Food and Drug Law, 4th (University Casebook Series)
Food and Drug Law, 4th (University Casebook Series)
Overview
Approximately 25 cents out of every dollar spent by American consumers is for a commodity regulated by the Food and Drug Administration. The agency has jurisdiction over food, drugs, cosmetics, medical devices, biological products, animal food and drugs, and tobacco products, as well as electronic products that emit radiation and products that spread communicable disease. FDA regulation thus touches the production and sale of most products that fill the shelves of our supermarkets and drug stores and virtually every product prescribed or used by the medical profession. The agency's responsibilities range from the simplest foods and personal care products to the most technologically sophisticated innovations of biotechnology and medical engineering. Food and Drug Law is the law governing the actions taken by FDA and its sister agencies to oversee the safety of this vast universe of products, to ensure that their labeling (and in some cases advertising) is accurate and informative, and to shepherd safe and effective new products onto the market. The book contains many court cases, but to reflect the diverse forums in which food and drug law is developed and enforced, the text also contains many other types illustrative materials: Federal Register preambles, warning letters, regulatory guidance documents, Congressional hearing testimony, scholarly articles, newspaper opinion pieces, and many others. In addition, the book offers a generous amount of original content, in which the authors guide the reader through the complexities of the statutory and regulatory scheme. Moreover, like past editions, the Fourth Edition includes numerous illuminating notes, which offer a gold mine of fascinating examples of the law in action. The Fourth Edition, like previous editions, is extraordinarily valuable for practitioners. But notably, the book has been reorganized and edited so as to make it more useful than ever for students and professors. Much important contextual material has been moved to the front of the book, so students will grasp essential administrative, jurisdictional, federalism, and enforcement issues before mastering the intricacies of the product-specific chapters. The casebook thus provides an introductory window into administrative law for students who have not yet taken the basic Administrative Law course, as well as for first year students taking Food and Drug Law as an elective. The chapter on human drugs has been thoroughly reorganized to improve its comprehensibility. Throughout the book, other changes to organization and presentation have been made with professors and students in mind. The Fourth Edition is completely updated through the early fall of 2013. It includes a new chapter on tobacco regulation to reflect the responsibilities FDA acquired under the Family Smoking Prevention and Tobacco Control of 2009. It also incorporates all the other statutory amendments since 2007 (for example, the Food and Drug Administration Act, the Food Safety Modernization Act, and the Food and Drug Administration Safety and Innovation Act). Every major development of the past six years is addressed, from the significant First Amendment cases to the preemption of tort suits to the drug compounding crisis to the regulation of bioengineered salmon.Description
Condition Guidelines
Books - New and Used
The following guidelines apply to books:
- New: A brand-new copy with cover and original protective wrapping intact. Books with markings of any kind on the cover or pages, books marked as "Bargain" or "Remainder," or with any other labels attached, may not be listed as New condition.
- Used - Good: All pages and cover are intact (including the dust cover, if applicable). Spine may show signs of wear. Pages may include limited notes and highlighting. May include "From the library of" labels. Shrink wrap, dust covers, or boxed set case may be missing. Item may be missing bundled media.
- Used - Acceptable: All pages and the cover are intact, but shrink wrap, dust covers, or boxed set case may be missing. Pages may include limited notes, highlighting, or minor water damage but the text is readable. Item may but the dust cover may be missing. Pages may include limited notes and highlighting, but the text cannot be obscured or unreadable.
Note: Some electronic material access codes are valid only for one user. For this reason, used books, including books listed in the Used – Like New condition, may not come with functional electronic material access codes.
Shipping & Delivery
Shipping Fees
- Stevens Books offers FREE SHIPPING everywhere in the United States for ALL non-book orders, and $3.99 for each book.
- Packages are shipped from Monday to Friday.
- No additional fees and charges.
Delivery Times
The usual time for processing an order is 24 hours (1 business day), but may vary depending on the availability of products ordered. This period excludes delivery times, which depend on your geographic location.
Estimated delivery times:
- Standard Shipping: 5-8 business days
- Expedited Shipping: 3-5 business days
Shipping method varies depending on what is being shipped.
Tracking
All orders are shipped with a tracking number. Once your order has left our warehouse, a confirmation e-mail with a tracking number will be sent to you. You will be able to track your package at all times.
Damaged Parcel
If your package has been delivered in a PO Box, please note that we are not responsible for any damage that may result (consequences of extreme temperatures, theft, etc.).
If you have any questions regarding shipping or want to know about the status of an order, please contact us or email to support@stevensbooks.com.
Returns & Refunds
You may return most items within 30 days of delivery for a full refund.
