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Questions include how to prevent cross-contamination and how to comply with FDA’s gluten-free rules.
One path available to supplement makers seeking to manufacture and label gluten-free is that of third-party certification. The following certifications are available:
While Celiac Support Association’s Larry Brauer says that, currently, only about 2% of CSA’s seal-program applicants are nutritional supplements (instead of foods), and National Foundation for Celiac Awareness’s vice president Jennifer North says the NFCA’s Gluten-Free Certification Program focuses most of its outreach efforts on food manufacturers, gluten-free certification remains a viable option for supplement manufacturers.
One such manufacturer, New England-based Gluten Free Therapeutics (GFT), is, at the time of this post, in the process of obtaining CSA’s recognition seal. Leigh Reynolds, the company’s president, has a background in the heavily regulated pharmaceutical industry and says GFT chose CSA’s certification because of its especially stringent testing protocols. (GFT manufactures nutritional supplements specifically for the Celiac and gluten-sensitive populations.) Reynolds describes the certification-application process as “time-consuming but not difficult or onerous,” and she says much of it is based on a paper audit conducted by the company itself. GFT’s application submission will include the paper audit and related documentation from raw-ingredients suppliers, and a list of GFT’s products and product information-including high-risk (for gluten contamination) and low-risk ingredients.
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