Find out how a surprise website review by the FDA yielded high marks because Mamaki of Hawaii was proactive in hiring Tap~Root to review their structure function claims and marketing copy.
Start-up tea company Mamaki of Hawaii was preparing boxes to go to print and production. They hired Tap~Root to review the natural product labeling for regulatory compliance and to assist in developing additional key messaging points based on their science.
As part of her review, Risa Schulman looked at the Mamaki website, mama-kii.com. She informed the Mamaki team that websites are considered an extension of the labeling, and that their site contained a number of claims that she suggested would be considered out of compliance by the FDA. The Mamaki team agreed to revise the website in concert with the message points developed for the box.
Two months later, the company had initial dealings with the FDA regarding shipping raw material into the US. Because of the unique nature of the material, the FDA was very cautious and reviewed the company’s website. As a result of discussions with the FDA, Mamaki management came to realize that the FDA had not only reviewed the website but also substantial portions of the company’s operations. This surprise review could have caught Mamaki, a small company still operating “under the radar,” totally off guard. But since they had engaged Tap~Root and revised their website as suggested, “the FDA gave us clearance and high marks.”