On July 3rd, 2011, U.S. FDA gained official power to suspend registration of food facilities and also extended capabilities to administratively detain food. The agency also introduced new required questions to the Prior Notice System. Additionally, U.S. FDA announced an anti-smuggling strategy and draft guidance on new dietary ingredients. All of these recent developments stem from the FDA Food Safety Modernization Act (FSMA), which was signed into law earlier this year.
U.S. FDA’s power to suspend the registration of food facilities effectively closes any facility that created, caused, or is responsible for food having a reasonable probability of adverse health consequences to humans or animals. U.S. FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States. Registration may be held in suspension until U.S. FDA determines the cause to be rectified and that no further health consequences exist. U.S. FDA also announced its right to require “corrective action plans” from suspended facilities as proof that no further health consequences exist.
Similarly, U.S. FDA’s new extended power of administrative detention of food shifts the previous detention paradigm and allows U.S. FDA to proactively halt food suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern. If U.S. FDA suspects food to have been produced or processed in unsanitary conditions, U.S. FDA may administratively detain food products for up to 30 days.
In an effort to be more proactive, U.S. FDA has also introduced new requirements for Prior Notice filings. In the new system, U.S. FDA will require filers to indicate whether a food product has ever been refused entry to another country, and, if so, which countries. U.S. FDA claims this will help the agency target higher risk products and regions.
U.S. FDA’s newly released anti-smuggling plan also portrays the agency’s move towards prevention of unsafe foods being sold and consumed in the United States. The anti-smuggling strategy was developed in coordination with the U.S. Department of Homeland Security’s Customs and Border Protection (CBP) and reviews critical data indicative of products and regions which require a higher level of scrutiny. U.S. FDA plans to share information with CBP to assist in deterring food smuggling.
Alongside the preventative measures detailed above, U.S. FDA has also been tasked via FSMA with generating several new Guidance Documents. One such new Guidance Document that was published earlier this week is the draft guidance on new dietary ingredients. While the final version is yet to come, this draft guidance reviews the methods in which a manufacturer wishing to use a dietary ingredient should notify the U.S. FDA before adding such ingredients to products. This new requirements aims to protect consumers from unnecessary public safety concerns from new dietary ingredients with unclear health risks.
While this has been a busy week for U.S. FDA, the agency has many, many more tasks to complete in order to fully implement the new law. Registrar Corp will continue to post new developments and is available for discussion 24/7 by phone at +1-757-224-0177 or via online Live Help. To receive U.S. FDA regulatory updates, visit: https://www.registrarcorp.com/fda-updates