• The Acheson Group

New FDA Guidances Zero In on Specific Elements of Regulations

Updated: Nov 22, 2018


New FDA Guidances Zero In on Specific Elements of Regulations

Over the last few weeks, FDA has published three new guidance/draft guidance documents, two of which focus on very specific segments of the food industry: co-manufacturers and “solely engaged,” and the other on menu labeling. Menu labeling and “solely engaged” are both draft guidance, while the co-manufacturer supply-chain program is final and became immediately effective because, the Agency states, “FDA has determined that prior public participation is not feasible or appropriate.”


Following are summaries of the three documents … and what they mean to those who are impacted.


Guidance: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food

For this guidance, co-manufacturing is defined as “a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party.” It is a fairly standard industry definition, but beneficial that FDA includes it, so their definition is clear as well.

Industry had expressed concerns that the requirements of the supply-chain program mandated by FSMA’s Preventive Controls and FSVP rules would necessitate co-manufacturing agreement revisions allowing brand owners to share information such as supplier audits.


But, they said, this would take a significant period of time, impeding their ability to meet compliance dates. So, to provide time for contracts to be revised, FDA issued the guidance to explain the supply-chain program responsibilities of co-manufacturers and announce the specific circumstances under which FDA will – temporarily – not take enforcement action against a co-manufacturer that is not in compliance.


Specifically, until November 6, 2019, FDA does not intend to take enforcement action

related to supplier approval requirements, when:

  • The brand owner conducts supplier approval activities;

  • The co-manufacturer describes these activities in its food safety plan; and

  • The co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner.

  • related to supplier verification requirements, when:

  • The brand owner determines and/or conducts supplier verification activities for its co-manufacturer;

  • The co-manufacturer describes these activities in its food safety plan; and

  • The co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner.

My interpretation of this is that co-manufacturers have a clear responsibility to be compliant with all aspects of FSMA as it relates to their activities. But this guidance has bought some time for supply chain control programs. We have run into a number of instances in which the co-manufacturer is required to use specific suppliers and actually wants to go beyond the controls that the brand owner has undertaken. In some of these situations, the brand owner has not been cooperative, which I find to be a problem from a FSMA perspective. When FDA begin to enforce this part of FSMA it will be the co-manufacturer that gets the 483, not the brand owner!


Draft Guidance: Application of the Solely Engaged Exemptions in Parts 117 and 507

This draft guidance is issued to help establishments determine whether they are “solely engaged” in certain activities, and thereby exempt from certain requirements of FSMA. These include:

  • Exempt from human food CGMP requirements Part 117, subpart B are establishments solely engaged in:

  • the holding and/or transportation of one or more raw agricultural commodities.

  • hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing or processing, such as roasting nuts).

  • Exempt from human food preventive controls requirements Part 117, subparts C and G are facilities that are solely engaged in:

  • the storage of RACs (other than fruits and vegetables) intended for further distribution or processing.

  • the storage of unexposed packaged food.

  • Exempt from animal food CGMP requirements Part 507, subpart B are establishments solely engaged in:

  • the holding and/or transportation of one or more RACs

  • hulling, shelling, drying, packing, and/or holding nuts and hulls (without manufacturing or processing, such as grinding shells or roasting nuts).

  • ginning of cotton (without manufacturing/processing, such as extracting oil from cottonseed).

  • Exemption from animal food preventive controls requirements Part 507, subparts C and E are facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing.

  • the storage of unexposed packaged animal food that does not require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.

Essentially, the summary states, if all of the activities performed by an establishment are exempt under one or more exemptions, then the establishment is not subject to the requirements. But – if any part of a facility is engaged in an activity subject to requirements, then the entire facility is subject to the requirements.


Draft Guidance: Menu Labeling Supplemental Guidance

Intended to address concerns on the implementation of menu nutrition labeling, the draft guidance implements a question/answer format focused on eight key factors: Calorie disclosure signage for self-service foods, including buffet foods; Criteria for distinguishing between menus and marketing materials; Methods for providing calorie disclosure information; Compliance and enforcement; Determining nutrient content for standard menu items; Covered establishments; Standard menu items; and Alcohol.


Through its responses, FDA includes expanded and new interpretations of policy; clarifies additional options for complying with the labeling requirements; incorporates graphics to convey its thinking; and identifies places where it intends to be more flexible. The goals, FDA states, “are to ensure that consumers are provided with consistent nutrition information they can use to make informed choices for themselves and their families, and to guide industry to clearly understand the flexible manner in which the requirements can be implemented.”


Through the draft guidance, FDA has also withdrawn two Q&As from its previous menu labeling guidance (5.17 and 5.18), replacing them with new information to address the issue of distinguishing between menus and other information presented to the consumer.

We are very happy to see FDA pushing out guidance to help food companies figure out how to interpret the new regulatory requirements. We always urge the companies we work with to pay close to guidance documents because there is a lot of great information in them that goes way beyond the basic rules. So if you need help to figure out how these guidance documents impact you, please give The Acheson Group a call at 800-401-2239.

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

CONTACT US

info@achesongroup.com

Toll free 800.401.2239

  • White Twitter Icon
  • White LinkedIn Icon

© 2020 The Acheson Group. All Rights Reserved.

WEEKLY NEWSLeTTER

Join our e-mail list to receive

our weekly Industry Insights!