International

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.

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.

Conflicted experts should be allowed to participate as nonvoting members and panels should take a benefit-risk vote on product-specific applications, the majority of respondents said in a survey conducted by 3D Communications.

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.

Plastics – specifically the reduction of virgin plastic in packaging and the move to recyclable or refillable packaging – is one of nine priority topics Kenvue is focused on as part of its global sustainability strategy, according to the company’s global head of packaging innovation, sustainability and experience, David Lickstein.

Height of plaintiff attorney’s argument to present evidence which would prompt speculation by a jury was request to parse research by Kenvue’s lead expert, who coordinated the International Consensus Statement on ADHD by the World Federation of ADHD, where he’s president.

A round-up of the latest global health and wellness moves: Nestlé and Dr Reddy's name JV head; Be-sup hires comms and regulatory director; Ascendis Health appoints interim CFO.

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.”

In this installment of HBW Insight’s “Inside Regulatory Affairs” series, we hear from Sharee Crumbey and Monica Sharda, regulatory affairs specialists at The Honest Company, about the mounting challenges and rewards of the job.

As it considers what route to take to independence, Sanofi's Consumer Healthcare business – recently rebranded as Opella – has been changing its approach to marketing, according to chief growth officer Alberto Hernandez. In this exclusive interview, Hernandez explains how “Crazy Elevating Creativity” is delivering real results for Sanofi's top OTC brands. 

David Ball moves from Bayer’s North America business to be Perrigo’s first chief brand and digital officer. He joins CEO who also moved to Perrigo from Bayer with decades of branded product experience.

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 CHPA’s Mike Bailey, senior vice president of regulatory and scientific affairs; and regulatory and scientific affairs VPs Marcia Howard and Jay Sirois.

California Senate Appropriations Committee suspends consideration of bill for current session after it and Judiciary Committee voted to recommend passing the bill earlier in session. Legislative sessions continue in Massachusetts and New Jersey with bills for similar restrictions.

WishGarden Herbs marks 45 years with line extensions; Obesity doctor develops SoWell supplements for GLP-1 patients; Vital Proteins makes sustainability vital in packaging; and interior decoration and rent awards in vitaminwater campaign.

Amulet announces $5.8 million in series A financing led by HealthX Ventures along with Incite Ventures, AllerFund, Mendota Venture Capital and Great Oaks Venture Capital. Allergy Amulet is for on-the-go testing of food to determine whether allergens are present.

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

Herbalife adds distributors and training as sales slow; Amphastar bullish on Primatene Mist $100M full-year target; and ChromaDex net sales up 12%.

With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.