FDCA

Separate bureaux within the FDA regulate surfactants used in cosmetics, foods or drugs. The specific regulations of the Act for each of the three product categories are codified in different sections of Title 21, Code of Federal Regulations. The intended product category determines how a surfactant is regulated under FDCA. 

---

FDCA defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body. Therefore, a product becomes a drug based upon its intended use and not upon its composition or source [26]. A pharmacist may violate the FDCA if he or she recommends and sells a dietary supplement for the treatment of a particular disease—the pharmacist would be indicating the product as an unapproved drug. However, if the pharmacist is not selling the product, the FDCA would not be violated. 

If a pharmacist posted a sign in a pharmacy claiming a dietary supplement is effective in treating or preventing a certain disease, the pharmacist would be violating the FDCA. The product would be considered a drug but not properly labeled as a drug and therefore would be misbranded. 

Pharmacy compounding is specifically allowed under the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. 353A). Pharmacists who compound a drug product for an identified individual patient based on the... 

Passage of major amendments (the Kefauver Bill) to the 1938 FDCA, which... 

Medical Device Amendment to the FDCA requiring for devices that not only effectiveness be proven, but also safety. 

Pesticide chemical residues are not considered food additives . Therefore they must adhere to different requirements. Section 408 of the FDCA authorizes the Environmental Protection Agency (EPA) to establish a tolerance for the maximum amount of a pesticide residue that may be legally present in or on a raw agricultural commodity. This section also authorizes the EPA to exempt a pesticide residue in a raw agricultural commodity from the requirement of a tolerance. The requirements for pesticide chemical residues depend on whether they are present on raw agricultural commodities or processed foods. Pesticide residue limits for specific foods are provided by the EPA and can be accessed at http //www.epa.gov/pesticides/food/viewtols.htm. 

Federal Food, Drug and Cosmetics Act (FDCA) provides the Food and Drug Administration (FDA) authority to regulate the manufacturing of drugs and pharmaceuticals and the use of packaging and additives in food and cosmetics. 

Refer to Sections 7.2.1 and 7.2.2 about the CDER and CBER. It should be understood that small and large molecule drugs are legislated differently the former under the Food, Drug and Cosmetic Act (FDCA) and the latter under the Public Health Service Act (PHSA). 

Oxidation of HMF was also attempted in situ directly from fructose, using a membrane reactor or encapsulating PtBi/C into a polymeric silicone matrix, and again, with air as the oxidant. However, the yield was never more than 25%. A further attempt to obtain FDCA directly from fructose involved a one pot reaction in the presence of cobalt acetyl-acetonate encapsulated in sol-gel silica, at 155 °C and with 2 MPa of air pressure giving FDCA with 99% selectivity directly from fructose at a conversion of 72%. ... 

Drugs which are manufactured not in accordance with any cGMP requirement, including the quahty control and quality process mandates, are adulterated under the FDCA. Section 351 of 21 U.S.C. defines a drug as adulterated... 

In addition to the for-cause inspections, the FDCA mandates that the FDA routinely inspect a manufacturer s facilities for cGMP compliance every two years. This applies to domestic and foreign facilities which manufacture drugs for sale within the United States.7 Unfortunately, this two-year mandate is rarely satisfied because the FDA s district offices, which are charged with the responsibility for the inspections, lack sufficient resources to conduct regular cGMP compliance inspections. 

Chapter 7 of the Regulatory Procedures Manual (March 2007, available at www.fda. gov) provides detailed instructions to FDA personnel regarding recalls. The FDCA does not authorize the FDA to order a manufacturer to recall a drug product.11 In practice, however, the manufacturers or distributors of the drug products are encouraged to implement and carry out recalls voluntarily to fulfill their responsibility to protect the public. It is not uncommon for a company to discover that one of its products is defective and recall it entirely on its own or the FDA informs a company of its findings that one of its products is defective and suggests or requests... 

If the company does not comply, then FDA can seek judicial enforcement under the FDCA. 

The FDCA expressly permits administrative seizure on the basis of an ex parte showing of reasonable belief [21 U.S.C. 334 (g)]. Seizure of a company s inventory deprives the company of both capital investment and potential profit. 

Injunctions The FDCA expressly authorizes the courts to restrain and enjoin acts that are in violation of 21 U.S.C. 331, which includes prohibition of adulterated products. FDA policy provides that an injunction action is appropriate where ... 

Introduction Criminal prosecutions of violations of the FDCA are intended to further the goal of protecting the health and safety of the public. The FDA historically has not pursued criminal charges unless the defendant shows a continuous or repetitive course of violative conduct, with the exception of intentional violations, fraud, or danger to health.18... 

Individual versus Corporate Liability Introducing an adulterated product into interstate commerce is a strict liability crime that can be enforced against individuals in positions of sufficient authority and responsibility as well as their company. Persons at risk are those who, at minimum,20 fail to take adequate measures to prevent the cGMP violations. As such, warning letters and other communications are often directed at presidents and CEOs as well as their companies. As stated by the U.S. Supreme Court21 in 1964, just two years after the FDCA as we know it was passed ... 

The [FDCA] imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur. The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the pubhc has a right to expect of those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the pubhc that supports them. 

Scheme 1. Oxidation products derived from HMF 2,5-furandicarboxaldehyde (FDC), 5-hydroxymethyl-2-furancarboxylic acid (HFCA), 5-formyl-2-furancarboxylic acid (FFCA) and 2,5-furandicarboxylic acid (FDCA).

---