OTC Drugs

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.

PATIENT ACCESS TO UNAPPROVED MEDICAL PRODUCTS WOULD BE ALLOWED under legislation introduced by Rep. Peter DeFazio (D-Ore.) on July 12 and Sen. Tom Daschle (D-S.D.) on July 14. Called the Access to Medical Treatment Act, the legislation would allow health practitioners to administer unapproved drugs, devices, foods or dietary supplements to patients as long as there is no evidence the treatment causes harm and the patient is informed about the treatment and its possible side effects. DeFazio's bill is identified as HR 2019; Daschle's version will be assigned a bill number the week of July 17.

Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process. 

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.

Perrigo aims its new SolpaOne high-strength paracetamol effervescent at UK pharmacists, who now have expanded powers as part of the UK government's Pharmacy First initiative. 

OTC erectile dysfunction treatment Eroxon has made it to the Nordics through local distributor Navamedic, which has reported strong consumer uptake.

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.”

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.

The FTC says its final rule banning fake consumer reviews and testimonials will help to restore its depleted toolbox for obtaining civil penalties. The agency maintains the final rule’s benefits will greatly outweigh costs for honest companies increasingly set back by bad actors in the space.

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.

HBW Insight presents a new series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries. In this first installment, we speak to AESGP's Christelle Anquez-Traxler and Oliver Hartmann, senior regulatory science & strategy lead, and regulatory & legal affairs director respectively.