​.

Selenium is the only mineral that has a qualified health claim for general cancer reduction incidence. Calcium can use a claim for colon cancer. Other nutritional compounds that can use cancer reduction claims are some antioxidants, vitamins E and C, green tea, and some tomato compounds.

To access the full list on FDA’s website, click here​.


Cypress Systems’ SelenoExcell is produced through a fermentation process using the Saccharomyces cerevisiae​ strain, selected for its 50 to 55 percent protein content and optimal growth perimeters.

The yeast is said to convert inorganic – or low bioavailability – forms of selenium into organic – or high bioavailability – forms. The yeast, which is pasteurized so that it becomes inactive, incorporates selenium into its protein structure. The pure culture strain chosen ensures product consistency and purity, said the firm.

Cypress said SelenoExcell is the only certified 100 percent organically bound high selenium yeast standardized with the National Cancer Institute. It has been standardized to contain 1200 micrograms of organically-bound selenium per gram of yeast.

The GRAS (generally recognized as safe) status allows for its use in a range of food categories. These include: Baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruit and fruit juices, processed vegetables and vegetable juices, commercial soups and soup mixes, and medical foods.

Approved inclusion rates are 5 micrograms selenium per serving of food. This level was selected in order to ensure that a maximum combined intake level from consuming foods fortified with selenium would not exceed 150 micrograms per day, explained Willis.

The ingredient comes in spray-dried powder form that can be easily blended with dry ingredients. Willis told that it poses no formulation challenges as it is incorporated into foods at very small amounts.

Water drinks are the only products not currently suited for SelenoExcell as the ingredient would not blend well. However, fruit juices and other high viscous drinks would be good candidates, he explained.

Willis said the cost to manufacturers should be "very small", ​due to the low inclusion rates.​The ingredient is currently priced at $24.00/kg for the dietary supplement market, and Willis expects this will remain at similar levels for the food market.

In theory, SelenoExcell has been available for use in foods since December 2006, when Cypress completed a GRAS self-affirmation for the ingredient. However, as is often the case, manufacturers of foods and beverages are reluctant to adopt a new ingredient unless the GRAS dossier is submitted to FDA for review, and the agency responds with a ‘letter of non-objection’.

Cypress confirmed that it received the FDA letter of non-objection earlier this month.

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