Category Archives: Enforcement

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FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal

By Donnelly L. McDowell on Posted in Drugs, Enforcement, FDA, FTC, Opioid Litigation
The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act.  In addition to the 11 joint warning letters … Continue Reading

AG Sessions Ends Obama-Era Policies Governing Federal Marijuana Enforcement; Sudden Wave of Enforcement Unlikely

By Kristi Wolff and Jaimie Nawaday on Posted in Drugs, Enforcement, Legislation, Regulation
Timed almost to the day that California legalized recreational marijuana, Attorney General Jeff Sessions announced on Thursday, January 4, that the Department of Justice has rescinded the Obama-era guidance (the Cole Memo) issued to federal prosecutors relative to marijuana enforcement. The announcement characterizes the move as an effort to restore prosecutorial discretion, noting that the … Continue Reading

State AGs and the New Administration

By John E. Villafranco on Posted in Dietary Supplements, Enforcement, FTC, Legislation, Regulation, State Attorneys General
As we discussed in recent interviews with Nutritional Outlook and Natural Products Insider, FTC enforcement against supplement companies is likely to evolve into something  much more reasonable under the new administration.  State attorney general activity, however, is likely to become more aggressive – or at least more widespread.  State regulators may perceive a need to … Continue Reading

Dietary Supplement Advertising

By John E. Villafranco on Posted in Class Actions, Dietary Supplements, Drugs, Enforcement, FTC, Legislation, Litigation, Regulation, State Attorneys General
Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below: Click here to view with images. STATE REGULATION State AGs and the New Administration … Continue Reading

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

By Kelley Drye on Posted in Drugs, Enforcement, Regulation
On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research.  This move is expected to expand and diversify the supply of marijuana for research use.  Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the … Continue Reading

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

By Donnelly L. McDowell on Posted in Enforcement, FDA, Foods and Beverages, Regulation
On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously released rules governing current good manufacturing practice, hazard analysis and risk-based preventive controls for human food and animal food (“the … Continue Reading

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

By Kelley Drye on Posted in Dietary Supplements, Enforcement, FDA, FTC
On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S. Postal Inspection Service, the IRS, the Department of Defense, and the U.S. Anti-Doping Agency. The event was flush with provocative … Continue Reading

Sysco Agrees to Pay $19.4M to Settle California Enforcement Challenging the Company’s Food Safety Practices and Related Public Statements

By Crystal N. Skelton and Sarah Roller on Posted in Enforcement, FDA, Foods and Beverages, Product Labeling & Marketing
The world’s largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve allegations that the company had engaged in unlawful food transportation and storage practices and had misrepresented its practices on the company’s website.  The Department alleged that the company held “perishable food and other food … Continue Reading

FDA Reopens Comment Period on Final Guidance Requiring INDs for Certain Food, Dietary Supplement, and Cosmetic Studies

By Donnelly L. McDowell on Posted in Cosmetics, Dietary Supplements, Enforcement, FDA, Foods and Beverages
The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the … Continue Reading

Honeygate II Highlights Supply Chain Risks For U.S. Buyers Of Imported Goods

By Sarah Roller on Posted in Enforcement, Foods and Beverages, Imports/Exports, Regulation
Still buying imports of dubious foreign origin from unrelated U.S. importers? Consider the case of Groeb Farms, Inc., which recently accepted criminal responsibility for fraudulently entered Chinese honey that had avoided $79 million in duties – despite not being directly involved in the honey’s importation. The takeaway: Not being the importer of record for fraudulently … Continue Reading

FDA Sets 10 ppb Action Level for Inorganic Arsenic in Apple Juice

By Kelley Drye Warren on Posted in Enforcement, Foods and Beverages, Product Safety
The Food and Drug Administration (FDA) has issued a draft guidance document entitled Arsenic in Apple Juice: Action Level in which it announces an action level of 10 ppb for inorganic arsenic in apple juice. This action level is consistent with the 10 ppb limit for arsenic set by the Environmental Protection Agency for drinking … Continue Reading

FDA Announces Final Rule Banning BPA from Infant Formula Packaging

By Kristi Wolff on Posted in Enforcement, FDA, Foods and Beverages, FTC, Legislation, Litigation, Medical Devices, Product Labeling & Marketing, Product Safety, Regulation, Scientific Research
The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the … Continue Reading

Handy Health Tracking Mobile App…Or Regulated Medical Device?

