Assuring Quality of Dietary Supplements for Cancer Patients: An Integrative Formulary Systems Approach

Area of Science:

• Nutritional Science
• Pharmaceutical Quality Control
• Oncology Supportive Care

Background:

• Dietary supplements exhibit variable quality, presenting risks to cancer patients who frequently use them.
• The US Food and Drug Administration (FDA) has documented widespread noncompliance with current Good Manufacturing Practices (cGMPs), increasing safety concerns.

Purpose of the Study:

• To investigate the quality practices of current and prospective suppliers of dietary supplements.
• To assess compliance with FDA regulations and identify critical quality markers.

Main Methods:

• Nine manufacturers were evaluated using a proprietary survey tool and audits.
• Information was gathered via nondisclosure agreements, manufacturing document reviews, FDA audit reports (Freedom of Information Act requests), site audits, and third-party analytical testing.

Main Results:

• Despite claims of cGMP compliance, several suppliers had FDA warning letters, product recalls, or failed independent testing for potency and purity.
• Issues included lack of product specifications, inadequate testing, insufficient supply chain controls, and confirmed melamine contamination in protein powders.

Conclusions:

• Findings highlight significant variability in dietary supplement quality, confirming concerns for patient safety.
• A rational process for assessing supplement quality is presented, relevant for both oncological and non-oncological settings.