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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.
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.
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
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
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
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
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
Regulatory Agencies Launch Unified Website for Biotechnology Regulation
January 16, 2020 | Blog
Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA
December 19, 2019 | Blog | By Joanne Hawana
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
Do You Want Fries With That?
October 11, 2019 | Blog | By Daniel Herling
Highlights of the FTC’s Workshop on Made in the USA Claims
October 3, 2019 | Blog | By Daniel Herling, Margaret Jewett
FTC Identifies Concerns With Plaintiff’s Lawyers Advertisements Concerning Risks Associated With Pharmaceutical Drugs
September 27, 2019 | Blog | By Daniel Herling
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
Acting Chairman Ann Marie Buerkle Withdraws Nomination, Announces Intent to Resign From CPSC, Effective October 27, 2019
June 18, 2019 | Blog | By Charles Samuels
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
FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers
May 23, 2019 | Blog | By Benjamin Zegarelli
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.