Science & Manufacturing Standards
Research is the most important value at First Endurance. We are driven by a desire to ensure our products are proven to enhance endurance performance, have scientific validation and are safe and legal for competition.
We are meticulous about research and go out of our way to make sure we have addressed each of our stringent requirements. All products that First Endurance develops are based on human scientific research.
Everybody says they use the finest quality ingredients, but First Endurance is over the top. We have a long history from being on the supply side and making dietary supplements in-house. We know all the right players when it comes to sourcing, and we do actually only use the best ingredients from the best manufacturers. Because dietary supplement labeling is terse and not detailed, we may look similar to other products’ ingredients, but rest assured: we go beyond the norms.
Having a long experience in the dietary supplement industry, we know lowest pricing is usually the primary selection criteria for ingredients for others. Not us. Our ingredients are chosen only for their merits, purity, and reliability – and, just like everything else we do, we aren’t guessing. We defer to the science, using the exact ingredients, sources, and doses that show results in the clinical research that informs our formulas.
At First Endurance, we refuse to reduce costs by using “pixie dust” amounts of ingredients just to dress up the label. Our formulations utilize the same levels (sometimes more) of the active ingredients that were used in the actual human scientific research.
First Endurance was built on the premise of offering a high end product line to professional athletes and endurance athletes training at a high level.
Every First Endurance product is manufactured in a NSF Certified, ISO-certified, cGMP compliant, and FDA-inspected facility.
We have worked with the world’s best endurance athletes since 2002. During that time there have been thousands of drug tests performed on our athletes with no adverse findings. This is not a coincidence. Since inception, we have had a process-based approach that was developed to ensure no cross contamination
The Process Based Approach:
- First Endurance owns all of its intellectual property. This means we develop our formulas in-house, so we have complete control over sourcing our ingredients. This allows us to choose our manufacturing facilities to ensure they meet our standards and gives us the control to change ingredient suppliers at any point.
- First Endurance quality standards require manufacturing facilities that are regulated by the FDA to be cGMP (Good Manufacturing Practice) certified.
- Our ingredients are sourced only from reputable companies that do not broker or source ANY banned substances or nutrients that have not undergone strict safety measures. Our suppliers only offer ingredients that are GRAS (Generally Recognized as Safe), have a CAS registry and offer an MSDS (Material Safety Data Sheet).
- When ingredients are received they are tested for purity and potency before they can be released into our manufacturing facility. This two-pronged test ensures the ingredient is exactly as it states.
- Every LOT of finished product produced has a corresponding Certificate of Analysis from a third party lab. This analysis assures the ingredients listed on the label are the only ingredients in the product.
- Our strict standards completely eliminate the risk of inadvertent cross contamination, ensuring that our entire manufacturing process and product line remains clean and free of all banned substances.
Industry Primer
Below, we’ve put together a primer on the rules, regulations, and manufacturing standards governing supplement product standards. But if you ever have any question about our sourcing, ingredient choice, Certificates of Analysis, or processes, then please ask! Those are our favorite questions to answer, because we’re confident that nothing else even comes close.
First Endurance sells dietary supplements, a separate subset of foods. Both foods and drugs (medicines) are regulated by separate guidelines from the United States Food & Drug Administration (FDA) outlining how to make and sell foods and drugs. When dietary supplements became a unique, separate form of food in 1994’s Dietary Supplement Health and Education Act (DSHEA), the FDA was tasked with establishing guidelines for dietary supplements. In 2007, the FDA issued those guidelines:
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule.
21 CFR Part 111
Federal Register, Vol. 27, No. 121, Monday, June 25, 2007, page 34752 [Docket No. 1996N-417]
These rules and regulations are known as cGMPs or CGMPs. Before supplements, FDA issued four other separate cGMPs for foods: 1) infant formulas; 2) thermally-processed low-acid canned food; 3) acidified food; and 4) bottled water. Dietary supplements became the fifth separate food cGMP.
Unlike foods – but like drugs – dietary supplements are a combination of adding specific amounts of individual nutrients/compounds and/or foodstuffs like herbs. Labeling requirements include how much of a nutrient is in each serving, so the FDA pays attention to how dietary supplements products are made to ensure what’s labeled is actually in the supplement
CGMPs for dietary supplements focus on how the label claims are confirmed/verified by manufacturing practices. These practices include two basic ways of confirming label claims: 1) record keeping of how the product was made from individual ingredients (like drugs and foods); and 2) actual product testing to measure the amount of each nutrient listed (like drugs).
The FDA realized that testing every nutrient listed in each batch made would be enormously expensive and burdensome, and being foods, the FDA defaulted to record keeping of a dietary supplement’s manufacturing to verify compliance with label claims. This is how dietary supplements were made for decades before and after DSHEA, and cGMPs simply codified that process.
To comply with FDA requirements, First Endurance maintains records to confirm that products follow cGMPs, and FDA inspections. Typically, industry standards test a batch of the finished products for a fat-soluble and a water-soluble nutrient to verify that their manufacturing process is working as intended. Manufacturing companies run those tests in-house or by a third-party contract testing laboratory; when the products are tested, companies receive Certificates of Analysis (COAs) that detail and confirm a product’s content.
Another key for cGMP compliance is to choose the right manufacturers – those that provide COAs, and understand testing and overages (ensuring ingredient levels meet the label claim and account for testing variability and degradation during shelf-life). Before that, working with the right suppliers will also provide consistent quality and verified COAs.
Again, we maintain up-to-date records and have all of our COAs, and we’re happy to share them on request. Any questions? Just ask!
