The Keys to Trusting Your Manufacturer:


Hey folks, let me share with you how and why you can trust your manufacturer. The key to trusting them is their competence. Unlike the pharmaceutical industry, the dietary supplement industry is not as tightly regulated, but it still relies on the same science. Specifically, in dietary supplementation and contract manufacturing, there are plenty of formulators. But here's the thing - "formulator" is a really generic term that doesn't carry much weight in the scientific or biological industry. A formulator might be someone with a business degree who's good with numbers and has a basic understanding of materials. While they can help create a functional formula, it might still have some issues when it comes to functionality, manufacturing, or quality testing.

If your product has low potency on testing, concentration issues, or microbial contamination, can your manufacturer explain those issues to you and identify the root cause? That's where the difference between a formulator and a formulation chemist or scientist comes in. These folks have gone through formal education and training to help you create a consistent product, starting from connecting your concept to a theoretical formulation design and walking you through the process of product development. Formulation chemists understand the chemical properties of all your raw materials and how they apply to your formulation matrix to ensure a consistent and complete product. Consistency is not only important for your customers and product, but it's also an FDA requirement. You need to show that your finished product is consistent from one batch to the next, that is if the formulation hasn't changed. If you don't, it could lead to a recall or a warning letter from the FDA. So, it's important to make sure the manufacturer has invested in utilizing a higher level of professionalism by bringing on formulation scientists and chemists who are adequately educated and trained to perform formulation chemistry. This helps protect your formulation and maintain FDA compliance according to 21 CFR part 1-11.

When it comes to formulating, communication is key. It's essential to share all of your ideas with the manufacturer and collaborate to create a top-notch product. In my experience, customers often come to us with formula issues, like failing testing or quality problems, as well as consistency issues such as separation or clogging without any clear explanation. We often have to reverse engineer the problem and come up with a plan to fix it. One thing I notice a lot is that people want to use fat-soluble bioactives, such as vitamin D3, in a water-based solution. So imagine you drop oil into water - it forms little blobs that don't dissolve. This can create dispersion and concentration problems, and the formulation becomes inconsistent; you won’t get the same bioactive concentration per dose. But, it's a simple conversation to explain the technology that can be used to emulsify these ingredients to help with that problem, and at Triton Nutra Group, we've developed our own proprietary technology over the past 10 years to do just that. It doesn't add much to the cost of the product if done right, but it’s always good to communicate clearly with the customer about everything. And so when it comes to liquid extraction - something we do all the time here at Triton Nutra Group - it may seem simple, but it's actually an ancient pharmacy technique that concentrates bioactive constituents from medicinal plants to improve our health. So an experienced formulation chemist can not only tell you which herbs we're using, but also about the liquid extraction process, the extraction ratio, and how it's evenly dispersed in every single dose.

A dump and mix process is the simplest way to get as much herb into a solution with the hope of extracting as much bioactive material as possible, but liquid extraction is a much more precise, timed and calculated process that ensures you get a consistent ratio every single time. The main difference is between a simple process being sold and a scientifically proven technical process that has been used for hundreds of years in the pharmacy industry. The liquid extraction process is much more complex and involves a calculated ratio of water and solvents to extract the herb product with precise values, which is always beneficial. As a formulation scientist, I've learned that providing technical information is useful in marketing and it's something that I often communicate to our customers. It's a combination of understanding the intention, finding what works, making it work, and explaining how it works to the customer. Providing technical information to the customer is critical so they can share it with their clients.

Another crucial aspect is effective documentation, which starts in R&D, and then manufacturing takes that documentation and ensures FDA compliance by controlling and replicating it every time. The documentation also needs to clearly show the process that was followed so that as the label holder, you can answer any questions from the FDA with confidence. Many companies emerged during the COVID pandemic that claimed to support the immune system, so the FDA has been especially vigilant and keeping an eye on the growing market to ensure that the products being sold to customers are accurately labeled. And that's where our operational expertise comes in - we are making sure the product is consistent every single time. We often chat with customers about which tests are appropriate for their formulation - whether it be liquid, powder, tablets, or capsules - and there are three that are a must. These include bioactive concentration, which proves consistency through formulation matrix; microbial panel, which requires testing for yeast, mold, aerobic plate counts, pathogens; and then the heavy metal test. So, the FDA tells us what we should be testing and what standards to follow, but it's up to the manufacturer to set the actual specs.

A lot of our customers wonder whether these specs are really the best fit for their product, and most of the time, they're not. The main issue we see is that the bioactive concentration is too low, or the potency isn't what's claimed on the label. But, the customer doesn't usually get an explanation as to why that's happening. Turns out, the testing method being used isn't always validated, and most customers don't even know to ask about it. The specs for micros are totally different from the ones used for vitamins. Sometimes, the micros may seem way high, but that's just because the manufacturer used the wrong specs for a dietary supplement that includes nutraceuticals. It's not technically out of spec, just incorrect for that particular formula. We're seeing this happen a lot, so we're here to help our customers with testing in the quality area and finished product criteria testing. We use ISO certified and accredited third-party labs to make sure we're using the right methods. And if we can't find a lab, we'll tell the customer and come up with a plan. We do this because we care - it's just one of the many services we offer. If something's new, like a new active ingredient or an unusual mix of herbs, we can help create the right testing methods. This makes sure the finished product meets the correct specifications and helps avoid quality issues we often come across.

Lastly, you gotta make sure you're doing things right. You need qualified scientists, operational expertise, and the right manufacturing practices to handle R&D and production. Good documentation and testing are also key. At Triton, we've got all these things down pat, but it's super important to have scientific justifications for each step. Otherwise, the FDA might come after you if your label claims are lower than what's on the label, if your CFA results don't match, or if your product is contaminated for no reason. Trust us, recalls are no joke, it's a huge headache and it'll cost you a ton of money. You'll have to collect all the documentation and product that's out there, bring it back, and then the FDA will hold it in quarantine. When you work with a professional manufacturer like Triton, you can avoid these issues and gain peace of mind. Save yourself the trouble and work with us!If you want to put an expiration date on your bottle, the FDA says you gotta go through a stability protocol. We can make your product last for two years based on its chemistry. But every bioactive and material has its own degradation rate, which we factor in during the formulation process. We keep a database of thousands of them and some are real divas when it comes to heat. Once it's proven to be stable, you can keep that expiration date on the bottle.