Dr. Robert Califf, Commissioner of the Food and Drug Administration recently announced a proposal to change the human foods program related to food safety. This article will provide a supplemental review of the FDA statement, “FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities“, but we still highly recommend you read the full document.
Evaluation of the FDA Food Program:
The FDA requested that the Reagan-Udall Foundation would conduct an evaluation. The results ended up identifying several issues around structure, resources, culture, and authorities of the current food program. The needs that were identified as a result were an improved emergency response system, modernized data systems and a better regulatory program. Following the evaluation the commissioner of the FDA promised Americans a “transformative vision” that would fulfill the mandate of the FDA to ensure the safety of food products.
Dr Robert Califf’s transformative vision includes a food advisory committee to assist with “scientifically grounded decision-making”:
- A consolidation of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA), under a new organization, called the Humans Food Program (HFP)
- Hiring a single leader, a “Deputy Commissioner” for the HFP, who reports directly to the FDA Commissioner, will remove redundancies, and has authority over policy, strategy, and regulatory program activities within the HFP.
In addition, two new entities will exist within the HFP:
- A Center for Excellence in Nutrition
The CEN will prioritize the agency’s efforts to help American consumers make better-informed food choices, through collaboration with the industry to offer healthier, more nutritious food products.
- An Office of Integrated Food Safety System Partnerships
The OIFSSP will focus on food safety response activities with State and Local regulatory partners to “more effectively meet the vision of an Integrated Foods Safety System” as envisioned by the Food Safety Modernization Act of 2011.
FDA Modernized Data Systems Need:
FDA will look to meet this need by putting their focus on “strengthening their information technology and analytical abilities” to “fulfill the promise described in the New Era of Smarter Food Safety”. It was all proposed that the ORA be transformed into an enterprise-wide organization with regulatory authority over the entire HFP and FDA regulatory programs.
What is the significance of this for the U.S food industry?
If this statement does pass the proposal stage, it could mean a lot. The food regulations wouldn’t be effected, however the pooling of resources and reorganization of departments could indeed result in much improved resource managements and FDA regulatory oversight.
How can Quality Smart Solutions serve you?
Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).
Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published.
Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Importer of Record Licensing, NDIN/GRAS Ingredients and GRAS Notifications).
Help with facility registration, FSVP agent, and US Agent.