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Food & Drug Law Practice Group

Rodriguez O’Donnell’s FDA Practice Group is led by:  Thomas J. O'Donnell - 773-314-5001, todonnell@chicago.rorlaw.com
R. Kevin Williams - 773-314-5002 - kwilliams@chicago.rorlaw.com

The FDA Practice Group focuses on domestic and international FDA and USDA related matters with particular focus upon compliance with FDA and USDA requirements for foreign sourced (imported) products.  Failing to comply with FDA or USDA requirements can result in refusal or rejection of shipments intended for the US market. In addition, these governmental agencies may issue import alerts that are specific to product/manufacturer or shipper combinations resulting in a virtual importation ban of the affected products.

Domestic and International matters handled by Food & Drug Law Practice Group include:

One of the most unique capabilities at Rodriguez O’Donnell is its ability to combine and integrate specific legal and regulatory strengths into a unified whole, providing our clients with solutions that take into consideration the intersection of multiple federal regulatory regimes. For instance, our attorneys and associated consultants are as fluent in discussing FDA requirements as well as those imposed by USDA. In addition, because of their background and experience, they are capable of evaluating problems in the context of Customs, International Trade, and International Tax considerations while reviewing the FDA, USDA, or other governmental agency requirements associated with a given matter. 

As federal power has expanded over the last several years, in response to the terrorist attacks of September 11, 2001, so has the jurisdiction and “reach” of the U.S. federal regulatory agencies. For instance, FDA and USDA both have new jurisdictions to regulate, directly, the transportation of food across state lines through the Safe Transportation of Food Act. Because we have two premier attorneys who routinely handle maritime and transportation matters for freight forwarders, carriers, NVOCCs, etc., Rodriguez O’Donnell is uniquely situated to provide integrated advice and counsel regarding FDA, USDA, Customs, Department of Transportation, Federal Maritime Commission, and U.S. Coast Guard issues.

Rodriguez O’Donnell attorneys and consultants regularly represent domestic and international clients before the Food & Drug Administration, USDA and U.S. Customs and Border Protection (Customs) in matters relating to the importation and exportation of FDA-regulated products.  Our firm emphasizes proactive compliance strategies covering the requirements of multiple U.S. regulatory agencies. This ensures compliance is comprehensive and is achieved in a cost-effective manner. This approach is intended to put the foreign manufacturer or shipper or the US importer in the best position to seek expedited clearance from FDA, USDA and other regulatory agencies on imported shipments.  Rodriguez O’Donnell provides compliance counseling through legal based strategies to reduce the risk of regulatory actions resulting from non-compliance. Rodriguez O’Donnell also provides a full array of litigation services, which are available to our clients in matters relating to FDA, USDA, Customs and trade, and maritime law. Back to top

Bioterrorism Act Compliance

In 2002, the President of the United States signed into law the Public Health Security and Bioterrorism Preparedness and Response Act (the “Bioterrorism Act” or “BTA”). The BTA was a direct response to the terrorist attacks of September 11, 2001 and was intended to provide FDA with new tools to prevent and respond to bioterrorism.   It focused primarily, although not exclusively, upon foods.

The BTA expanded FDA’s authority with respect to foods through four specific areas of new FDA regulatory power:

  • (1) Registration of food facilities with FDA (foreign and domestic);
    (2) Prior notice of virtually all imported food shipments under FDA authority;
    (3) Recordkeeping requirements for food facilities (to include transporters of food in the U.S. and international carriers bringing food into the U.S.);
    (4) FDA administrative detention (not import detention) of food where there is credible evidence that such food presents a threat of serious adverse health consequences or death.

FDA has implemented these four major areas by promulgating four sets of bioterrorism regulations.  Rodriguez O’Donnell attorneys regularly provide guidance and representation with respect to all aspects of the BTA, FDA’s implementing bioterrorism regulations, the agency’s bioterrorism security guidance for food, cosmetic, drugs, and biological products establishments and their respective products. 

For instance, Rodriguez O’Donnell attorneys are able to advise clients regarding prior notice of food imports and food facility registration requirements, evaluation of record keeping compliance, responding to FDA requests for records under the agency’s BTA record keeping authority, identifying opportunities for clients to protect the confidentiality of biosecurity related information and data, handling FDA or Customs refusals and delays due to BTA enforcement at U.S. Ports of Entry, implementation of FDA’s product security and bioterrorism guidance, and integration of biosecurity principles into C-TPAT programs.

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Import Alerts

Through Import Alerts (or the automatic detentions list) , FDA publicly identifies products that are likely to be Detained Without Physical Examination ("DWPE") for a variety of reasons. FDA asserts its authority to automatically detain products under Section 801(a) of the Federal Food Drug and Cosmetic Act (FFDCA).  That Section states, "[i]f it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under [unsanitary] conditions . . . then such article shall be refused admission . . . or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 505 [relating to new drug approvals) . . . then such article shall be refused admission . . . ."

Typically FDA Import Alerts identify a manufacturer, shipper, grower, importer, or a geographic area -- which may be as large as a specific country -- as the source of product that appears to violate the FFDCA. Import Alerts instruct FDA import inspectors, investigators, and compliance officers to automatically detain, or detain without physical examination, all imports of the affected products from the listed manufacturer, shipper, grower, importer, or geographic area.  Once on an Import Alert, FDA will routinely continue to automatically detain the affected product(s) until the manufacturer, shipper, grower, or importer demonstrates to FDA that the apparent violation has been corrected.

There are over 150 separate FDA Import Alerts that affect, literally, thousands of manufacturers, shippers, growers and importers, and hundreds of countries.  The FDA’s Import Alerts can be accessed at the following link: www.fda.gov/ora/fiars/ora_import_alerts.html. 

