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Consumer Product Matters A product safety and consumer related regulation and litigation blog

Tag Archives: OTC drugs

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), U.S. Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held a public meeting to solicit stakeholder feedback on… Continue Reading

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

Posted in Advertising, Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Federal Trade Commission (FTC), Manufacturer Product Safety, Product Liability

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about this uniquely-regulated class of consumer products.  Today, FTC released… Continue Reading

Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Posted in Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past six years (since a 2010 consumer alert about… Continue Reading

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA)

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency’s monograph system.  Agency leader Dr. Janet Woodcock wrote last week in Health Affairs that FDA’s “current system of… Continue Reading