By Kristi Wolff on Posted in Enforcement, FDA, FTC, Medical Devices, Product Labeling & Marketing, Product Safety, Regulation
The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for … Continue Reading

DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings

By Kristi Wolff on Posted in DHHS, Enforcement, FDA, Medical Devices, Product Labeling & Marketing, Product Safety, Regulation
The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs and … Continue Reading

Day 2 of Medical Device Mobile App Hearings Focuses on Patient Benefits

By Kristi Wolff on Posted in Enforcement, FDA, Medical Devices, Product Labeling & Marketing, Product Safety, Regulation
The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.” The subcommittee heard from … Continue Reading

FDA Releases International Food Safety Capacity-Building Plan

By Kelley Drye Warren on Posted in Enforcement, FDA, Imports/Exports
As required by Congress under the Food Safety Modernization Act, the Food and Drug Administration (FDA) released its International Food Safety Capacity-Building Plan on February 28, 2013. The plan outlines how the FDA intends to expand the technical, scientific, and regulatory capacity of foreign governments over the next five years. The plan describes four key … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

By Kelley Drye Warren on Posted in Cosmetics, DHHS, Drugs, Enforcement, FDA, Product Labeling & Marketing, Product Safety, Regulation, Uncategorized
According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading

Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds

By Kelley Drye Warren on Posted in Drugs, Enforcement, Litigation
Applying the First Amendment in a way that could significantly alter the prosecutorial and regulatory landscape in Food and Drug cases, the United States Court of Appeals for the Second Circuit has overturned the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, where his prosecution and conviction … Continue Reading

DOJ Is Prosecuting Customs Fraud Through Sarbanes-Oxley’s Obstruction Of Justice Statute

By Sarah Roller on Posted in Enforcement, Foods and Beverages, Imports/Exports
Most products sold in this country – whether imported or made here – are subject to a matrix of federal laws and regulations intended to provide Americans with significant benefits, such as safe food, safe products and a cleaner environment. The compliance costs for producers here and abroad are substantial. Further, imports can be subject … Continue Reading

Opportunity for Comment: FDA Outlines Enforcement Discretion for Dog and Cat Food Products

By Kristi Wolff on Posted in Enforcement, FDA
The Food and Drug Administration has released a draft Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats. This guidance is important for all manufacturers of dog or cat food products. Increased Prevalence of Disease Claims and Product … Continue Reading

FDA’s Scrutiny of Personal Care Products in 2011

By Kelley Drye Warren on Posted in Cosmetics, Enforcement, FDA
It is often said that “beauty lies in the eye of the beholder.” A review of Food & Drug Administration (FDA) enforcement activity in 2011 reinforces how personal care products are beheld by FDA. A new article published by HAPPI — the Household and Personal Products Industry magazine — highlights important regulatory considerations for personal … Continue Reading

FDA Releases Guidance on Administrative Detentions on the Heels of its First Post- FSMA Seizure

By Sarah Roller on Posted in Enforcement, FDA, Foods and Beverages
Today, the Food and Drug Administration (“FDA”) released a guidance document for industry titled “What You Need to Know About Administrative Detention of Foods.” The guidance comes just a week after the FDA announced its first administrative detention under the expanded authority granted by Congress in the Food Safety Modernization Act. The FDA will issue … Continue Reading

Growing FDA and FTC Collaboration Changes Regulatory Landscape for Marketers

By Kelley Drye Warren on Posted in Enforcement, FDA, FTC
It is no secret that marketers are striving for ways to legally and effectively educate consumers about the health benefits provided by food and dietary supplement products. In fact, Natasha Singer of the New York Times recently reported on the growth of “functional foods” marketed with health benefit claims — a $37.3 billion market in … Continue Reading
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