Our firm routinely provides clients with regulatory and legal strategies to obtain removal from FDA Import Alerts.  More importantly, we are able to guide clients in avoiding being placed on Import Alert status. 

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FDA or USDA Import Delays, Import Detentions, Reconditioning Plans, Import Refusals & Re-importation of Previously Refused Foods

  • FDA or USDA Import Delays (examinations, samplings, etc.): When FDA or USDA (or Customs-Agriculture) wish to examine, sample, or review documentation related to a shipment of product under their jurisdiction, the time delay in obtaining release can drag on for weeks or even months.  This can be very detrimental to an importer’s ability to meet a scheduled delivery. Because USDA conducts its review on imported products at the manifest level, rather than the entry level, if USDA stops cargo for review, the carrier is then often prohibited from releasing the shipment to the importer or owner.  This can cause an importer to incur substantial demurrage charges. FDA conducts its review at the entry level, and ordinarily Customs has already conditionally released the shipment to the importer while it awaits an FDA entry decision.  If an importer distributes a shipment that has not been released by FDA and the agency decides to examine or sample it, Customs will demand that the importer redeliver it for FDA inspection or sampling. This may require the importer to contact buyers and attempt to retrieve the product for FDA examination.

    When responding to a Governmental import hold for information or sampling, detailed knowledge of the pertinent agency’s regulatory scope helps refine the type of information the agency is seeking. Preparing in advance for such holds is particularly important to reduce the length of the delay. Rodriguez O’Donnell regularly reviews entry requirements for clients to ensure the appropriate records, permits, and certifications are in place prior to exporting to the US. When a government agency stops the shipment, Rodriguez O’Donnell is often able to expedite the agency review and obtain a quicker release.   Back to top
     
  • Import Detentions: When FDA detains an imported product the FDA officer is required to provide the importer or consignee with sufficient notice indicating it appears the imported product is in violation of some substantive provision of the FFDCA. The notice should indicate the imported article may be subject to refusal of admission under Section 801. The shipment remains under detention and will ultimately be refused admission unless the importer of record overcomes the appearance of a violation.  Once refused under Section 801, a product must be destroyed unless it is exported under Customs supervision within ninety (90) days of the date of the FDA refusal.

    In certain cases, FDA is incorrect in its assumption that a detained article should be refused admission. In other cases, there are ways to bring the article into compliance or to remove it from FDA’s legal jurisdiction.  Moreover, it may be possible to overcome the appearance of the violation altogether. 

    Rodriguez O’Donnell may be able to obtain an FDA release of your detained product and avoid the costs of exporting or the waste of destroying the product once refused admission.  Back to top
     
  • Reconditioning or Re-Labeling Plans: Even when FDA or USDA has detained an imported shipment, it may be possible to recondition or relabel that product to bring it into compliance and obtain release. Application must be made to recondition or relabel imported products and must be specific as to the steps to be taken, the place and timing where the process will occur, the person or company performing the process, and the method of verifying the reconditioning or re-labeling was successful.  Second attempts at reconditioning or relabeling may also be applied for, but the application must include an explanation why the first attempt failed and how the second attempt will be different and is likely to succeed.  Rodriguez O’Donnell assists clients in designing reconditioning protocols and making application to FDA or USDA to bring detained imported products into compliance for US distribution.  Back to top
     
  • Import Refusals of Admission: If an importer, owner or consignee fails to respond to a notice of detention, or fails to convince FDA or USDA that a detained shipment is not in violation of FDA or USDA law or regulation, FDA will issue a Notice of Refusal or Customs will reject the entry. Under these circumstances, Customs will issue a demand for redelivery (in the case of an FDA refusal) or will require exportation or destruction. Either way, the refused or rejected article ordinarily cannot be distributed in the US. Failing to comply with a refusal or rejection can have serious implications, including claims for liquidated damages up to three (3) times the value of the goods, forfeiture and destruction of the imported product, and/or civil monetary penalties.  Once a shipment is refused or rejected, it is much more difficult to obtain its release.

    Rodriguez O’Donnell has been able to overcome refusals and rejections for clients by quickly addressing the underlying reasons and authorities for the agency action. Back to top
     
  • Re-importation of Previously Refused Foods: Under the Bioterrorism Act, it is now possible to re-import foods that were previously refused admission by FDA.  An importer wishing to re-import previously refused food must establish that the food complies with the relevant provisions of the law and regulations when the product is reimported.  Back to top
     

FDA Import Refusals: Rescission

In certain cases, Rodriguez O’Donnell has been uniquely successful in obtaining rescissions of FDA refusals of admission. Although difficult to do and rarely accomplished, sometimes FDA is so wrong in its application of its law, its regulations, or administrative and procedural processes that only rescission of the refusal will remedy the error. Ordinarily, when Rodriguez O’Donnell is successful at such appeals to the FDA, the product is released into domestic commerce for free sale within the US.  It is necessary to act quickly in cases where FDA has already refused the shipment.  It is equally important to resolve the issue prior to the exportation deadline. Therefore, these cases are handled in an expedited fashion.
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Customs Enforcement Mechanisms for Violations of Other Agencies’ Requirements & Petitions for Mitigation, Cancellation, or Remission

For more details, see also our Customs and International Trade Practice Group area and our Topic Archive

Agencies like FDA, USDA, and the Consumer Products Safety Commission (CPSC) rely upon Customs’ administrative and civil remedies when the other government agency comes to the conclusion that a regulated product has been, or is being, imported in violation of regulatory requirements.  Most commonly, these agencies seek Customs assistance in accomplishing the following on their behalf:

