Ensuring Quality: Methyl-Life's Quality Assurance Practices in USA Manufacturing

The events of the past few years have seen people all over the world seek out new and better ways to optimize their health. Since 2020, sales of dietary supplements and nutraceuticals have soared[1]. 

Consequently, the role of quality assurance practices by supplement manufacturers has never been more important.

When comparing supplement brands, there are several important factors to consider. Along with reputation, cost, and valid research, a major indicator of efficacy is a brand’s quality assurance practices.

In the USA, supplements are not rigorously regulated as pharmaceutical drugs. This makes robust quality management systems[2] even more crucial. 

That’s where Methyl-Life® excels. Our dedication to customer satisfaction underpins our stringent measures to maximize the safety, efficacy, and reliability of our products. 

First, let’s explain the difference between quality assurance vs. quality control.

What is quality assurance?

Quality assurance focuses on processes and systems implemented to ensure the overall quality of supplement manufacturing. It involves establishing guidelines, procedures, and standards to prevent defects and ensure consistency in the final product.

What is quality control?

Quality control involves inspecting and testing specific samples during production to identify and address any deviations from the established standards. 

Our commitment to quality

As one of the world’s best-known methylfolate supplement manufacturers, Methyl-Life® is 100% dedicated to the current Good Manufacturing Practices (cGMP) set by the US Food and Drug Administration (FDA)[3]. These practices encompass rigorous testing, quality control, and adherence to strict standardized procedures during manufacturing, packaging, and distribution. Our USA-based manufacturing facility is registered with AND audited by the FDA routinely. Not only that, but Methyl-Life's® manufacturing plant has also invested in NSF Certification[4], which means there's an additional set of rigor that is placed on the manufacturing of products by the third-party, non-profit National Sanitation Foundation[5]. This foundation works to ensure that all products produced by a manufacturer adhere to specific SOPs (standard operating procedures) that meet public health and safety standards. Not all dietary supplement manufacturers go through the extra steps and cost to become NSF Certified, but we feel it's an important extra step that's needed to ensure compliance and the highest quality standards for our customers. Because Methyl-Life's® founding owner, Jamie Hope, takes these products daily, there is a stringent awareness placed on purity and all of the steps needed to prevent adulteration of any kind.

So, how do we do it?

1. Ingredient Research: Methyl-Life® reviews active ingredients from around the world, looking for the most promising options and highest absorption forms available. Any ingredients decided upon for a new product formula often get ingested first by the founding owner to verify the nutrients' actual effectiveness in a human body (instead of relying on what's been touted in theorizing research or an animal study).

2. Manufacturer Assessment: Before we work with a supplier, we conduct a thorough evaluation of their credentials and certifications. We ensure they are compliant with regulatory standards and have proven track records in delivering quality ingredients. 

This assessment provides us with the transparency we need to be fully informed about the origins of our ingredients, traceability  and production processes. It is imperative that every single component of our products meet the required quality benchmarks so that we can stand behind our promise to customers. We also strive to minimize the risk of harmful substances or impurities being present in our ingredients so that we can fully safeguard consumer health.

3. Third Party Ingredient Testing/Acceptance: Every ingredient we use in our products undergoes third-party testing to confirm that it matches every detail on the Certificate of Analysis. If any ingredient doesn't meet the standard COA, it gets rejected and we don't use it in our products. The below lists each of the tests that are specifically run on every single ingredient before it can be "accepted" and "used" in a product formula. 

• Identity – to ensure it’s the material that was purchased and 100% matches its COA
• Purity/Potency – to ensure the ingredient actually matches the stated purity/potency ratios on the COA
• 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 USP limits

If any ingredient fails any of these steps in the verification process, it is rejected and cannot be used. It then gets thrown away or sent back to its original manufacturer for further testing.

4. Product Formulation: Methyl-Life's® USA-based manufacturing facilities then closely follow the cGMP/NSF generated SOPs (standard operating procedures). These precisely detailed steps ensure the ingredients are correctly calculated, measured, blended, tableted/capsuled, weighed, tested, bottles sealed, and successfully passing all quality control requirements along the way with flying colors. This results in a finalized product.

It is worth noting that Methyl-Life® takes an extra measure of care to ensure that many of our formulas are created with a 10-20% active ingredient overage. This is so some of our  flagship products will survive a full 3-year shelf life and still be able to easily pass a potency test (this proves it "meets its label claims"). A good manufacturer will usually 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 says there should be in it).

An amazing fact - Methyl-Life® had some unopened 5-year old products sent to a folate specialist's lab in Switzerland along with some of its competitor's products to be tested. Of course we learned that the results showed Methyl-Life® products were still FULLY POTENT, EVEN AFTER 5 YEARS, and I'm guessing you already know that I'm going to say our competitor's products did not even meet the labels' claims.

5. Verifying a Final Product: Another little known fact is that 3rd-party lab testing on finished products is not required by the FDA, the cGMP process or NSF standard operating procedures. So a company does not need to double-check their manufacturer's accuracy. However, Methyl-Life® feels this is an extremely important step as it allows us to validate the work of our manufacturing facility and it’s just another check we can do to ensure our products are made to the standard we require for our customers.

