Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling

Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC

20160825

Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed ("RACCs") that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the number of nutrients for customary servings of foods that companies must list on the Nutrition Facts label. FDA has also changed its regulations on single-serving packages, again affecting the number of nutrients that will need be disclosed on the label. Thus, FDA's new regulations have a direct impact on the amount of fat, sodium, and sugars that companies must disclose on the Nutrition Facts Label. Some foods may appear higher in these nutrients than before the new regulations. This paper analyzes the changes and discusses implications for food companies.

Why FDA Views Registration as a FSMA Priority

The Food Safety Modernization Act’s provisions on food facility registration are especially significant from FDA’s perspective because they will enable the agency to know much more about the businesses whose products are covered by the landmark law.

On July 14, 2016, the agency issued a final rule on Amendments to Registration of Food Facilities. The amendments aim to improve the registration, which was first required in December 12, 2003 as part of FDA’s implementation of the Bioterrorism Act of 2002. The expanded registration under Section 102 of FSMA builds on the requirement in Section 415 of the Food Drug & Cosmetic Act (FDCA), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA.

Among other changes, the final rule requires an email address for registration. This may seem to be a small change, but a functioning email contact address will greatly enhance FDA’s ability to contact a registered facility or the registered agent. Similarly, the requirement to renew the registration every two years will help ensure that the on-file information remains reasonably up-to-date. In addition, in order to register, facilities will have to assure the agency that FDA will be allowed to inspect the facility.

FDA believes the changes introduced in the new rule will help it to act more quickly in response to food-related emergencies and will help target its inspection resources more efficiently. Effective July 14, 2016, registrations must specify the type of activity conducted at the facility for each food product category. In addition, all registrations must be submitted electronically starting on January 4, 2020.

The final rule includes a provision allowing a registrant to submit a written request for a waiver explaining why it is “not reasonable to submit the registration, registration renewal, update, or cancellation to FDA electronically or to explain why it is not reasonable to provide the email address of the owner, operator, or agent in charge of the facility.”

Definition of retail establishment expanded 

Currently, retail food establishments are not required to register as food facilities. The final rule broadens the definition of a retail establishment, so operations in the newly expanded category will not be required to register.

Section 102(c) of FSMA directs FDA to amend the definition of the term “retail food establishment” to include: the sale of food products or food directly to consumers at a roadside stand or farmers’ market where the stand or market is located other than where the food was manufactured or processed; the sale and distribution of such food through a community supported agriculture program; and the sale and distribution of such food at any other such direct sales platform.

In addition, the agency is requiring additional data elements in food facility registrations, including a unique facility identifier (UFI) and it is planning to verify information submitted in registrations.

At the proposed rule stage, the agency proposed to amend the regulation to shorten the timeframe for submitting updates and cancellations from 60 calendar days to 30 calendar days. However, in response to comments from stakeholders, it has withdrawn that proposal and the final rule requires updates within 60 days of any change.

FDA’s Design Control Requirements for Medical Devices

FDA reviewers and field investigators evaluate design control requirements and processes for medical devices and make recommendations based on whether the manufacturer has the required checks and balances in place.

Design controls are a mechanism for bringing the design of certain class I and all class II and class III investigational devices under the umbrella of the good manufacturing practices (GMPs). In 1996, the GMP requirements were revised to include design control and they have become a part of the Quality System Regulations (QSR). Manufacturers must demonstrate compliance with the QSR and, as of 1996, with design control requirements.

Once the product definition and regulatory strategy have been prepared, medical device developers must work to comply with the design control provisions of the QSR as the device development process moves forward. The QSR is the medical device equivalent of the pharmaceutical current good manufacturing practices (cGMPs). The QSR, unlike cGMPs, also regulates the device development process via its design control provisions (21 CFR 820.30) which describes the device developer’s requirements under the design control provisions of the QSR.

Design controls are an integrated set of management practices (policies, processes, and procedures) which are applied to control design activities while assessing quality and correcting errors through a reiterative device process control. Once management has determined that the device is feasible and the decision has been made to transition from research to clinical applications, the design control process begins. As such, the device application becomes part of corporate quality system.

Here is a summary of key points from the full White Paper on FDA’s Design Control Requirements for Medical Devices posted on the EAS website:

  • Risk and hazard analysis activities are required as part of total product life cycle (TPLC).
  • The standard for the application of risk management (ISO 14971) for medical devices is part of TPLC.
  • The risk management process covers risk analysis, risk evaluation, and risk controls through Corrective and Preventive Action (CAPA) plan and design control requirements.
  • Design control requirements play a key role from device design prototype, manufacturing process controls and the finished device for user needs.
  • The extent of testing and evaluation is proportional to the level of risks associated with the device technology and intended clinical use.
  • FDA reviews the “safety and effectiveness” of the device and it is essential that any risks and hazards are mitigated to “acceptable” levels.

The full White Paper reviews medical device design, medical device quality systems and GMPs. device design control components, and FDA’s Quality System Inspection Technique (QSIT).