  • Customs demand for redelivery (for refusal of admission or failure to hold product another government agency wishes to physically examine or sample)
  • Customs liquidated damages claims
  • Civil monetary penalties under 19 U.S.C. 1592 or 1595a
  • Customs administrative forfeiture (or civil forfeiture; seizure) under 19 U.S.C. 1595a Back to top
     
  • Customs Demands for Redelivery and Liquidated Damages Claims: Once refused by FDA, or another agency, an imported article must be exported or destroyed under Customs’ supervision within ninety (90) days of the refusal.  Customs will ordinarily issue a demand for redelivery of refused products within thirty (30) days of the issuance of the refusal. Failure to redeliver such products can result in liquidated damages (Customs bond action) in amounts up to three (3) times the value of the refused merchandise. Persons subject to a notice or claim for liquidated damages have the right to petition Customs seeking mitigation or cancellation of the case against them. If you find your refused article has already been distributed in domestic commerce and you are unable to re-export it, Rodriguez O’Donnell may be able to assist you in mitigating – or even canceling – Customs’ liquidated damages claimed for failing to redeliver the refused product. Back to top

For more details, see also our Customs and International Trade Practice Group area and our Topic Archive.

  • Civil Monetary Penalties (19 USC 1592 or 1595a(b)): Whereas liquidated damages claims arise out of the bond agreement between Customs and the importer of record (a contract claim), penalty actions are more like civil tort claims for more egregious violations of federal law.  Even though they are designed to compensate for “wrongs,” they are still civil claims, they are not criminal prosecutions. The basis for such claims ordinarily consists of allegations that an importer has imported something contrary to US law in a manner that raises the concern that the violation was somehow designed to defraud the government.  For instance, when an agency wishes to examine imported product and the importer presents for inspection product from a different shipment, one that was entered previously or later than the shipment FDA has slated for examination or sampling. Such substitution cases, if proven, can result in civil monetary penalties up to the domestic value of the products at issue, depending upon the statute under which Customs proceeds.  Civil monetary penalties may be assessed against persons who are directly responsible for an illegal importation, their agents if they participate in the importation, and others who facilitate, aid or abet the illegal importations.  Rodriguez O’Donnell attorneys routinely handle Customs civil monetary penalty cases seeking mitigation or cancellation based upon mitigating factors or arguments that challenge the basis of the claim. Back to top

For more details, see also our Customs and International Trade Practice Group area and our Topic Archive.

  • Customs Administrative or Civil Forfeiture (Seizures): Similar to Customs’ civil monetary penalty actions (see above), Customs has the authority to forfeit (seize) products that are imported contrary to law if the product fails to comply with the regulatory requirements imposed for health, safety, or conservation. Customs may also seize things that are used to facilitate importations contrary to law, such as vehicles or other product(s) used to conceal an illegal importation. Rodriguez O’Donnell attorneys regularly file petitions on behalf of clients seeking remission of products seized by Customs. The basis of these petitions depends upon the facts of each case but often involve challenges to the underlying regulatory authority that Customs claims forms the basis of the “contrary to law” finding.
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For more details, see also our Customs and International Trade Practice Group area and our Topic Archive.

  • Petitions for Mitigation, Cancellation, or Remission: In most cases, the importer, owner, or consignee has some defenses or grounds for mitigation, cancellation, or remission of the Customs enforcement action.  In the case of liquidated damages or civil monetary penalties, the importer should seek mitigation or cancellation of the case.  In the case of an administrative or civil forfeiture (Customs seizures), the claimant should seek remission of the seized goods.  But the basis for mitigation, cancellation, or remission usually lies in the laws, regulations, administrative procedures, and policies of the other government agency – not Customs’. 
  • Too often, an importer’s petition is based solely upon Customs’ procedures and practices.  In Customs enforcement actions that rely upon the law of another agency, careful scrutiny of the other government agency’s (e.g., FDA’s, USDA’s, CPSC’s) actions is crucial to the petitioner’s or claimant’s success or failure. Because of Rodriguez O’Donnell’s unique ability to cross-link the various federal regulatory regimes, our attorneys regularly petition Customs for relief from liquidated damages claims and penalty actions with frequent success. Although each case is unique, and no prior case can guarantee future results, Rodriguez O’Donnell attorneys have successfully obtained cancellation and substantial mitigation of Customs cases saving clients huge sums of money.
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For more details, see also our Customs and International Trade Practice Group area and our Topic Archive.
 

FDA Enforcement Actions: Administrative, Civil, and Criminal

FDA is somewhat limited in its enforcement options, but it compensates by being relentless when it executes its options. Due to limited agency resources, FDA will often take a case it initiates very seriously and is willing to pursue the case to all sorts of ends. FDA’s enforcement options include:

  • FDA in rem Seizures: When FDA has a preponderance of evidence that a regulated product is in violation of the FFDCA, the agency has the authority to seek (through the U.S. Department of Justice) a court ordered seizure of the affected products. FDA seizures are implemented through a civil trial in a federal court. Only under very limited circumstances (certain criminal enforcement authorities) can FDA seize something without instituting a court action or at least a seizure warrant. Back to top
     
  • FDA Administrative Detention (not import detention): FDA has the authority to administratively detain certain products (human and animal foods and medical devices) while they are in commerce. This administrative action is designed to prevent the owner or possessor from distributing the goods for a limited period of time, while an administrative hearing is held respecting the merchandise. These actions are relatively rare and ordinarily only occur if there is a concern that the affected products may be distributed prior to FDA initiating a seizure.  Administrative detentions occur pursuant to an administrative hearing and do not occur in a federal court.   Back to top
     
