Dietary Supplement GMPs Could Lean Toward Drug Model, Troy Hints
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed rule on dietary supplement Good Manufacturing Practices could more closely follow the pharmaceutical GMPs model than would be preferred by the supplement industry
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FDA's proposed rule on dietary supplement Good Manufacturing Practices could more closely follow the pharmaceutical GMPs model than would be preferred by the supplement industry. Speaking at the Council for Responsible Nutrition's annual conference in Savannah, Ga. Oct. 7, FDA Chief Counsel Daniel Troy told industry reps "some of you may not like the proposal, and you may think we've gone too far." "We have tried to impose the fewest regulatory burdens necessary to have efficient, effective regulation," Troy maintained. Although the Dietary Supplement Health & Education Act states that supplement GMPs "shall be modeled after" comparable regulations for foods, Troy noted supplements "are not made like food is made." "Our proposal...really does try [to] be effective, and try to address the particular issues that have to do with making dietary supplements," the agency lawyer said. "We are genuinely interested in your comments and your reactions," Troy told the industry audience, adding that the reg "was written to be a very open-minded" proposal. The GMP proposed reg was received by the Office of Management & Budget Oct. 4, marking the third time the proposal has been sent to OMB. Small business concerns and whether GMPs should more closely resemble food manufacturing regs than drug requirements are among the issues FDA is believed to have reconsidered (1 (Also see "Dietary Supplement GMPs Proposal Could Ring In New Year For CFSAN" - Pink Sheet, 30 Sep, 2002.), p. 7). The subject of supplement GMPs also arose in Senate Health Committee members' written questions to FDA Commissioner nominee Mark McClellan, MD/PhD, as part of the White House advisor's confirmation process. Sen. Tom Harkin (D-Iowa) asked what steps McClellan would take "to ensure that the proposed rule on GMPs is promptly published and final regulations are promulgated." In his written response, McClellan notes the OMB review is slated to take 90 days. "If confirmed, I will work to implement GMPs for dietary supplement manufacturers as quickly as possible," he says. During the confirmation process of former FDA Commissioner Jane Henney, MD, in 1998, Henney also said she would work to ensure that GMPs "are promulgated as soon as possible" (2 (Also see "Dietary Supplement Censure May Be Based On "Significant" Risk - Henney" - Pink Sheet, 21 Sep, 1998.), p. 8). Henney left the FDA top post in January 2001, two months after the agency sent the GMPs proposal to OMB for the first time. During her confirmation, Henney also stated DSHEA provides "adequate statutory authority" to protect public health. In response to senators' written questions concerning regulation of supplements, McClellan says he would work with HHS and Congress to implement DSHEA "in accordance with congressional intent." "While my examination of issues relating to dietary supplements has allowed me to appreciate the challenges the agency faces under [DSHEA], at this time I do not have specific statutory changes to recommend," McClellan tells the committee, which unanimously approved his nomination Oct. 9 (see 3 (Also see "Labeling Based On Consumer Comprehension Data Stressed By McClellan" - Pink Sheet, 14 Oct, 2002.) ). McClellan's response leaves the door open for him to offer future recommendations that Congress revisit DSHEA. Sen. Richard Durbin (D-Ill.) is expected to push for changes to the law during the next congressional session. The nominee was not asked any questions specifically about regulation of ephedrine alkaloid-containing products during his brief confirmation hearing, which took place the day before a high-profile Senate subcommittee hearing on ephedra chaired by Durbin. However, Health Committee Chairman Edward Kennedy (D-Mass.) raised the issue in written questions, asking McClellan whether he supports the removal of ephedra from the market. Noting that FDA expects the Agency for Healthcare Research & Quality/RAND review of ephedra to be completed in February, McClellan says: "I believe that this comprehensive review will provide an important basis for [any] possible further FDA actions" under DSHEA. |