Hmm....FDA approval? I think you are talking about FDA endorsement for a particular treatment - such as diahrea. That would certainly require large-scale clinical trials...not that trials have not already be done in different countries, and a quick perusal of bromelain and pineapple in pubmed will enlighten.
In terms of diahrea the mode of effect on humans is the same as in our porcine friends.
p.s. - If it can be used as an ingredient in food without limitation, it stands to reason that it can be used (without food - as a supplement) - without limitation.
From the FDA website:
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[Code of Federal Regulations][Title 21, Volume 3][Revised as of April 1, 2017][CITE: 21CFR184.1024]
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TITLE 21--FOOD AND DRUGS
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CHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES
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SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
(a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation derived from the pineapples Ananas comosus and A. bracteatus L. It is a white to light tan amorphous powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.32). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC, or may be examined at Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) In accordance with 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32910, June 26, 1995, as amended at 78 FR 14666, Mar. 7, 2013]
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