  • FDA Temporary Restraining Orders (TROs) and Civil Injunctions: Occasionally, FDA will seek intervention from a federal judge restraining certain conduct by a person or company that is believed to be in violation of the FFDCA.  When the FDA seeks and obtains a TRO, it does so ex parte, which means the private party often does not know about the action at the time and certainly does not appear, but the FDA (through the U.S. Department of Justice) makes an entirely one-sided argument as to why the TRO should issue. Because the private party is notified, TROs are effective for relatively short time frames and are routinely followed up with a Preliminary Injunction hearing before a federal judge. At the preliminary injunction hearing, the person who or company which has been restrained by the TRO has to opportunity to show why he/it should not now be enjoined by the court until further proceedings can be undertaken. The FDA must demonstrate by a preponderance of the evidence that the private party is violating the FFDCA, the government is likely to prevail during a full trial seeking to permanently enjoin the party, and the government (or the public) will be harmed if the court does not step in and preliminarily restrain the private person. Permanent Injunctions are trials in federal court and the FDA has the burden of proof.   Back to top
     
  • FDA Criminal Prosecution: The FFDCA contains dozens of “prohibited acts,” which, if committed, can result in serious criminal sanctions.  The FFDCA is a “strict-liability” criminal misdemeanor statute. Persons who commit prohibited acts can be criminally convicted notwithstanding their intent (or lack thereof) to commit a crime.  Back to top
    • FDA Criminal Misdemeanors: If convicted for a strict liability misdemeanor crime, the defendant, if an individual, could be sent to jail for up to one year. Any defendant could be forced to pay very large criminal fines and penalties, and in certain circumstances, “disgorgement” is available (where the defendant is ordered by the sentencing judge to “disgorge” or give up the profits and gains obtained through criminal conduct).  The FDA, through the U.S. Department of Justice, must demonstrate, beyond a reasonable doubt, the FFDCA violation occurred and the defendant was the person responsible for it having been committed.  FDA need not demonstrate that the defendant intended to perpetrate any fraud in order to obtain a misdemeanor conviction. Back to top
       
    • FDA Criminal Felonies: If a person commits a prohibited act with the intent to defraud or mislead, that person can be convicted and sentenced under the felony provision of the FFDCA. A person so convicted could be sentenced to up to 10 years in prison (depending upon the FFDCA provision violated). A person could defraud or mislead the FDA preventing the agency from conducting its statutorily mandated mission to regulate foods, drugs, cosmetics, devices, and other products under its mandate, and be convicted under the felony provisions of the FFDCA.   Back to top
       
    • FDA Criminal Prosecution vs. Investigations: The FDA does not prosecute its own criminal cases.  Rather the U.S. Department of Justice must bring the criminal case to court.  FDA does, however, investigate many criminal cases under certain limited federal criminal enforcement jurisdiction related to counterfeit drugs. Under this authority, FDA has established the Office of Criminal Investigations (OCI), which conducts the majority of criminal investigations related to the FFDCA. OCI obtains and executes search warrants, arrest warrants, conducts physical surveillance, obtains and serves grand jury subpoenas, obtains and reviews telephone toll records, bank records, and the like, in order to try to build a case against an individual, company, or conspiracy.
       
    • FDA Criminal Investigation/Defense Experience: Rodriguez O’Donnell attorneys have participated in investigating or prosecuting (as former Governmental Agents or Attorneys) and defending (in private practice) federal criminal cases involving counterfeit drugs, substitute drugs and biological products, prescription drug diversion, and prescription devices. Back to top
       
  • FDA Consent Decree: Sometimes the U.S. Government and persons it alleges have violated the FFDCA will enter into an agreement to settle a case and avoid taking the case to trial. Private parties often will enter into a consent decree with the FDA, agreeing not to participate in certain conduct of market activity.  If a consent decree is too broadly worded (something FDA would like to accomplish) it can unnecessarily restrict otherwise legal and unrelated activity that was never at issue in the dispute with the FDA.  Rodriguez O’Donnell assists clients in protecting their rights while negotiating consent decrees on their behalf. Back to top
     
  • FDA Debarment: When certain criteria are met, FDA may seek to debar an individual from participating in a particular industry, filing certain applications with the agency, or appearing before the agency on behalf of another. The result of debarment is the debarred person is functionally prohibited from engaging in any business involving the relevant product.  These actions are administrative in nature and occur pursuant to an administrative hearing. Back to top
     

Import and Export Requirements

FDA regulates products worth approximately twenty five (25%) percent of the U.S. Gross National Product and roughly one third of all commercial lines of entry declared at US ports of entry. USDA and the Food Safety Inspection Service (FSIS) regulate meat, poultry, and eggs, and products containing meat, poultry, and eggs.  The importation of these highly regulated commodities implicates complicated laws, regulations, and procedures.  Identifying and complying with the multitude of regulatory requirements can be time consuming and confusing.

Rodriguez O’Donnell advises international and domestic clients regarding the regulatory requirements affecting their imported shipments.  Additionally, Rodriguez O’Donnell assists clients in complying with the vast array of governmental requirements in an effort to reduce delays and interruptions during the importation process.

In addition, exporting products from the US can be illegal if those products are not in conformity with US law or if the product is restricted in sale in international markets. Some foreign purchasers require certifications that demonstrate products intended for export may be lawfully sold in the US or lawfully exported under US law. These certificates are issued by the agencies having regulatory authority over the products.  Rodriguez O’Donnell assists clients in identifying export requirements or restrictions and in avoiding violations of export laws and regulations.  Back to top

For more details, see also our Customs and International Trade Practice Group area and our Topic Archive.
 

