FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Category: OTC Drugs

Posted on Friday, December 22 2017 at 9:08 pm by
FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

By Carolina M. Wirth

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug products, the agency has issued a draft guidance proposing a new, risk-based enforcement approach for drug products labeled as homeopathic.  Following the public hearing, FDA received more than 9,000 comments in response to its request for “broad public feedback on its enforcement policies related to drug products labeled as homeopathic.”[1]

According to FDA, after considering the information obtained from the public hearing, as well as the comments submitted to the public docket, it determined that

it is in the best interest of the public health to issue a new draft guidance that proposes a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval.[2]

While the draft guidance provides a risk-based enforcement framework for products labeled as homeopathic, it leaves open the question as to how the agency will address the marketing of homeopathic drug products in the future considering that the draft guidance, when finalized, will withdraw FDA Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed,[3] which was issued by the agency in 1988. Read the rest of this entry »

Posted on Tuesday, September 13 2016 at 8:58 pm by
Just Use Soap and Water . . . . FDA Issues Final Rule on the Safety and Effectiveness of Antibacterial Soaps and Body Washes

By: Carolina M. Wirth

The Food and Drug Administration (FDA or Agency) issued a Final Rule last week establishing that over-the-counter (OTC) consumer antiseptic wash products[1] containing certain active ingredients are no longer generally recognized as safe and effective (GRAS/GRAE) and as a result cannot continued to be marketed.  The Final Rule applies to consumer antiseptic wash products intended to be used with water and rinsed off after use, including antibacterial soaps, hand washes and body washes.[2]  However, excluded from the Final Rule are healthcare antiseptics (80 Fed. Reg. 25,166), consumer antiseptic rubs (81 Fed. Reg. 42,912), antiseptics identified as “first aid antiseptics” and found in the 1991 First Aid Tentative Final Monograph (56 Fed. Reg. 33,644), and antiseptics used by the food industry.[3]

Read the rest of this entry »