The proper identification of botanicals is a critical piece of GMP compliance, and one that is often flagged as lacking in FDA warning letters. Below is an example of a specification sheet that I created during my graduate studies. This is a necessary part of GMP documentation to help ensure a product is free from adulteration.
Graduate school taught me how to apply rational product design in herbal formulation through body system assessment, evaluation of herbal actions, and the application of scientific knowledge. This project involved research on pathophysiology of a particular disease, evaluation of the existing herbal products on the market, development of a product and brochure design, and concluded with a presentation about the project. It reflects my passion for the use of herbs to promote women’s health, so you’ll have to overlook my marketing design skills!
As I look back at the product brochure, I realize that the use of the word “PMS” and the phrase “premenstrual syndrome due to hormonal imbalance” are disease claims that are not permitted by the FDA (if I was actually selling a product). I completed this project before my compliance classes and have since learned that any marketing associated with a product, whether it be in a brochure, “liking” a Facebook post, or customer testimonial, must not contain any disease references.
Herbs are excellent allies for women’s health. This presentation from Grad school demonstrates the research and thought process that I used to design a formula that promotes healthy ovulation in women. It covers the physiological and traditional rationale for the formula, my formulation philosophy, overviews on the herbs used, and the marketing, dosage, and safety language for the product.
I was really satisfied with the formula that I created using this process of “rational product design,” and I have not seen anything like it on the market. It combines traditional and scientific knowledge to support women’s reproductive function. Blending traditional Appalachian and Native American herbs with Chinese medicine and Ayurveda, the formula was designed to gently, yet effectively help women regain hormonal balance.