FDA Facility Registration & Product Listing: Food Canning Establishment (FCE) Registration, Scheduled Process Filings (SIDs) & Food Facility, Drug or Device Establishment Registration

FDA requires facilities that manufacture foods, drugs, and devices to register with the agency. Some registration processes are more complicated than others. Whereas FDA Food Facility Registration (required by the Bioterrorism Act), and drug and device establishment registrations are relatively simple, Food Canning Establishment registrations and their accompanying Scheduled Process Filings are more complicated. Additionally, the new Bioterrorism Act registration requirements for foreign drug and device manufacturers are becoming more involved.  In addition, manufacturers of drugs and devices intended for the US market must list their products with FDA. Rodriguez O’Donnell regulatory consultants assist clients in fulfilling their registration and listing obligations with the FDA.   

Under the Bioterrorism Act, foreign drug and device manufacturers must provide to FDA in their facility registration the identity of known US importers. When drugs and devices are imported, a statement must be filed with FDA identifying the registration numbers of various companies in the supply chain, sometimes tracing the product back to the original manufacturer and covering every person who possessed the article throughout distribution. The level of detail required by FDA varies depending upon the type of entry being filed.

Food Canning Establishments must register with FDA the facilities that process and cook canned foods for US consumption and they must describe the products processed at each facility.  The FCE registration is in addition to the Bioterrorism Act food establishment registration requirement. When a food canning establishment registers with FDA, it receives an FCE number.  That FCE number is then used to file its scheduled processes of all the canned products manufactured at the facility for US consumption. The verified cook details (time/temperature/kill rate) of the scheduled process must be described to FDA in the filing, along with supporting documentation. After FDA reviews the scheduled processes and supporting data, the agency issues SID numbers that are unique and specific to the product and the packaging size (can or pouch size). FDA usually requests the FCE and SID information for shipments of canned food at the time of entry.

Rodriguez O’Donnell regularly assists clients in fulfilling their registration, listing, and scheduled process filing requirements. Additionally, Rodriguez O’Donnell assists clients who find their products delayed at the border due to errors in governmental data systems. Back to top
 

FDA Labeling and Electronic Product Certification Requirements

Did you know that the single most frequent reason that a foreign manufacturer’s product is stopped, detained, and refused admission by FDA at the U.S. border or port of entry has something to do with the product’s labeling?  FDA’s labeling regulations can be some of the most confusing and detailed regulations a manufacturer or shipper ever tries to interpret.  Rodriguez O’Donnell routinely provides advice and counsel regarding food and dietary supplement labeling, electronic product (e.g., lasers and radiation emitting products) certification requirements, and cosmetic labeling. This includes providing advice about Nutritional Labeling requirements, ingredients statements, Nutrition Facts panels, and health claims.

There is a reason why FDA focuses so heavily on product labeling requirements, and it has little to do with public safety.  If FDA samples an imported product but finds no FFDCA violation associated with it, then the agency must pay the importer, owner, or consignee the cost of sample.  If, however, there is some violation, even if it is a highly technical labeling issue, the agency does not pay for the samples it takes. Therefore, FDA tends to find labeling violations with nearly every food, cosmetic, dietary supplement, drug, and device it examines or samples.

It is critical to ensure your product labels comply with U.S. requirements before you export to the United States.  The design of the label can emphasize, through pictures or images, certain aspects of the product that results in the product being misbranded under the law. Type size and information location is prescribed by FDA regulation.  Improper declaration of ingredients can result in FDA detentions and refusals.   Back to top

  • Food Labeling and Nutrient Content, Structure-Function, or Health Related Claims: FDA’s labeling regulations related to conventional foods, dietary supplements, or medical foods can be quite complex. This is particularly true respecting the types or scope of labeling or advertising claims that may be made about the product. FDA permits “nutrient content claims,” certain “structure-function” claims and “qualified” (and sometimes “unqualified”) “health claims,” depending upon the product, its ingredients and nutrients, and the health benefit associated with its consumption. Such claims can increase the marketability of your products in the US market. Back to top
     
  • Electronic Product Certification Requirements: Products that emit light, sound, or ionizing radiation are subject to the Radiation Control for Health and Safety Act of 1968 (“Rad Health Act”).  Product subject to the Rad Health Act must bear certifications regarding compliance with the appropriate regulatory requirements. Additionally, many products imported into the US must be reported to the FDA prior to importation.  FDA regulates electronic products such as computer monitors, televisions, DVD and CD players and readers, mercury lamps and ultra-violet lamps, infra-red light emitting devices, laser pointers, and ultrasound machines. FDA regulates medical and non-medical uses of such devices. Many of these products require specific labeling, including warning labels, to comply with FDA regulations. Back to top

Rodriguez O’Donnell is able to provide you with legal and regulatory counseling related to labels, certifications, or advertising claims related to your products.
 

FDA current Good Manufacturing Practices (cGMPs) and Quality System Regulations (QSRs)

FDA requires that all regulated products be processed, packed, and held under sanitary conditions.  The framework for FDA’s sanitation requirements are laid out in regulation but most of the substantive information is contained in various FDA guidance documents posted in all sorts of different places on the FDA website. In addition to basic sanitation, FDA requires foods, drugs, medical devices, dietary supplements, and biological products be manufactured, packed, and held in conformance with cGMPs (or Quality Systems Regulations – QSRs – in the case of medical devices).  CGMP requirements are more fully described in FDA regulations than the sanitation requirements.  A tremendous amount of substantive and product/process specific information, however, is hidden in FDA guidance documents or garnered by direct experience related to the FDA’s inspection process. FDA regularly inspects domestic and foreign facilities for compliance with cGMPs.

Rodriguez O’Donnell assists clients in bringing their facilities into compliance with cGMP and QSR requirements in preparation for FDA inspections. In addition, after an inspection, FDA may issue a Notice of Inspectional Observations, or an FD 483, or a warning letter, in which it describes objectionable conditions observed during an inspection and alleged violations of FDA laws.  Rodriguez O’Donnell assists clients by guiding their responses to FD 483s and warning letters.  Back to top


Dietary Supplements

The regulation of dietary supplements is different than FDA’s regulation over "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring its dietary supplement is safe before it is marketed.

