Adulterated products

In 1982, seven people died from consuming cyanide-laced Tylenol capsules. The incident resulted in a total product recall, massive negative pubHcity for the product, new requirements for safe packaging, and a federal statute making product tampering a crime (2). Since that time, the packaging industry has become visible to most consumers. This awareness has benefited the consumer by a reduction in loss of life due to consumption of adulterated products from tampering. Never before has an industry reacted so swiftly to resolve a problem. 

Passage of Pure Food Act, including provisions for the regulations of drags to prevent the sale of misbranded and adulterated products. Enforcement by the Chemistry Laboratory, Agriculture. 

Honey and maple syrup are complex products of high market price (813C — 23%o). The main source of adulteration is cheap high fructose corn syrup (813C — 13%o) or cane sugar (813C —ll%o) and the adulterated product is easily detected at levels as low as 10% or so of added sugar. 

Blumenthal M. The rise and fall of PC-SPES new generation of herbal supplement, adulterated product, or new drug Integrative Cancer Therapies 2002 1 266-270. 

The FDA has the right to conduct surveillance inspections of manufacturing facilities for the purpose of enforcement. The goal of inspections is to minimize consumers exposure to adulterated products. 5... 

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 ... 

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 ... 

External Characters.— The colour, clearness and smell are noted. A yellowish colour indicates a poorly rectified or old or adulterated product (especially one containing crude pine oil). Turbidity or opalescence indicates the presence of suspended impurities, particularly water. The smell, which is well observed by rubbing a little of the oil between the hands, may indicate the presence of mineral or tar oils, etc. 

Goods should be assigned an accurate status that indicates their position within the supply chain at any particular point in time. Examples could include Received, On Hold, Quarantined, Available, Planned, Picked, Dispatched, In Transit, Delivered, Rejected, Referred, and Awaiting Life Extension. Quarantined Status may apply to goods shipped without Certificate of Analysis, returned products, damaged products, incomplete products, counterfeit products, expired products, misbranded and adulterated products, or goods from an unauthorized Suppher. 

The ancient Greeks, Romans and Arabs all regulated food and drugs. Principally, their concern was with product purity, one of the three pivotal concepts that still form the basis for drug approval today. The typical penalty in ancient times for violating the standards was the loss of the dominant hand that had made the adulterated product. The Arabs were probably the most conscientious of regulators, with standards for about 2000 drug products, and, like today s FDA, they were the first to establish a professional staff of food and... 

In the United States, the Food Drug and Cosmetics Act (FDCA) also creates statutory offences for certain actions or inactions. For example, it is not permissible to sell a misbranded drug or device, or one with labeling that is false, misleading or fails to bear adequate directions for use. In addition, an adulterated product may not be introduced, such as one that has been modified from its intended use. 

An adulterated product is one in which a product is unfit to be sold as a result of... 

Both agencies worked within the confines of ancient Progressive Era statutes that provided inadequate authority to operate effective deterrence-based enforcement programs. FDA s primary enforcement tool was a court action to seize adulterated products, for which it had the burden of proving that the particular items seized were probably contaminated. USDA s only weapon was the atom bomb of closing down the production facility. Neither agency had authority to assess civil penalties tailored to fit particular violations. FDA even concluded that it lacked authority to require repeat violators to take corrective action. ... 

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