Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products globally, transmits information to internal stakeholders and formats serious events to the FDA Medwatch format for submission.

The Personal Care Products Council is actively working with the FDA’s cosmetics office director Linda Katz and principal deputy commissioner Namandje Bumpus to ensure the agency has the tools it needs to continue rolling out MoCRA, says Tom Myers, the association's president and CEO. Also, the 2024 US presidential election and the problem of misinformation.

In addition to sustainability, Myers noted DEI and advancing alternatives to animal testing among key priorities for the group. “We have member companies that really lead the way on many of those. We want to be able to amplify their good work and their messaging, because they are good corporate citizens” and “it’s what consumers are demanding anyway,” he said in an interview.

Attorneys discuss potential impacts on consumer health products industry from Supreme Court’s “Loper Bright” decision in June on litigation brought by two fisheries, Loper Bright v. Raimondo and Relentless v. Department of Commerce.

Numerous cosmetic ingredients that preserve cosmetics by releasing formaldehyde could be prohibited in products sold in Washington state in coming years, but stakeholders have a chance to weigh in now and shape the rulemaking. Shari Franjevic, implementation head for the Toxic-Free Cosmetics Act within the state's Department of Ecology, discusses.

Oral Essentials filed a Fast-Track SWIFT review case with the National Advertising Division against competitor GuruNanda LLC, whose endorsers claimed its pulling oil could reverse cavities. The marketer agreed to ensure that claims in question were discontinued.

Legislator education is key to checking state bills that overreach, says Ross, executive VP of government affairs at the Personal Care Products Council, discussing the rising tide of US state bills aimed at restricting ingredient use.

FDA reminds companies which registered with agency solely to manufacture OTC sanitizers during COVID-19 public health emergency they will be subject to FY2025 OTC monograph user fees if they don’t delist and deregister as monograph drug manufacturers by 12 a.m. on 31 December.

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials. 

Committee’s report published with FY2025 appropriation states a different approach to establishing FDA regulation of non-drug products containing hemp as a derivative of cannabis de-scheduled as controlled substance in the US since 2018.

The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle. 

Finished product following Reagan-Udall food safety programs review establishes Human Foods Program in commissioner’s office while also realigning centers, offices and divisions across agency to improve collaboration with regulatory affairs, which conducts facility inspections and other field operations.

The National Advertising Division provides guidance to “minimalist” beauty and personal-care marketers with its review of “simple” claims on Native deodorant, body wash and other personal-care products.

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

The European Commission fines International Flavors & Fragrances Inc. and its French division €15.9m after a senior employee deleted WhatsApp messages with a competitor during an inspection, part of an ongoing antitrust investigation into four major flavors and fragrance manufacturers.

Proposition 65 titanium dioxide lawsuits have been halted by a ruling in California in a First Amendment case, which could bode favorably for other scientific challenges to mandated warning labels.

Elixir Cosmetics has reached a $2.3m settlement with US consumers in California state court over alleged violations related to isopropyl cloprostenate use in Babe Lash and Babe Brow offerings. On 5 May, plaintiffs making similar allegations filed suit against the company in New York federal court.

Beauty and personal-care companies should draft an artificial intelligence use policy as soon as possible, regardless of their AI plans, given its ubiquity and the potential for employees to use it on their own, says Melanie Howard, partner at Loeb & Loeb LLP.