CHPA Statement Regarding FDA’s Recent Warning Letters to Three Homeopathic Drug Companies

The Consumer Healthcare Products Association (CHPA) issued the following statement regarding warning letters sent by the Food and Drug Administration (FDA) to three companies for significant violations of current good manufacturing practice regulations.

“CHPA and our members share FDA’s interest in protecting public health. We applaud FDA’s recent actions to weed out bad actors, including companies that do not meet manufacturing standards, whose products contain harmful ingredients, or are marketing over-the-counter products with prescription indications. 

 
“Homeopathic drugs are regulated under the federal Food, Drug and Cosmetic 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 view FDA’s recent activities as a step in the right direction in protecting consumer health. We look forward to seeing the Agency’s final guidance on homeopathic products in the coming months.” 

On December 18, 2017, FDA released a draft guidance on the agency’s proposed risk-based approach to prioritize enforcement and regulatory actions for homeopathic products. Click here  to view CHPA’s submission regarding the draft guidance.
###

 


The Consumer Healthcare Products Association (CHPA) is the 138-year-old national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering self-care by preserving and expanding choice and availability of consumer healthcare products. chpa.org