|4-8.100||Persons to Contact at CPB|
|4-8.200||Federal Food, Drug, and Cosmetic Act Litigation|
|4-8.205||FDCA Litigation Involving Drugs, Medical Devices, Food, and Dietary Supplements|
|4-8.210||Felony Prosecutions—"Intent to defraud"|
|4-8.215||Strict Misdemeanor Liability and “Park” Misdemeanor Liability Under the FDCA|
|4-8.230||Defensive FDCA Litigation|
|4-8.300||Odometer Fraud Prosecutions|
|4-8.400||Elder Fraud and other Mass-Marketing Fraud Schemes|
|4-8.500||The Consumer Product Safety Act and Other Statutes Administered by the Consumer Product Safety Commission|
|4-8.600||Odometer Fraud Prosecutions|
4-8.010 - Introduction
The Consumer Protection Branch of the Civil Division (“CPB”) is responsible for criminal and civil litigation and related matters arising under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and other federal statutes that protect public health and safety. The Branch also enforces, through civil actions, statutes that regulate unfair and deceptive trade practices, and it defends government programs and policies in consumer-related areas.
CPB, created in 1971, has been central in developing the caselaw under the various consumer protection statutes over which CPB has jurisdiction pursuant to 28 C.F.R. § 0.45(j), and the Branch retains considerable expertise in these areas of the law. The statutes identified in 28 C.F.R. § 0.45(j), including the FDCA, give rise to felony and misdemeanor prosecutions as well as civil cases.
CPB serves several functions for investigations and cases handled by USAOs: (1) to ensure that USAOs do not overlook unique policy or factual concerns that frequently affect litigation under CPB’s statutes; (2) to ensure that USAOs do not have to “reinvent the wheel,” when CPB already has jury instructions, briefs, and other pleadings on relevant points; and (3) to obtain the Assistant Attorney General’s approval as needed before filing cases in these areas.
When an agency partner such as the Food and Drug Administration (“FDA”) refers a matter to CPB, CPB either will retain and handle the matter, or request a USAO to handle the case individually or in partnership with CPB. In two particular areas, USAOs sometimes receive matters directly from investigative agencies without CPB’s involvement. These are matters under the FDCA and the odometer tampering statutes. The sections below discuss requirements for USAOs pursuing such cases.
The statutes assigned specifically to CPB include statutes administered by the FDA, the Federal Trade Commission, the Consumer Product Safety Commission, and the National Highway Traffic Safety Administration. A complete list is located at 28 C.F.R. § 0.45(j).
4-8.100 - Persons to Contact at CPB
Contact information for CPB can be found in the directory “Expertise in the Civil Division.”
4-8.200 - Federal Food, Drug, and Cosmetic Act Litigation
USAOs must notify and consult with the CPB upon opening any civil or criminal investigation (including securing a search warrant) into possible violations of the FDCA, 21 U.S.C. § 301, et seq. Notice and consultation is provided through the Director, Deputy Director, Senior Counsel, or Assistant Director (see the directory “Expertise in the Civil Division”). CPB will confirm receipt of and respond to the notification from the USAO within 15 business days. The USAO and CPB should consult as to what role, if any (e.g., non-monitored, monitored, jointly handled, or other), CPB will play in the matter. CPB may elect to monitor investigations and cases that are not jointly handled and that it deems to have nationwide implications, based on the facts or the law.
Investigations and cases that have nationwide implications may include, but are not limited to, instances in which:
- a publicly traded corporation is a criminal target or criminal defendant;
- a subject or target raises the possibility that the First Amendment is a defense to any liability to which their actions may give rise;
- a subject’s or target’s individual liability, criminal or civil, is based on the “responsible corporate officer” doctrine (the so-called Park doctrine);
- the conduct at issue led to death or other serious bodily injury;
- the amount of any criminal fine, forfeiture, disgorgement, and/or restitution or of any civil penalty may exceed $100 million; and
- the conduct at issue involves fraud on or misleading the FDA.
