Food and Drug Administration : Particular Administrative Agencies

Food and Drug Administration

Search Articles

Legal Issues Relating to the Food and Drug Administration Rule on Children and Tobacco
U.S. Dept. of Health and Human Services, Office of the General Counsel
Summary prepared by the Food and Drug Administration regarding the rule on children and tobacco which is aimed at regulating commercial speech to ensure that an illegal activity is not promoted.
The Next Mass Tort?
Faegre & Benson LLP
This article reviews the potential next mass tort in the nutraceuticals market.
Children and Tobacco: A Retailers Guide To The New Federal Regulations
U.S. Dept. of Health and Human Services, Office of the General Counsel
Retailers Guide from the Food and Drug Administration regarding regulations to restrict the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents (21 CFR Part 897).
Summary of Fourth Circuit Court of Appeal's Ruling On the Food and Drug Administration's Jurisdiction and Regulation of Tobacco
U.S. Dept. of Health and Human Services, Office of the General Counsel
Summary from the Food and Drug Administration (FDA) of the Fourth Circuit Court of Appeal's ruling that the FDA lacked the jurisdiction to regulate tobacco products, reversing the April 27, 1997 decision of the U.S. District Court for the Middle District of North Carolina.
Guide On Consultation Procedures: Foods Derived From New Plant Varieties

Industry guide prepared by the Food and Drug Administration on consultation procedures regarding foods derived from new plant varieties.
Small Business Food Labeling Exemption
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration which describes small business food labeling exemptions under 21 CFR 101.9(j)(1).
Consider Potential FDA Objections to Pharmaceutical Trademarks
Pillsbury Winthrop Shaw Pittman LLP
Companies developing pharmaceutical products know the importance of selecting and clearing a trademark early in t.
Non FDA Approved RX Medication
Ginsberg & O'Connor, P.C.
Recently, medical evidence concerning popularly prescribed diet pills has raised the possibility that thousands of .
How Will Prescription and Over The Counter Drugs Affect My Pregnancy?
Salvi, Schostok & Pritchard, P.C.
You don't need to make this decision on your own. Always consult your physician, particularly your obstetrician, be.
The Changing Landscape of Advertising & Marketing Law
of McMillan LLP
The landscape of laws, regulations and codes governing advertising and marketing is complex and multijurisdictional. This past year has brought about significant change for advertisers and marketers in the following areas.
Year 2000 Law Bulletin, March 1999

This bulletin provides information about the potential effects of the Y2K problem on medical devices and the health industry.
OSHA Warns of Latex Hazards
Law Office of Jon L. Gelman
Despite the fact that Federal agencies have not yet been able to reach a consensus on the regulation of latex glov.
Latex Allergy Sensitivity and Employee Exposures
Law Office of Jon L. Gelman
Latex gloves used by health care workers and others have allegedly caused respiratory, cardiovascular and skin diso.
The Development of Consumer Rights in the United States Slowed by the Power of Corporate Political Contributions and Lobbying
Richard Alexander of Alexander Hawes LLP
This article discusses the progress of consumer rights legislation in the wake of the growth of corporate lobbying efforts.
Food and Drug Administration Recall Policies
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration (FDA) which explains the three classes of recalls and discusses FDA's role in the recall process.
Guidance for Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances used in Food Contact Articles
U.S. Dept. of Health and Human Services, Office of the General Counsel
Guide which lists the information that should be submitted to FDA when requesting that the agency review a specific use of a food contact article to determine whether its components will require regulation as a food additive.
Staking a Claim to Good Health
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration (FDA) which provides a description for consumers of the FDA authorized health claims and some specifics on their use.
Dietary Supplement Health and Education Act Summary
U.S. Dept. of Health and Human Services, Office of the General Counsel
Summary prepared by the Food and Drug Administration of the Dietary Supplement Health and Education Act.
Texas Sets Pace in Drug Tort Reform
Joseph S. Cohen of Beirne, Maynard & Parsons, L.L.P.
For at least the last 20 years, two counties in Texas had become affectionately known as the number 1 and number 2 litigation hell holes in the nation. The courts in those counties frequently set the nationwide pace for critical pretrial activities in mass tort litigation. Courts in those counties decide everything from who gets deposed and when, to what documents get produced and when, and finally to who gets to see those documents and when.
Employers Exhale: United States Supreme Court Medical Marijuana Decision Aids Employer Anti-Drug Programs
Nancy N. Delogu and Dale L. Deitchler of Littler Mendelson, P.C.
Employer drug and alcohol abuse prevention and testing programs recently received a boost when the U.S. Supreme Court ruled in Gonzales v. Raich, No. 03-1451 (June 6, 2005), that state laws authorizing the use of marijuana to treat illness do not insulate drug users from federal law making such behavior criminal.
Users Facilities Requirements Under the Safe Medical Devices Act
Ivan J. Punchatz of Buchanan Ingersoll & Rooney PC
Manufacturers should be aware of their responsibilities and requirements under the Safe Medical Devices Act. They m.
Off-Label Promotion: Weighing the Impact of Rulings Setting Back FDA's Authority to Regulate
Buchanan Ingersoll & Rooney PC
The decision of the U.S. District Court for the District of Columbia in Washington Legal Foundation v. Shalada1 (WL.
Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations
U.S. Dept. of Health and Human Services, Office of the General Counsel
Guide from the Food and Drug Administration which provides assistance to manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic.
The New Food Label
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration (FDA) which explains the FDA's new food labeling regulations.
Labeling of Juice Products Small Entity Compliance Guide

