Food and Drug Administration (FDA) has issued a rule which provides that certain active ingredients used in products OTC (over-the-counter) are not recognized as safe.
The Food and Drug Administration has issued a final rule that establishes that certain active ingredients used in over-the-counter (OTC) of consumers antiseptic products intended to be used with water are not generally recognized as safe and effective and are mislabeled. Within the FDA rules, this final rule was published after considering the recommendations of the NDAC (Nonprescription Drugs Advisory Committee).
How antiseptics and disinfectants are classified
The group of products covered by this final rule known as “consumption” antiseptics include a variety of personal care products designed to be used with water, such as antibacterial soaps, washing of hands and antibacterial liquid soaps. As discussed in section III.B.3, these products can be used by consumers for their personal use in the home and in public places frequently, every day. In the configuration of consumption in the U.S.A., where the target population is composed in general of healthy individuals, the risk of infection and the extent of the spread of the infection is relatively low in comparison with the health establishments, where patients are generally more susceptible to infection and the potential for the spread of the infection is high.
This final rule covers only OTC (Over The Counter) of consumption antiseptics that are intended for use, either as a hand washing or a bath gel, but that are not identified as “first aid” antiseptics in the TFM 1991 First Aid (56 FR 33644), antiseptics for health care (80 FR 25166), antiseptic consumption rubs (81 FR 42912), or antiseptics used by the food industry. The distinctions between washes and rub for consumption, and between the washings of the hands of consumers and liquid soaps are discussed in detail in the 2013 Consumer Wash PR (78 FR 76446 to 76447 to the) and the Consumer 2016 Rub PR (81 FR 42912). The completion of the monograph for consumer antiseptic washing products and some other papers for triclosan active ingredient is subject to a Consent Decree entered by the District Court for the Southern District of New York on November 21st ,2013, the Natural Resources Defense Council, Inc . v. United States Food and Drug Administration, et al., 10 Civ. 5690 (S.D.N.Y.).