Earthrise Spirulina Meets All Food Safety Guidelines
The safety of spirulina is of great importance to Earthrise. The Earthrise farm is subject to inspections by the U.S. Food and Drug Administration and the State of California. Its success in exceeding all food safety and quality standards is attributed to the remote farm location, clean air and water, premium quality nutrients, and the total quality management approach to quality control. Earthrise, the world's largest spirulina producer, has an ISO 9001:2008 Registered Quality Management System. ISO 9001:2008 is the most comprehensive of the standards and covers product design, engineering, manufacturing, purchasing, marketing and sales. The ISO quality standards are presently recognized in over 80 countries across the world.
Approved as Food in Over 20 Countries
Spirulina has a long history of human consumption and is known as a safe, nutritious microalga. In the past 30 years, it has been marketed and consumed as a safe human food and has been approved as a food for human consumption by many governments, health agencies and associations of over 20 countries. Based on 30 years of safety and quality research, many countries and organizations have established Spirulina Quality and Safety Standards. Our technicians collect samples from the pond water and the final dry product for about forty different analytical tests. Only after each lot has passed all tests is it certified ready to ship, accompanied by a Certificate of Analysis.. Additionally, independent laboratories in the USA and Japan periodically confirm protein, pigments, amino acids, vitamins, minerals, microbiology and heavy metals.
GRAS (Generally Recognized as Safe) is a procedure where a company submits a notice to the FDA (Food and Drug Administration) reporting their determination, through scientific procedures, that their product is GRAS for addition to a variety of foods. Conclusion of the notification procedure (through a written response by the FDA) provides assurance to both consumers and food manufacturers that the FDA has had an opportunity to review the safety evaluation of the product for its intended use.
In March 2003, Earthrise Nutritionals submitted a joint notice to the FDA determining that its spirulina met the requirements for GRAS for use in specialty foods, powdered nutritional drink mixes, snacks (such as popcorn) and as a condiment in salads and pasta. FDA had no objection to the GRAS determination. A copy of the letter from FDA regarding the GRAS notice is found in the FDA's website at www.fda.gov.
Pesticide Free Spirulina
Earthrise Nutritionals has never used pesticides or herbicides. Because more and more people are concerned about pesticide residues in their foods, Spirulina has been additionally tested for residual environmental residues since 1993. Independent lab tests have not detected any of over 66 possible contaminant residues. We believe this extra level of assurance is important to quality-conscious natural food customers. The safety of Spirulina means being free of pesticides or herbicides.
Algal Toxin Safety Research
Because of concern about toxic blue-algae growing in lakes, Earthrise developed a program to assure these toxic algae are not present in spirulina ponds. First, daily microscopic examinations of the living culture are conducted. Second, in cooperation with university researchers, farm scientists have developed immunoassay and enzyme inhibition bio-assay methods to detect nano gram levels of toxins. Very few laboratories in the world are capable of such analysis. The safety of spirulina means continuous research and standardized testing.
How Spirulina is Quality Controlled?
Our California grown spirulina powder is manufactured in accordance with Current Good Manufacturing Practices (cGMP) promulgated under the United States Federal Food, Drug and Cosmetic Act and applicable California statutes and regulations. These laws assure that the facilities, methods, practices, and controls used in the manufacture, processing, packing, or holding of food products are in conformance with or are operated in conformity with Good Manufacturing Practices to assure that the food products are safe for consumption and have been prepared, packed, and held under sanitary conditions.
Earthrise Nutritionals is the only producer of Spirulina in the continental USA, which has determined its Spirulina as GRAS (Generally Recognized as Safe) by scientific procedures and FDA review.
The Earthrise Farm has its own state-of-the art laboratory that conducts scores of important quality control tests both on the live Spirulina in cultivation as well as the final product. Each lot of product produced daily undergoes testing and verification before it is released for sale. The shipment of the product is accompanied by a Certificate of Analysis that states the identity, potency, and safety of the product.
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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.