The FDA yesterday announced that it will not be taking action against manufacturers of hand sanitizer as long as they meet certain guidelines. In a rare move, FDA issued a complete guidance for manufacturers of hand sanitizer in response to lowered availability from the COVID-19 spread nationwide.
Hand Sanitizer Regulation
Hand sanitizer is regulated as an OTC drug by the FDA. In most cases, if the ingredients and labeling meet the OTC drug monograph for antiseptic rubs, the product does not require advanced approval. However, if the ingredients and labeling do not, it requires a New Drug Application, costing in the millions and taking years to go through clinical studies to prove effectiveness.
The FDA has provided this guidance to give manufacturers a step by step guide on how their hand sanitizers must be made and labeled in order to avoid enforcement action. Although the guidelines are pretty black and white, it allows companies, like the current explosion of liquor distilleries, to make and sell sanitizer during this worldwide crisis.
Adverse Event Reporting
Manufacturers must be weary of following the guidance and ensure that they have a system for adverse event reporting. AER is required to intake any adverse events or injuries that occur from the use of their products. These reports should be submitted to FDA, should an injury occur. Sanitizers meeting the guidance requirements are deemed safe and effective allowing consumers to trust that they can be used with lower risk.
This will see a boom in the industry, which has already been expanding in the last few weeks and will likely continue until the virus ceases to spread.
Call Bustos Law Group for more information and guidance (832) 592-7851.