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The United States Food and Drug Administration has published certain product recall policies applicable to consumer products.
The manufacturers or distributors of the product carry out most recalls of products regulated by FDA voluntarily. In some instances, a company discovers that one of its products is defective and recalls it entirely on its own. In others, FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply.
If the firm does not recall the product, then FDA can seek legal action under the FD&C Act . These include seizure of available product, and/or injunction of the firm, including a court request for recall of the product.
This cooperation between FDA and its regulated industries has proven over the years to be the quickest and most reliable method to remove potentially dangerous products from the market. This method has been successful because it is in the interest of FDA, as well as industry, to get unsafe and defective products out of consumer hands as soon as possible.
FDA guidelines for companies to follow when recalling defective products under the Agency's jurisdiction are published in Title 21 of the Code of Federal Regulations , Part 7. These guidelines make clear that FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the Agency.
The guidelines also call on manufacturers and distributors to develop contingency plans for product recalls that can be put into effect if, and when needed. FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.
Generally, FDA accepts reports and other necessary recall information submitted by e-mail. In many cases, this has become routine for some firms and FDA district offices. However, FDA maintains the prerogative for investigational visits and other in-person communications where the agency considers it appropriate.
The guidelines categorize all recalls into one of three classes according to the level of hazard involved.
Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
Class II recalls are for products that might cause a temporary health problem or pose only a slight threat of a serious nature. One example is a drug that is under-strength but that is not used to treat life-threatening situations.
Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.
FDA develops a strategy for each individual recall that sets forth how extensively it will check on a company's performance in recalling the product in question. For a Class I recall, for example, FDA would check to make sure that each defective product has been recalled or reconditioned. In contrast, for a Class III recall, the Agency may decide that it only needs to spot check to make sure the product is off the market.
Even though the firm recalling the product may issue a press release, FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard. For example, if a canned food product, purchased by a consumer at a retail store, were found by FDA to contain botulinal toxin, an effort would be made to retrieve all the cans in circulation, including those in the hands of consumers. As part of this effort, the Agency also could issue a public warning via the news media to alert as many consumers as possible to the potential hazard.
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Food quality is a concept often based on the organoleptic characteristics and nutritional value of food. Producers reducing potential pathogens and other hazards through food safety practices is another important factor in gauging standards. A food's origin, and even its branding, can play a role in how consumers perceive the quality of products.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The International Nomenclature of Cosmetic Ingredients (INCI) are the unique identifiers for cosmetic ingredients such as waxes, oils, pigments, and other chemicals that are assigned in accordance with rules established by the Personal Care Products Council (PCPC), previously the Cosmetic, Toiletry, and Fragrance Association (CTFA). INCI names often differ greatly from systematic chemical nomenclature or from more common trivial names and is a mixture of conventional scientific names, Latin and English words. INCI nomenclature conventions "are continually reviewed and modified when necessary to reflect changes in the industry, technology, and new ingredient developments".
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market-to-consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.
The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
Adulteration is a legal offense and when the food fails to meet the legal standards set by the government, it is said to have been Adulterated Food. One form of adulteration is the addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which results in the loss of the actual quality of the food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed. In the case of seafood, adulteration may refer to species substitution (mislabeling), which replaces the species identified on the product label with another species, or undisclosed processing methods, in which treatments such as additives, excessive glazing, or short-weighting are not disclosed to the consumer.
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Produce traceability makes it possible to track produce from its point of origin to a retail location where it is purchased by consumers.
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Bernardo T. Chua is from the Philippines and has worked for years in multi-level marketing. He worked as an executive with Gano Excel first in the Philippines. After three years he helped expand Gano Excel to Hong Kong and Canada and then to the United States. Chua moved to California and became president of Gano Excel U.S.A. Gano Excel marketed products with ganoderma in them. These products included capsules, instant coffee and other food products.
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The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
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