From Teacup to Medicine Cabinet: Botanical Teas Approved as Over-the-Counter Medicine

In the 1980s, Traditional Medicinals found itself at a crossroads that would
shape the future of the company—and the entire herb industry. The FDA issued an ultimatum: if we wanted to continue making medicinal claims about our teas, we had to comply with their Over the Counter (OTC) standards. It was a daunting task, but one that set us on a path toward greater credibility and long-term growth.

Our president at the time, Lynda LeMole, dove into the FDA’s requirements and regulations, researching the intricate details of OTC monographs. She saw this challenge as an opportunity. With her leadership, we adapted our formulas to meet FDA OTC standards and upgraded our facility to become fully compliant, even obtaining a drug manufacturing license. This was a groundbreaking move, making Traditional Medicinals one of the few herbal companies to meet such stringent regulations.

The impact was profound. Conforming to FDA standards not only enhanced our quality control and manufacturing practices but also opened the door to larger, national retailers. We went from being available in small, local health food stores to having a presence on mainstream shelves across the country. This shift gave us the chance to reach more people, expanding access to herbal medicine and furthering our mission of education.

As Lynda herself put it, "This positioned us to be both a quality leader and a company working for the betterment of the entire herb industry." Our pioneering efforts didn’t just benefit Traditional Medicinals; they set a new standard for the entire industry, raising the bar for quality, transparency, and consumer trust. In the 1980s, Traditional Medicinals faced a critical moment that would transform the company and set new standards for the herbal industry. The Food and Drug Administration (FDA) delivered an ultimatum: if the company wanted to continue making medicinal claims about its teas, it would need to conform to the FDA’s Over the Counter (OTC) drug standards or be forced to drop the claims altogether.

Rather than retreating, Traditional Medicinals saw this as an opportunity. Lynda LeMole, the company’s president at the time, spearheaded the effort to navigate the complex regulatory landscape. She delved into FDA requirements and OTC monographs, guiding the company through the necessary changes. The result? Traditional Medicinals became one of the first herbal companies to meet FDA standards, earning a drug license and upgrading its facility to comply with strict OTC regulations.

This milestone was more than just a regulatory win. By meeting these high standards, Traditional Medicinals positioned itself as a leader in quality and opened doors to major national retailers—something unheard of for herbal companies at the time. The brand, once confined to small health food stores, was now able to reach a much larger audience, marking a pivotal expansion in the accessibility of herbal medicine.

The move also solidified Traditional Medicinals' reputation for rigorous quality
control and elevated manufacturing practices, raising the bar for the entire
herbal industry. “This positioned us to be a quality leader but also a company that
really worked for the betterment of the entire herb industry,” LeMole noted.

By stepping up to the FDA’s challenge, Traditional Medicinals not only ensured its
own growth but also helped pioneer a new standard of excellence for herbal products, setting a precedent that would benefit the industry for decades to come.