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FDA Searching for Deputy Commissioner for Human Foods

The U.S. Food and Drug Administration has begun a national search for a new deputy commissioner for human foods and is providing an update on the proposed restructuring of the agency’s Human Foods Program and Office of Regulatory Affairs to enhance coordination, prevention and response activities.

“My search for a new deputy commissioner for human foods is underway, the first recruitment effort open to both external and internal candidates under the agency’s expanded Title 21 hiring authority for a foods-related position,” said FDA Commissioner Robert M. Califf, M.D.  “I’m looking forward to starting the interview process and making a selection for this important position as soon as possible.

“There have also been a number of questions about the proposed operational changes for ORA and how these plans will work with changes to the Human Foods Program. I cannot stress enough that my vision is focused on a new, agency-wide model where the activities and responsibilities of the regulatory programs and ORA are better synced to improve efficiency and effectiveness with clear decision rights so that everyone knows who has authority.”

For the proposed Human Foods Program, one key to success will be an empowered deputy commissioner for human foods who will report directly to the FDA commissioner. The agency is focused on identifying a candidate that has the expertise to provide leadership over the FDA’s nutrition and food safety programs (including programs aimed at preventing and responding to chemical, microbial and other hazards). The ideal candidate will have executive-level and real-world experience sufficient to lead the newly envisioned Human Foods Program and its vast remit. This individual will also have clear line of authority over the proposed Human Foods Program, which would include the existing components of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and certain human foods-related components of ORA.

To ensure the new Human Foods Program and all other regulatory programs at the FDA are successful, work on an agency-wide transformation effort of how the programs and field functions are organized and operate is underway. The FDA’s proposal will create a new model that better integrates ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs. The deputy commissioner for human foods and other program leads will be charged with setting strategic direction for food inspections and have authority over program resource allocation. To achieve these goals, the agency has started the process of:

  • Assessing specific functions of ORA, CFSAN and OFPR to be unified into a new Office of Integrated Food Safety Systems Partnerships that will engage with state, local, tribal, and territorial food safety regulatory partners. The assessment will also include how best to enhance connectivity with international food safety partnership programs.
  • Analyzing inspection and compliance functions that sit within both ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process as well as integrate new automation and information technology support. The new processes will enable ORA and program personnel to function as a multidisciplinary team, eliminating sequential steps, immediately bringing the best expertise to bear on the problem at hand, and speeding decisions.
  • Determining how best to empower the deputy commissioner for human foods and leaders of other programs, along with the associate commissioner for regulatory affairs, to oversee program and field resource allocation, including publicly mapping the budget to functional activities to provide clarity on resource allocation.
  • Ensuring seamless coordination across the FDA and state-operated food laboratory operations by evaluating the foods laboratory programs, including the relationships, roles, and responsibilities among CFSAN, CVM, ORA and state-operated laboratories.
  • Improving the FDA’s ability to conduct risk prioritization to deliver the highest public health benefit by performing an extensive evaluation of how the Human Foods Program accomplishes risk management, particularly risk prioritization, given the multitude of demands and the scarce resources, and how this can be used to guide dynamic work planning and resource allocation.
  • Planning for greater enterprise transformation of certain ORA IT functions, which will be coordinated with the FDA’s Office of Digital Transformation. This move builds on the existing project to create an enterprise-wide platform for managing inspections and compliance activities. ODT will drive upgrades to FDA-wide IT systems.
  • Evaluating training programs, including for FDA investigators, to see how they can best serve the needs of both the FDA, regulatory partners and regulated industry. This will include assessing whether some training functions or roles should be unified into the Human Foods Program and other product programs.

In addition, the FDA is announcing that this vision will include moving cosmetics regulation and color certification functions out of CFSAN and into the Office of the Chief Scientist. This proposed move will better align the expertise of the agency’s cosmetics subject matter experts with the Chief Scientist who is focused on research, science, and innovation that underpins the agency’s regulatory mission, and recognize the evolution and innovation in this product space. Further, this shift will leverage the FDA’s areas of expertise across the agency as it works to implement the Modernization of Cosmetics Regulation Act of 2022. The office will closely collaborate with the FDA’s Human Foods Program, Center for Drug Evaluation and Research, Office of Minority Health and Health Equity and Office of Women’s Health.

“Our proposal specifically tackles issues identified in two independent evaluations of our food programs, one conducted by the Reagan-Udall FoundationExternal Link Disclaimer and an internal evaluation of the agency’s infant formula response. We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication. We intend to fix this and strengthen both the regulatory programs and field force,” Califf said. “Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

The FDA is seeking to finalize its proposal this fall. This process includes the development of a reorganization package that contains the newly designed structure, an established budget and a detailed mapping and crosswalk of staff from the current to new organization. The package then undergoes a thorough review before advancing to Congress for a 30-day notification period where members may raise any concerns that the FDA may need to address. Afterward, the FDA will issue a Federal Register Notice, provide notification to and engage, as needed, in negotiations with the Unions for impacted staff, prior to initiation of the new proposal. The FDA will continue to engage with stakeholders throughout this process.

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FDA Withdraws Food Standards Proposed Rule Based on Comments

The U.S. Food and Drug Administration is withdrawing the 2005 proposed rule, “Food Standards; General Principles and Food Standards Modernization,” in response to comments received in 2005 after publication of the proposed rule and in 2020 after the FDA reopened the comment period for the proposed rule.

