Modern Herb Shop, Inc. – FDA Warning Letter, Feb 28, 2015

The FDA issued a Warning Letter to Melanie Fine of Modern Herb Shop Inc. in February 2015, following a review of their website, modernherbshop.com. The FDA determined that several products, including "Bone Knitting Powder," "Bu Zhong Yi Qi Wan," "Burn Ointment," and "Yunnan Baiyao," are promoted for conditions that classify them as unapproved new drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the "Act").

The products are deemed drugs because their labeling and advertising claim to cure, mitigate, treat, or prevent diseases (e.g., bone fractures, hepatitis, multiple sclerosis, burns, infections) or affect body structure/function. As "new drugs," they require FDA approval based on scientific data demonstrating safety and effectiveness, which Modern Herb Shop Inc. lacks. Marketing these unapproved new drugs violates section 301(d) and 505(a) of the Act.

Furthermore, many conditions addressed by these products are not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. This renders the products misbranded under section 502(f)(1) of the Act, violating section 301(a). The letter also notes that some products, despite being labeled as herbal supplements, make disease claims, classifying