FDA is responsible for taking action against any unsafe dietary supplement product but only after it reaches the market. Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission (FTC) regulates dietary supplement advertising.  These two agencies work closely together to regulate labeling and advertising claims associated with dietary supplements and other products.

The DSHEA amended the FFDCA to provide FDA with express statutory authority to prescribe current good manufacturing practice (CGMP) regulations for dietary supplements. On March 13, 2003, FDA published a proposed rule that included provisions regarding manufacturing, packaging, labeling, testing, quality control, releasing for distribution, and holding of dietary ingredients and dietary supplements. Although these regulations are pending final adoption by the FDA, manufacturers (foreign and domestic) must take adequate steps to ensure their current manufacturing operations conform to FDA’s expectations. 

Rodriguez O’Donnell provides clients with the information and expertise necessary to ensure compliance with labeling and CGMP requirements and FTC’s advertising regulations and guidelines. Back to top
 

FDA’s Hazard Analysis & Critical Control Points (HACCP) – Seafood & Juice

FDA has issued regulations requiring seafood and juice manufacturers, processors, handlers, and importers follow HACCP principles. When FDA finds a problem with imported seafood or juice, the agency often will ask to see the foreign supplier’s HACCP plan.  If your product is subject to FDA’s HACCP requirements, it is important to conduct a hazard analysis of the product and the manufacturing-handling-shipping processes, to correctly identify potential hazards.  Those potential hazards must be controlled at appropriate points and using relevant strategies and measurements. These controls must also be documented. 

On too many occasions, international suppliers and processors borrow a HACCP plan from others in the market place and substitute it as their own. This is a common and dangerous mistake.  Each HACCP plan must be specifically tailored to the products and processes undertaken in a given facility.  Another common mistake, particularly among multiple food processors, is to over-commit in the HACCP plan and then fail to implement the plan completely.  If this is detected, FDA is able to specific action against the processor for failing to follow the processor’s own HACCP plan.

Rodriguez O’Donnell routinely assists clients in conducting hazard analyses and preparing HACCP plans. At times, Rodriguez O’Donnell has been able to leverage a client’s adherence to the HACCP regulations and guidance documents to obtain removal from FDA import alert or release of FDA detained products.  Back to top
 

FDA’s Filer Evaluation Program

In order to participate in FDA’s electronic import entry filing and screening system (Operational Administrative System for Import Support – “OASIS”), customs brokers and other filers often find themselves subjected to an FDA audit process the agency calls its Filer Evaluation Program. Other than persons that transmit prior notice to FDA (through Customs’ entry processing system), FDA law does not grant FDA jurisdiction over Customs filers.  Nevertheless, in order to participate in OASIS, most filers have undergone one or more Filer Evaluations. In this process, FDA inspectors compare electronically filed or transmitted entry information in OASIS with the documentation that underlies the transmission.  Where FDA finds too many errors (according to the agency’s unpublished procedure and criteria), filers could be placed on dual filing status, requiring submission of paper records for each electronically filed entry, until FDA is “satisfied” that the filer can participate in the program with an “acceptable” erRodriguez O’Donnell rate. All the procedures and criteria are unpublished. Nonetheless, Rodriguez O’Donnell assists customs brokers and other filers in managing the Filer Evaluation process and its outcomes. Back to top
 

FDA Warning Letters and Untitled Letters

When FDA conducts an inspection of a regulated facility, it will conclude the inspection discussion with the facility’s management – most often the senior manager posted at the facility.  During this discussion, the FDA Inspector may identify a series of objectionable conditions observed during the inspection and the inspected firm has the ability to ask questions regarding the inspector’s observations.  Depending upon the severity of the objectionable conditions, the FDA Inspector may issue an FDA Form 483, outlining the observations that are most objectionable.  After the inspection is concluded, the FDA may issue a “Warning Letter” regarding the violations observed. Warning Letters are public documents and are published on FDA’s Internet site.

Under other circumstances, where violations observed during the inspection are worthy of note, but there is no clear authority for the FDA to regulate a specific aspect of a firm’s processes FDA may issue an Untitled Letter.

FDA will expect a written response to Warning Letters and Untitled Letters.  These responses must address the agency’s concerns and should include manufacturing, storage, processing or operating procedural changes undertaken based upon the inspection. 

Rodriguez O’Donnell assists firms (foreign and domestic) in responding to FDA Warning and Untitled Letters. Back to top
 

Ingredient (GRAS) Assessments

As food research and technology advances, new food ingredients are being introduced into the food supply. Food ingredients may only be used in conventional food manufacturing if they are Generally Recognized as Safe (GRAS) or if they are the subject of a food additive regulation. 

Most food ingredient GRAS determinations are self-made by the manufacturer. “Prior sanctioned” food ingredients may be marketed without any prior notification to FDA. Ingredients that are GRAS for their intended uses – because they were commonly used in food for the intended uses prior to the food additive amendments to the FFDCA or they are determined to be GRAS based upon scientific evidence – may be used in food without prior notification to FDA.

Although FDA does not require submission of a GRAS assessment determined by the manufacturer, FDA could disagree with the manufacturer and take regulatory action against the food containing an ingredient that FDA believes is not GRAS.  As a consequence of a “not GRAS” determination by FDA, the agency may require the ingredient be subject to a food additive regulation prior to its use in foods. This can be costly and can have severe consequences for food products that have already gained market acceptance. 

