Dietary supplement companies often come to us unsure of how the U.S. Food and Drug Administration (FDA) regulates their products. The requirements are not immediately clear, especially when label claims and terms such as “nutraceuticals” or “functional foods” (not recognized by FDA) can blur the distinction between supplement and drug. In fact, FDA regulations for dietary supplements mirror those for food and beverages, but with some significant differences. Below lists some of the key requirements supplement companies should follow to ensure FDA compliance.
FDA Registration:
Facilities that manufacture, pack, or hold dietary supplements for U.S. consumption must register with FDA. Facilities located outside of the United States must designate a U.S. Agent for FDA communications at the time of registration.
FDA requires supplement facilities to renew their registrations between October 1 and December 31 of each even-numbered year, regardless of when they initially registered. For example, if a facility registers with FDA in September 2018, it will still need to renew its registration between October 1 and December 31, 2018.
