Independent Supplement Testing at Ovaterra: Why We Commit to It (Part I)
Quality is non-negotiable
At Ovaterra, we believe quality is non-negotiable. We have a unique quailty process that encompasses the entire lifecylce of our supplements from the concept stage all the way to the moment they reach your door. One important part of this process is the testing of every batch at independent laboratories – an additional step we take, on top of the QA testing that our ingredient suppliers and manufacturers conduct. But what exactly do we test for? And why? Let’s have a look.
What we test our supplements for
For all of our supplements, we test for the following, using an independent laboratory that has been accredited under both ISO/IEC 17025 and cGMPs (current Good Manufacturing Practices, a set of FDA-enforced regulations).
Tests to ensure you get what you expect from the labels
- Potency of the main ingredient(s): This confirms that our supplements contain the correct amount of the main ingredient(s) per serving. We know many of our customers take a specific number of tablets or softgels each day, based on what their doctors recommended specifically for their reproductive health. Ensuring that you are getting just the amount you – and your doctor – expect from Ovaterra supplements is our top priority.
- Form of the main ingredient(s): In many cases, our partner laboratory also tests for the specific form of the ingredients we use. For example, our Vitamin D supplement uses a specific form of Vitamin D – Vitamin D3 (cholecalciferol) – which is the same form as our skin synthesizes under sun exposure, for a reason. So, we test for this specific form, rather than for any forms of Vitamin D.
Tests to ensure that the supplements are safe and clean
- Heavy metal contamination: Heavy metals harm our health. Some, like mercury, are neurotoxins, while others, like lead, cause systemic health issues. Crucially, heavy metals can pass from the mom to her unborn baby. While it is very difficult to completely eliminate heavy metals from foods and dietary supplements, we make sure you are not exposed to higher-than-acceptable amounts through our supplements. We test for the four most common heavy metals: lead, mercury, arsenic and cadmium.
- Microbiological contamination: Many of our supplements use plant-derived ingredients rather than synthetic ingredients. Our flagship, Fertinatal DHEA, for example, uses DHEA that is extracted from a species of wild yam. Supplements with plant-derived ingredients are more prone to microbial contaminants than synthetic ones because things like salmonella, E. coli and other microorganisms naturally exist in the air, soil water and so on where the source plants grow. We believe this is a particularly important set of tests to ensure safety of our products. We test for specific microbes like salmonella, as well as for total microbial, yeast and mold count to cast a wide net.
- Gluten: Celiac disease affects about 1% of the population, with far more people reporting gluten sensitivity (prevalence varies widely between studies, from less than 1% to 13%). We test our products for gluten content so those with celiac disease and gluten sensitivity can safely support their health with our supplements.
Additional testing for special cases
While the tests listed above are conducted on all of our supplements, we have an additional test for Fertinatal DHEA: Micronization levels.
- Micronization: Micronization testing is specific to our Fertinatal DHEA. Fertinatal was co-developed with the fertility experts at the Center for Human Reproduction (CHR), based on their research on DHEA and women’s reproductive health. Fertinatal uses DHEA particles that have been micronized to the same size range as the DHEA the doctors at CHR used in their studies, and we make sure, through micronization testing, that this standard is met.
Why we test independently
Selection of manufacturing partners is a major pillar of our quality process. We work with some of the most trusted manufacturers in the dietary supplement industry. Our manufacturing partners follow the cGMP guidelines throughout their manufacturing processes and conduct their own in-house quality testing. Many of our partners even have experience in pharmaceutical manufacturing, where official standards are much higher.
This is to say - we independently test our supplements not because we don’t trust our manufacturing partners – we do. (Otherwise, we wouldn’t be working with them!). We commit to our own independent testing as a safety measure to catch anything that might have fallen through unexpected cracks – and for your peace of mind while on this important journey.
One more reason we test independently
There have been occasional reports of dietary supplements containing far less of the ingredients than claimed, those made with hidden pharmaceutical ingredients or supplements contaminated with heavy metals. These issues tend to be prevalent in certain types of dietary supplements, including those for weight loss, bodybuilding and sexual enhancement. These quality and safety problems are also typically associated with supplements manufactured outside of the United States.
While none of these apply to Ovaterra's supplements that are made in the United States, this is the background against which our rigorous testing procedures were developed.
Independent testing adds significantly to both our production cost and timeline. Despite the additional burden in dollars and hours, we believe it’s an integral part of our quality process.
What happens if supplements don’t pass the test
Testing is as good as the actions we take based on the results. At Ovaterra, we don’t put supplements on the shelf unless they pass our independent laboratory testing. In fact, we did once send back a batch to a manufacturer when the test results did not meet our standard.
Thankfully, it was a one-time occurrence, long time ago, when Ovaterra was in its infancy and working with a new manufacturer who we left soon after. This experience solidified our commitment to independent testing and informs our current vetting process for manufacturing partners.
Ovaterra's work toward transparency
In Part II of this series, we’ll cover what we consider to be acceptable for the main ingredients and contaminants – and delve into the science that supports our standards. We are also hard at work toward transparency: Our quality team is working in the background to set up a system that would let you see the specific quality documentation for the supplements in your hands.
Stay tuned - and please reach out if you have any questions. We are with you.
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