Captek Softgel International



FDA yet to offer support for misguided NDI policy

Since FDA issued its controversial New Dietary Ingredient (NDI) Draft Guidance on July 5, 2011, the agency continued with incomplete answers on a detailed 128-item Freedom of Information Act (FOIA) Request, seeking support to what most in the industry is viewed as specious assumptions and unfounded conclusions. FDA’s answer to this request, significantly, was: “We searched our files and found no responsive information.” Similarly, there were no actual responsive documents as to FDA’s dramatic new policy on Probiotics or on “chemical alteration.” With these non-responses, key novel recommendations in the NDI Draft Guidance remain completely baseless and unfounded. FDA has yet to provide answers to support its recommended radical policy changes.

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