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Think Your Food Packaging Complies with FDA? Maybe Now. Maybe Not Later.Think Your Food Packaging Complies with FDA? Maybe Now. Maybe Not Later.
No longer one-and-done, FDA’s newly proposed post-market assessment for chemicals in food also extends to packaging components already cleared by the agency. And its post-market enforcement program may include inspections of food packaging manufacturing plants. Are you and your suppliers prepared?
7 Min Read
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At a Glance
- FDA’s post-market assessments include packaging components; inspections of manufacturing plants may soon follow.
- Comprehensive reviews target chemicals in food for safety; firms must prepare for detailed FDA evaluations and oversight.
- Develop policies, train staff, and assert rights to navigate potential FDA inspections effectively in the future.
In January 2023, the US Food and Drug Administration (FDA) announced a reorganization within the Agency to create the Human Foods Program (HFP) as a replacement for the Center for Food Safety and Applied Nutrition. Implementation of the reorganization began on October 1, 2024.
As a part of HFP, FDA is developing an enhanced systematic process for the post-market assessment of chemicals in food. The intent of this process is to allow FDA to “proactively” identify and target chemicals in the food supply for assessment in a structured manner based on risk.
The post-market assessment process involves a systematic process to select and determine the nature of the assessment to be applied.
1. Review: The first step of a post-market assessment is to review available information concerning a chemical through monitoring of multiple sources.
2. Triage: The second step is to complete a sort of triage to determine the need for post-market assessment of substances subject to information gathering based on the quality of the collected information and an impact assessment.
3. Assessment: The third step is to decide whether a Focused or Comprehensive Assessment is in order (more on this below).
Which type of assessment should you use?
The Focused Assessment is intended to be a compact review for substances that may pose less complex assessments and thus lend themselves to more ready risk assessments, a determination of whether risk management may be in order, and if so, publication of the review conclusions and the risk management action to be taken. If a substance is found to require a more extensive review, it may be referred for a Comprehensive Assessment.
Comprehensive Assessments of substances present in food or food packaging whether as food additives or contaminants are expected to take a much lengthier period of time to review, likely years. Thus, the first step will be for the Agency to prioritize substances to be reviewed. The prioritization process alone may take months to complete. Once prioritized, selected substances will begin the comprehensive assessment process. The FDA review will include the following:
• Assessment of the hazard(s): evaluation of the nature of adverse health effects associated with the identified hazard(s) and population(s) of concern.
• Assessment of the anticipated dietary exposure: characterization of the dietary exposure of the population and relevant subpopulations.
• Assessment of the risk from exposure to the hazard(s): integration of dose/response and dietary exposure to estimate likely risk to relevant populations.
• Identification of data gaps or research needed to support the scientific assessment.
The purpose of this Comprehensive Assessment is for FDA to determine if substances or ingredients intentionally added to food directly or by way of the use of packaging materials continue to meet the “reasonable certainty of no harm” standard or if actual or estimated dietary exposures exceed levels considered safe.
Similarly, for contaminants, the Agency will determine whether the risks presented may need to be limited or reduced to assure safety. In either case, the step following the conclusion of the assessment will involve the development of appropriate risk management options to attain public health benefits, along with estimate of the resources needed to implement the various options, and a determination of whether, and if so, what exposure or toxicity data may be needed from industry or other stakeholders. Once completed, agency leadership will determine the appropriate steps to take and proceed to publication of the final Risk Assessment and Risk Management Review document.
Although wrapped up in a lot of bureaucratic jargon, the process is not likely to be all that different than what took place over the last few years with short-chain grease-proofing agents, such as those used for paper products. FDA determined that newly available data — related to bioaccumulation and toxicity — raised questions about the original safety determinations made by the agency during the Food Contact Notification review process for several of the products years earlier.
FDA determined that the bioaccumulation data was such as to call for new two-year animal studies to shore up safety conclusions. In addition, FDA concluded that the perceived risk required immediate action to begin market removal of products, with a phase-out over a three-year period (and an anticipated 18-month period to exhaust existing stocks).
Finally, and importantly, to assist in post-market assessment of the effectiveness of the market withdrawal, FDA requested product samples of the manufacturers of the effected products and instituted “a surveillance sampling assignment” for product presence in paper following the phase-out period.
In fact, this “assignment” was the equivalent of an on-site inspection program, something with which packaging manufacturers are generally not familiar.
What FDA’s surveillance monitoring program means.
FDA’s right to enter an establishment is only permissible based on its inspection authority under the Federal Food, Drug, and Cosmetic Act. That authority extends to any “factory, warehouse, or establishment” in which food is manufactured, processed, packed, or held for introduction into interstate commerce. It includes ingredient and component manufacturers. It also includes vehicles used to transport or hold such products in interstate commerce and records of interstate shipment.
Whether FDA’s authority extends to entering a manufacturing establishment for food contact substances (FCSs) and packaging components or not, it is not something to argue about when FDA is at the door requesting an inspection. Let’s just say that there is sufficient ambiguity in the law that it might be difficult to defeat FDA’s attempt to enter the premises, especially when backed by a court order.
John Keeble / Contributor via Getty Images News
Once in the establishment, FDA is entitled to examine “all pertinent equipment, finished and unfinished materials, containers, and labeling.” However, access to offices and other areas not related to food processing or storage can be restricted.
FDA investigators should present a written notice of inspection (FDA form 482) and appropriate credentials. Inspections must be conducted at reasonable times, within reasonable limits, and in a reasonable manner. A warrant is not required unless “consent” is denied. However, refusal to permit FDA to conduct an inspection is a prohibited act. So, think twice and have a lawyer on hand before doing so.
By statute, FDA is not entitled to view financial data, sales data (other than shipment dates), or pricing data; personnel data (other than personnel qualifications); or research data. In addition, by policy, FDA does not routinely seek access to internal quality audit reports.
FDA may collect samples of products or labeling but must provide part of the official samples to facility owners upon request. However, companies also usually take their own samples. FDA is to pay “fair value” for samples, but most companies do not ask for payment. Finally, FDA is required to provide a copy of the analytical results of samples upon request.
The statute is silent on employee interviews, but inspectors may seek to talk to various employees during inspections. Companies should establish at an early stage who inspectors may talk to and limit contact to appropriately trained staff. If appropriate personnel are unavailable, companies should arrange to provide answers to inspector’s questions when the appropriate personnel are available.
Concerning the signing of documents, companies are not required to sign anything, especially an affidavit. Importantly, one should not be signed until it is reviewed and approved by counsel since it may constitute an admission of guilt.
Prepare now and know what you should and shouldn’t do.
In conclusion, companies should develop a written procedure for handling FDA inspections that includes identification of company spokesperson, a policy on photographs and audio recording, and policies on signing documents and interviewing of personnel.
In addition, all staff should be trained on what to do if there is an FDA inspection. Company personnel should cooperate with government officials, as appropriate.
Finally, companies should determine when to assert their rights.
We may be several years off from these types of regular inspections of food packaging manufacturing establishments given that FDA is only just beginning to ramp up its post-market review program. And, even then, such inspections could be rare.
However, as matters involving the presence of chemical substances in food take on greater political capital, it is probably worthwhile to prepare now for the assessments and the post-market inspections which may follow.
The comment period on the program is open until January 21, 2025. Share your thoughts or read through what others are saying here.
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