For monitored matters, CPB may request status updates on the matter’s progress and legal and factual theories. At least 15 business days before filing a civil complaint or criminal charges in a monitored matter, a USAO must notify and consult with CPB regarding the factual and legal basis for, and potential nationwide implications of, the charges. Throughout the course of monitored matters, USAOs are required to report to CPB significant matters of FDCA policy and interpretation, questions of first impression concerning the FDCA, and any adverse court decisions.
For non-monitored matters, continued consultation with CPB throughout the course of the investigation’s and matter’s development is encouraged but not required. However, a USAO handling a non-monitored matter should notify and consult with CPB if a court issues an adverse decision concerning the FDCA or if, based on new facts, allegations, legal theories or other developments, the matter now raises novel or significant legal or policy issues under the FDCA or other issues of national importance.
As reflected in the U.S. Attorney Procedures manual, attorneys from the FDA may not be appointed as Special Assistant U.S. Attorneys without the approval of CPB’s Director.
The discussions below focus on the major types of FDCA cases and significant issues that are common to most FDCA matters.
4-8.205 – FDCA Litigation Involving Drugs, Medical Devices, Food, and Dietary Supplements
The FDCA generally prohibits the introduction into interstate commerce of unapproved new drugs, certain types of medical devices absent appropriate clearance or approval, and drugs and medical devices not made in accordance with current good manufacturing practices. The FDCA also prohibits the introduction into interstate commerce of contaminated or otherwise adulterated food, which could include food made under insanitary conditions. Dietary supplements are treated as food or drugs under the FDCA depending on their intended use. Consultation with CPB as required under USAM 4-8.200 will ensure USAOs have access to the most recent developments in the often complex area of FDCA litigation.
4-8.210 – Felony FDCA Prosecutions – “Intent to defraud”
Any person or entity that commits a prohibited act set forth in 21 U.S.C. § 331 violates the FDCA. A person or entity committing such an act “with the intent to defraud or mislead” is guilty of a three-year felony. 21 U.S.C. § 333(a)(2). Intent to defraud or mislead can be established by demonstrating a fraud upon either the ultimate consumer of the product, or upon the FDA, or both. That is, a person or entity whose fraudulent conduct is directed at the FDA, as is common in black market and other contexts, is guilty of felony behavior, and should be prosecuted on that basis.
4-8.215 – Strict Misdemeanor Liability and “Park” Misdemeanor Liability Under the FDCA
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. CPB attempts wherever possible to bring felony charges to deal with fraudulent behavior. Nevertheless, misdemeanor liability can attach to behavior that maymay not merit felony prosecution. What is more, an individual who stands in responsible relation to the violative conduct, even if he or she did not engage in the conduct itself, may be liable under the “responsible corporate officer” doctrine (the so-called Park doctrine).
4-8.220 – FDCA Seizures
FDA routinely recommends seizure actions under the FDCA (authorized by 21 U.S.C. § 334) by direct referral to USAOs. Most of these actions involve filthy storage conditions at food warehouses and similarly clear FDCA violations. However, some seizure recommendations are based on novel or difficult legal theories. Consultation with CPB as required under USAM 4-8.200 will ensure USAOs have access to the most recent guidance.
4-8.225 – Tobacco
CPB handles tobacco-related litigation in both affirmative and defensive contexts. Typically defensive cases challenge rulemakings or guidance issued by FDA’s Center for Tobacco Products, as well as product-specific determinations relating to the marketing of new tobacco products...
4-8.230 – Defensive FDCA Litigation
CPB is primarily responsible for defending FDA actions when challenged under the Administrative Procedure Act or other statutes. These cases typically come directly to CPB from FDA. USAOs served with a complaint against FDA should notify CPB.
4-8.300 – The FTC Act and Other Statutes Administered by the Federal Trade Commission
CPB is primarily responsible for civil and criminal litigation and grand jury proceedings arising under the Federal Trade Commission Act (“FTC Act”) (15 U.S.C. § 41 et seq.). Upon appropriate certification by the Federal Trade Commission, CPB is responsible for the institution of criminal proceedings under the FTC Act (15 U.S.C. § 56(b)), and for determining whether the Attorney General will commence, defend, or intervene in civil proceedings under the FTC Act (15 U.S.C. 56(a)). 28 C.F.R. § 0.45(j).
