FDA Announces Public Meeting to Discuss Modernizing Food Standards of Identity

  • This is a very interesting update: the situation has to be strictly monitored by interested parties and trade associations representing food manufacturers and exporters to the US market.
  • The U.S. Food and Drug Administration today announced it will hold a public meeting on September 27, 2019, to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity and to provide information about changes the FDA could make to existing standards of identity.  FDA is particularly interested in changes that could be made across categories of standardized foods, often referred to as horizontal changes, to provide flexibility for manufacturers to develop healthier foods. FDA is particularly interested in changes that could be made across categories of standardized foods, often referred to as horizontal changes, to provide flexibility for manufacturers to develop healthier foods and to facilitate innovation.
  • The initiative is part of the agency’s comprehensive, multi-year Nutrition Innovation Strategy (NIS), which is designed to encourage industry innovation to improve the nutrition and healthfulness of food.  As part of the NIS, FDA is seeking to modernize food standards of identity in a manner that will: (1) protect consumers against economic adulteration; (2) maintain the basic nature, essential characteristics and nutritional integrity of food; and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce healthier foods.
  • Because the agency issued many standards of identity decades ago, FDA and many stakeholders are concerned that some standards are out of date and may impede innovation. As consumers continue to seek more nutritious food options, FDA wants to ensure that standards of identity, or requirements outlining the content and production of certain food products, meet these expectations.  During a 2018 public meeting  on FDA’s Nutrition Innovation Strategy, many participants expressed general support for FDA exploring modernization options that could permit changes across all standards of identity, or broad categories of standards, to facilitate innovation and flexibility to reformulate products to produce more nutritious foods. FDA is seeking input about horizontal changes that may provide manufacturers with additional flexibility to use, for example, new technologies and new or novel ingredients without impacting the basic nature and essential characteristics of standardized foods.
  • The September 27th meeting will be held from 8:30 a.m. until 5:00 p.m. at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. The meeting will include introductory presentations, a panel presentation, oral comments by attendees, as well as breakout sessions. Public meeting attendees are encouraged to register online to attend the meeting in person and via live webcast.
  • For questions about registering for the meeting or to register by phone, contact Mark Gifford, SIDEM, 1775 Eye Street, NW, Suite 1150, Washington, DC 20006, 240-393-4496, EventSupport@Sidemgroup.com.
  • For general questions about the meeting or to request special accommodations due to a disability, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, phone: 240-402-1731, email: Juanita.Yates@fda.hhs.gov.
  • For more information about the meeting, as well as instructions on registration and requesting to make an oral presentation, see the Federal Register Notice announcing the meeting and the  meeting page.
Important Dates to Remember:
  • Request to make an oral comment: September 12, 2019
  • Request special accommodations due to disability: September 12, 2019
  • Advanced registration closing date: September 20, 2019
  • Public meeting: September 27, 2019, 8:30 a.m. to 5:00 p.m.
  • Deadline to submit written/electronic comments: November 12, 2019

 

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule (Food defense)

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. It provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

Here you can find also an FDA fact sheet on the final rule on food defense.

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.
While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration, on the contrary,  is addressed in the final preventive controls rules for human and animal foods.

We already treated food defense topic in a previous post regarding EU situation.