Insights on Life Sciences

The Federal Trade Commission has announced a proposed settlement and consent order in its investigation of a US-based water filtration company.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

In an interview with Dope Magazine, Food and Drug associate Emily Leongini discusses how the US Food and Drug Administration (FDA) is currently responding to the proliferation of state-legalized cannabis and how that could impact the growing cannabis industry.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

Today, January 19, 2017, FDA and USDA published a flurry of new policy documents related to the agencies’ regulation of plants, animals, and microorganisms produced using new breeding methods, like gene editing. 

Health Care partner Linda Baumann was heavily quoted in several Bloomberg BNA publications on the outlook for health care fraud and abuse enforcement in 2017.

On December 9, 2016, the Senate Agriculture Committee filed report language for the National Bioengineered Food Disclosure Law, the legislation signed into law by President Obama in July to amend the Agricultural Marketing Act of 1946.

On December 7, 2016, FDA published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements, and cosmetics.

USDA’s Food Safety Inspection Service (FSIS) recently announced that meat and poultry products may use the Nutrition Facts label recently finalized by FDA earlier this year.

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

A California federal court ruled in favor of the US Environmental Protection Agency and agricultural trade associations represented by Arent Fox LLP after a group of plaintiffs, including environmental activists, alleged that the federal agency had not done enough to regulate pesticide-coated seeds.

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

A review of FSIS recall data from the past five years indicates that recalls of meat and poultry products due to the presence of foreign matter contamination have grown in number, particularly over the past year.

From large corporations to small nonprofits, from urban centers to rural communities, the 2016 elections will have an impact across all sectors of the economy and globally as well.

Earlier this week, the US Food and Drug Administration (FDA) issued revised food safety standards known as the “Manufactured Food Regulatory Program Standards” (MFRPS).

On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade.

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.

The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.

As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.

Forty-two Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2017.

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time.

The Beer Institute (BI) announced last week that is was implementing a “Brewer’s Voluntary Disclosure Initiative” intended to encourage its membership to begin disclosing nutritional information about its products on product labeling, packaging and on product websites.

The House of Representatives has voted 306-117 to approve the bipartisan GMO disclosure bill to amend the Agricultural Marketing Act of 1946 and to establish a mandatory National Bioengineered Food Disclosure Standard.