The Consumer Healthcare Products Association (CHPA) issued the following statement today regarding a Food and Drug Administration (FDA) draft guidance on the agency’s proposed risk-based approach to prioritize enforcement and regulatory actions for homeopathic products:
“CHPA and our members who manufacture homeopathic drug products share FDA’s interest in protecting public health. FDA’s proposed risk-based approach to prioritize enforcement and regulatory actions for homeopathic products is an approach commonly used by the agency.”
“Currently, homeopathic drugs are regulated under the federal FD&C Act. Manufacturers are subject to routine inspections and are required to register with the FDA and list their drug products. Controls like current Good Manufacturing Practices (cGMPs), serious adverse event reporting, standardized labeling, and compendial standards are all in place to assure quality and safe use.
“We applaud FDA for focusing their enforcement efforts on homeopathic drug products that do not meet manufacturing standards, contain harmful ingredients, or are over-the-counter products with prescription indications.
“CHPA and our members look forward to submitting comments and thank FDA for the opportunity to provide input.”
