The Food Safety Modernization Act (FSMA) of 2011 aims to ensure the safety of the U.S. food supply with a focus on preventing, rather than responding to, food contaminations. FSMA requirements apply to domestic and imported human and animal food products, including dietary supplements, regulated by the US Food and Drug Administration (FDA).

URGENT: Food Facilities Must Renew FDA Registrations by December 31, 2018

The FSMA mandates that facilities that manufacture, process, pack, or hold food, beverages or dietary supplements for consumption by U.S. consumers register with the FDA. Registration is renewable every even-numbered year. Accordingly, all previously registered food facilities must renew their registration by December 31, 2018. As part of this process, importers must also designate their US registered agent, another FSMA requirement. Failure to renew by the deadline may lead to having shipments detained.

Registration is free. The owner, operator, or agent in charge of the facility may also authorize an individual to submit the renewal on their behalf.  Renewals can be submitted electronically using the FDA Industry Systems site. Renewals may also be submitted by mail or fax using FDA Form 3537.


FDA issues Guidance for Industry & FDA Staff on Mandatory Food Recalls

The FSMA gives the FDA authority to mandate recall of articles of food and dietary supplements that the FDA determines may be adulterated or misbranded and likely to cause illness or death to humans or animals. Prior to FSMA, this mandatory recall authority was in effect only with respect to infant formula.  The FDA has issued its Guidance for Industry on Mandatory Food Recalls. Industry may submit electronic or written comments regarding this guidance at any time.


 Voluntary Qualified Importer Program (VQIP) application portal open.

The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program established under the FSMA that provides expedited review and importation of human and animal foods into the United States for approved applicants. These importers must achieve and maintain a high level of control over the safety and security of their supply chains. Participating importers will be able to import their products into the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. To participate, importers must have a minimum three-year history of importing into the U.S., meet other eligibility criteria and pay a user fee. The portal is now accepting applications for FY 2020. More information is available here and in the FDA’s Guidance for Industry.


Other requirements for US food importers:

Access the list of FDA Rules and Guidance to Industry here. Contact us for more information or for assistance with FSMA Compliance.


Updated Labeling Requirements for Packaged Foods

US food labelling laws require that packaged foods destined for the consumer carry nutrition labeling. Furthermore, the information must be easily read and understood by the ordinary individual under customary terms of purchase and use. In other words, the average grocery shopper should be able to easily read and understand the nutritional information provided on a can or package.

The FDA has developed a new label design that changes the way nutritional information must be presented to consumers. Note that the final design has been updated since the FDA’s original proposal in 2015. Industry has also been given additional time to comply with the new requirements –

  • January 1, 2020, for manufacturers with $10 million or more in annual food sales.
  • January 1, 2021 for manufacturers with less than $10 million in annual food sales

To this end, the FDA:

  1. Has issued the following Guidance for Industry: Nutrition and Supplemental Facts Labels Questions and Answers; and
  1. Invites comments from industry on its Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion (& other issues related to the new labeling requirement.) Submit comments by January 4, 2019.

 Contact us for more information or for assistance with responding to/complying with FDA labeling requirements.