The U.S. Food and Drug Administration (FDA) has a broad mandate to protect the public health by ensuring that foods—including dietary supplements—(except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled. FDA also ensures that human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. It is also responsible for protecting the public from electronic product radiation, assuring that cosmetics are safe and properly labeled, regulating tobacco products, all the while advancing the public health by helping to speed product innovations.
Beginning with the Food and Drug Act of 1906, FDA has managed more than 200 laws that have been passed by the Congress that comprise the modern Federal Food, Drug and Cosmetic Act (FDCA). The FDCA, as we know it today was enacted in 1938, and established the first uniform federal standards for the safety of food, drugs and cosmetics. Enacted following the elixir of sulfanilamide tragedy, which involved the use of an untested anti-bacterial medicine using diethylene glycol (anti-freeze) as a sweetener resulting in 100 deaths, this law included the first preapproval process for new drugs and created the modern definition for products in that category of anything that is “intended” to treat, cure, prevent or mitigate disease in man or other animals.
FDA’s Authority
The FDCA provides FDA with the power to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products or cosmetics are manufactured, processed, packed or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products or cosmetics in interstate commerce for purposes of enforcing the law and any related regulations.
The most common reason for an inspection is to monitor compliance with good manufacturing practices (GMP), which for dietary supplements, can be found at 21 CFR Part 111. Routine inspections can also take place if FDA has an ongoing compliance program in a specific area, such as for sanitation checks, pesticide and chemical residue checks or imported acidified and low-acid canned foods.
For cause, inspections can take place in instances where FDA suspects that there might be an ongoing violative condition in a facility, for instance the presence of microbes such as listeria or salmonella or serious GMP failures as indicated by a recall for a manufacturing quality failure.
FDA Enforcement Options
Under the FDCA, the agency is given numerous tools that are used to notify firms of regulatory/legal violations and to provide an opportunity to correct those actions or to coerce compliance. These range from administrative actions that alert companies to potential violations of the FDCA and provide an opportunity for corrective actions to criminal prosecutions in conjunction with United States Attorneys across the country.
Administrative – These are enforcement devices internal to FDA.
Form 483: This is also known as a Report of Inspectional Observations and is issued at the conclusion of an inspection when an FDA Investigator determines that significant compliance issues exist that require formal notice and correction. It is basically a list of items requiring corrective action. The initial response to the agency is due within 15 working days and should lay out a detailed corrective action plan for each item cited. If, for some reason, the investigator has listed an item in error, the response should explain the nature of the mistake in great detail and describe the actual, compliant conditions at the facility. So 483s, while not confidential, are generally available to the public by Freedom of Information Act Request only (though they are published on the FDA website in matters of extreme public interest.
Warning letter: This is the next step up in seriousness of actions FDA can take. It is exactly what it sounds like, a formal warning from FDA that there is a matter of serious regulatory concern that requires corrective action in order to avoid potentially much more serious enforcement by the agency. For dietary supplement companies, warning letters are most frequently issued following an inadequate response to a 483 or where unapproved drug claims are being made and the agency may decide to skip the 483 and proceed directly to a warning letter … Detailed responses describing the cause of the problems identified and a corrective action plan are mandatory in response within 15 working days. Current warning letters are published on FDA’s website every Tuesday.
Judicial/Legal: Should FDA determine that a situation is too serious or unlikely to be resolved by an administrative remedy, or a 483 or warning letter has proven insufficient to cause a company to come into compliance, FDA has a number of much more serious enforcement options at its disposal. These actions will always involve the support of the U.S. Department of Justice.
Seizure: This is a court order allowing FDA to take possession of property (food, supplements, drugs, etc.) of product that is seriously out of compliance. It is frequently used in matters that the agency views as extremely serious, such as food stored in a filthy, rodent infested warehouse, or where there is a dispute requiring a device to allow a matter to be brought before a federal court. Seizure actions are usually easily recognizable because they are commenced against that offending product, such as United States v. 20 Cases of XXXX. In these cases, either the company involved enters the case as “claimant” to defend the products or may choose to do nothing, which generally results in a court order for forfeiture and destruction.
Well-known examples of FDA seizures are the black currant oil cases brought in the late 1980s. In those cases, the companies chose to defend the products from seizure and were ultimately able to establish that the FDA had no legal justification to sieze the products in the first instance.
Injunction: This is another form of court order that is one the most potent enforcement devices at FDA’s disposal. It will direct a company and/or individual(s) to cease an activity that has been determined or appears likely to be in serious violation of the FDCA. These are most frequently seen where FDA has determined that a company has been given numerous opportunities to come into compliance with GMP regulations and has failed to do so. It will then obtain an order requiring the company to cease production until such time as FDA determines that it has come into compliance with the law. Very few companies confronted with such an order are ever able to resume normal operations. Actions described above can become injunction actions if the company does not adequately address the problem that led to the initial seizure.
Criminal Prosecution
In FDA’s discretion, every violation of the FDCA is potentially a criminal offense. The power to prosecute, while not used very often, is the ultimate power vested in the agency. Types of incidents where this power may be brought to bear include where companies or individuals flout FDA authority by ignoring warning letters or injunctions, or where there is serious consumer injury. Prominent recent examples include cases against Peanut Corporation of America (nine deaths, 714 illnesses—five executives and the corporation were prosecuted for felony offenses), melamine contamination of wheat gluten in pet food (hundreds of pets sickened, numerous pet deaths—company executive pled guilty to misdemeanor offense) and The Real Deal, Inc. for falsification of GMP records (guilty pleas by company and responsible executives).
Significantly, misdemeanor violations of the FDCA can be prosecuted under the principle of “strict criminal liability,” meaning that the government does not have to prove that the individuals in charge had an intent to violate the law. It merely needs to demonstrate that a violation occurred and that the person or company charged was responsible. This principle has been upheld twice the by the U.S. Supreme Court in United States v. Dotterweich (1943) (the general manager of a drug company held responsible for shipments of adulterated and misbranded drugs even though he was not directly involved) and United States v. Park (1975) (the CEO of Acme International prosecuted for failure to follow an FDA directive to clean up the company’s food warehouses, even though he was not directly responsible) based upon the court’s conclusion that individuals and companies take on a special obligation when they enter into business selling FDA regulated products.
Conclusion
Despite popular perception that FDA’s enforcement powers are limited to attempts to persuade companies to comply with the FDCA and applicable regulations, the agency actually has a broad array of enforcement options that it is able to deploy as it deems necessary to assist it in its mission of ensuring the safety and efficacy of the United States’ supply of foods, drugs and cosmetics. NIE
Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations. He can be reached at [email protected].