CPB also is primarily responsible for litigation arising under other statutes overseen by the FTC, including the Consumer Credit Protection Act (15 U.S.C. §§ 1611, 1681q and 1681r), relating to the disclosure of credit terms; and section 11(l) of the Clayton Act (15 U.S.C. § 21(l)) involving violations of orders issued by the Federal Trade Commission. CPB works with the FTC to bring cases under the Fair Debt Collection Practices Act (15 U.S.C. §§ 1692-1692p); the Credit Repair Organizations Act (15 U.S.C. §§ 1679-1679j); the “Do-Not-Call” provisions of the Telemarketing Sales Rule; and other statutes overseen by the FTC. FTC staff frequently refer matters to CPB for criminal investigation where a civil action by the agency uncovers egregious wrongdoing. CPB also defends actions brought against the FTC. The Antitrust Division is responsible for bringing civil penalty actions under Section 7A of the Clayton Act, whether they arise from DOJ or FTC investigations. The Antitrust Division handles such cases on behalf of the FTC pursuant to a Memorandum of Understanding, or the DOJ may appoint FTC attorneys as Special Attorneys to file and litigate their own Section 7A cases under DOJ supervision. (Where an FTC investigation of, or civil action concerning, an antitrust violation uncovers conduct warranting criminal investigation or prosecution under the antitrust or related statutes, the FTC refers the matter to the Antitrust Division, see generally USAM Title 7: Antitrust. With approval from the Antitrust Division, USAOs can also investigate and prosecute under the antitrust statutes either alone or jointly with the Antitrust Division).
4-8.400 – Elder Fraud and other Mass-Marketing Fraud Schemes
CPB regularly prosecutes large-scale criminal and civil cases against domestic and international elder fraud schemes and other mass-marketing fraud schemes. CPB focuses on schemes that use telemarketing or mass mailings to target victims nationwide. CPB is available to provide guidance to USAOs investigating large-scale elder fraud and other cross-border schemes.
4-8.500 – The Consumer Product Safety Act and Other Statutes Administered by the Consumer Product Safety Commission
CPB is primarily responsible for civil and criminal litigation and grand jury proceedings arising under the Consumer Product Safety Act (15 U.S.C. § 2051 et seq.), which authorizes the CPSC to pursue recalls and requires manufacturers to report dangerous products. CPB also is responsible for litigation under the Federal Hazardous Substances Act (15 U.S.C. § 1261 et seq.), which requires warning labels on hazardous products and empowers the CPSC to ban products where a label would not adequately protect consumers; the Poison Prevention Packaging Act (15 U.S.C. § 1471 et seq.), concerning child-resistant packaging; and the Flammable Fabrics Act, relating to flammable clothing and interior furnishings (15 U.S.C. § 1191 et seq.). 28 C.F.R. § 0.45(j).
CPB is responsible for determining under the Consumer Product Safety Act (15 U.S.C. § 2076(b)(7)), whether the Attorney General will initiate, prosecute, defend, or appeal actions relating to the Consumer Product Safety Commission. 28 C.F.R. § 0.45(j). Matters relating to the CPSC are referred directly to CPB. CPB also defends actions brought against the CPSC.
4-8.600 – Odometer Fraud Prosecutions
CPB is primarily responsible for civil and criminal litigation and grand jury proceedings arising under the Automobile Information Disclosure Act (15 U.S.C. § 1231 et seq.), as well as the odometer requirements section and the fuel economy labeling section of the Motor Vehicle Information and Cost Savings Act (15 U.S.C. § 1981 et seq.). 28 C.F.R. § 0.45(j).
CPB should be contacted when an odometer fraud investigation is opened so that information regarding potential overlaps with other cases can be shared. CPB also should be provided a copy of any proposed indictment or information at least two weeks before presentation or filing, so that necessary approvals can be obtained. In general, unless a USAO requests more active assistance on such investigations, CPB will merely monitor the case thereafter.
[updated April 2018]