Assuring dietary supplement quality for cancer patients: An integrated formulary systems approach.

Abstract

e20663 Background: Studies reveal up to 80% of cancer patients use some form of dietary supplements (DS). Despite the need for additional research, evidence exists that some DS may be of clinical value. In order to provide safe DS recommendations to patients, we created a Dietary Supplement Formulary Committee (DSFC). Methods: Twelve manufacturers (marketing 19 DS brands) with a reasonable reputation among providers for quality were selected. A survey tool was created to measure critical quality, GMP and FDA compliance practices; information was obtained via non-disclosure agreements; manufacturing documents were audited and compared to survey responses; FDA audit reports were obtained under Freedom of Information requests; site audits were conducted; and third party analytical testing was performed. Results: All 12 companies claimed to be operating in full compliance with FDA regulations. However, 3 had received Warning Letters from FDA for GMP violations; 2 performed a product recall within the last 5 years; 4 reported products that failed Consumerlab.com for potency or purity; 1 did not have product specifications; 1 was found by FDA to have inadequate testing; 1 was found to have a lack of sufficient controls throughout the supply chain to guard against microbiological contamination; and 2 had confirmed melamine contamination or lack of melamine testing on protein powders. Additional concerns included the use of subcontractors for certain operations, lack of stability data to support expiration dates, material discrepancies between claims and actual practice, and failure to change UPC (Universal Product Code) numbers when active ingredient formulas change. Conclusions: We observed considerable variation in the quality of DS, and in the level of compliance, which raises concerns for patient safety. One company met all quality standards. The combined use of the measures described above allowed for informed product selection. The variable quality practices identified here emphasize the need for careful formulary oversight. The USP (United States Pharmacopeial Convention), ConsumerLab.com, and the NSF International’s certification programs are current resources available to help identify quality DS.