Guide from the Food and Drug Administration which explains for small businesses the legal requirements set forth in the current regulation for the labeling of juice products that have not been processed to prevent, reduce, or eliminate harmful bacteria
Questions and Answers on Beef Products Contaminated With E. coli O157:H7
U.S. Dept. of Health and Human Services, Office of the General Counsel
Answers to questions regarding the testing of beef products contaminated with E. coli O157:H7 from the Food and Drug Administration. Discusses protocols for testing and actions which should be taken once it has been determined the beef is contaminated.
The Food and Drug Administration Modernization Act of 1997
U.S. Dept. of Health and Human Services, Office of the General Counsel
Backgrounder from the Food and Drug Administration which describes the Modernization Act of 1997.
International Trade Regulation
Richard G. Dearden 1 and Wendy J. Wagner 2 of Gowling Lafleur Henderson LLP
"Security trumps trade has become a political mantra in the United States " since the terrorist attacks on September 11, 2001. The most serious issue affecting Canada 's international trade performance today is unrestricted access to the U.S. marketplace. The Canadian government has restructured institutions to adjust to this new trade and security nexus.
Panel Analyzes First Amendment Concerns Raised in Pharmaceutical Regulation

Recent court decisions reflect increasing judicial interest in the constitutional protections afforded to speech regarding the safe and effective use of pharmaceutical drugs.
FDA to Regulate the Reprocessing of Disposable Medical Devices by Hospitals
Arent Fox LLP
Recently, the Food and Drug Administration issued draft guidelines demonstrating how the agency will regulate hospitals that re-use disposable or single use medical devices.
Arent Fox Alert: Amendments Signed into Law Overhauling Fastener Quality Act
Lawrence F. Henneberger 1 of Arent Fox LLP
This article discusses some changes in the Fastener Quality Act.
Federal Trade Commission's Enforcement Policy Statement on Food Advertising
Federal Trade Commission
Statement from the Federal Trade Commission (FTC) which provides guidance interpreting the FTC's enforcement policy with respect to the use of nutrient content and health claims in food advertising.
Herbal Supplements: Buyer Beware
James Edwin Keim
For the past several years, an herbal supplement craze has been sweeping the country. Promises and claims of fast .
Procedure for Obtaining Certificates for Export of Foods and Cosmetics
U.S. Dept. of Health and Human Services, Office of the General Counsel
Question and answer guide for manufacturers engaged in exporting Food and Drug Administration regulated food and cosmetic products to a foreign country.
How to Report Adverse Reactions and Other Problems with Products Regulated by the Food and Drug Administration
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration (FDA) on how to report complaints and adverse reactions with products regulated by the FDA.
Regulatory Requirements for Marketing Cosmetics in the United States
U.S. Dept. of Health and Human Services, Office of the General Counsel
Industry guide prepared by the Food and Drug Administration regarding regulatory requirements for marketing cosmetics in the United States.
Food Additives
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration which explains the regulation of food additives under the Federal Food, Drug, and Cosmetic Act of 1938.
Dietary Supplements and Their Natural Dangers: Things to Know
Law Office of Christopher E. Grell
The Law Offices of Christopher E. Grell is one of only a handful of law firms in the United States who represents.
FAQ: Import Questions
Gatti & Associates
What is the meaning of "importation"? Are U.S. importers free to deal with all countries when importing prod.
Arkansas class Y drug offenses and parole eligibility
John Wesley Hall
Manufacturing crude methamphetamine has become relatively easy, and more and more people are looking for a fast .
Preemptive Defense May Soon Fade in Toxic Shock Syndrome Cases
Tydings & Rosenberg LLP
Toxic Shock Syndrome, (hereinafter "TSS"), a serious and often fatal blood disease, has been linked to the use of m.
Circuits Split Over Federal Preemption of State Claims Against Medical Device Manufacturers
Tydings & Rosenberg LLP
Manufacturers of medical devices suffered a major setback recently when a federal appellate court held that "premar.
The FDA Alert--October 1999
Akin Gump Strauss Hauer & Feld LLP
On August 6, 1999, the Food and Drug Administration (FDA) proposed to amend its current regulations governing the 180-day market exclusivity that is granted to certain generic drug products. This proposed rule represents a significant change to the current landscape of drug exclusivity.
FDA: Too Little Too Late
Law Office of Jon L. Gelman
Claims resulting from latex exposure in the workplace continue to crowd the court dockets at epidemic levels.
FDA Alert--February 1999
Akin Gump Strauss Hauer & Feld LLP
On December 28 the White House became the latest governmental entity to address the issue of whether on-line pharmacies should be regulated, proposing an initiative that would subject pharmacies selling drug products over the Internet to regulation by the Food and Drug Administration (FDA).
Negligence Law Reform: How It Will Hurt YouÃ‚Â…
Sokoloff and Weinstein, P.A.
This article concerns the newly proposed legislation facing our lawmakers in the U.S. Congress that will directly i.
How the Department of Homeland Security Will Change Your Business
Joel Sherwood Summer of Miller Nash LLP
Homeland security is really an amalgam of some 40-plus different federal laws. Many states have their own counterparts. These laws affect plant security, identification of key assets and processes, background checks on new employees, employee access to sensitive areas, cybersecurity, and transportation of products and services.
What's The "Skinny" on Fen-Phen?
Gale White of White and Williams LLP
By the time fenfluramine and its sister drug, dexfenfluramine were recalled, an estimated 6 million Americans and a.
Cosmetic Labeling
U.S. Dept. of Health and Human Services, Office of the General Counsel
Guide for consumers from the Food and Drug Administration on how to read cosmetic labels. Also describes how cosmetic labels are regulated.
The Principle Requirements of the Federal Food, Drug, and Cosmetic Act Relating to Foods
U.S. Dept. of Health and Human Services, Office of the General Counsel
Synopsis from the Food and Drug Administration for consumers regarding the principal requirements of food law.
The Duty to Use Pharmacogenetics and Pharmacogenomics to Reduce the Risk of Idiosyncratic Drug-Induced Liver Injury
Jack E. Urquhart,C. Kelvin Adams and Laura E. De Santos of Beirne, Maynard & Parsons, L.L.P.
Drug manufacturers do not have a legal duty to use pharmacogenetics or pharmacogenomics to reduce the risk of idiosyncratic drug-induced liver injury, according to Texas defense attorney Jack E. Urquhart and associates C. Kelvin Adams and Laura E. De Santos, who say the fields are simply too immature to serve as the foundation for a liability claim
Cosmetic Good Manufacturing Practice Guidelines