The proposed rule, jointly published with the U.S. Department of Agriculture Food Safety and Inspection Service, was intended, in part, to establish a set of general principles for the FDA and USDA-FSIS to use when considering whether to establish, revise, or eliminate a food standard.

In public meetings the FDA held in July 2018 and September 2019, stakeholders said that due to changes in manufacturing, food technology, market trends and nutrition science since 2005, the FDA should solicit new data and information when determining next steps for the proposed rule. As a result of that feedback, the FDA reopened the comment period in February 2020, for FDA-specific aspects of the proposed rule.

Many of the comments submitted suggested that the general principles be revised and consolidated to make the principles easier to understand and implement. The FDA and USDA-FSIS agree and are withdrawing the proposed rule to reconsider how best to approach general principles and food standards modernization to ensure any future revised general principles are consistent with the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act.

A joint FDA and USDA effort to publish a new proposed rule on principles for food standards modernization was included in the Fall Unified Agenda.

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Bell Flavors & Fragrances Announces Strategic Promotions

Bell Flavors & Fragrances, Inc. has announced strategic promotions within the company’s Flavor and Fragrance divisions as well as Internal Operations and Finance departments at its headquarters in Northbrook, Ill.

FLAVOR DIVISION

Benjamin Stanley, CRC has been promoted to senior corporate chef and manager of sweet applications. Stanley will continue managing the Sweet Applications Team, including internal and customer projects. He will continue ideating around and promoting innovative flavors for Bell’s Spark Trends and other programs.

Since joining Bell 3.5 years ago, Stanley has played a critical role on the Culinary Applications Team, in which he demonstrates a strong commitment to widening Bell’s flavor market share and boosting Bell’s visibility within the confection and sweet goods industry. Stanley recently graduated with a master of science degree in Innovation from Northeastern University’s D-Amore-McKim School of Business.

Andrew Petrou has been promoted to flavorist II. Petrou will continue to ideate around and develop cutting-edge savory flavors for use in a variety of food and beverage applications.

Petrou is a key member of Bell’s Savory team, supporting the Bell Technology & Innovation Center and successfully developing new savory flavors. He was recently accepted into the Society of Flavor Chemists with full certification status and is one of the few certified members specializing in Savory Flavor Chemistry. Petrou holds a bachelor of science degree in chemistry from the University of Illinois Urbana-Champaign.

Cody Heinz has been promoted to director of sales. Heinz will implement and manage Bell’s sales metrics tool. He will engage in a variety of initiatives to support sales goals and equip the sales team with transparent, effective and efficient sales management data and resource planning.

Heinz recently celebrated ten years with Bell Flavors & Fragrances, holding roles as an Inside sales representative and national account manager. Heinz earned a master of business administration in business administration, management & operations from Lake Forest Graduate School of Management and a bachelor of science degree in kinesiology & health from Miami University of Ohio.

FRAGRANCE DIVISION

Kenny Enriquez has been promoted to director of sales. Enriquez will be responsible for implementing and managing key sales metrics. He will support the sales team with utilizing transparent, effective and efficient sales management data and engaging in resource planning and tracking profitability.

Prior to this role, Enriquez was a sales key account manager and account executive at Bell. Enriquez holds a master of business administration from Lewis University and a bachelor of arts in economics from the University of Kansas.

Ted Heinz has been promoted to fragrance business development manager. Heinz will be a key player in Bell’s business development initiative to continue strengthening the Fragrance division.

Heinz joined Bell in 2005 as an analytical department analyst, transitioning into internal sales, then his former position as an account manager. Heinz holds a bachelor of science in communication and business from St. Norbert College in De Pere, Wis.

OPERATIONS DEPARTMENT

Olu Famoyin has been promoted to director of manufacturing. Famoyin will lead the Manufacturing, Shipping and Maintenance teams, propelling Bell’s commitment to optimizing productivity, maximizing efficiency, and ensuring full compliance with processes, quality standards and safety policies.

Famoyin joined the Bell Flavors & Fragrances family as an associate director of operations where he worked on manufacturing improvements and adoption of a new ERP system. Famoyin played a pivotal role in implementing shipping improvements to optimize day-to-day operations. Famoyin earned a bachelor’s degree in chemistry from Rutgers University and has extensive Flavor industry experience leading multiple sites.

FINANCE DEPARTMENT

Theresa Link has been promoted to controller. Link will be responsible for general accounting, payroll, cash management, internal controls and financial closes for Bell’s Northbrook and New York locations. She will also ensure accurate financial statements and analyses to support the business.

Link has been a dedicated member of the Bell family for 17 years. Prior to this role, Link was Bell’s Director of Cost Accounting. She possesses expertise in inventory costing, cash management and general ledger, and serves as a subject matter expert for Bell’s ERP system. Link earned her master of business administration in accounting and finance from Elmhurst University.

Brian Enriquez has been promoted to director of cost accounting. In this new role, Enriquez will continue implementing a new product system, working closely with Bell’s Operations Team to evaluate manufacturing labor and overhead rates and tracking incurred costs from raw materials to finished products.

Prior to this role, Enriquez was Bell’s senior manager of finance and pricing. Enriquez earned his bachelor’s degree in financial planning and master’s degree in finance from the University of Illinois Urbana-Champaign.

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