Only 16% Of Supplement Makers Surveyed Report AEs To FDA - GMP Study
This article was originally published in The Tan Sheet
Executive Summary
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.
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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. The most common response to reports of AEs was identity and composition testing (157 firms) and recalling the product (140 firms), according to the May 17 survey report. Fifty-eight companies said they reformulate the product in response to AE complaints. Over half (150) of the companies have written procedures for handling consumer complaints. FDA surveyed 966 dietary supplement manufacturers, repackagers, suppliers, distributors and importers/exporters regarding their manufacturing practices; 238 forms were completed and returned. FDA contracted the Research Triangle Institute to conduct the survey, which was administered via mail and telephone from Nov. 29, 1999 to Feb. 4, 2000. The survey comprises questions on products and markets, good manufacturing practices, personnel, buildings and facilities, equipment, quality control and lab operations, production and process controls, warehousing, consumer complaints and plant information. Not surprisingly, the bulk of the firms surveyed (110, or 46%) were very small, having less than 20 employees, or small (114, or 48%), with between 20 and 500 employees. Fourteen were large, with more than 500 employees. The respondents predominantly were manufacturers and distributors of vitamins, minerals, herbals and botanicals. Thirty of the firms also produce OTC drugs. About two-thirds (159) of the total respondents reported they follow published GMPs, with the most often selected model being FDA food GMPs (99 firms), followed by FDA drug cGMPs (48 firms) and U.S. Pharmacopeia GMPs (42 firms). Breaking down the responses by company size, the survey indicates the larger firms more often follow published GMPs, with 12 of the 14 large firms doing so, followed by 86 of the 114 small companies and 61 of the 110 very small businesses. For plants not following GMPs, in response to the question regarding how they verify the identity, purity and composition of ingredients and products, the majority (46) said they use a Certificate of Analysis, 14 employ sanitation standard operating procedures, 20 use another quality assurance program, 16 use a Certificate of Identity and 24 utilize another type of program. The respondents were split roughly down the middle regarding ownership of their plants - 118 own their own facilities and 107 lease them. The vast majority (205) of the respondents noted they have a unit or person responsible for quality control, and 151 add they have written procedures for that QC person or unit to follow. For plants that receive ingredients, 198 said they require suppliers to provide a Certificate of Analysis and 141 reported they verify the reliability of that CoA. Raw material testing is done by 185 of the firms, to confirm the identity of the ingredients (182 firms), detect contamination (180) and determine potency (109). Almost seven in 10 (162 firms) reported they conduct tests on in-process materials and/or finished products for the same reasons as the raw material analysis: identity of ingredients (154 firms), contamination (150) and potency (105). One hundred and seventy-nine companies said they hold representative reserve samples of each batch. On the topic of warehousing, 152 of the respondents said they have temperature control but only 39 have humidity controls in their warehouses. Just over half (135) of the respondents have written procedures for storage to ensure against adulteration as well as deterioration of both product and container, and 147 have written precautions to reduce the risk for mix-ups, adulteration or contamination. FDA announced it was conducting the survey in the Oct. 6, 1999 Federal Register (1 (Also see "Supplement Manufacturing Practices Survey Proposed By FDA" - Pink Sheet, 11 Oct, 1999.)). The agency expects to publish a proposed rule on supplement GMPs in September, according to the most recent unified agenda (2 (Also see "Fixed-Combination OTCs Derived From Botanicals Due For Rulemaking" - Pink Sheet, 1 May, 2000.)). |