We have been publishing a series of posts related to US Food Regulation. We have already completed four parts of the series. The first part of the series entitled “US Food Law and Regulation Series: Part 1” was focused on the discussion of different regulatory body such as FDA, USDA/FSIS, CDC, NMFS, EPA, DHS etc. “US Food Law and Regulation Series: Part 2” described the issues related to food, dietary supplement and drug. The third part was about the "History of the regulation of dietary supplements (US Food Regulation series: Part 3). In the fourth part, we discussed on the topic of "Jurisdictional overlap between FDA and USDA (US Food Regulation series: Part 4)".
In this post we will discuss about the "Federal Inspections and Law Enforcement Tools used by FDA".
Generally, FDA does not go to the facility for inspection on a daily basis. FDA conducts warrantless inspections generally for a special cause such as recall, adverse events, or for surveillance inspection. The regulatory work can be divided into two groups: “pre-market” and “post-market surveillance” activities.
Center for Food Safety and Applied Nutrition (CFSAN) of FDA is mainly responsible for pre market activities of food products. In addition, Center for Veterinary Medicine (CVM), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Device and Radiological Health (CDRH), and Center for Tobacco Products (CBT) are also product-oriented centers of FDA focusing on pre-market surveillance activities.
The post market surveillance activities are mainly the responsibility of Office of Regulatory Affairs (ORA). It works for all the six product-oriented centers and not only for CFSAN. Hence, it carries out investigation of drug, medical device, cosmetic, biologics, veterinary products, food, beverage, and dietary supplements. The criminal investigation part of FDA is handled by Office of Criminal Investigations (OCI).
FDA enforcement tools
FDA uses different law enforcement tools as per Food, Drug and Cosmetic act. The most important tools are as follows:
It is simply a notice of potential violations found during inspection and is issued by the inspector after facility inspection . It only contains opinion of inspectors and is not reviewed by a compliance office or other FDA officers prior to being issued.
b) Warning letters as enforcement instruments
The first enforcement tool used by FDA is a warning letter, which functions as a prior notice. This is not a statutory creature and is not mandatory. FDA can initiate formal enforcement action without warning letters.
The Form 483 and warning letters are informal enforcement actions of FDA. There are five formal enforcement actions taken by FDA: (1) seizures and administrative detentions, (2) recalls, (3) import refusals and alerts, (4) restraining order or injunctions, and (5) suspension of facility registration.
The decision of seizure by FDA is taken only when there is a question of safety. Seizure requires court warrant and is carried out by US Marshals. FDA is only involved indirectly. An administrative detention is less severe form of temporary action. After FSMA regulation, if FDA agents have “reason to believe food is adulterated or misbranded”, they can take temporary hold of products for 30 days to carry out investigation.
2) Recalls
Recall is one of the best known FDA enforcement actions. Recall is mainly linked with some type of outbreak of food-borne illness. Generally, recall is a voluntary action carried out by the manufacturer. After the enforcement of Food Safety Modernization Act (FSMA), FDA is authorized to force a recall without court order under certain circumstances.
3) Import Refusal and Import Alerts
Before entering the US market, products must pass through both the customs and FDA. Previously, FDA agent used to randomly inspect the containers based on their experience or previous history. Now, FDA has launched PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) system which uses a complex algorithm to determine the risk and the likelihood of violation on a particular product. The new system is an example of Risk based food import control system.
The legislation states that FDA can refuse entry to a products based on the examination of samples that appears adulterated or misbranded. FDA may also issue an import alert that essentially acts as a blacklist. If a facility is on an import alert, all the shipments can be refused (detention without physical examination (DWPE)). The petition-for-removal from import alert takes a long process (may be more than a year) and must present evidence on how the violation was corrected. FSMA regulation has mandated a new rule known as Foreign Supplier Verification Program (FSVP).
4) Restraining Order or Injunctions
When FDA needs an enforcement to be applied within a short time, restraining order is preferred, as seizure procedure is impractical. The temporary restraining order is effective for 10 days. FDA must either release the product or seek a preliminary injunction.
5) Suspension of Registration
FSMA has granted the FDA to suspend a facility’s registration and stop its operations. Under such condition, it cannot manufacture, sell or market its products.
……………….end of part 5
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Related post to read
US Food Law and Regulation Series: Part 1
US Food Law and Regulation Series: Part 2
References
M. C. Sanchez, Food Law and Regulation for Non-Lawyers, Food Science Text Series, DOI 10.1007/978-3-319-12472-8_2, © Springer International Publishing Switzerland 2015
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