To be eligible for a return, your item must be unused and in the same condition that you received it. It must also be in the original packaging.
Several types of goods are exempt from being returned. Perishable goods such as food, flowers, newspapers or magazines cannot be returned. We also do not accept products that are intimate or sanitary goods, hazardous materials, or flammable liquids or gases.
Additional non-returnable items:
- Gift cards
- Downloadable software products
- Some health and personal care items
To complete your return, we require a tracking number, which shows the items which you already returned to us.
There are certain situations where only partial refunds are granted (if applicable)
- Book with obvious signs of use
- CD, DVD, VHS tape, software, video game, cassette tape, or vinyl record that has been opened
- Any item not in its original condition, is damaged or missing parts for reasons not due to our error
- Any item that is returned more than 30 days after delivery
Items returned to us as a result of our error will receive a full refund,some returns may be subject to a restocking fee of 7% of the total item price, please contact a customer care team member to see if your return is subject. Returns that arrived on time and were as described are subject to a restocking fee.
Items returned to us that were not the result of our error, including items returned to us due to an invalid or incomplete address, will be refunded the original item price less our standard restocking fees.
If the item is returned to us for any of the following reasons, a 15% restocking fee will be applied to your refund total and you will be asked to pay for return shipping:
- Item(s) no longer needed or wanted.
- Item(s) returned to us due to an invalid or incomplete address.
- Item(s) returned to us that were not a result of our error.
You should expect to receive your refund within four weeks of giving your package to the return shipper, however, in many cases you will receive a refund more quickly. This time period includes the transit time for us to receive your return from the shipper (5 to 10 business days), the time it takes us to process your return once we receive it (3 to 5 business days), and the time it takes your bank to process our refund request (5 to 10 business days).
If you need to return an item, please Contact Us with your order number and details about the product you would like to return. We will respond quickly with instructions for how to return items from your order.
Shipping Cost
We'll pay the return shipping costs if the return is a result of our error (you received an incorrect or defective item, etc.). In other cases, you will be responsible for paying for your own shipping costs for returning your item. Shipping costs are non-refundable. If you receive a refund, the cost of return shipping will be deducted from your refund.
Depending on where you live, the time it may take for your exchanged product to reach you, may vary.
If you are shipping an item over $75, you should consider using a trackable shipping service or purchasing shipping insurance. We don’t guarantee that we will receive your returned item.
Overview
Approximately 25 cents out of every dollar spent by American consumers is for a commodity regulated by the Food and Drug Administration. The agency has jurisdiction over food, drugs, cosmetics, medical devices, biological products, animal food and drugs, and tobacco products, as well as electronic products that emit radiation and products that spread communicable disease. FDA regulation thus touches the production and sale of most products that fill the shelves of our supermarkets and drug stores and virtually every product prescribed or used by the medical profession. The agency's responsibilities range from the simplest foods and personal care products to the most technologically sophisticated innovations of biotechnology and medical engineering. Food and Drug Law is the law governing the actions taken by FDA and its sister agencies to oversee the safety of this vast universe of products, to ensure that their labeling (and in some cases advertising) is accurate and informative, and to shepherd safe and effective new products onto the market. The book contains many court cases, but to reflect the diverse forums in which food and drug law is developed and enforced, the text also contains many other types illustrative materials: Federal Register preambles, warning letters, regulatory guidance documents, Congressional hearing testimony, scholarly articles, newspaper opinion pieces, and many others. In addition, the book offers a generous amount of original content, in which the authors guide the reader through the complexities of the statutory and regulatory scheme. Moreover, like past editions, the Fourth Edition includes numerous illuminating notes, which offer a gold mine of fascinating examples of the law in action. The Fourth Edition, like previous editions, is extraordinarily valuable for practitioners. But notably, the book has been reorganized and edited so as to make it more useful than ever for students and professors. Much important contextual material has been moved to the front of the book, so students will grasp essential administrative, jurisdictional, federalism, and enforcement issues before mastering the intricacies of the product-specific chapters. The casebook thus provides an introductory window into administrative law for students who have not yet taken the basic Administrative Law course, as well as for first year students taking Food and Drug Law as an elective. The chapter on human drugs has been thoroughly reorganized to improve its comprehensibility. Throughout the book, other changes to organization and presentation have been made with professors and students in mind. The Fourth Edition is completely updated through the early fall of 2013. It includes a new chapter on tobacco regulation to reflect the responsibilities FDA acquired under the Family Smoking Prevention and Tobacco Control of 2009. It also incorporates all the other statutory amendments since 2007 (for example, the Food and Drug Administration Act, the Food Safety Modernization Act, and the Food and Drug Administration Safety and Innovation Act). Every major development of the past six years is addressed, from the significant First Amendment cases to the preemption of tort suits to the drug compounding crisis to the regulation of bioengineered salmon.Description
Condition Guidelines
Books - New and Used
The following guidelines apply to books:
- New: A brand-new copy with cover and original protective wrapping intact. Books with markings of any kind on the cover or pages, books marked as "Bargain" or "Remainder," or with any other labels attached, may not be listed as New condition.
