Quality & Testing

Oxford Healthspan Primeadine Original and Gluten Free Open

Sourced and Made in Japan

We source our raw material from Japan and manufacture it there in an FDA-registered facility.

When searching for the best source of supplemental spermidine, Japan's historic love for spermidine-rich foods like natto and shiitake mushrooms, scientific authority in longevity and autophagy (cell renewal), and it being home to some of the world's longest lived people made it the obvious choice.

Japan also happens to have one of the strictest food safety protocols in the world. You may be aware of how strict the Japanese standards are because of how they treat coffee. Imports to Japan that don't meet what might be called ‘draconian’ rules on purity, mold toxicity and mycotoxin levels are turned around at the port, where owners of these shipments will then send that same coffee to the US and other countries with more relaxed regulations.

In addition, we wanted a manufacturer of spermidine that was not just certified to be clean, pure and free of toxins, pesticides and heavy metals by the Japanese government-sponsored Japanese Institute for Health Food Standards; we wanted one that was specifically managed according to ISO22000 food safety standards.

What is ‘ISO22000’ and why is it the Best When it Comes to Food Safety?

ISO stands for the International Organization for Standardization. They have certain guiding principles around measuring, managing and organizing risks and manufacturing procedures. You may be familiar with the ISO9001 designation, which is a valuable, but generic certification that a company is manufacturing products in a standardized and consistent way that meets customer expectations. Its principles apply to a wide array of industries, from paper pulp to supplements.

ISO22000, however, is a food safety specific certification based on the guidelines of the Codex Alimentarius Commission, a joint venture between the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

ISO22000 certification guarantees the safety of food ingredients from farm to fork. Rigorous safety and purity testing is part of this certification, as is environmental risk. For instance, is the farm or manufacturing facility next to an environmental polluter that might cross-contaminate? Raw materials are also tracked and traced from individual farms to actively identify any quality control issues in a timely manner and keep them from entering the supply chain.

Our supplier is both ISO22000 certified and Good Manufacturing Practices certified (cGMP) by the Japan Institute for Health Food Standards (JIHFS), a branch of the Japanese government. Only 150 companies in all of Japan have this certification.

They also adhere to HACCP (Hazard Analysis and Critical Control Point) standards, which the FDA endorses as very good food safety risk management and hazard prevention. Finally, our Japanese manufacturing facility is registered with the US Food & Drug Administration and has been inspected and approved by the US FDA. Interestingly, as a country, Japan has the highest number of food manufacturing facilities registered with the American FDA, after the United States itself and ahead of France.

Our approach to health applies to our Supply Chain as well: prevention and sustainability must start as close to the source as possible, and we take this into account at every step of the way to make sure that you get the highest quality available. This includes the arrival of our ultra high quality raw materials in the US, where they undergo further purity testing and are then sent to an FDA-registered, certified Good Manufacturing Practice facility, encapsulated in vegan capsules, bottled and safety sealed.

Oxford Healthspan Primeadine Original and Gluten Free Open Bottles

Synthetic vs. Plant-Derived

Synthetic spermidine is a 2-dimensional chemical mimic, but we should never forget that molecules are 3-dimensional. Humans have co-evolved with plants over millenia and our bodies recognize the 3-dimensional molecules made by plants. Our bodies can recognize some elements of 2-dimensional mimics, but they are akin to the mirror images of your hands when you put your palms together - 2-dimensionally identical, and yet your right hand cannot wear a left-handed glove. 

We have tested other spermidine products whose labels state they contain 'wheat germ with spermidine' and noticed that they have a small amount of wheat germ 'cut in' with high amounts of synthetic spermidine. Often, these are high dose, low cost options with no guarantee that they will work, or that they are safe. Synthetic spermidine has not been tested for safety or efficacy in humans, only plant-derived spermidine has.

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Our Certifications

Third-party certification is the best method of verification to ensure the statements being made are indeed validated by outside sources and up to that particular organization’s standards. It’s not the easy way to go, but worth the extra effort.

Made in a FDA-Registered Facility

An FDA-registered facility must provide evidence to the FDA that they have identified potential hazards with the products being produced in that facility, are implementing preventative controls to address those hazards, and are monitoring the performance of the controls to ensure that they are effective. A registered facility must also show that they comply with State, local, county, tribal, or applicable non-Federal food safety laws, and is subject to regular inspections.

GMP (Good Manufacturing Practice) Certification

The GMP approval indicates that the manufacturing and production process is consistently high quality by following guidelines to minimize risks during product production.

Japan Health Food and Nutrition Food Association

The JHFA, a branch of the Japanese government, provides certification to food products that meet the voluntary standard which is obtained through undergoing a rigorous review process to ensure quality and safety. Only 150 companies in all of Japan have this certification.

Lab Tested

Our suppliers have the most advanced extraction process and rigorous quality control and testing to meet the standards of the Japan Health Food and Nutrition Food Association. In addition, our spermidine is encapsulated in an FDA cGMP facility in the US and undergoes independent 3rd party testing for purity and potency there as well.

Vegan

Vegan is defined as: no animal or animal by-products to include flesh, bones, dairy, eggs, honey, fur, leather, wool, down feathers, and cosmetics or chemical products tested on animals. Our products do not contain any animal or animal by-products or chemical products tested on animals.