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Category Archives: Manufacturer Product Safety

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The Turn of the “Made in America” Claim Enforcement

Posted in Advertising, Consumer Product Safety, Federal Regulations, Federal Trade Commission (FTC), Importer Safety, Manufacturer Product Safety, Private Labeler Product Safety

It has recently been reported that President Donald Trump is looking for ways to defend American-made products by certifying legitimate U.S. goods and aggressively going after imported products unfairly sporting the “Made in America” label, the White House said on July 18, 2017. President Trump announced that his administration would crack down on “predatory online… 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

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

Counterfeit Products Are Often Unsafe Products – More Reasons to Aggressively Police Infringement of Your Trademarks and Trade Dress

Posted in Consumer Product Safety, Manufacturer Product Safety, Private Labeler Product Safety, Product Liability, Retailer Product Safety, Supply Chain Risk Management

Our colleagues in Mintz Levin’s Intellectual Property Practice, Aarti Shah and James Wodarski, recently authored an expert analysis piece in Law360 that examined the use of the U.S. International Trade Commission (ITC) to combat a rising tide of counterfeits and knockoffs in all kinds of consumer product industries.  Aarti tells us that, in addition to the… 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

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

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

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

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

California Plaintiffs Say that Size Matters: Consumer Fraud Class Action Challenges Slack-Fill in Protein Products

Posted in Advertising, Consumer Product Safety, Drugs & Cosmetics, Food and Beverage, Litigation, Manufacturer Product Safety, Private Labeler Product Safety

According to named plaintiffs in a consumer fraud action filed in December in the Southern District of California, size matters when making it comes to making a purchase.  In fact, Plaintiffs claim that the average consumer’s purchasing decision is “heavily dependent” on the size of the package. Plaintiffs have sued Defendant MusclePharm for “intentionally packaging its… Continue Reading

What is CPSC’s Statute of Limitations for Civil Penalties? That’s a Gabelli Question

Posted in Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Manufacturer Product Safety, Retailer Product Safety

After filing a Section 15(b) report and conducting a recall with the Consumer Product Safety Commission (“CPSC”), it is not uncommon for a company to wonder whether it timely filed its report under the Consumer Product Safety Act (“CPSA”). A question sometimes asked of us is how much time must pass before the company can… Continue Reading

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

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

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two and three will take place on March 9 and March 30 in Dallas, Texas and Davis, California, respectively. These meetings are an integral part… Continue Reading

The Future of Hoverboards: Federal Safety Standard or Voluntary Safety Standard?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), Manufacturer Product Safety, Retailer Product Safety, Supply Chain Risk Management, Voluntary Standards

Over recent weeks, national media outlets have reported extensively on multiple claims from consumers that hoverboards—self-balancing scooters growing immensely in popularity, particularly over the holiday period—have caught fire.  Much of the focus of these claims has been related to the overheating of the hoverboards’ lithium ion batteries.  In the wake of these reports, major airlines… Continue Reading

Three More FSMA Rules Finalized As the Year Comes to a Close

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

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the Act). The Final Rules on Foreign Supplier Verification Programs, produce safety, and accredited third-party certification were released by… Continue Reading

CPSC & DOJ Stop Two Companies from Future Importation of Children’s Products with Far-Reaching Consent Decrees

Posted in Children's Products, Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Federal Regulations, Importer Safety, Litigation, Manufacturer Product Safety, Product Liability

Earlier this week, the U.S. Department of Justice (“DOJ”)—at the behest of the CPSC—filed suit in California federal court against two companies and three individuals for importing products that violate the Federal Hazardous Substances Act (“FHSA”) and Consumer Product Safety Act (“CPSA”). The respective lawsuits can be accessed here and here. The individuals and companies—Brightstar… Continue Reading

FDA Releases Two Final Food Safety Rules: What You Need to Know

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

Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals. The final rule on Preventive Controls for Human… Continue Reading

Legislative Action to Remove Microbeads from Personal Care Products Intensifies

Posted in Drugs & Cosmetics, Federal Regulations, Manufacturer Product Safety, State Consumer Protection Laws, State Regulations, U.S. Congress

The International Campaign Against Microbeads in Cosmetics is most likely celebrating this week, following the California State Legislature’s passage of a bill that would prohibit the use of plastic microbeads in personal care products after January 1, 2020.  The bill, AB 888, now heads to Governor Jerry Brown’s desk for his signature.  Although several states already… Continue Reading

California Joins rest of Country in “Made in USA” Rules

Posted in Advertising, Consumer Product Safety, Federal Regulations, Federal Trade Commission (FTC), Manufacturer Product Safety, State Regulations, State Unfair Competition Laws

California, the beacon of individualism and often marching to its own set of rules, has joined the rest of the country as Gov. Jerry Brown has signed SB 633 which revises California’s take on what constitutes “Made in USA”. Up until this week, existing California law prohibited the sale or offering for sale in the… Continue Reading

Hidden Costs of Common Beauty Treatments?

Posted in Consumer Product Safety, Drugs & Cosmetics, Food & Drug Administration (FDA), Litigation, Manufacturer Product Safety, Product Class Actions, Product Liability, Retailer Product Safety, State Consumer Protection Laws

The “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions stemming from their daily use of nail products, many of which contain potentially harmful chemicals. A New York Times exposé on the health conditions affecting… Continue Reading

What is CPSC’s Fast Track Recall Program and When Should Companies Utilize It?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Manufacturer Product Safety, Private Labeler Product Safety, Product Liability, Retailer Product Safety, Supply Chain Risk Management, Voluntary Recalls

So what is the CPSC’s “fast track recall” program and what is the benefit of participating in it? What is a “stop sale notice” and why does the CPSC generally request it for fast track recalls? What else is required by the CPSC in order to participate in the program and what are the potential… Continue Reading

FDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018

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

Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over the next three years. PHOs in ready-to-eat foods like baked goods, snack foods, and frozen foods represent Americans’ major dietary… Continue Reading

Tenth Circuit Lifts Stay on CPSC’s Magnets Rule

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Federal Regulations, Manufacturer Product Safety, Voluntary Recalls

As we wrote about earlier this month, on April 1, 2015, the U.S. Court of Appeals for the Tenth Circuit (“Tenth Circuit”) temporarily stayed the effective date of “the enforcement and effect” of the CPSC’s safety standard for certain high-powered magnet sets.  Specifically, the Court stayed the safety rule pending consideration of the CPSC’s response… Continue Reading

CPSC & DOJ Sue Michaels Stores for Failing to Report Product Safety Hazard and Filing Misleading Information

Posted in Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), CPSC Civil Penalties, CPSC Enforcement Actions, CPSC Product Recalls, Litigation, Manufacturer Product Safety, Retailer Product Safety

For the first time in recent memory, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) jointly announced the filing of a lawsuit in federal court for the imposition of a civil penalty and injunctive relief for violation of the Consumer Product Safety Act (CPSA). The lawsuit is against arts and crafts retailer… Continue Reading

California Appellate Court Takes on Proposition 65 Warning Triggers

Posted in Children's Products, Distributors, Food and Beverage, Litigation, Manufacturer Product Safety, Product Liability, Prop 65, Retailer Product Safety, State Consumer Protection Laws, State Product Safety Laws, State Regulations, Supply Chain Risk Management

Recent attempts to modify California’s Safe Drinking Water and Toxic Enforcement Act of 1986, Proposition 65, have been the work of the California Legislature.  (See A Sane Tweak To Proposition 65 and California Reenters the GMO Food Labeling Arena – This Time Through The Legislature).  This past week, however, the California Appellate Court for the… Continue Reading