CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.
CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.
Join Duffy MacKay, Senior Vice President of Dietary Supplements at CHPA, and George Paraskevakos, Executive Director of the International Probiotics Association to explore the science behind probiotics, why gut health is so important, and what’s next for this growing category.
CHPA supports efforts to harmonize the current Quality System Regulation with international quality management system requirements. However, CHPA recommends that FDA address several points of concern or clarification when finalizing the Proposed Rule.
This week, the Senate Judiciary Committee held a hearing to look into legislative solutions to protect consumers who purchase goods on online platforms, namely the INFORM Consumers Act.
This week CHPA filed an amicus brief urging the 9th Circuit U.S. Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.
CHPA’s argues both constitutional precedent and federal rules on class action lawsuits require classes that capture members who actually have a viable claim and potential right to recovery; not classes in which some consumers are even plausibly harmed.
CHPA this week filed an amicus brief urging the 9th Circuit US Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.
