The extinction of homeopathic practitioners, desired by many, has not occurred yet, because of their tenacity and creative efforts to spread their knowledge, and also because homeopathy is an open code science accessible to scholars, wise men and women, who work to deepen the knowledge of homeopathy. – Felipe Cardenas Tamara, homeopath
On December 18, 2017, the U.S. Food and Drug Administration (FDA) issued a draft guidance proposing a new, risk-based enforcement approach to drug products labeled as homeopathic. This policy guidance is more vague for manufacturers in its enforcement approach than the current guidance for homeopathic drug regulation and has the potential to limit the marketing of, and access to, homeopathic products that people now rely on.
Officials at the FDA claim that because the homeopathic drug industry has grown, they “need to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. The approach also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.”
Homeopathy Faces A Catch-22
Under U.S. law, homeopathic drugs are required to meet the same approval rules as other drugs. But under a policy adopted in 1988, the agency has used “enforcement discretion” to allow the items to be manufactured and distributed without FDA approval under the enforcement policies in FDA’s Compliance Policy Guide (CPG) 400.400.
After a 2015 public hearing, the FDA determined that it is in the best interest of public health to issue a Draft guidance that includes a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of products that potentially pose a higher risk to public health.