COVID-19 has drastically altered market demands and in response, some companies are temporarily changing their business models to manufacture products that are desperately needed. We have ethanol plants manufacturing hand sanitizer, clothing companies making surgical gowns, and plastic molding companies making face shields.
One hurdle to making this pivot with your business is familiarizing yourself with the regulatory obligations that apply to the new product. For example, the Food and Drug Administration (FDA) regulates medical devices such as surgical gowns, gloves, masks, and face shields. Hand sanitizer is regulated by the FDA as an over-the-counter drug as well as by the Tobacco Tax and Trade Bureau (TTB) because of its alcohol content. The FDA and TTB have relaxed some regulations and issued guidance to assist companies that are looking to help in this time of need. However, there are still guidelines and regulations that must be followed.
If you think it’s time to make this pivot with your business, Brown Winick can help you navigate the applicable regulations. Reach out to your BrownWinick attorney for assistance or submit a message through our Contact Us form.
For updates on COVID-19 and new guidance provided by BrownWinick attorneys, please visit our COVID-19 Resource Page.