![](https://www.mintz.com/sites/default/files/styles/banner/public/media/images/2018-09-12/Viewpoint-Landing_Consumer-Product-Safety_Mintz.jpg?itok=eLUZNK9X)
Consumer Product Safety
Viewpoints
Filter by:
CPSC Adopts Final Rules for Button Cell and Coin Batteries with Sweeping Requirements
September 25, 2023 | Blog | By Charles Samuels, Evelyn French, Matthew Tikhonovsky
On September 11, 2023, the Consumer Product Safety Commission (CPSC) voted to adopt sweeping safety requirements, pursuant to Reese’s Law, for button cell and coin batteries and products containing these batteries or designed to contain them. In a direct final rule, the Commission adopted ASNI/UL 4200A-2023 as the mandatory safety standard for button cell and coin batteries, which includes extensive construction, performance, labeling, and certification requirements.
Read more
Recent Developments Signal Headwinds for Homeopathic Drug Products
June 26, 2023 | Blog | By Joanne Hawana
Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes articles recognized in the official Homoeopathic Pharmacopoeia of the United States (a historical perspective can be found in this ScienceInsider article from 2015, when government scrutiny was beginning to increase). But on the other hand, there is growing consensus that the effectiveness of such products is not supported by scientific evidence and that they are, in many cases, mere placebos that do not actually treat the patient’s medical conditions; in the worst cases, they contain harmful ingredients that may cause serious injury.
Read more
Fifth Circuit Finds Flaws in CPSC Rulemaking on Phthalate Limits Highlighting Another Rulemaking Misstep for the Agency
March 22, 2021 | Blog | By Charles Samuels, Evelyn French
The Administrative Procedure Act (the “APA”) requires federal agencies to take specific steps when creating new rules and regulations. As a federal agency, the Consumer Product Safety Commission (the “CPSC”) must follow these steps—referred to as “notice and comment rulemaking”—as well as comply with its statutory specific requirements—in order to put into place new product safety regulations.
Read more
Exercise Equipment Manufacturer, Cybex, Hit with $8 Million Civil Penalty for Late Reporting Demonstrates Aggressive CPSC Enforcement Posture
February 16, 2021 | Blog | By Charles Samuels
In early January, after referral by the CPSC to the Department of Justice (and probably the subject of an Acting Chair Adler public comment), fire extinguisher manufacturer Kidde reached a settlement with the government to pay a $12 million civil penalty for underreporting to the CPSC the scope and nature of defect, failure to report timely, making misrepresentations to the CPSC, and misusing a registered safety certification mark. The civil penalty seems to have signaled the start of a more aggressive approach to CPSC enforcement.
Read more
Consumer Product Safety Advocates Pen Memorandum to Biden Transition Team Foreshadowing Push for More Active and Aggressive CPSC
December 9, 2020 | Blog | By Charles Samuels, Evelyn French
Courts Being Used to Challenge Efficacy of Recalls
November 23, 2020 | Blog | By Daniel Herling
There’s a new class action trend consumer product companies need to be aware of that is not only causing additional stress when faced with a recall but also increased expense and adverse publicity.
Read more
CPSC Inspector General Concludes 2019 Data Breach Was Much More Significant Than Reported and Caused by Mismanagement and Incompetence
October 7, 2020 | Blog | By Charles Samuels, Evelyn French
CPSC Sued Over Lack of Access to Consensus Standard Incorporated Into CPSC Regulation
May 26, 2020 | Blog | By Charles Samuels, Evelyn French, Evan Moore
FDA Places Two Food Orders on Restaurants’ Tables
April 8, 2020 | Blog | By Daniel Herling
The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.
Read more
Representative Rush's Section 6(b) Bill -- Stripping Basic Due Process Protection With Little Justification or Benefit
January 20, 2020 | Blog | By Charles Samuels, Evelyn French
In the latest challenge to Section 6(b), Congressman Bobby Rush has introduced HR 5565, the Safety Hazard and Recall Efficiency Information Act, which would amend Section 6(b) by stripping it of its most basic due process, as well as increasing enormously the penalties for late reporting.
Read more
Regulatory Agencies Launch Unified Website for Biotechnology Regulation
January 16, 2020 | Blog
In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.
