Manufacturing
Jessica Spence joins as North American president while CFO Dan Sullivan becomes COO and Francesca Weissman, finance and business strategy SVP, adds CFO to her title in latest executive office changes by the marketer of brands including Schick men's and women’s shaving, Playtex, Stayfree, Carefree and o.b. feminine care and Banana Boat and Hawaiian Tropic sun care.
Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”
Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.
Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.
In addition to commentary and information about the OTC drug, dietary supplement and cosmetic industries, speakers offered candid remarks on subjects well known across the consumer health industry or well recognized by consumers.
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.
“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.
In this episode of HBW Insight's Over The Counter podcast, we connect with Neil D’Souza, CEO of Makersite GmbH, a data software company based in Stuttgart, Germany that offers “next generation” product data management tools that help personal care and other industries manage product sustainability, cost and compliance.
Present as a contaminant in some personal care and cleaning products, 1,4-dioxane continues to be a concern for California’s Department of Toxic Substances Control under the state’s Safer Consumer Products regulation despite limits already imposed on 1,4-dioxane content in those product categories by New York.
“We're significantly investing more in reaching more consumers, but we're doing it in a very different way,” says CGO Charmaine England. Brands may be “iconic,” but on their own they’re not driving sales growth, says CEO Thibaut Mongon.
Laifen, Opalescence Moon, Lewie and quip are among US companies with recent launches to boost their oral care market shares. Recent launch by Arm & Hammer global oral care brand also targets driving growth in the category.
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to AHPA's director of regulatory affairs, Robert Marriott.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.
Viome Life Sciences launches VRx MyBiotics Toothpaste & Gel to complete its Oral Health Solution system; Liquid Core Gum’s Edge Performance made with its Liquid Core and Flavor Wave properties and distributed in packaging developed using sustainable cardboard tubes; and NOW Health Group launches Omega-3 Gummy Chews and E-Sport Reaction supplements.
Mentholatum says two line extensions made with 2% salicylic acid and its "Oxy for Every Kind of Ne" campaign reinforce the brand’s “commitment to tackling every type of acne—from face-ne and chin-ne to body-ne.”
“We continue to believe that taking care of your health or someone in your family is the last place to look to make a change or save a few pennies,” says CEO Ron Lombardi. Firm more frequently using air freight services so Clear Eyes products are on store shelves when consumers expect.
Brimonidine tartrate eye drops remain key sales driver among Canadian firm’s consumer health lines with 12% growth in the latest quarter. B+L expects pending launch of preservative-free line extension to sustain Lumify as a driver as generics of original formulation are approved.
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.
House and Senate reports again reference sunscreen but add admonishment that FDA “harmonize its approach with international testing standards.” Item exclusive to House report encourages guidance for drug firms on successfully submitting an application for Rx-to-OTC switch of an oral contraceptive.