PVP-Iodine

What Is It?

PVP-Iodine, also called Povidone-Iodine, occurs as a yellow-brown powder and is a broad-spectrum microbicide used in a wide variety of products including before and after surgery for disinfect the skin of the patient and the hands of the healthcare providers as well as used for minor wounds. It is a complex of polyvinylpyrrolidone and iodine. PVP-Iodine is used primarily in the formulation of topical antiseptics and can also be used in the disinfection of hard surfaces like food handling equipment. These products are regulated as Over-the-Counter (OTC) drugs or as pesticides in the United States.

Why is it used in cosmetics and personal care products?

In cosmetics and personal care products, PVP-Iodine functions has historically been used as a topical antimicrobial agent (i.e., also known as consumer antiseptics) and as a cosmetic biocide to help cleanse the skin. However, on September 6, 2016, the FDA issued a final rule on the ‘Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,’ concluding that OTC consumer antiseptic products intended for use with water (including antibacterial soaps, hand washes, and body washes) that contain any of 19 specific active ingredients (including PVP-Iodine) can no longer be marketed. The FDA concluded that manufacturers had not adequately demonstrated products containing these ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Prior to the FDA ruling, some manufacturers had already started removing these ingredients from their products.

Scientific Facts:

PVP is a man-made polymer that is combined with iodine, the latter of which is an essential element for living things.

Safety Information:

CIR Safety Review: The CIR Expert Panel, in reviewing the available data on PVP, decided to include studies on the PVP-Iodine. The CIR Expert Panel acknowledged that although the PVP-Iodine complex constitutes a separate entity from the PVP polymer, the majority of studies conducted on the complex demonstrated its safety. Because fewer adverse effects would be expected from PVP compared to the PVP-Iodine complex, the CIR Expert Panel was confident that studies conducted on the PVP-Iodine complex supported the safety of PVP.While PVP may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union, iodine (and PVP-iodine) is not allowed to be added to cosmetic and personal care products marketed in Europe (See Annex II, listing 213).

Resources:

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration:

OTC Drug Home Page

Status of OTC Drug monographs

Search the Code of Federal Regulations

EU Cosmetics Inventory