type of recall classes

There are three classes of recall used by the FDA and USDA: Class 1, Class 2 and Class 3, often represented with Roman numerals I, II and III respectively. While both the FDA and USDA have their own definitions of product recall classes, they follow the same general rule – 1= most serious / dangerous, 2= potentially dangerous and 3 = least dangerous. Regardless of the classification level of a recall, consumers are advised to take each of them seriously and follow the instructions provided by the agency responsible for the recall.

FDA RECALL CLASSES DEFINED
When the US Food and Drug Administration (FDA) recalls a product, they classify it into three classes (much like USDA) based on the relative health risk:

Class I Recalls by the US Food and Drug Administration (FDA) are the most severe type of FDA recall. In a Class-I recall there is a potential for serious injury or death.

Class II Recalls are issued on products that have a lower chance of causing major injuries or death, but where there is still the possibility of serious enough adverse events to have irreversible consequences.

Class III Recalls are not very likely to cause adverse health consequences, but there is still a chance and therefore the product is being recalled.

USDA RECALL CLASSES DEFINED
When the United States Department of Agriculture (USDA) Recall Committee recommends a recall, they classify the recall into three classes (much like FDA) based on the relative health risk:

Class 1 USDA recalls are the most serious and involve a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.

Class 2 USDA recalls involve a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.

Class 3 USDA recalls involve a situation in which eating the food will not cause adverse health consequences.

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garage sale

If you're planning a garage sale or organizing a church bazaar, you'd best beware: You could be breaking a new federal law. As part of a campaign called Resale Roundup, the federal government is cracking down on the secondhand sales of dangerous and defective products.

The initiative, which targets toys and other products for children, enforces a new provision that makes it a crime to resell anything that's been recalled by its manufacturer.

"Those who resell recalled children's products are not only breaking the law, they are putting children's lives at risk," said Inez Tenenbaum, the recently confirmed chairwoman of the Consumer Product Safety Commission.

The crackdown affects sellers ranging from major thrift-store operators such as Goodwill and the Salvation Army to everyday Americans cleaning out their attics for yard sales, church bazaars or - increasingly - digital hawking on eBay, Craigslist and other Web sites.

This is an example of government gone insane. There is no area of our economy that Obama doesn't want top regulate. They will also reap the "benefit" of crippling private charities by over regulation thereby forcing more people to turn to the government for help.

These people are truly evil.

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5 things u must know about product recall

Consumers in the United States depend on the government to ensure the safety of products sold in the country. Given the volume and diversity of commodities available through various distribution channels across the nation, monitoring product safety is a monumental task. Product defects occur.

Recent news headlines have alerted us to tainted foods and defective medical devices that have been withdrawn from circulation because of their threats to public health. Each consumer needs to have reliable information necessary to take appropriate action when recalls happen . This article poses and answers five simple questions about the product recall process used in the United States.

1. Which agency has responsibility for product recalls?

The Federal Drug Administration (FDA) is the federal agency responsible for ensuring the safety of a variety of products in widespread use in the U.S.

2. What products are subject to recall?

The FDA regulates and monitors the safety of a long list of products, including:

* Drugs used by humans and animals

* Vaccines

* Biologics, such as blood, blood-based products, and transplantable human tissue

* Animal feed

* Medical devices

* Radiation-emitting products

* Cosmetics

* Approximately 80% of the foods eaten in the U.S. (the FDA does not regulate meat, poultry, and egg products).

3 . Why does the agency recall products?

Yes, you guessed correctly. The primary reason for a recall is to protect public health and safety. When an FDA-regulated product is either defective or potentially harmful, it is removed from the market -- permanently, or until the problem is fixed.

According to FDA, it is rare for the agency to request a recall. Most product calls are voluntary. Sometimes a company discovers a problem and recalls a product on its own. In other situations, a company initiates the recall after FDA raises concerns about a product.