Industry guide from the Food and Drug Administration regarding cosmetic good manufacturing.
OTC Labeling Requirements
Buchanan Ingersoll & Rooney PC
On March17th the Food and Drug Administration (FDA) issued, amidst great fanfare, a regulation governing labels fo.
Increased FDA Scrutiny of Clinical Investigators May Signal Trouble for Researchers and Company Sponsors
Robert G. Pinco
Enforcement statistics suggest an increase in violative conduct identified by the Agency in its oversight of clini.
Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries
U.S. Dept. of Health and Human Services, Office of the General Counsel
Guidelines from the Food and Drug Administration on how to submit a request to export to foreign countries products subject to the Federal Food, Drug, and Cosmetic Act and other acts the Food and Drug Administration administers.
Frequently Asked Questions About Preemption and Food and Drug Administration's Final Rule on Tobacco
U.S. Dept. of Health and Human Services, Office of the General Counsel
Document prepared by the Food and Drug Administration (FDA) which answers frequently asked questions regarding preemption and the FDA's final rule on tobacco.
Off-label Provisions Of The Food And Drug Modernization Act Found Unconstitutional
Kathleen Joyce 1
This Alert discusses case law and legislation regarding off-label provisions of the food & drug administration.
Waxman-Hatch Law: What's Better For The Nation's Public Health, More Research Or Cheaper Generic Drugs?
Connolly Bove Lodge & Hutz, LLP
The United States Patent Laws grant to a patentee the right to prevent others from.
Pfizer/Pharmacia Merger--The Biggest Just Got Bigger
M. June Casalmir and Bernard Rhee of Bryan Cave LLP
The FTC recently approved the merger of Pfizer Inc. and Pharmacia Corporation. Pfizer is purchasing Pharmacia for an estimated $60 billion solidifying its position as the world's largest pharmaceutical company. Pfizer will control 11 percent of the world's pharmaceutical market, up from 8 percent, with annual revenue estimated to increase to $46 billion from $32 billion.
BEXTRA – No Different Than Vioxx

On April 7, 2005, the U.S. Food and Drug Administration (FDA) asked Pfizer, Inc., to remove its Cox-2 inhibitor, BEXTRA, from the market. Pfizer recalled BEXTRA, citing the potential for increased risk of heart attack and stroke. While sound evidence exists that BEXTRA also causes severe forms of skin disorders, including Stevens Johnson Syndrome (SJS) in patients taking the drug, Pfizer denied the recall was based upon these adverse skin conditions.
Proposed FDA Regulation Should Be Opposed

This newsletter covers a new rule issued by the Food and Drug Administration regarding the Medical Device Amendments Act of 1976 which would not only expose manufacturers to more lawsuits, it would deny consumers access to some life-saving or life-enhancing products.
Drug Price Competition and Patent Term Restoration Act
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration which explains Title II of the Drug Price Competition and Patent Term Restoration Act under which certain patent holders have the opportunity to extend the terms of certain patents.
Analysis of the New Requirements for Dietary Supplement Labels
U.S. Dept. of Health and Human Services, Office of the General Counsel
Analysis for consumers of the New Requirements for Dietary Supplement Labels from the Food and Drug Administration.
Frequently Asked Questions About New Food and Drug Administration Tobacco Regulations
U.S. Dept. of Health and Human Services, Office of the General Counsel
Draft guidance from the Food and Drug Administration regarding rules which effective February 27, 1997 which prohibit retailers from selling cigarettes, loose cigarette tobacco, and smokeless tobacco to anyone under age 18, and require retailers to verify by means of photo identification the age of anyone under age 27 who wishes to purchase these products.
Summary of Federal District Court's Ruling On the Food and Drug Administration's Jurisdiction Over, and Regulation of Cigarettes and Smokeless Tobacco
U.S. Dept. of Health and Human Services, Office of the General Counsel
Summary from the Food and Drug Administration (FDA) of the Greensboro, North Carolina, Federal District Court's ruling on April 25, 1997 that the FDA has jurisdiction under the Federal Food, Drug, and Cosmetic Act to regulate nicotine-containing cigarettes and smokeless tobacco.
