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.

Objectives of the survey "are to learn about the existing practices and to help the agency formulate a policy to ensure that dietary supplements are produced under conditions that will minimize safety problems resulting from manufacturing without imposing unnecessary costs to the industry," FDA says.

"The survey data will be used to estimate the percentage of establishments, by product type (e.g., herbals and botanicals, vitamins and minerals, etc.) and size, that are currently practicing GMPs," the agency states in an information collection request supporting statement.

FDA submitted the survey proposal to the Office of Management & Budget for emergency processing under the Paperwork Reduction Act. The agency is seeking a 30-day public comment period.

Use of normal OMB clearance procedures, which require up to 120 days of public comment, "would be likely to result in public harm; several recent illnesses and deaths are suspected to have resulted from the lack of cGMP for dietary supplements," the agency says, referring to regulatory actions related to digitalis-contaminated plantain and roughly 20 recalls of contaminated dietary supplement products in recent years.

The survey proposal marks the latest in a series of steps FDA has taken to solicit input in the area of dietary supplement GMPs. The agency published an advance notice of proposed rulemaking on GMPs in the Feb. 6, 1997 Federal Register (¹ Also see "Industry dietary supplement GMP proposal published for comments in ANPR." - Pink Sheet, 10 February, 1997.)

Public meetings on supplement GMPs for small businesses were held in Las Vegas July 12 and Salt Lake City, Utah Sept. 28 (² Also see "GMP Identity Test Exemption For Small Ingredient Batches Suggested To FDA" - Pink Sheet, 19 July, 1999. and ³ Also see "Single Identity Test For Botanicals "Makes Sense" - Israelsen" - Pink Sheet, 4 October, 1999.). A third meeting is scheduled for Oct. 21 in Baltimore, Md. Also, FDA reps recently visited six dietary supplement facilities to better understand industry manufacturing practices (⁴ Also see "CFSAN Visiting Supplement Companies For Information On Developing GMPs" - Pink Sheet, 20 September, 1999.)

A sample of 717 companies that manufacture, pack or hold dietary supplements will be selected for surveying from the universe of 2,004 firms in the Dietary Supplement Enhanced Establishment Database developed for the agency by the Research Triangle Institute (RTI) in North Carolina. The sample allocation, stratified by company size and product type and representative of subpopulations of interest, is designed to yield 400 completed surveys.

Firms initially selected will be contacted by phone and screened for eligibility. Those deemed eligible will be recruited for the mail survey. Companies that do not return the mail survey in the specified time period will be contacted by telephone. If necessary, a third follow-up call will attempt to collect responses to the survey over the phone.

RTI will develop and administer the survey in conjunction with its data collection subcontractor, Harris Interactive.

A draft of the 25-page survey asks supplement firms whether they practice GMPs and, if not, how they verify the identity, purity and composition of supplement products and ingredients.

The survey inquires about written procedures and records for personnel with regard to disease control, personal cleanliness, education, training and experience. Questions are asked regarding the documentation of building and facility maintenance and equipment sanitization.

The survey asks about quality control procedures, testing policies and standards for raw materials, in-process materials and finished products, as well as written procedures for laboratory operations.

Firms also are requested to provide information on written records pertaining to production and process controls, storage and distribution procedures, and handling and documentation of consumer complaints and adverse event reports. FDA estimates a reporting burden of 1.13 hours per survey response.

The agency seeks OMB approval in early November, with data collection commencing shortly thereafter. FDA hopes to have a final report produced by Feb. 28.

During the comment period, RTI will conduct a pretest of the mail survey with up to nine supplement firms. The survey will be revised following completion of the pretest.

Supplement Manufacturing Practices Survey Proposed By FDA

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