Comment from Alliance for Natural Health USA
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Summary: The Alliance for Natural Health USA (ANH-USA), a nonprofit watchdog organization, supports the inclusion of Choline Chloride on the 503A bulk drug substances list. They argue that the FDA should focus on the ingredient's proposed use rather than specific disease indications, noting that functional and nutraceutical uses have significant clinical value.
The Alliance for Natural Health USA (ANH-USA) is responding, via the attached, to FDA's questions regarding the nomination of Choline Chloride for inclusion on the 503A bulk drug substances list.
We would like to reiterate that the Agency's original request asked only for ingredients' proposed use, not the disease condition or indication.