The United States Food and Drug Administration Food, Drug and Cosmetic Act

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Navigating the Maze of E-Cig Marketing Regulations

Federal regulators, and states, counties and cities throughout the country, are enacting new laws, rules and regulations in the e-cigarette marketing space. How can e-cig manufacturers and related marketing affiliates...more

Washington Healthcare Update

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

IVC Filter Litigation – Judge says no to Protective Order

Plaintiffs in a Multi District Litigation (“MDL”) filed complaints against Cook Medical Inc. (“Cook”) and alleges that Cook knowingly presented false information regarding the safety profile of its IVC filters to physician...more

FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications

New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

Product Liability Update: October 2016

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

A Banner Week For Buckman Preemption

There used to be a TV show called “That Was the Week That Was.” It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career. Without an ounce of...more

Another Reason Why Medical Device Class Actions Don’t Work

The Ninth Circuit filed a preemption opinion the other day that should help prevent the “foodification” of medical device litigation. That made-up word refers to the wasteful food-related class action litigation that has...more

FDA Issues New Draft Guidance: New Dietary Ingredient Notifications and Related Issues

Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be...more

FDA Releases Final Rule Allowing Voluntary Risk Reviews of Food Additives to Continue

The Food and Drug Administration (FDA) says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” (GRAS) reviews. The agency recently released its GRAS...more

Protecting Food Industry Whistleblowers: FDA, OSHA team up under FSMA

In 2011, when the Food Safety Modernization Act was passed, it sought to revamp food safety in the United States. Since then, the Food and Drug Administration (FDA) has been hard at work passing regulations to implement the...more

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

Federal Jury Convicts Two Former Acclarent, Inc. Executives on Misdemeanor Charges Related to Off-Label Marketing of Medical...

On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”

Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

USP Says European Market Shows Mandatory USP Standards Would Improve Biosimilar Approval, Acceptance in U.S.

Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more

AGG Food and Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Streamlines the Expanded Access Approval Process for Individual Patients

The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner...more

A Symbolic Victory? FDA's Final Rule On Stand-Alone Symbols In Medical Device Labeling Raises Important Litigation Risk Questions

FDA this week released a final rule that will undoubtedly raise new litigation questions for medical device manufacturers in the context of product liability claims. The final rule, for the first time, permits medical device...more

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