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Questions include how to prevent cross-contamination and how to comply with FDA’s gluten-free rules.
With awareness and diagnoses of Celiac disease and gluten intolerance growing, along with an increase in consumers who are eliminating or reducing gluten in their diets for other reasons, manufacturing for and marketing to the gluten-free community may make good business sense for nutritional supplement companies. Individuals with Celiac disease in particular are typically advised by clinicians to take nutritional supplements at the time of diagnosis, to begin to replenish crucial nutrients their intestines have failed to absorb, and throughout the duration of their prescribed gluten-free diets to fill any nutritional gaps created by unfortified and less-nutrient-dense processed gluten-free foods.
For the Celiac community, as well as anyone following a strict gluten-free diet, nutritional supplements must replace the specific vitamins, minerals, and other nutrients they may be lacking, such as calcium, folate, iron, B12, vitamin D, and fiber. These supplements must also be gluten-free themselves, and if the “gluten-free” claim is made on the label and in marketing materials, these products must comply with FDA’s rule regarding “gluten-free” labeling, which went into effect in August of 2014.
The questions for supplement manufacturers interested in pursuing gluten-free claims for their products include “How can I ensure compliance with FDA’s rule?” and “What are the points in my manufacturing process where cross-contamination with gluten is possible?” Also a consideration for supplement companies? Whether to apply for official gluten-free certification.
The following four slides provide some answers to these questions and additional suggestions from experts on how to address the challenges of gluten-free manufacturing.
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