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 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.
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.
Last week, Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.) introduced the Stopping Harmful Offers on Platforms by Screening Against Fakes in E-Commerce (SHOP SAFE) Act, intended to protect consumers by stopping the online sale of harmful counterfeit products. This follows introduction of the same legislation by House Judiciary Committee Chairman Jerrold Nadler (D-N.Y.) and Congressmen Darrell Issa (R-Calif.), Henry C. "Hank" Johnson, Jr. (D-Ga.), and Ben Cline (R-Va.).
Senators Dick Durbin (D-Ill.) and Bill Cassidy, M.D. (R-La.) recently introduced legislation to combat the online sale of stolen, counterfeit, and dangerous consumer products by ensuring transparency of high-volume third-party sellers in online retail marketplaces.
During this episode, get a behind-the-scenes look at CHPA’s policy priorities and the role that the new Congress plays in shaping healthcare from CHPA’s Federal Government Affairs Vice President Marc Schloss and Director Taylor Holgate.
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).
This week, by a vote of 321-101, the House of Representatives passed H.R. 1996, the SAFE Banking Act. The SAFE Banking Act prohibits a federal banking regulator from penalizing a depository institution for providing banking services to a legitimate cannabis-related business.
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.