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Category Archives: Federal Regulations

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Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

Posted in Advertising, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Product Class Actions

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products. Then last fall FDA released a new guidance document on what constitutes a “healthy” food and proper labeling of… Continue Reading

Cosmetics Reform Activity Begins in the 115th Congress

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress, Uncategorized

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015 (H.R.4075). Overall, the proposed legislation would amend… Continue Reading

False Labeling Lawsuits Get Hung Up On Faulty Damages Models

Posted in Advertising, Federal Regulations, Food and Beverage, Litigation, Product Class Actions

Some of our colleagues from Mintz Levin’s Class Action Practice, Joshua Briones, Crystal Lopez, and Grace Rosales, recently authored an interesting and timely article in the Bloomberg BNA Product Safety & Liability Reporter. The article examines certain defenses in consumer fraud class actions over product labeling – specifically, defenses based on faulty damages models. Beyond proving the… Continue Reading

FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress

Posted in Federal Regulations, Food & Drug Administration (FDA), Tobacco Products, U.S. Congress

As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA oversight and requirements under the May 2016 Deeming Rule for tobacco products. In Monday’s Federal Register, FDA issued a final rule to exclude products derived… Continue Reading

FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Product Liability

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements.  Adverse events can be any negative reaction to a product, such as a serious illness or allergic… Continue Reading

BREAKING: COURT RULES POSITIVELY FOR CPSC IN FEDERAL CIVIL PENALTY CASE AGAINST SPECTRUM BRANDS

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, CPSC Product Recalls, Federal Regulations, Litigation

We do not get many court decisions in the CPSC world, but yesterday we received one.  Last evening, a Wisconsin federal district court essentially held in the Government’s case against Spectrum Brands, Inc. (Spectrum) that (1) Spectrum failed to timely report defective coffee pots in violation of Section 15(b) of the Consumer Product Safety Act… Continue Reading

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

Posted in Advertising, Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Federal Trade Commission (FTC), Manufacturer Product Safety, Product Liability

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about this uniquely-regulated class of consumer products.  Today, FTC released… Continue Reading

CPSC in a Post-Election Government: Restraint and Moderation Are Required by All Sides

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Federal Regulations, State Consumer Protection Laws, State Product Safety Laws, U.S. Congress

We have had a huge election result, perhaps the most significant in our lifetime, potentially even exceeding what was called the Reagan Revolution.  It is critical, particularly for anybody from Washington DC, to have a great deal of modesty and humility in prognosticating the future under the Trump administration even in the CPSC world.  We… Continue Reading

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014).  More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation.  The HELP Committee also heard from experts in… Continue Reading

Stuck in the Middle with the FTC

Posted in Advertising, Federal Regulations, Federal Trade Commission (FTC), Litigation, State Consumer Protection Laws, State Unfair Competition Laws, Supply Chain Risk Management

“…Clowns to the right of me, jokers to the left, here I am…” -Stealers Wheel (1972) Legal actions regarding “Made in the USA” claims, whether prosecuted by the Federal Trade Commission (FTC) or through various state unfair trade practices acts, often settle early in the proceedings.  For example, in 2014, the FTC issued 16 “closing… Continue Reading

Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Posted in Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past six years (since a 2010 consumer alert about… Continue Reading

Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling.  In addition, while the process is underway, the Agency intends to exercise enforcement discretion for (meaning it will not take action against) foods labeled with the term “healthy”… Continue Reading

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Uncategorized

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks.  The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and it also completed work on a National Strategy for Modernizing the… Continue Reading

Hot CPSC Jurisdictional Issues: Does the CPSC Have Regulatory Authority Over Amusement Park Rides and Guns?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Federal Regulations, State Product Safety Laws, State Regulations, U.S. Congress

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in the media: does the U.S. Consumer Product Safety Commission (CPSC) have the authority to address… Continue Reading

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Posted in Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Federal Regulations, Food & Drug Administration (FDA)

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries.  Newly enacted Federal requirements for ENDS and their components and parts… Continue Reading

CPSC Chairman Kaye and Commissioner Adler: Current Civil Penalties Approach Works

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Federal Regulations, Litigation, U.S. Congress

Yesterday, CPSC Chairman Elliot Kaye and Commissioner Robert Adler issued a lengthy joint statement vigorously defending the Commission’s current approach to civil penalties against various criticisms voiced by Commissioners Joe Mohorovic and Ann Marie Buerkle as well as stakeholders in the business community.  Their overarching message: such criticisms are without merit and are, in reality, a call for lesser penalties; there will be no change… Continue Reading

House Passes GE Labeling Bill; Obama Expected to Sign

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods.  Already approved by the Senate last week, the bill is now expected to be signed into law by President Obama, according to a White House… Continue Reading

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

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Manufacturer Product Safety

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 liability, also called the Park doctrine, for their role in introducing into interstate commerce eggs that had been adulterated with… Continue Reading

Senate Passes Bill Requiring Labeling for Genetically Engineered Foods

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress, Uncategorized

Four months after the Senate defeated a GE labeling bill (S.2609) introduced by Agriculture Committee Chairman Pat Roberts (R-KS), the upper chamber Thursday night passed, 63-30, a compromise measure (S. 764) that Roberts co-wrote with Senator Debbie Stabenow (D-MI), the Ag Committee’s Ranking Member. Unlike Roberts’s original bill, he and Stabenow’s version would mandate the… Continue Reading

Massive CPSC Recall Leaked to the Press by “CPSC Source” Prior to Official Agency Announcement

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Enforcement Actions, CPSC Product Recalls, Federal Regulations

Today the U.S. Consumer Product Safety Commission (“CPSC”) and Health Canada announced a massive joint recall with IKEA involving over 35 million pieces of furniture that can pose a tip over hazard to small children. While we would normally write about the recall itself, a troubling development has caught our attention.  A CPSC employee prematurely… Continue Reading

The Last Set of Major FSMA Regulations Are Done!

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Supply Chain Risk Management

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the… Continue Reading

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA)

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency’s monograph system.  Agency leader Dr. Janet Woodcock wrote last week in Health Affairs that FDA’s “current system of… Continue Reading

Senate Appropriations Bill Targets FDA Rulemaking Agenda

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed unanimously by the committee last month, the bill would give FDA marching orders to mandate the labeling of genetically engineered (GE) salmon, while putting… Continue Reading

CPSC Reaches Second Civil Penalty Agreement in As Many Weeks; Sunbeam Products to Pay $4.5 Million to Resolve Late Reporting Allegations

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Federal Regulations, Litigation

The U.S. Consumer Product Safety Commission (CPSC) is set to announce yet another civil penalty settlement.  Sunbeam Products d/b/a Jarden Consumer Solutions (Sunbeam or the Company) has agreed to pay a $4.5 million civil penalty to resolve charges that it knowingly failed to immediately report certain defects and an unreasonably risk of serious injury involving… Continue Reading