OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.

The agency’s committees for Risk Assessment and Socio-Economic Analysis will check comments and take relevant evidence-based information into consideration as they develop their opinions. Final opinions will be delivered to the European Commission “in the shortest possible timeframe,” ECHA says.

The US Federal Trade Commission is "fully prepared" to bring forward cases after issuing hundreds of penalty offense notices in April regarding health claims substantiation, and it is likely to seek injunctive and monetary relief, said Samuel Levine, director of the FTC’s Bureau of Consumer Protection, at the National Advertising Division’s annual conference in Philadelphia.

The US FTC’s Sam Levine, director of the Bureau of Consumer Protection, discusses the advent of AI and the compounding risks consumers face in today’s evolving, largely unregulated, profoundly uncertain digital age.

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”

The BBB National Program Inc. expects to double the number of National Advertising Division SWIFT reviews completed in 2023 compared with last year as stakeholders grow more comfortable with the process. At its annual conference in Philadelphia 19-20 September, NAD said it is speeding up the time it takes to complete both SWIFT and standard track reviews.

Canadian firm launches US sales of Lumify Eye Illuminations 3-in-1 Micellar Cleansing Water and Eye Makeup Remover, Nourishing Lash & Brow Serum and Hydra-Gel Brightening Eye Cream. Each product contains hyaluronic acid, a fluid in eyes and joints which acts as a cushion and lubricant.

FDA announces plans to make submission portal available in October for meeting registration deadlines for facilities and product listings under Modernization of Cosmetics Regulation Act. Guidance also provides more specifics on data that should be submitted to agency.

Amid period of 3-0 decisions by commission, President Biden nominates two state solicitor generals for vacant FTC seats, both reserved for GOP appointments. Virginia’s Andrew Ferguson previously clerked for Justice Thomas and was Senate GOP leader McConnell’s chief counsel; Utah’s Melissa Holyoak led a conservative advocacy group focused on fighting class action lawsuits and aggressive regulation.

Appropriations Agriculture, Rural Development, FDA and Related Agencies Subcommittee marked up its FY2024 bill on 18 May, proposing $6.579bn for FDA. Total is up from current budget of $6.562bn, but Biden administration proposed $7.2bn for FY2024.

The specter of reformulations, market disruptions and potential litigation hangs over Washington state as HB 1047 sits on Governor Jay Inslee’s desk. The Toxic-Free Cosmetics Act, seen by industry stakeholders as a metastasized version of California’s legislation of the same name, would ban the sale of cosmetics containing formaldehyde releasers or trace lead above 1 ppm, in addition to PFAS, ortho-phthalates and other ingredients.

An end to US COVID-19 PHE on 10 April doesn’t end inflationary pressure on prices for consumer packaged goods. OTC, supplements and personal care product firms could be reporting consumers during Q1 were going along with price increases, opting for less expensive options or buying less.

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”

Director-general John Chave discusses regulatory heavy-handedness in the EU, implications for animal testing, declining European investment, and Cosmetics Europe’s message to policymakers going into the 2024 EU elections and beyond.

The mega-retailer is defending a proposed class action in Minnesota federal court over its ‘Target Clean’ marketing and label, which it has awarded "independently" to around 4,000 products in its stores. Consumer plaintiffs allege some offerings contain ingredients on the program's “formulated without” list, as well as other hazardous substances that ought not be in clean products. Pending litigation against Sephora stands to be influential.

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance

“AMG decision had a dramatic effect on the ability of the FTC to get money in federal court. That said, there are still a lot of ways for the FTC to get money when they bring law enforcement actions,” advertising regulation attorney Daniel Kaufman.

Cosmetic product manufacturers can expect the plaintiffs’ bar to leverage new record-keeping, GMP and other provisions of the Modernization of Cosmetic Regulations Act to bring or advance litigation, Crowell & Moring attorneys say. They note some defensive tactics that could prove effective.