March xx, 2018
Scott Gottlieb, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-002
Dear Commissioner Gottlieb,
We write in regard to the December 18, 2017 draft guidance on homeopathic drug products, “Drug Products Labeled as Homeopathic,” (No. FDA-2017-D-6580). We applaud the U.S. Food and Drug Administration’s risk-based approach in deciding whether to bring enforcement action against homeopathic drug products.
While we support the FDA’s commitment to reevaluating the existing regulatory framework, “Conditions Under Which Homeopathic Drugs May Be Marketed” (CPG 400.400), we are concerned that the draft guidance withdraws CPG 400.400 in its entirety without providing a comprehensive replacement. As you know, CPG 400.400, originally enacted in 1988, eliminated confusion surrounding the definition of a homeopathic drug and has provided clear guidance for industry, stakeholders, providers, and consumers. Given the withdrawal of CPG 400.400, we have concerns that the draft guidance is silent on the definition of homeopathic products. Further, the draft guidance fails to offer appropriate instructions in regard to the support necessary for making product claims and appropriate product labeling. CPG 400.400 explicitly provided a clear regulatory framework to ensure safe homeopathic products are accessible to patients, and we encourage the FDA to preserve these guidelines as part of the regulatory framework in its new risk-based enforcement guidance.
Moving forward, it is our primary concern that any final FDA guidance provides a clear framework that will establish trust among consumers that homeopathic products are closely regulated, labeled, and defined. Likewise, we hope that such guidance will build upon the FDA’s past and present work to eliminate confusion and uncertainty among consumers.
We appreciate your commitment to ensuring quality and safe drug products and thank you for considering our concerns as you work to establish the appropriate regulatory framework for homeopathic products.
RYAN A. COSTELLO
Member of Congress