2017 IN REVIEW – U.S. FDA FOOD AND BEVERAGE REGULATIONS
2017 brought a host of changes for food manufacturers and importers. The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry. Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules. Take a look below at some of the regulatory highlights that occurred this year.
FDA Removed 28% of Food Facility Registrations from its Database
Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database. The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.
Australia Received Systems Recognition with U.S. FDA
In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States. Australia follows New Zealand and Canada as the third country to receive this recognition. U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.
As of this writing, the three recognized countries have not published lists of firms in good compliance standing. As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.
The FSVP Compliance Deadline for Most US Importers Passed
The first compliance deadline for the FSVP Rule passed on May 30, 2017. Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation. In August, FDA began inspecting covered importers for their compliance with FSVP requirements. The next FSVP compliance date is March 19, 2018.
Compliance Dates Passed under the Preventive Controls Rules
Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017. These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards. Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.
FDA Proposed Extension of Label Rule Compliance Dates
In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales. Smaller businesses would be provided an additional year. Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.
FDA Proposed to Revoke Authorized Health Claim for Soy Protein
FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease. Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings. This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.
FDA Issued Draft Guidance for Refusal of Inspection
In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.” FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal. Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.
Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018. The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming. Registrar Corp can offer assistance.
2017 brought a host of changes for food manufacturers and importers. The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry. Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules. Take a look below at some of the regulatory highlights that occurred this year.
FDA Removed 28% of Food Facility Registrations from its Database
Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database. The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.
Australia Received Systems Recognition with U.S. FDA
In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States. Australia follows New Zealand and Canada as the third country to receive this recognition. U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.
As of this writing, the three recognized countries have not published lists of firms in good compliance standing. As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.
The FSVP Compliance Deadline for Most US Importers Passed
The first compliance deadline for the FSVP Rule passed on May 30, 2017. Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation. In August, FDA began inspecting covered importers for their compliance with FSVP requirements. The next FSVP compliance date is March 19, 2018.
Compliance Dates Passed under the Preventive Controls Rules
Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017. These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards. Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.
FDA Proposed Extension of Label Rule Compliance Dates
In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales. Smaller businesses would be provided an additional year. Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.
FDA Proposed to Revoke Authorized Health Claim for Soy Protein
FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease. Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings. This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.
FDA Issued Draft Guidance for Refusal of Inspection
In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.” FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal. Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.
Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018. The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming. Registrar Corp can offer assistance.
