Supplement Manufacturing Practices Survey Proposed By FDA
This article was originally published in The Tan Sheet
FDA is proposing to conduct a survey of dietary supplement companies' existing manufacturing practices for use in developing its proposed rule on industry-wide GMP standards, the agency says in an Oct. 6 Federal Register notice.
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A scant 37 (16% of 238) dietary supplement establishments that responded to an FDA manufacturing practices survey said they report consumer complaints of adverse events to FDA.
Concerns over the economic burden that small companies will face when implementing Good Manufacturing Practices for dietary supplements should not delay or unduly affect FDA's rulemaking, industry commenters advise.
DIETARY SUPPLEMENT GMPs: "COMPETENT MEDICAL" EVALUATION OF REPORTED ADVERSE EVENTS may be needed to "determine whether follow-up action is necessary to protect the public health," FDA states in an advanced notice of proposed rulemaking on current Good Manufacturing Practice regs for dietary supplements. The notice, published in the Feb. 6 Federal Register, requests comments on an industry proposal for dietary supplement GMPs and a number of related GMP topics, including the appropriate review of adverse event reports. Comments will be accepted by the agency through May 7.