The Office of Regulatory Affairs (ORA) is responsible for inspection and enforcement of FDA regulations. Inspections are done through its 5 regional divisions and 20 district offices. Procedures for FDA inspections follow guidelines put forth in FDA’s Investigations Operations Manual. The FDA can conduct inspections for “cause” such as complaints, or through its regular surveillance. The inspections are not continuous as with the USDA. The FDA inspector can gain entry to a food facility at any “reasonable time” without a warrant, by showing his badge and presenting a written Notice of Inspection (Form 482). Failure to allow the Inspector to enter the facility is considered a criminal offence. Refusal of consent to an FDA inspection will result in the FDA seeking an administrative inspection warrant.

The fourth amendment of the constitution protects the citizens of the United States from unreasonable searches and seizures carried out by the government without a warrant. While this applies to individuals in their homes, it does not apply to commercial businesses that are considered to be “perversely regulated”. The nature of the food business requires surprise visits without a warrant in the interest of public safety. Anyone who is in the food business must be “reasonably aware” of the requirement for inspections. Therefore by being in the food business, you automatically consent to warrantless inspections.

Form 483 and the Establishment Inspection report (EIR)

Upon completion of inspection, if the Investigator observes conditions that may constitute a significant violation of the FD&C act he will issue a Form 483. This form notifies the company of the objectionable conditions. The observations are presented and discussed with Senior Management to make them aware. At this time the responsible person may respond orally to the findings and take immediate corrective actions as is appropriate. The company also has the option to respond in writing within 15 days. However it is recommended that they respond earlier; preferably within 10 days to correspond to the time required for the Investigator to submit the EIR report. Responding to the 483 gives the company the chance to tell their side of the story. Along with the 483, the Establishment Inspection Report (EIR) is presented, which gives a detailed narrative summarizing the inspection; including names and titles of individuals who were interviewed, responsible party on-site, records examined, and summary of findings. Both the 483 and EIR are reviewed by the FDA office that issued the inspection to determine if further action such as a Warning Letter is needed.

Warning Letter

Warning letters act as an “informal enforcement action”. Their purpose is to identify significant violations and recommend steps to achieve compliance. It acts as “prior notice” before taking more consequential actions. Prior notice is not a regulatory requirement but the agency’s policy. Therefore the FDA has the right to take action without prior notice in the interest of public safety. Action without prior notice may arise from a history of violations, intentional violations and/or a reasonable possibility of the situation resulting in injury or death. Warning letters are made public on the FDA’s website.

Seizure

Seizure is the confiscation and holding of goods. It is done when there is a “probable cause” (reasonable grounds) that there is a violation of the FD&C act. The order is issued by a Judge and the goods are therefore under federal jurisdiction. It is the responsibility of US marshals to carry out seizures, and not FDA agents. When goods are seized, the owner has three options. (1)  He may do nothing; in which case the goods are destroyed. (2) He may challenge the action in court, and delay action, or (3) He could enter into a consent decree where the owner negotiates and agrees on a course of action(s) with the FDA. For example, the company may agree to re-label products.

Restraining Order or Injunction

Since a seizure of domestic products require “probable cause”, the FDA may use a restraining order or an injunction to act more quickly. The FDA can obtain a restraining order from a Judge without having to show any evidence of harm. The order goes into effect for 10 days. After 10 days, the FDA either releases the product or seek a “preliminary injunction” from a Judge, to allow the FDA time to gather evidence to prove the harm posed by the product, or time for the owner to fix the problem. If the preliminary injunction time is running out and the FDA wants to hold the product longer, the FDA can apply for a permanent injunction which will continue to hold the product until it complies with FDA’s requirements.

Administrative Detention

The restraining order and injunction has been the FDA’s preferred method to control non-conformances quickly. However with FDA’s expanded powers under the food safety modernization act (FSMA), Administrative Detentions will replace the role of restraining orders. Administrative detention is a temporary hold on goods. No court order is needed to carry out the detention. This happens when the FDA has “reason to believe” that the food is adulterated or misbranded. The maximum hold time is 30 days. This period allows the FDA enough time to make a fair assessment if seizure or recall of the goods is needed. Assessment may include product sampling, testing, and facility inspection.

