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FSVP Compliance Inspections Began in June, FDA Spokesman Says
September 28, 2017 |FDA

The Food and Drug Administration began conducting Foreign Supplier Verification Program compliance inspections for importers in June 2017, an FDA spokesman said. “We conduct these inspections with the 'educate while we regulate' approach, which encourages good communication between FDA and Industry to build a solid culture of compliance,” the spokesman said. “In regards to enforcement, FDA’s initial enforcement priorities will be on gaining compliance through education of the FSVP importers; however we reserve the right to take action for food safety problems that pose an imminent public health risk.” FDA has been scheduling its FSVP inspections by a phone call to the FSVP importer, the spokesman said.

FDA Issues Guidance on 'Request for Designation' Process for Classification as Drugs or Devices
September 26, 2017 |FDA

The Food and Drug Administration issued a new guidance document outlining its request for designation process for obtaining a formal determination of a product’s classification as a drug or device, it said. The document details the process for requesting a formal determination, as well as the general concepts and definitions used by FDA in its decision process for making classification determinations, FDA said.

FDA Won't Enforce Some Cigar Labeling Requirements Taking Effect in 2018
September 22, 2017 |FDA

The Food and Drug Administration will not “at this time” enforce warning label size and placement requirements for certain cigars and small packages set forth in its May 2016 final rule “deeming” new tobacco products (see 1605050011), it said in a recent guidance document. The agency “does not intend to take enforcement action” as long as the required information appears on the carton or other outer container or wrapper, or on a tag “otherwise firmly and permanently affixed to the small package,” FDA said. The warning label requirements take effect in August 2018.

FDA Announces Training Module for Carriers Covered by Food Sanitary Transportation Rule
September 21, 2017 |FDA

The Food and Drug Administration on Sept. 20 announced a new online training module to help carriers transporting food products comply with Food Safety Modernization Act regulations on the sanitary transportation of human and animal food. The free, one-hour course is “designed to provide basic food safety training to transportation operations personnel,” and may satisfy minimum requirements of FDA’s sanitary transportation rule for “rail and motor vehicle carriers covered by the rule to provide food safety training to their personnel engaged in transportation operations,” FDA said. Alternatively, carriers may use the module to complement or enhance their own training, train their personnel using their own training programs, or provide training obtained from a third-party vendor, the agency said. The sanitary transportation rule began taking effect in April 2017, with the compliance date for small businesses covered by the rule coming in April 2018 (see 1604050023).