Table 1.

Categories of submitters and explanations

Category	Explanation
Academia	Included individual academics and academic groups
Healthcare	Included healthcare associations and health professionals
Industry	Included companies, industry associations and individuals from industry
Individual consumers	Category only used when provided in the submitter information
Mixed associations	Defined as associations comprising at least one industry and non-industry organisation
Federal government	Category only used when provided in the submitter information
Spam	Recorded when the comment content was clearly not related to the content of the FDA document
Other	Recorded when the submitter was not one of the above categories but was identifiable. An example was the US Technology Policy Committee of the Association for Computing Machinery
Unknown	Recorded when no category was listed in the submitter information, insufficient information was provided to identify the submitter category (ie, a name, but no affiliation was provided) and when the commenter was listed as ‘Anonymous’.

FDA, Food and Drug Administration.