- Why Trustwell
The dietary supplement industry is on a rapid trajectory for growth, especially as health-conscious consumers focus more on self-care trends and their dietary choices. But as the industry grows, so does the regulatory oversight that keeps the industry in check.
Dietary supplements require the use of Supplement Fact panels to notify customers of what is contained within the supplement, as well as appropriate dosage and other elements. The Food and Drug Administration (FDA) dictates strict guidelines on how Supplement Facts panels appear on a product, how nutrient content is calculated and shown, potential allergens, and other elements required for declaration. Despite the complicated nature of some of these guidelines, the FDA is strict on following them. And companies that fall short or miss a key element could face an FDA warning letter or costly recall.
On top of the FDA’s guidelines, there are also state-specific guidelines that can add layers of difficulty to compliance, like California’s Prop 65. Monitoring compliance across these regulatory bodies can become a full-time job unto itself, which is why a solution that provides the government guardrails for compliance can simplify the entire process. This was the case for one dietary supplement company, Thorne HealthTech.
A Major Formulation Upgrade from Digital Spreadsheets
For many years, Brian used digital spreadsheets to track the ingredients and formulas for over 300 products at Thorne. It took him a few weeks to input all the formulas, and each required strict alignment with FDA guidelines for calculating percent Daily Values (%DVs), using approved units of measure for nutrients, and more. One slight mistype or miscalculation in the spreadsheet could throw off the entire formula. Accuracy is key, Brian noted, but it was a challenge to adjust when formulas or ingredients changed.
Brian’s team was eager for an easier way to manage formulas. Eventually, he reached out to learn more about Genesis Supplements for formulation and label creation. He found that Genesis not only verified his calculations were correct, but also included all the government guardrails for formulation built directly into the software. Plus, it only took him a few minutes to build formulas, rapidly reducing the time it took for him to verify and manage the product line.
If an ingredient changed, Brian could easily enter the new ingredient and amount, see an instant formula and label adjustment, and double check the work for compliance alignment. This new approach would be a game-changer for streamlining his formulation process.
But they found this wasn’t the only benefit that the software could provide.
Instant Label Generation for Faster Speed to Market
While Genesis Supplements can help with formulations, it also automatically creates Supplement Fact labels that include all the essential elements to aid businesses in maintaining government compliance. This includes allergen declarations, the heavy metal warnings to align with CA Prop 65, and all the essential formatting elements a Supplement Facts panel requires.
Thorne’s R&D team was excited for this streamlined process, but they also found that it ramped up their ability to quickly get products to market. Brian shared:
“By having the formula built into Genesis and an auto-generated FDA-compliant label being created, we’re able to take the label and give it to our marketing team so they can have an idea upfront of what information should be on the label. They can work with that, which is better than starting out in the dark. This especially helps when we have a new product launch.”
Similar to how Genesis Foods can help companies launch food products faster, the Genesis Supplements software can provide the same degree of assistance in getting new products on the shelves. With streamlined formulation, automated labels, and built-in guardrails to aid with compliance, supplement companies like Thorne can revolutionize their R&D and compliance process with our gold-standard labeling and formulation software by Trustwell.
Experience the Difference with Genesis Supplements 2.0
The latest version of Genesis Supplements (2.0) has been released, which includes regulatory alignments, streamlined menu options, bug fixes, and other product enhancements. You can read the full release notes to learn more.
Plus, Trustwell offers professional online training courses with complete regulatory review for beginners for various Trustwell Connect products. With our online events, you can access hands-on training, ask product questions, and learn the fundamentals of Genesis Supplements, with a primary focus on FDA regulations.
To read a real-life example of how Thorne and Brian Potter found a solution with Trustwell’s Genesis Supplements, download our case study today. And to learn more about accurate formulation and labeling with our Genesis Supplements solution, contact our team to schedule a free demo.