Is Dissolution Test Mandatory for Dietary Supplement?

[v9991]

PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111&showFR=1

Sec. 111.3* Definitions
Quality*means that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.
...
Product complaint*means any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice. Examples of product complaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead).
...
Sec 70. Specifications
(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

Further USP general chapter 2040...
https://www.usp.org/usp-nf/official-text/revision-bulletins/disintegration-and-dissolution-dietary-supplements-dissolution-section
<2040> Disintegration and Dissolution of Dietary Supplements,

"Soft gelatin capsule preparations of dietary supplements meet the requirements for Disintegration."

usually dissolution is considered as considered as an indicator of product performance. (efficacy...since it indicates availability of active ingredient invivo, ready for absorption)

given above two references
FDA regulations are not really indicating efficacy to be part of specifications (accounting for the product, its function or intended use etc);
+
USP has been postponing the requirement of dissolution requirement for soft gel capsules for quite some time.


My Query :-
btw, product is multivitamin and multimineral product
1) can I continue relying on DT(disintegration) QC-specification test for
release of batch.
2) what kind of review/risk-assessment(for not considering dissolution test parameter) i must have in place before going ahead with DT as QC-test parameter.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!