Are Your Enzymes Really Gluten-Free?
Formulators, you know there is a huge market for gluten-free products. You consciously decide to formulate and provide them. But are you sure the enzymes you’re sourcing can be labeled gluten-free? And if not, what are the consequences?
Gluten-free diets are increasingly common nowadays. Approximately 7% of Americans are gluten intolerant or have celiac disease (an autoimmune disease that interferes with the absorption of gluten and gluten-containing foods).Consumers with gluten sensitivity are willing to spend more money to protect and support their health.
Specialty Enzymes & Probiotics is proud to offer gluten-free enzymes compliant with the new FDA guidelines.
The New FDA Gluten-Free Rule
In 2020, the FDA confirmed new regulations stating ingredients in food labeled “gluten-free” must not contain (1) a gluten-containing grain; and (2) an ingredient derived from a gluten-containing grain (unless the ingredient has been processed to remove gluten and the finished food still has less than 20 ppm).
The FDA further stated any food containing enzymes derived from a gluten-containing grain cannot be labeled “gluten-free” unless the manufacturer can unequivocally demonstrate that gluten (above 20 ppm) is not present in the growth media.
What It All Means for You
Under the new FDA gluten-free rule, you cannot label your products “gluten-free”, “no gluten”, “free of gluten”, “without gluten” or something similar unless they meet the above guidelines.
The FDA is likely to consider incorrectly labeled gluten claims misbranded, which may open you up to costly recalls or enforcement actions.
Beyond the labeling of your products, the new rule affects your (and/or your contract manufacturer’s) facilities, cGMPs and HAACP. In those programs, any enzymes that must be labeled gluten-containing should be segregated and stored as an allergen would be. If they aren’t, the FDA’s view is that it can lead to cross-contamination with otherwise gluten-free ingredients. In short, you must have the appropriate preventative controls and prerequisite (PRPs) programs to handle these enzymes.
Our Enzymes ARE Gluten-Free
Unlike many companies that purchase their enzymes from outside sources, Specialty Enzymes & Probiotics is a true manufacturer. Our family of companies develops our enzymes straight from the microbe. It’s critical to us that we not only provide the highest-quality enzymes, but also ensure we do our homework to support our customers.
We invested years of research and manpower to provide enzymes that comply with the new FDA gluten-free rule, and we are proud to offer gluten-free enzymes for a wide range of applications.
What’s Special About Specialty Enzymes & Probiotics
We uphold the highest quality standards for all our products. Our state-of-the-art manufacturing facilities are NSF GMP, FSSC 22000 and GFSI certified. Our in-house analytical and microbiological laboratories are ISO-17025 certified, and our facilities are accredited by elite organizations, including The Non-GMO Project, OK Kosher and ISA Halal.
Truly Gluten-Free
Too many dietary supplement and food manufacturers continue to market their products as “gluten-free” without verifying their enzyme ingredients are truly gluten-free, potentially violating FDA regulations.
Ensure your products meet FDA regulations by using gluten-free enzymes. Contact us today to talk about our truly gluten-free enzyme solutions!
