Supplements, Certifications and Calibrations

I have used the terms Pharmaceutical Grade and Weapons Grade to describe the potency of our fish oil. In a recent post I walked through what Pharmaceutical Grade actually means in practice. There is more to making a real supplement than the label on the bottle, and most consumers never see any of it. So here is the rest of the picture.

It starts with the raw materials and the audits we run on our suppliers, their facilities, and their packaging plants. Then come storage conditions. What is the temperature and humidity, how is it logged, and who reviews the logs?

Anything we bottle or package at our own plant has to meet the same level of detail. Because our facility has the capability to store, manufacture, and package pharmaceuticals as well as nutraceuticals, we operate under the same rules. Equipment is calibrated against NIST (National Institute of Standards and Technology) references. Temperature, humidity, weight, and sterility data are generated on demand for any alphabet agency that asks. Our on site staff double checks those numbers at least twice a day so the readings do not drift.

We also run accelerated degradation studies. The premise is that any bottle has to survive the worst real conditions it is likely to see, including hours in the back of a delivery truck in summer. If a product cannot hold up there, it cannot hold up in your cabinet.

Why this matters most for fish oil

Oxidation is the silent killer of an omega 3 product. Every step in the supply chain is a chance for the oils to degrade. We start with the lowest total oxidation values in the industry, well below GOED and other published standards, and we hold them. Glass bottles, vacuum sealed where appropriate, low oxygen headspace, and short distribution windows do the rest.

What to look for on a label

“Pharmaceutical Grade” has no strictly enforced legal definition for supplements. That makes the term cheap on a marketing page and expensive in a manufacturing plant. A few real signals worth asking about before you buy any supplement, mine or anyone else’s:

• Where are the raw materials sourced and audited?
• Is there a Certificate of Analysis per lot?
• Is the facility cGMP compliant for both nutraceutical and pharmaceutical manufacturing?
• For fish oil specifically, what is the total oxidation (TOTOX) value, the peroxide value, and the anisidine value?
• Is the bottle glass or amber plastic, and is it vacuum sealed?

You and I put this in our bodies every single day. The standard for a supplement that goes into a 60 year old who is still doing the work should be at least as high as the standard for the medication you would not take twice. That is the spirit we manufacture in.

Doc