Rodriguez O’Donnell assists clients in determining whether food ingredients are GRAS or whether they must be (or already are) the subject of food additive regulations.   Back to top
 

FDA Color Certification and Declaration Requirements

FDA strictly regulates food, drug, cosmetic, and medical device color additives.  Many color additives still require batch certification by FDA (Department of Health and Human Services) prior to their use in FDA regulated products intended for the US market. Some colorants are illegal or non-permitted.  Failing to declare – or failing to properly declare – color additives, certified or otherwise, could result in the product being deemed adulterated or misbranded. 

FDA has issued hundreds of Import Alerts respecting food and cosmetic products that contain illegal, non-permitted, undeclared, or uncertified color additives. Proper product formulation, color certification, and ingredient labeling is critical to obtaining access to the US market.

Rodriguez O’Donnell regularly assists foreign and domestic manufacturers and importers in demonstrating to FDA that color additives contained in imported products are certified, permitted, legal, and properly declared.  Back to top

FDA and EPA Tolerances and Testing for Pesticides in Foods

The Environmental Protection Agency (EPA) regulates pesticide chemical used in foods through a regulatory tolerance publication process. Specific pesticide chemicals may be used in specific foods for particular reasons. The pesticide chemical residues that are permitted to remain on the food vary.  When FDA determines that a pesticide chemical was used on a food for which no tolerance has been established, or where the residue exceeds the residue tolerance level allowed, the agency will ordinarily issue an import alert for the specific grower/processor – product – pesticide combination and automatically detain future shipments until it receives evidence that establishes future shipments are not likely to contain the illegal pesticide or residues or at a level above the regulatory tolerance established by EPA.

Rodriguez O’Donnell regularly assists clients in complying with FDA and EPA requirements related to pesticide application and pesticide chemical residues. For example, Rodriguez O’Donnell has worked with FDA and EPA to amend a regulation that was causing imported processed foods to be automatically detained because FDA was requiring the reporting of a pesticide chemical residue analyses on an “as is” basis (that is on a concentrated or processed basis) rather than on the “ready to eat” basis.  The result of FDA’s misapplication of the EPA and FDA laws and regulations was that shipments of processed foods were being improperly refused by FDA. Back to top
 

Managing FDA Product Recalls (Foods, Drugs, Medical Devices, Cosmetics, Biological Products – imported or domestic)

At times, a product is found to contain a deleterious substance or to have been manufactured, processed, packed or held under such conditions that it is unsafe or presents a hazard to the public. If FDA cannot gain control over the product through an administrative detention (foods or medical devices) or with the assistance of an embargo by a State health or agriculture authority, FDA may seek a product recall by the manufacturer or distributor. In some cases, FDA has the authority to mandate that recall.  In other cases, the FDA may use press announcements and news alerts to notify the public of the health risk (and pressure the manufacturer to initiate a “voluntary” recall).  Once a recall is initiated, whether voluntarily or involuntarily, it is critical to know how deeply into the market place the recall should go. Additionally, FDA expects the recalling firm will keep the agency apprised of its progress.  Properly stating that progress can help avoid future litigation and future liability.

Rodriguez O’Donnell assists clients in designing recall plans, reporting recall progress, and negotiating recall strategies with FDA or State personnel.  Back to top

Reporting Requirements for Light and Radiation Emitting Products (Electronic Product Reporting) to Obtain FDA Accession Numbers

Many products are subject to the Radiation Control for Health and Safety Act, including cellular telephones, microwave ovens, laser transmitting devices, such as DVD or CD readers or laser points, X-ray machines or cabinets (industrial, transportation security, or medical), UV or IR emitting devices, televisions, and many other consumer products. Some of these products must comply with regulatory performance standards. 

Virtually all electronic products are subject to FDA reporting requirements by the manufacturer or its designee.  Electronic product reporting requirements of families of products, unique brands, and models can be used to control parallel imports of expensive products from third countries into the US.  Failing to file required reports, update such reports, and certify compliance with performance standards or properly label (including warning indications) can result in expensive delays or import refusals. There are various reporting requirements, which may include initial product reporting, supplemental reporting, abbreviated product reporting, and annual update reports. 

Ionizing radiation emitting devices (powerful laser devices and radiation emitting devices) are strictly regulated by FDA and must comply with complex performance standards that relate to safety mechanisms, labeling requirements, housing design standards, locking mechanisms, repair and operational instructions, and similar standards.

Electronic products that are also medical devices must also comply with FDA’s medical device regulatory requirements (facility registration, device listing, pre-market notification and/or pre-market approval).

Rodriguez O’Donnell assists electronic product manufacturers and importers in complying with the myriad of requirements related to electronic product reporting, labeling, and certification.  Back to top
 

Review and application of FDA Guidance Documents relative to products and processes; Good Guidance Practices (GGPs); and the Food and Drug Administration Modernization Act (FDAMA)

Rodriguez O’Donnell attorneys are very familiar with the FDA’s use of Guidance documents to provide information or agency expectations to regulated industry and its own regulatory inspectors and compliance officers and how quickly a regulated company can run afoul of some unknown and ambiguous statement or “requirement” contained in such Guidance documents. Having worked within and outside the agency, Rodriguez O’Donnell attorneys and consultants have drafted, edited, and revised numerous guidance documents respecting imported articles, antiterrorism and security measures, applicability of GMPs to biological products, Bovine Spongiform Encephalopathy (BSE) and animal derived ingredients in FDA regulated products and other highly complex regulatory, scientific, and legal issues. 

At times FDA has various guidance documents to disseminate its “current thinking” about complex and vital regulatory matters that have far reaching consequences to regulated industry.  Such documents include:

  • Compliance Policy Guides (CPGs);
  • Compliance Program Manual Guides (CPMGs);
  • Inspection or Sampling Assignments and Plans;
  • Import Alerts;
  • Public Policy Statements or News Alerts;
  • Unpublished Procedural Documents;
  • Regulatory Procedures Manuals; and
  • Investigations Operations Manuals.