- Used - Good: All pages and cover are intact (including the dust cover, if applicable). Spine may show signs of wear. Pages may include limited notes and highlighting. May include "From the library of" labels. Shrink wrap, dust covers, or boxed set case may be missing. Item may be missing bundled media.
- Used - Acceptable: All pages and the cover are intact, but shrink wrap, dust covers, or boxed set case may be missing. Pages may include limited notes, highlighting, or minor water damage but the text is readable. Item may but the dust cover may be missing. Pages may include limited notes and highlighting, but the text cannot be obscured or unreadable.
Note: Some electronic material access codes are valid only for one user. For this reason, used books, including books listed in the Used – Like New condition, may not come with functional electronic material access codes.
Shipping & Delivery
Shipping Fees
- Stevens Books offers FREE SHIPPING everywhere in the United States for ALL non-book orders, and $3.99 for each book.
- Packages are shipped from Monday to Friday.
- No additional fees and charges.
Delivery Times
The usual time for processing an order is 24 hours (1 business day), but may vary depending on the availability of products ordered. This period excludes delivery times, which depend on your geographic location.
Estimated delivery times:
- Standard Shipping: 5-8 business days
- Expedited Shipping: 3-5 business days
Shipping method varies depending on what is being shipped.
Tracking
All orders are shipped with a tracking number. Once your order has left our warehouse, a confirmation e-mail with a tracking number will be sent to you. You will be able to track your package at all times.
Damaged Parcel
If your package has been delivered in a PO Box, please note that we are not responsible for any damage that may result (consequences of extreme temperatures, theft, etc.).
If you have any questions regarding shipping or want to know about the status of an order, please contact us or email to support@stevensbooks.com.
Returns & Refunds
You may return most items within 30 days of delivery for a full refund.
To be eligible for a return, your item must be unused and in the same condition that you received it. It must also be in the original packaging.
Several types of goods are exempt from being returned. Perishable goods such as food, flowers, newspapers or magazines cannot be returned. We also do not accept products that are intimate or sanitary goods, hazardous materials, or flammable liquids or gases.
Additional non-returnable items:
- Gift cards
- Downloadable software products
- Some health and personal care items
To complete your return, we require a tracking number, which shows the items which you already returned to us.
There are certain situations where only partial refunds are granted (if applicable)
- Book with obvious signs of use
- CD, DVD, VHS tape, software, video game, cassette tape, or vinyl record that has been opened
- Any item not in its original condition, is damaged or missing parts for reasons not due to our error
- Any item that is returned more than 30 days after delivery
Items returned to us as a result of our error will receive a full refund,some returns may be subject to a restocking fee of 7% of the total item price, please contact a customer care team member to see if your return is subject. Returns that arrived on time and were as described are subject to a restocking fee.
Items returned to us that were not the result of our error, including items returned to us due to an invalid or incomplete address, will be refunded the original item price less our standard restocking fees.
If the item is returned to us for any of the following reasons, a 15% restocking fee will be applied to your refund total and you will be asked to pay for return shipping:
- Item(s) no longer needed or wanted.
- Item(s) returned to us due to an invalid or incomplete address.
- Item(s) returned to us that were not a result of our error.
You should expect to receive your refund within four weeks of giving your package to the return shipper, however, in many cases you will receive a refund more quickly. This time period includes the transit time for us to receive your return from the shipper (5 to 10 business days), the time it takes us to process your return once we receive it (3 to 5 business days), and the time it takes your bank to process our refund request (5 to 10 business days).
If you need to return an item, please Contact Us with your order number and details about the product you would like to return. We will respond quickly with instructions for how to return items from your order.
Shipping Cost
We'll pay the return shipping costs if the return is a result of our error (you received an incorrect or defective item, etc.). In other cases, you will be responsible for paying for your own shipping costs for returning your item. Shipping costs are non-refundable. If you receive a refund, the cost of return shipping will be deducted from your refund.
Depending on where you live, the time it may take for your exchanged product to reach you, may vary.
If you are shipping an item over $75, you should consider using a trackable shipping service or purchasing shipping insurance. We don’t guarantee that we will receive your returned item.
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