Meeting New FDA Standards
for Dietary Supplements
For over ten years, we have been aware of of a proposed rule that would put the FDA in charge of regulating Dietary Supplements, including herbal extracts. At first, all we could find on the topic was a loose set of regulations that evoked a variety of responses within the herbal community, everything from fear to certainty that they would never be passed. Our initial response was less than enthusiastic. Our eyes would glaze over as we poured through the columns of technical jargon. We foresaw sterile environments, heavy machinery, and robot-operated systems.
After several years of integrating the fact that the regulations were probably going to become law, our outlook began to shift. We began working towards some aspects of the regulations (which cover everything from the physical space the products are made in to the process of the manufacturing), especially more in-depth record-keeping. We opened the doors of our new apothecary in 2004, a building which was designed around the new regulations.
After years of preparation the FDA did finally pass 21 CFR Part 111 in June of 2007, putting into effect the Final Rule for the Current Good Manufacturing Practice in Manufacturing, Labeling, or Holding Operations for Dietary Supplements. The compliance date for businesses our size is June 25, 2010.
As we combed through the rules more carefully, we have definitely found a silver lining. By working in cooperation with the FDA regulations, we have found many positive changes--from consistency and quality control of our products to streamlining our procedures to increase efficiency in the workplace.
We also are very grateful to be in North Carolina, where there is a lot of support for natural products and medinal herbs, related to the transition from tobacco farming. Adding the support of our local Asheville-Buncombe Technical College, the North Carolina Small Business and Technology Development Center, and the North Carolina Natural Products Association, to our increasingly positive outlook, and we were able to formulate a plan towards compliance! We feel excited that through compliance we gain more confidence in our products, our claims, and the future of our small business.
So the women at Red Moon Herbs take a big step forward into the future, to embrace the direction of our industry with gusto and confidence. We are busily working behind the scenes, taking our classes and upgrading our systems. The products you have come to love and trust will mostly remain the same.
In fact, Red Moon probably won’t look much different to the outside world, but take a peek inside our doors and we feel that you will be pleasantly surprised to see us bridging the gap between folk wisdom and the government, between the past and the future.
