New regulations focus on ensuring quality and safety in dietary supplements and nutraceutical manufacturing.

Nutraceuticals and Dietary Supplements

The dietary supplement and nutraceutical market is changing rapidly in response to the FDA's new Dietary Supplement Current Good Manufacturing Practices (cGMPS) "Final Rule" (21 CFR Part 111), published on June 25, 2007. The Final Rule adopts all requirements specified in 21 CFR 210 and 211, which affect pharmaceutical manufacturers, and apply to all companies that manufacture, package, label, or hold dietary supplements and nutraceuticals. Dietary supplements or nutraceuticals imported from outside the United States are also subject to the Final Rule.

According to the FDA, cGMPs are intended to establish a comprehensive system of process controls, including documenting each stage of the manufacturing process, to help minimize or detect problems like contamination early in the manufacturing process. The process controls that are part of cGMPs 210 and 211 are essential to ensure that dietary supplements or nutraceuticals are manufactured, packaged, held, and labeled in a consistent and reproducible manner. The Final Rule was also implemented to align with current ICH guidelines including - Q2r1, Q7, Q8, Q9, and Q10. These documents, published by the International Conference on Harmonization, establish best practices for instrument and analytical procedure validation, as well as implementing a robust quality system.

Compliance Dates

As of June 25, 2010, all dietary supplement and nutraceuticals companies are expected to be in compliance with the final rule. Companies found to be out of compliance could be subject to 483s, warning letters, or non-approvable letters indicating a regulatory deviation.

Who is Affected?

The ruling affects any company that manufactures or sells dietary supplements, nutraceuticals, and over the counter (OTC) products intended to be used by the public.

How the Final Rule Affects Water Quality Measurement and Control

The dietary supplement Final Rule has specific requirements for how nutraceutical and related manufacturers monitor and control their water systems. To learn more, please visit our TOC Analysis and the Final Rule section.