4. What criteria are used to determine product risks?

Regardless of the initiator, risks associated with product defects vary. Consequently, the FDA uses the level of hazard to categorize all recalls into one of three classes:

* Class I includes dangerous or defective products that predictably could cause serious health problems or death. Products, such as the recent cases of faulty pacemakers and bacteria-tainted peanut butter, fall under this category. Other examples include foods with undeclared allergens and a product label mix-up on a lifesaving drug.

* Class II products might cause a temporary health problem, or pose only a slight threat of a serious nature. An example would be an under-strength drug, which though sub-standard, may not be life threatening.

* Class III products are unlikely to cause any adverse health reaction, but they are recalled for violating FDA product labeling or manufacturing laws. An example would be minor defects in product packaging.

5. Where can consumers get updates on product recalls?

The FDA does not publicize all recalls in the media. It uses media publicity only when the public needs to be alerted to a serious hazard associated with a defective product. However, you can obtain full details about all recalled products in the FDA's weekly publication titled Enforcement Report. You can sign up for updates at the agency's website: http://www.fda.gov/ForConsumers/default.htm.

Rachel Agheyisi is an economist with over 25 years of business research, writing, and corporate consulting experience. She is the Executive Director of Report Content Writer, a company that specializes in writing white papers and case studies used by IT companies for generating leads in the biotech, financial services, and health care industries.
http://www.reportcontentwriter.com

Email me at rachel@reportcontentwriter.com on how I may help you develop content-rich white papers and case studies.

Added admin on August 29, 2009

Filed Under: National, State, Local

Tags: defective products, drug recalls, FDA, food recalls, product recalls, tainted foods

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Product Liability: making a claim

LIABILITY FOR MANUFACTURING OR DISTRIBUTING A DEFECTIVE PRODUCT IN INDIA

In India, Product liability law, also called “products liability”, governs the liability of manufacturers, wholesalers, distributors, and vendors for injury to a person or property caused by dangerous or defective products. The goal of product liability laws is to help protect consumers from dangerous or defective products, while holding manufacturers, distributors, and retailers responsible for putting into the market place products that they knew or should have known were dangerous or defective.

Civil Product liability in India is, essentially, governed by

a) The Consumer Protection Act, 1986

b) The Sales of Goods Act, 1930

c) The Monopolies and Restrictive Trade Practices Act, 1969 (hereinafter referred to as the “MRTP Act”)

d) The law of Torts.

e) special statues pertaining to specific goods

The laws relating to product liability, in India, have been constantly evolving, by way of judicial interpretations and amendments, to become one of the most important socio-economic legislations for the protection of consumers. The legislation, in respect of product liability in India, though was enacted to protect the interest of consumers but the same was, earlier, construed narrowly, thereby frustrating the object sought to be achieved. The trend, however, has changed in the recent times with the Courts adopting a pro-consumer approach. The Courts, in India, have now started awarding compensation and damages which are more punitive than compensatory in nature.

In Wheels World vs. Pradeep Kumar Khurana MANU/CF/0280/2002 the complainant, a doctor by profession, complained to the respondent about deficiency in service in not repairing, free of charge, a technical fault, which occurred during warranty period, in his new Montana car and then not delivering the same for a period of 4 years. A sum of Rs. 30, 000/- with interest @ 18% per annum from 2/7/1988 to 7/5/1992, was awarded as compensation, in favour of the complainant for his suffering, both professionally and otherwise, on account of non availability of car for a period of 4 years. Further interest, at the same rate for the same period, was also awarded on an amount of Rs. 82, 000/-, being the price of the car as well as an amount of Rs. 55, 00/- towards costs and, last but not the least, an amount of Rs. 50, 000/-, which was deposited by the Respondent on account of stay of imprisonment, was also awarded to the petitioner.