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Since 1997, after enactment of the Food and Drug Administration Modernization Act (FDAMA), FDA is required to observe certain procedural steps prior to issuing agency guidance that represents a change in policy or approach respecting regulated industry practices or regulated products.   These procedures are called Good Guidance Practices (“GGPs”) and they are routinely ignored by the agency.

In many circumstances, FDA will assert that it is inconvenient to receive public (industry) comment or participation prior to implementation of agency guidance.  The result is industry is required to interpret and follow literally dozens of applicable agency guidance documents that could change unexpectedly or are published after a company has relied upon prior agency statements regarding a regulatory topic. In other situations, industry must be aware of the agency’s application of regulatory requirements by keeping abreast of various letters to industry and/or warning letters to specific companies.

FDA Guidance documents can cover manufacturing practices and procedures, inspection procedures, interpretation of regulations or statutes, tolerances or defect action levels that FDA will impose for given adulterants or deleterious substances, labeling requirements or claims.  FDA claims that certain of its documents are “mere” guidance and are not intended to bind the agency or industry. Nevertheless, FDA inspectors are expected to follow agency guidance unless they obtain concurrence from FDA supervisors to ignore the guidance. Thus, the application of Guidance documents often looks like implementation of a regulation or rule.  Because it is much easier for FDA to amend, modify, create, or completely remove guidance documents than regulations or rules, the agency tends to manage its regulatory process (and the regulated industry) through guidance rather than the administrative rule making process.

Rodriguez O’Donnell attorneys are very familiar with the application of FDA guidance to industry practices, company processes, and regulated products. Rodriguez O’Donnell regularly interprets agency Guidance for the benefit of clients, advising or counseling them about applicability and implications of FDA guidance documents – whether published or unpublished.  Back to top
 

Evaluation and Challenge of FDA Procedures, Policies, Practices and Regulations under the Administrative Procedures Act (APA)

Because the FDA operates so freely under Guidance documents, many agency procedures, policies, and practices have never undergone the scrutiny and rigor that ordinarily accompanies regulation or rule making processes. Under the Administrative Procedures Act (APA), FDA procedures, policies, and practices may be subject to challenge as “arbitrary and capricious” or FDA’s implementation of guidance or procedures may demonstrate that FDA intended to bind its own inspectors or compliance officers or the industry.

Under such circumstances, the agency’s actions might be challenged successfully as ultra vires (outside the scope of the authority granted to the agency by Congress); an implementation of a rule or regulation without following the required “notice and comment” procedures mandated by the APA; or as “arbitrary and capricious.” Under any of these challenges, the agency’s action could be reviewed and reversed as invalid by a District Court. 

Rodriguez O’Donnell has used such arguments to defend against FDA and USDA administrative, regulatory, and civil actions.   Back to top
 

Evaluation and Advice Related to U.S. Department of Agriculture (USDA) Permit and Foreign Veterinary Health Certificate Requirements

The parallel regulatory regime to FDA that affects imported human and animal foods, drugs, cosmetics, and biological products is that of the US Department of Agriculture (USDA), which includes the Food Safety and Inspection Service (FSIS), Plant Protection and Quarantine (PPQ) and the Animal and Plant Health Inspection Service (APHIS).  After the events of September 11, 2001, APHIS Inspectors were transferred to the US Department of Homeland Security, Bureau of Customs and Border Protection and now consist of “Customs Agriculture.”

USDA has primary regulatory authority over the importation of meat, poultry and eggs and food products that contain meat, poultry and eggs.  It also is responsible for ensuring that US agricultural crops are protected from pests and that US animal stocks are protected from exotic diseases.  Thus, much of USDA’s activities involve inspections of meats, eggs, and agricultural products to ensure they do not act as a vehicle for damaging pests or diseases that could have widespread effect in the US.

FSIS shares jurisdiction with FDA on some meat-containing products, the line of distinction being roughly around 2% or more of a product consisting of meat or meat by-products results in FSIS jurisdiction. FDA and USDA have been particularly concerned with the threat of Bovine Spongiform Encephalopathy (BSE or Mad Cow’s disease).  USDA concerns itself primarily with the risk that imported products containing ingredients of animal origin could eventually contaminate animal feed in the US and thereby increase the threat that BSE could gain a greater foothold in the US.  Similarly, the Avian Influenza crisis in Asia, slowly making its way into Africa and the EU, could threaten US poultry stocks, if USDA fails to establish safeguards to prevent its introduction in the US.

USDA and FSIS primarily require permits prior to importation of meats, poultry, eggs, and animal products that contain meat (pork, beef, poultry, etc.).  In addition, USDA often requires an original veterinary health certificate from the counterpart animal health inspection agency of the foreign government (the country of origin of the meat, poultry, or eggs) certifying that the animals from which the poultry or meat products originated were healthy and did not exhibit indications of disease. 

Many importers of products that contain (or even might, but do not contain) animal protein have recently been the subject of USDA (Customs Agriculture) manifest holds, resulting in substantial delays at ports of entry and increased demurrage costs. USDA recently issued guidance to Customs Agriculture to assist the latter agency in applying the various regulatory requirements of USDA that were previously applied by APHIS.

Rodriguez O’Donnell regularly assists clients by ensuring that the required permits, veterinary health certificates, ingredient lists, and entry and shipping documentation are adequate to facilitate USDA release. When shipments experience significant delays, our clients often contact us to assist in negotiation release of the shipment as quickly as possible.

Rodriguez O’Donnell’s FDA Practice Group is led by:  Thomas J. O'Donnell - 773-314-5001, todonnell@chicago.rorlaw.com
R. Kevin Williams - 773-314-5002 - kwilliams@chicago.rorlaw.com

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