Be Assured

At NBI we only create products that we take ourselves or give to our family members. So you can be assured that we have taken the steps to ensure that only the best raw materials go into our products, and our manufacturing and quality assurance processes adhere to the highest standards in the industry. We do all this not because it is the most economical way to create and manufacture products. Because it's not. We do this to ensure that every time someone purchases a NBI product they can rest assured that we've gone the extra mile to make sure that our formulations, raw materials and manufacturing are the best in the industry.

Product Formulations

Our product formulation philosophy is very simple. Create products based on clinical trials and the best reasearch from around the world. NBI maintains a database of more than ten thousand research citations, and routinely searches the National Library of Medicine's database of more than forty million articles for new, cutting edge research on nutrients and their beneficial health effects. Our products have been so well researched, that NBI Pharmaceuticals, Inc, a company founded by Drs. Neustadt and Pieczenik in 2010 has received four orphan drug designations from the US FDA for MK4 for the possible treatment of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), hepatocellular carcinoma (HCC, liver cancer) and acute promeylocytic leukemia. While MK4 has not been approved by the FDA as a medicine, as a natural product it is available in Osteo-K and Osteo-K Minis to promote healthy cellular function, healthy blood and grow stronger bones.

Raw Materials

The ingredients that go into every NBI product are of the highest purity and in forms that your body can absorb and use. For example, the MK4 used in Osteo-K and Osteo-K Minis is the purest form of MK4 available on the market. And the minerals in NBI's products are in their amino acid chelated forms, which are the most absorbable forms. Many companies will skimp on their raw material costs and use "-oxide" forms of minerals or, in the case of calcium, they'll use calcium carbonate. The problem is that the body cannot absorb these minerals. In fact, in the case of magnesium oxide the body only absorbs about 2% of what is in the pill. The rest just passes right through you and out in your stool.

Manufacturing and Quality Assurance

NBI's manufacturing and quality assurance exceed industry standards. All NBI products are manufactured in the United States at an FDA-inspected facility. The 175,000 square foot facility is FDA-approved and cGMP certified. GMP stands for Good Manufacturing Practices, whcih is defined by the FDA. This certificatiation means the facilities, equipment, and processes have been reviewed and approved by the FDA, and verifies the ability to create products that meet the organization’s strict guidelines for consistent identity, quality, strength, and purity.

But NBI goes beyond just the standard set by the FDA. Its manufacturing facility maintains certifications from six separate, independent organizations.

 

GMP Certification

The Natural Products Association GMP Certification Program is designed to verify compliance of member suppliers of dietary supplements with a standardized set of good manufacturing practices (GMPs) developed by the Natural Products Association. This program ensures that all elements of the manufacturing process are reviewed to provide reasonable assurance that processes are sufficiently controlled so that products meet their purported quality.

NSF Certification (Sports Supplements)

NSF is one of the most widely-respected and recognized global third-party certification providers. For more than 60 years, NSF International has been protecting consumers through testing and certifying products, including dietary supplements, cookware, faucets, and home water treatment systems.

Natural Products Association (NPA) Certification

In order to help consumers identify what is natural and maximize their well-being, Natural Products Association supported by leading natural personal care companies has developed a natural standard for personal care products. NPA working with manufacturers, suppliers, retailers and the personal care industry at large to define standards and make it easy to identify personal care products that meet that standard.

American Herbal Products Association (AHPA)

The American Herbal Products Association (AHPA) is the only national trade association that is focused primarily on herbs and botanicals and herbal products. Founded in 1982, AHPA is the oldest of the non-profit organizations that specializes in service to the herbal industry. It is the voice of the herbal products industry and AHPA's membership represents the finest growers, processors, manufacturers and marketers of botanical and herbal products.

FDA Registered

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods.The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market. The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.

 

 

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