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.
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.
The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) request that FDA withdraw its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).
CHPA released the following statement in response to new research published in Clinical Toxicology. The study found nine illegal stimulants, including deterenol, in fraudulently marketed sports and weight loss supplements.
The Product Quality Research Institute (PQRI) is a non-profit consortium of that generates and shares timely, relevant, and impactful information to advance drug product quality and development. PQRI provides a unique forum to focus critical thinking, conduct research, exchange information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard-setting organizations.