The product liability law, in India, apart from the civil liability, also imposes criminal liability in case of non-compliance with the provisions of each of the below mentioned Acts. The said Acts are in addition to and not in derogation of any other laws in force, which implies that an action imposing penal liability can be simultaneously initiated along with a claim under civil law. Some of these are special Acts pertaining to sale of specific goods such as food, drugs, cosmetics etc.. The provisions of these enactments are preventive in form , though the relief envisaged is an action for breach in civil or criminal court.

· The Foods Adulteration Act, 1954

· The Food Safety and Standards Act, 2006

· The Drug & Cosmetics Act, 1940

· The Indian Penal Code, 1860

· The Standards of Weights and Measures Act, 1956

· The Agricultural Produce (Grading and Marking) Act, 1937 for marking and grading of commodities like vegetables, butter, etc.

· The Indian Standards Institution (Certification Marks) Act , 1952 to formulate a number of standards for different products by ISI

· The Bureau of Indian Standards Act , 1986

Each of the aforesaid Acts provides for imposition of fine and/or imprisonment in case of supply of defective products or adulterated consumables.

The Food Safety and Standards Act, 2006 is the most recent legislation which comprehensively deals with food and safety standards which are to be complied with by manufacturers and producers, non-compliance of which imposes a liability, upon defaulters, of fine, extending upto Rs. Ten Lakhs and/or imprisonment.

The provisions of Indian Penal Code (IPC), on the other hand, in respect of product liability, are attracted when the element of cheating and fraud can be attributed to such defects. For example, in the case of Smt. Uma Deepak v. Maruti Udyog Ltd Ors (2003) CPJ 90(MRTP) the Complainant alleged that the car sold by the opposite party was not only accidental but the price, for the same, was also overcharged. The Court, in response to the allegations made by the complainant, directed arrest of the Directors as well as the manager of the dealers/agents who sold the said defective car to the complainant and remanded them to judicial custody. Subsequent thereto, the said officers of the opposite party were released on bail and were directed to replace the disputed car with a new car.

Provisions of IPC are also attracted to provide punishment to offenders for false weights and measures , adulteration of goods ( food, drugs etc -6 months imprisonment, fine of 1000 rupees or both), and false property marks ( one year imprisonment, fine or both). The period of limitation as per Section 468 of the Criminal Procedure Code is 6 months if offence is punishable with fine only , and one year if offence is punishable with upto one year imprisonment and three years if offence is punishable with imprisonment of above one year and upto three years.

The provisions of the Standards of Weights and Measures Act, 1976 are attracted in case of any false packaging, weight or measure which does not conform to the standards established by or under the said Act and breaches the mandatory declaratory requirements on a package. If any mandatory declaration is found missing on the package a fine of upto 2000 rupees shall be levied as per Rule 39 of the Standards of weights and measures packaged commodity rules.

The Drugs and Cosmetic Act, 1940 also provides for criminal liability for manufacturers and producers of medicinal products or cosmetics etc, which do not adhere to the prescribed standards.

INDIA BUSINESS GUIDE

• Information Technology Amendment Bill 2008 • Antidumping law in India • Legal Review for Property Purchase Transactions • Registration of Designs in India • Incoterms 2000: Free on Board • Product liability law In india • Procedure for registration of patent in India • Foreign Direct Investment In Real estate in India • Marketing of Wine in India • Technology transfer Agreements in India • SPAM- NEED FOR AN EFFECTIVE LEGISLATION • Acquisition and sale of Immovable property in India • Taxation System in India • Setting Up a Joint Venture In India • Policy On Foreign Direct Investment • Patent and Prior art search In India • Trade Mark Registration In India • Foreign Exchange Regulations in India • Divorce in India • Incorporation of Business Entities In India • Community Trade Mark Registration • Brand Valuation • Food and Drug Industry in India • Legal Process Outsourcing • Procedure for Incorporating a Company in India • Real Estate Sector in India • Special Economic Zones • Wine Import India • Criminal Liability for misuse of Information Technology • Imposition of Anti-dumping Duty • Franchising Law in India • Importance of NDA in Employer – Employee Relationship

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