Import Refusal

Goods entering the United States are inspected by Customs and released to the importer on meeting Custom requirements. However, the importer must wait on an FDA release before distributing goods into commerce. If the importer release the goods into commerce and the FDA later orders an inspection, Custom will require that the goods be redelivered for the necessary inspection and sampling. Therefore the importer will have to retrieve the goods from buyers. Importers should therefore wait for the appropriate release from the FDA before moving their goods into commerce.

The FDA uses an information technology system called PREDICT i.e. “Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting” to predict and target high-risk shipments. The shipment product codes are entered into the PREDICT system which then access multiple databases to track and identify potential risk-factors and product history. Based on all the information it gathers, PREDICT assigns a score to the product and red flags those that indicate significant risks. Previous to PREDICT, inspections were completely random or based on hunches.

Imported products are held to a higher standard of compliance than domestic products. Remember that as I discussed earlier,  domestic products require probable cause in order to justify seizure. However, imported products just need to “appear” or “otherwise” to be adulterated or misbranded. Imported goods “appearing” as such are given an “Import Detention Notice” to the “Owner of Consignee” (person responsible for the shipment). This notice outlines the specific nature of the violation and cite the relevant regulation. The Owner of Consignee then has a 10 day window to request a “hearing”. This does not require a court appearance. It simply involves the Owner or Consignee providing oral or written testimony to an FDA Compliance Officer. Written testimony can be in the form of laboratory results. If the response is acceptable, the product is released. If not the products may be reconditioned. This can be done at the port-of-entry or in the warehouse of the  Owner or Consignee, under a customs bond. If the products cannot be satisfactorily reconditioned, the FDA will issue a “Refusal Notice” which will direct the importer to either return the product to its country of origin or destroy it.

The FDA can “detain without physical examination” (DWPE) if the importer is listed on the Import Alert  list. This is a “black list” of importers with known violations that could result in public health risk. It takes at least a year for an importer’s name to be removed from this list. They would have to prove that new systems are in place to prevent future violations. Proof may include objective evidence such as registration, test results, ingredient approval and implementation of food safety management systems.

Suspension of Registration

Suspension of Registration is a new authority given to the FDA through FSMA. This action prevents the production and distribution of products while the suspension is in effect. FDA can suspend a facility’s registration if it determines that (1) the facility caused a reasonable probability of adverse health effect in animals or humans, or (2) knew, or had reason to know about this reasonable probability.

Once a Suspension of Registration of facilities order has been issued, the registrant has the opportunity to request an informal hearing within two business days or at a time agreed upon with the FDA. Failing this request, the registrant waives his right for a hearing. Request for hearing is granted only when there is an “issue of fact” (material evidence) that warrants consideration in a hearing.

During the hearing, the registrant orally presents his case to a Presiding Officer designated by the FDA Commissioner. Otherwise, the registrant may waive his right for an oral hearing and request to respond in writing instead. Upon the hearing, the suspension order may be “vacated” or the registrant required to submit a corrective action plan to the FDA. The registrant may also skip the hearing request and move ahead with submitting a corrective action plan to the FDA. The suspension order is vacated when the FDA is fully satisfied that all non-compliance are fixed.

Recalls

Under FSMA, the FDA can compel a recall without the need for a court action. There are three classes of recalls.

Class I: Situations where product non-conformance could result in serious injury or death e.g. undeclared allergen, or unsafe levels of pathogens

Class II: Situations where the product could cause temporary medically reversible consequences but it is unlikely to occur e.g. pieces of plastic in a bottled beverage as a result of bulk packaging material falling into the mixing tank.

Class III: Situations that are unlikely to cause any adverse medical risk e.g. minor container defects, off-taste, or language other than English on the label

References: Sanchez, M. C. (2015). Food law and regulation for non-lawyers – A US perspective. New York, NY: Springer International.

Author

  • Courtney Simons

    Dr. Courtney Simons has served as a food science researcher and educator for over a decade. He holds a Bachelor of Science in Food Science and a Ph.D. in Cereal Science from North Dakota State University.