Methyl-Life® has chosen to pay for an additional step after the process at the manufacturing facility is complete and the product is ready to ship out. Methyl-Life® goes the extra mile and sends their final products to a third-party lab and pays for EVERY SINGLE BATCH to be randomly tested for potency to ensure it passes before it gets sold to customers.  

Technological proficiency

Our laboratory technicians apply strict testing procedures throughout our manufacturing processes so that all of our products meet - and typically exceed - industry standards.

This includes sophisticated analytical techniques to identify and quantify individual compounds within a supplement. This allows us to verify the potency and purity of active ingredients.

We also test for potential contaminants to ascertain that the supplement contains the intended ingredients without any unexpected or harmful substances.

Our stability testing involves subjecting our products to various environmental conditions (such as temperature, light and humidity) to assess the shelf life and ensure every supplement remains effective and safe over time.

Certifications and compliance

Methyl-Life’s® compliance with rigorous guidelines are reflected in our certifications and registration. Methyl-Life’s® manufacturing facility is FDA registered and audited as well as NSF Certified. 

We implement stringent quality control measures at every stage of the manufacturing process. We are committed to ensuring that our finished products meet the required standards of purity, strength, and composition.

Our cGMP best practices are followed to ensure that our facility adheres to FDA regulations and has passed all audits for quality control. The cGMP is essentially an FDA-recommended baseline for all supplement manufacturers as it proves we have the right safety practices in place to control risks and hazards. The rigorous third-party, NSF, performs the independent assessments to confirm these safety practices and processes. 

Methyl-Life® meets these criteria:

• Hygiene standards

Methyl-Life® manufacturing facilities maintain a high level of cleanliness, sanitation and "clean rooms" to prevent cross-contamination and ensure the integrity of our products.

• Trained personnel

We employ trained and qualified personnel who understand cGMP principles and follow the procedures to maintain product quality and safety. Our employees receive regular training on cGMP principles, safety protocols, and quality standards to uphold a culture of excellence and compliance.

• Documentation

All of our manufacturing processes, including equipment calibration, testing, and product formulations, are fully documented for traceability and accountability. 

• Raw material testing

All raw materials used in Methyl-Life® supplements undergo thorough testing to ascertain their purity and potency. These stringent quality checks allow us to identify and prevent potential contamination, adulteration, or mislabeling of products. 

• Third-party testing

Every product developed by the manufacturer has its own Certificate of Analysis (COA) based on post-production testing. In addition, EVERY batch is also third-party tested for potency at an independent lab to ensure the results are consistent. Feel free to ask our excellent customer service team to provide you with these details if you're interested in reviewing them.

• NSF Certification

NSF Certification is the highest assurance that a product has been tested by a trusted independent certification organization. This certification is well beyond FDA requirements as it ensures every aspect of a product's development is thoroughly evaluated. NSF Certification is not a one-off: it involves regular re-testing of products alongside on-site inspections of manufacturing facilities. 

• Batch testing (NOT skip-batch testing)

Each batch of finished products undergoes testing to verify its compliance with quality standards before being released for distribution. Many companies only employ skip-batch testing (i.e., batches are tested at random). At Methyl-Life®, we third-party test EVERY SINGLE BATCH - we believe our customers deserve the very best. This ensures that our consumers receive products with accurate ingredient lists, appropriate potency, and minimal risk of harmful impurities.

• Environmental control

Our manufacturing facility is equipped with environmental controls to maintain conditions such as temperature and humidity, preventing sensitive ingredients from degradation.

• Supplier verification

We conduct regular audits and verification of our every supplier to establish their adherence to cGMP principles and the quality of their raw materials.

• Customer services

Methyl-Life® puts every customer first. We address every query and question promptly and thoroughly to provide a resolution as quickly as possible.

Evolving through feedback

Methyl-Life® takes feedback seriously. We actively encourage our customers to share their experiences with our products and services. This information contributes to our continuous improvement and our relentless pursuit of excellence. It also allows us to address any concerns. We’re always looking for ways to improve or exceed our customers’ expectations!

Our website includes several options for customers to contact us, including an inquiry form. Our internal support team is available via email, and live chat. We do not outsource our customer support to any contractors or third-party companies: our customer support is entirely in-house.

We get many questions from our customers regarding MTHFR, supplements, and other health concerns. Our team of qualified health professionals respond to these personally. We also address the most common questions on our Customer Support page and have a website technical assistance page as well. It’s all part of our commitment to going the extra mile for our valuable clientele. 

The takeaway

Methyl-Life® is proud to be wholly transparent about its manufacturing procedures. Our long list of credentials and certifications reflects our tireless commitment to creating safe and effective products. We seek to not only meet but exceed our customers’ expectations in every way. 

Our robust quality assurance practices play a crucial role in upholding the integrity of the USA supplement industry and empowering consumers to make informed choices about their health and well-being.

Reference

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8416287/ 

2. https://smallbusiness.chron.com/important-businesses-practice-quality-control-69340.html

3. https://www.fda.gov/

4. https://www.nsf.org/knowledge-library/what-is-nsf-certification

5. https://www.nsf.org/