Manufacturing - Superior Quality

Methyl-Life® looks to find the best active ingredients available in the world.

Methyl-Life® only buys top ingredients from cGMP-compliant ingredient manufacturers.

cGMP stands for “current Good Manufacturing Practices”

as determined in a set of standardized guidelines for process and procedure. These are handed down from the FDA in a pamphlet. The manufacturing guidelines indicate that manufacturing facilities need to have SOPs in place (or “Standard Operating Procedures”) which ensure the facilities are in compliance with the FDA standards for “Good Manufacturing Practices”.

After purchase, the active ingredients go directly to cGMP certified contract manufacturing facilities in the USA where Methyl-Life® products are developed and created.

The cGMP contract product manufacturing facilities in the USA only accept the ingredients after using a testing lab to verify all of the below (if anything fails, an ingredient is rejected and not used, instead it gets sent back to its original manufacturer):

• Identity – to ensure it’s the material that was purchased and 100% matches its specification sheet or Certificate of Analysis (CofA)
• Purity – to ensure the ingredient actually matches the stated purity ratios indicated on the specifications sheet (CofA)
• Potency – to ensure the material matches the stated potency ratios listed on the CofA
• Microbes – to ensure the ingredient has not been contaminated by bacteria, mold, or other pathogens (i.e. e Coli, Salmonella, etc.)
• Metals – to ensure the material does not have any heavy metal content above the FDA limits

• The cGMP contract product manufacturing facilities in the USA works closely with Methyl-Life® to ensure the formula that customers need is indeed correctly calculated, measured, blended, tableted/capsuled, weighed, tested, sealed, and successfully passed all quality control requirements with flying colors.

• It is worth noting that Methyl-Life® takes an extra measure of care to ensure that our formulas are created with a 10-20% active ingredient overage. This is so the products will survive a 3-year shelf life and still be able to easily pass a potency test, which proves it meets its label claims. A "good" manufacturer will suggest a 5% overage. But we've all seen the news whistle-blowing on many products that upon release don't even meet their label claims (meaning there is not as much 'active' nutrient as the label is saying their is).

• A recent amazing fact Methyl-Life® had its unopened 5-year old products sent to a folate specialists' lab in Switzerland along with some of its competitors bottles to be tested. Of course we learned that the results showed our products were still FULLY POTENT AFTER 5 YEARS, and I'm guessing you know I'm going to say that our competitors products did not do so well. None of them were found to even meet the labels' claims.

• Now I suppose we should give them a break, since it was a 5 year old product we tested ... but we don't give ourselves a break, this is how we know our products are the most superior on the planet. No one has products as pure or potent as we do, and that's now a proven fact that we're incredibly proud of.

• A little known fact … many companies are using generic methylfolate ingredients that are amorphous salt based (even some patented ingredients are amorphous salt based) – these amorphous salt based ingredients can lose up to 16% potency per year because they are less stable. And if these companies don’t formulate with a very large amount of the overage in the formula, the product will not be as potent as the claim on the label says it is. Not only that, but often when an ingredient degrades, it can generate an unhealthy compound which can cause harm to the body. We discovered just this with one of the industry-leading patented methylfolates that our competitors use. Competing methylfolates don't cut it - when tested in a 60-day open air trial, over 19% of the nutrient degraded into a very specific compound that is NOT good for your health, so buyer be aware! Check out the results on that here.

• However, Methyl-Life® uses an internationally patented crystalline salt based methylfolate, which does not lose more than 1-2% potency max per year due to its superior stability. And wouldn't you know, our methylfolate is actually 3 times MORE pure than any other methylfolate on the planet - not only based on CofA (certificate of analysis) documentation, but purity and potency tests run as well. And we are incredibly proud of this fact!

• Another little known fact is that 3rd party lab testing on finished products is not required by the FDA or the cGMP process. So a company does not need to double-check their manufacturer's accuracy.

• However, at Methyl-Life®, we feel this is extremely important as it allows us to validate the work of our contract manufacturers and it’s just another check we can do to ensure our products are made to the standard we require for our customers. So Methyl-Life® pays additionally to have extra testing done on each production batch that we run. The products are sent away to a specialized lab that can measure the exact potencies in the product and further verify our products meet and in fact actually exceed their label claim.

• Once the cGMP contract product manufacturing facilities in the USA finalize the Methyl-Life® products, the products get shipped in their fully sealed and final packaging to the Methyl-Life® Fulfillment Center.

• And from our Methyl-Life® Fulfillment Center, the products get shipped out to you upon order.