Under federal law and regulations, many companies (and products) are required to be registered with the U.S. Food & Drug Administration (“FDA”). At Shehadeh Giannamore, PLLC, we provide comprehensive regulatory assistance to help you determine if and when to register with the FDA.
FDA registration is a relatively straightforward process whereby we submit certain contact information about a company, and sometimes its products, to the FDA. Clients often look to us to assist with the FDA registration process, but the first step is often to determine whether FDA registration is even necessary. Many companies and types of products are not required to be FDA registered. For example, cosmetics companies are not currently required to be FDA registered. Additionally, food products and supplement product are not required to be listed or FDA registered. However, manufacturers of foods and supplements must maintain active FDA registrations in order to import and market their products in the United States.
Once we have determined that FDA registration is required based on the particular company’s activities and products, we then can submit the FDA registration information on behalf of the company. Further, foreign companies are required to have a US Agent as part of maintaining an active FDA registration. We provide FDA Agent services to help our global clientele ensure that they are able to meet all relevant FDA regulatory requirements.
If you need help registering and listing your products with the FDA, need a FDA Agent or need other regulatory assistance, please contact us at contact@sglawfl.com.