Food Safety Initiative Fact Sheet
U.S. Dept. of Health and Human Services, Office of the General Counsel
Fact sheet from the Food and Drug Administration which explains the Clinton Administration's plan to strengthen and improve food safety under the Food Safety Initiative.
Food and Drug Administration Import Procedures
U.S. Dept. of Health and Human Services, Office of the General Counsel
Summary from the Food and Drug Administration of the procedures the Unlisted States importer must follow when handling food products.
The Food and Drug Administration's Seafood Regulatory Program
U.S. Dept. of Health and Human Services, Office of the General Counsel
Overview of the Food and Drug Administration's seafood regulatory program.
FDA Issues Guidance for New Strategy on Reuse of Single-Use Medical Devices: "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals"
Buchanan Ingersoll & Rooney PC
On August 14, 2000, the Food and Drug Administration ("FDA")'s Center for Devices and Radiological Health issued ".
FDAMA Provision Restricting Dissemination of "Off-Label Information" Held Unconstitutional
Buchanan Ingersoll & Rooney PC
In July 1999, the U.S. District Court for the District of Columbia issued the third in a series of decisions in Wa.
Office of Orphan Products Development Frequently Asked Questions
U.S. Dept. of Health and Human Services, Office of the General Counsel
Answers to frequently asked questions from the Office of Orphan Products Development regarding the use and designation of orphan drugs.
Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
U.S. Dept. of Health and Human Services, Office of the General Counsel
Industry guide from the Food and Drug Administration on how to file notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body.
Food Color Facts
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration which explains the regulation of food coloring under the Federal Food, Drug, and Cosmetic Act of 1938.
The Federal Government and Health Care Contractors: Maximizing Your Results When Participating in the Federal Marketplace
Frank M. Rapoport and Samantha L. Southall of Pepper Hamilton LLP
This article highlights some of the opportunities and pitfalls awaiting health care contractors in dealing with the Department of Defense and Department of Veterans Affairs.
Regulatory Preemption of Medical Devices
Kevin R. Costello of Sedgwick, Detert, Moran & Arnold LLP
The FDA has exercised a rigorous pre-market approval process for medical devices since 1976. Yet not all products liability claims involving medical devices are subject to federal regulatory preemption. This article defines the current boundaries between federal and state laws that affect medical devices.
Reducing Crime and Drug Dealing by Improving Place Management: A Randomized Experiment
John E. Eck 0 and Julie Wartell 1 of Department of Justice
This article discusses the results of a study that researched whether improved rental real-estate management could be induced by police action and whether this would reduce crime.
Say It Straight: The Medical Myths of Marijuana
Department of Justice
This Drug Enforcement Agency pamphlet challenges the medical use of marijuana arguments and discusses the political and social issues surrounding the use of marijuana.
The Practice of Environmental Law in Washington: When Should a Company Consider Washington Representation?
Frederick R. Anderson of Cadwalader, Wickersham & Taft LLP
When the importance of the matter requires a focused presence at agency headquarters, and in-house or trade associa.
Canadian Approaches to International Trade Regulation
Richard G Dearden of Gowling Lafleur Henderson LLP
"Security trumps trade has become a political mantra in the United States" since the terrorist attacks on September 11, 2001. The most serious issue affecting Canada's international trade performance today is unrestricted access to the U.S. marketplace. The Canadian government has restructured institutions to adjust to this new trade and security nexus.
Seizures and Forfeitures
US Customs Service
This guide provides information about seizures and forfeitures by the U.S. Customs Service.
Federal Government Debates Latex Regulations
Law Office of Jon L. Gelman
Federal agencies have not yet been able to reach a consensus regulation of latex gloves, exposure to which has resu.
Torts Case Law in Texas

