With most compliance deadlines having passed under the Food Safety Modernization Act (FSMA) and new requirements on the horizon, 2018 proved to be a busy year for the U.S. Food and Drug Administration (FDA). See some of this year’s regulatory highlights below.
The Second Compliance Deadline Passed Under the Foreign Supplier Verification Program (FSVP) Rule
As of March 19, 2018, most U.S. importers of food and beverages must implement FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses as required by the FSVP rule. FDA has been regularly inspecting importers for FSVP compliance since the first deadline passed in May 2017 and cited 289 importers in Fiscal Year (FY) 2018 for failing to develop FSVPs.
FDA Issues First Mandatory Recall Under FSMA
In April 2018, FDA ordered a mandatory recall of food containing powdered kratom from Triangle Pharmanaturals LLC after the Agency discovered salmonella in four separate samples. FSMA grants FDA the authority to require a recall when there is reasonable probability a food is adulterated or poses a serious risk to public health. FDA ordered the mandatory recall after Triangle Pharmanaturals did not cooperate with a request to voluntarily recall their kratom products.
FDA Permits 8 New Non-digestible Carbohydrates to be Declared Dietary Fiber
Under the Revision of the Nutrition and Supplement Facts Label final rule, isolated or synthetic non-digestible carbohydrates may only be declared as “dietary fiber” on a food label if FDA determines they have a physiological benefit. This excludes many carbohydrates commonly listed as fiber from being declared, effectively limiting certain labels’ abilities to make nutrient content or health claims.
After reviewing petitions and scientific literature on twenty-six carbohydrates, FDA intends to exercise enforcement discretion when any of eight additional fibers are declared on a label’s dietary fiber declaration.
The First Qualified Facility Attestation Deadline Passed On December 17, 2018
Under the Preventive Controls for Human Food rule, “Qualified Facilities” receive exemption from certain food safety requirements, such as the development of Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans and Supply-Chain Programs.
To take advantage of these exemptions for 2019 through 2020, most facilities were required to submit a Qualified Facility Attestation to FDA between October 1 and December 17, 2018. A facility may be eligible to submit an attestation if it averaged less than $1,000,000 in global food sales plus the market value of unsold food inventory during the previous three years.
Facilities that did not submit an attestation prior to December 17, 2018 may be subject to the full requirements of the Preventive Controls rule.
The First Voluntary Qualified Importer Program (VQIP) Application Period Began October 1, 2018
VQIP allows eligible U.S. importers to pay an annual fee for expedited review and release of foods specified in an approved VQIP application. FDA began accepting applications for VQIP on October 1, 2018. To participate in VQIP, eligible importers must submit an application and pay an estimated $16,400 upon application approval. VQIP benefits for approved importers who have paid the fee will begin on October 1, 2019.
FDA Began Collecting Fees for Food Export Certificates
As of October 2018, FDA changed the export certificate program for food. U.S. exporters may now request a Certificate to Foreign Government or Certificate of Exportability for their food or beverage. FDA charges a fee of $175 for the first certificate of either type, $155 for a copy, and $100 for subsequent copies of the same certificate.
Registrar Corp will continue to keep the food industry updated as we move into 2019 and encounter more changes to the FDA regulatory landscape. For assistance with FDA regulations, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.