Small and mid-size farms that produce herbal supplements are under new, stringent FDA regulatory and safety requirements because of a change in definition from "food product" to "dietary supplement." This status change has made these farms subject to FDA Current Good Manufacturing Practice (cGMP) regulations that are difficult and very expensive to implement. During a three-year period, federal inspectors cited 70% of the facilities that make dietary supplements for violating regulations. Blue Meadows Farm Labs LLC proposes to develop and commercialize a cost-effective and easy-to-use system that supports farmer-owned facility compliance with cGMP requirements, and an innovative, robust, and cost-effective suite of analytical equipment that currently represents a "bottleneck" for small manufacturersÂ’ compliance with FDA cGMP standards. Blue Meadows will work with small/mid-size farm operations in Wyoming and Missouri to test this development. The basic methods and approaches to collect and product data and results will include surveys, interviews, documentation of farmer growing and harvesting processes for herbs, software specification analysis and cost analysis, field testing, software user tests, and documentation comparison between farming/manufacturing processes and requirements. The ultimate goal of this SBIR project is to develop a suite of tools and processes to support small and mid-size farms and farm manufacturers in their efforts to meet Good Manufacturing Process (cGMP) requirements for dietary supplements. The anticipated results are a set of processes, analytical tools, and documentation that will represent an economically feasible method for farmer-owned herbal supplement manufacturers to meet these FDA requirements. The societal benefits that may be realized are not limited to the potential for improved economic vitality in rural areas where these manufacturing plants are located. An increasing number of peer-reviewed research articles validate the benefits of certain herbs for maintaining health or in treating chronic health conditions. An aging population, rapidly rising obesity rates, and escalating healthcare costs will make the domestic farm production of herbal plant supplements more important. U.S. farm production of herbal products that can definitively verify the source and identity of the plant material has become critical when adulteration and possible contamination of herbal products has become an increasing industry challenge, and many herbs collected from the wild are critically endangered across the globe. Blue MeadowsÂ’s proposed regulatory "compliance kit" can also be adapted to help farmers navigate FDA mandates under FMSA legislation, or address other regulatory farm compliance. With almost 40% of U.S. adults having used complementary or alternative therapies, farmers who can cost-effectively comply with FDA regulations and manufacture farm-grown herbal plant supplements will be in increasing demand.
