Compliance

Single-use packaging producers obligated under Oregon’s Extended Producer Responsibility law who still haven’t registered with program facilitators will struggle at this point to meet the fast-approaching material-reporting deadline, but should nonetheless jump into the process, says EPR consultant Michael Washburn.

Many small US and independent beauty brands are still unfamiliar with the Modernization of Cosmetics Regulation Act, as are owners of beauty brands based outside the US; the lack of education about the regulation is making many stakeholders at risk for non-compliance.

FDA publishes an updated registration guidance in the Federal Register 12 December to answer outstanding questions by stakeholders, including whether a single FEI number can be used for multiple related facilities.

The Washington State Department of Ecology will take interim policy action by 1 January, 2025 that will provide manufacturers alternative paths to compliance with the 1ppm lead limit under the state’s Toxic Free Cosmetics Act, the agency announces. It also anticipates opening a rulemaking related to lead impurities in cosmetics in 2025.

Personal care packaging producers should be prepared for Washington state’s 1 January deadline for ensuring personal care product containers are made up of at least 15% post-consumer recycled material, notes Angela Diesch, attorney at Amin Wasserman Gurnani, LLP, during a webinar hosted by Global Victoria, the trade facilitation agency for the state of Victoria in Australia.

The US FDA has generally not sent out enforcement letters to stakeholders of the Modernization of Cosmetics Regulation Act, but that doesn’t mean it’s not happening, says Amin Wasserman Gurnani, LLP attorney Angela Diesch, during a 19 November webinar hosted by Global Victoria, the trade facilitation agency for the state of Victoria in Australia.

California authorities say predominance of retailers licensed to sell hemp are compliant with ban published effective on 3 October through emergency regulation. But hemp industry’s contesting the regulation in state court, arguing state authorities inappropriately used emergency action to change state law on hemp products legislature passed in 2021.

The Federal Trade Commission’s Consumer Protection head Sam Levine says bipartisan leaders at the state and federal levels are taking on consumer protection issues like never before and using the FTC’s approach as a model for legislation.

Reorganization creating in Human Foods Program makes the work of additional staff available for dietary supplement office programs. FDA’s “got a little tiny workforce” for “a huge industry,” says Commissioner Robert Califf.

HiSmile, which is appealing a National Advertising Division case decision arguing that online advertising’s global footprint demands evaluation of ad claims by international standards, has been referred to the FTC for declining to participate or comply in recent NAD cases brought forward by Oral Essentials and Procter & Gamble.

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

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.

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 US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

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.

Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers. 

EAS Consulting Group’s John Bailey continues to chronicle regulatory developments under the Modernization of Cosmetic Regulations Act. In this installment, he outlines industry stakeholders’ questions and concerns related to 2023 announcements from the US FDA and provisions of the law that became effective (if not yet enforced) at year-end.

FTC Division of Marketing Practices assistant director concerned direct selling self-regulation group’s guidance “will encourage deceptive conduct and facilitate deceptive earnings claims.” DSA president says the concerns might reflect the thinking of agency’s staff more than the intent of the agency’s regulations.

Some advertisers try to avoid scrutiny of regulators and the National Advertising Division when making health-related claims by making a claim “softer.” Annie Ugurlayan, NAD’s assistant director, offers advice on assuring substantiation and a health claim match.

Valisure recommends FDA request recall and halt sales of products containing benzoyl peroxide due to its propensity to form the benzene. Products include numerous OTC monograph topical formulations as well Rx drugs with an acne indication available through approved applications.