A. NEGLIGENCE: 1. DUTY: a.Van Horn v. Chambers, 970 S.W.2d 542 (Tex., July 3, 1998): The Court h.
Health & Fitness Medical Products--Caveat Emptor & FDA Jurisdiction
Gregg A. Farley and Mark Obenstine 1 of Brobeck Phleger & Harrison LLP
This article discusses the issue of public safety when using quasi-medical devices without the guidance of a medical professional. This article outlines whether the FDA has jurisdiction over such health and fitness products that are marketed directly to consumers or over the internet.
Prospective Payment System Final Rule Benefits Device, Pharmaceutical, and Biological Industries
Bruce D. Armon of Saul Ewing LLP
On April 7, 2000, the Health Care Financing Administration (HCFA) published its final regulation (65 FR 18,434 et s.
Prospective Payment System Final Rule Implementation Delayed
Bruce D. Armon of Saul Ewing LLP
Shortly after the June 2000 issue of Update went to print, the Health Care Financing Administration (HCFA) announce.
Children and Tobacco: A Guide to the New Federal Regulations
U.S. Dept. of Health and Human Services, Office of the General Counsel
Guide from the Food and Drug Administration which outlines new federal regulations concerning children and Tobacco.
Practice Guidelines for Prescription Drug Trademarks
Gabrielle A. Holley of Pillsbury Winthrop Shaw Pittman LLP
The prescription pharmaceutical industry has matured rapidly with respect to its understanding of the value of trademarks. Ten years ago, it was uncommon to see advertisements for prescription medications. Today, with successes like Viagra® and Claritin®, one can hardly watch television or read a magazine without being exposed to an advertisement for the latest prescription medication. Prescription drug trademarks are important marketing tools that can add great value to a company.

Food and Drug Administration

FindLaw Career Center