Read more
Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA
December 19, 2019 | Blog | By Joanne Hawana
This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” (You can find our two prior posts on medical devices and prescription therapeutic products here and here, respectively.) In taking a wide-lens view of the past year, we see it as having presented a huge number of opportunities for the FDA to educate the public about its role in regulating non-prescription products sold directly to consumers. Most of the educational opportunities we highlight below came in concert with some other agency actions, like the issuance of Warning Letters to specific firms, but we’ve decided to cover only the key issues in the interest of keeping this post from turning into a long list of hyperlinks given the post’s already broad scope. Consumer products that fall within FDA’s jurisdiction include over-the-counter (OTC) drugs and OTC homeopathic drug products; tobacco and other nicotine delivery products; dietary supplements; foods and beverages for both humans and animals (technically, there is no such thing as an animal “dietary supplement”); cosmetics (sort of); and a wide variety of cannabis-derived consumer products that exploded onto the national landscape during 2019 and essentially cross into all of the aforementioned product categories.
Read more
First Indicators of FDA’s Policy Decision on CBD and Cannabis-Derived Ingredients: “Only Limited Data” and “Real Risks”
November 26, 2019 | Blog | By Joanne Hawana
We have previously blogged about the Food and Drug Administration’s year of listening and information-gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp” from the federal Controlled Substances Act. Among other things, the Agency issued a call for scientific information on a variety of topics identified in this April 3, 2019 notice; opened a public docket to receive written comments in response to those questions (docket no. FDA-2019-N-1482); and convened a public hearing in May 2019 to hear from stakeholders directly. Our summary of that May 31st hearing, which also provides an overview of the legal and regulatory landscape post-2018 Farm Bill, is available here. This intensive period of evaluation was led by an internal working group charged with making recommendations for the open scientific, technical, and policy questions created by the new legal status of hemp.
Read more
Do You Want Fries With That?
October 11, 2019 | Blog | By Daniel Herling
The old joke of “what do Philosophy majors ask at their first job?” takes on a new meaning in the world of Prop 65. On October 7, 2019, the California Chamber of Commerce filed a lawsuit in Federal court for the Eastern District of California (Complaint) challenging Proposition 65 warnings for food that contain the chemical Acrylamide.
Read more
Highlights of the FTC’s Workshop on Made in the USA Claims
October 3, 2019 | Blog | By Daniel Herling, Margaret Jewett
In Fleetwood Mac’s magnum opus, “Landslide,” Stevie Nicks croons, “Well, I’ve been ‘fraid of changin’ ‘cause I’ve built my life around you.” The FTC’s recent workshop on Made in the USA claims reveals a similar hesitancy to evolve, although panel discussions may presage altered approaches to enforcement of these claims. This workshop, held on September 26, consisted mainly of three panel discussions on various aspects of this issue.
Read more
FTC Identifies Concerns With Plaintiff’s Lawyers Advertisements Concerning Risks Associated With Pharmaceutical Drugs
September 27, 2019 | Blog | By Daniel Herling
I suspect that we’ve all had this experience. You’ve finished a long day of work, had dinner, and have cozied up on the couch with a glass of wine to watch a re-run of your favorite TV show. The show goes to commercial and all of a sudden, plastered across your screen, there is an “important consumer alert” concerning the alleged dangers of a particular prescription drug and that “if you or a loved one have been injured” to contact this law firm.
Read more
Commissioner Bob Adler Elected Vice-Chairman of the CPSC, Making Him Acting Chairman of the Agency
September 13, 2019 | Blog | By Charles Samuels, Evelyn French
It was confirmed that Commissioner Bob Adler was elected Vice-Chairman of the CPSC. Because there is no permanent CPSC Chairman at this time, Commissioner Adler will become the Acting Chairman of the agency until a permanent Chairman is confirmed. Commissioner Adler—a Democratic Commissioner—has served on the Commission since 2009.
Read more
Acting Chairman Ann Marie Buerkle Withdraws Nomination, Announces Intent to Resign From CPSC, Effective October 27, 2019
June 18, 2019 | Blog | By Charles Samuels
In a press release this afternoon, Acting Chairman Ann Marie Buerkle announced that she would be withdrawing her nomination to be the permanent Chairman of the CPSC, as well as her nomination for an additional 7 year term, which would have expired in October 2025
Read more
Cannabis-Derived Ingredients in FDA-Regulated Products: More Questions than Answers at FDA’s May 2019 Public Hearing
June 3, 2019 | Blog | By Joanne Hawana
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Stakeholders who attended the hearing presented many diverse viewpoints and the FDA panelists – who were in listening mode – received extensive information from across that spectrum of perspective.
Read more
FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers
May 23, 2019 | Blog | By Benjamin Zegarelli
On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.
In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.
Read more
In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Artificial Intelligence
- Awards
- Bankruptcy & Restructuring
- California Land Use
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Direct Investing (M&A)
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Growth Equity
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Pharmacy Benefits and PBM Contracting
- Portfolio Companies
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Products Liability & Complex Tort
- Projects & Infrastructure
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Special Purpose Acquisition Company (SPACs)
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Technology, Communications & Media Litigation
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Value-Based Care
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology