Manufacturing

Supplement Firms Could Lighten FDA Inspection Load, Need Lighter Drug Preclusion Touch – CRN

 

CRN suggestion that FDA prioritize facility inspections on firms which haven’t been cleared in third-party audits apparently has support at agency. But FDA hasn’t been receptive to adjusting its policy on precluding from use as dietary ingredients any substance studied or approved as a drug.

Stada Bolsters OTC Production With Romanian Site

 
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Stada will ship a wide range of consumer healthcare products from its new Romanian production facility, into which the German firm has invested over €70m.

US Nutrition Market Business News: Boka Well, Beachbody/HSAs, Dr Pepper/Ghost, More

 

Beachbody offers supplement sales using health savings accounts; PlantX, Boka launches oral health supplements; supplements take Form from RTE meal provider Factor; LIV3 JV behind marketing SugarShield; Ghost among Keurig Dr Pepper brands; and Nutra-Med Packaging expands with Legacy Pharma.

CRN Urges Tighter NDI Enforcement, Offers Its OWL As Model For FDA’s Potential Mandatory List

 

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”


Age-Restricting Sales Of Supplements, OTCs Remains Action Item For New Jersey Lawmakers

 

New Jersey Assembly passed bill amended to expand extensively in defining which products, or ingredients, would be subject to a ban on sales to consumers younger than 18.

CRN Appeals To US Supplement Industry For ‘Promoting A More Responsible Industry’

 

In first of two articles from recent interview, president and CEO Steve Mister discusses examples the trade group provides for self-regulation, “where people or companies who might not do it on their own because it would put them at a disadvantage if they were the only ones.”

US Nutrition Market People News: CRN/Radicle Award, Nourish, VSI, LabConnect, Akita, More

 

CRN/Radicle Trailblazing Woman Award to ChromaDex’s Yasmeen Nkrumah-Elie; Nourish’s TV ad campaign features US soccer star Alex Morgan; Vitamin Shoppe BodyTech Elite Altered Strength line sponsors Team Red, White & Blues; contract pharma/consumer health product development firm LabConnect appoints Wesley Wheeler CEO; Avanos’ Game Ready is “Recovery Partner” of NFL’s Nick Bosa; Akita adds Robert Hanson to advisory board; and BODi has wrestler as brand ambassador

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 

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.”


US Formula Market Astir With Changes As Congress Stirs Tighter Product Quality Regulations

 

Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.

US Consumer Health Market People News: WishGarden, ChromaDex, Vivazen, More

 

Liquid herbal blends firm WishGarden Herbs expands its leadership with three hires; ChromaDex appoints Ozan Pamir CFO; Vivazen adds CMO; Post Malone promotes poppi; and marketing consultant Gould gets ‘Most Influential’ nod.

Asking For More: Supplement MPL Authority For FDA, Agency Results For Congress, Industry

 

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.

Fresh From The CHPA Regulatory Conference Stage

 

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.


In Largest FDA Reorg, More Help Available For Supplement Programs’ ‘Little Tiny Workforce’

 

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.

Keeping Score In Drug Development And Innovation Game? Look To US FDA As The Referee – 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.

‘New Kenvue In Action Unleashed’ Isn’t The Business Consumers Remember From J&J

 

“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.

US Consumer Health Market News: Perrigo And NextFoods Execs, Gatorade Roster, Pharmachem

 

Atkinson moves from Haleon to Perrigo; NextFoods appoints CFO And CMO; Gatorade adds flag football QB to roster, makes fashion ‘Drop’; and Pharmachem adds ‘Innovations’ as independent company name.


Canada’s Magic Bag Compress Pops Up In US

 

Masdel expects its Original Magic Bag hot or cold compress to catch on as a popular as well as effective product from north of the border.

Perrigo’s Tab Owed To Shareholders Nine Years After Spurning Mylan’s Hostile Takeover? $97M

 

An end to litigation filed by institutional investors, insurance companies and pension funds comes four CEOs after Perrigo's chief exec during Mylan's tender in 2015, Joseph Papa, resigned to lead another firm in 2016. Plaintiff attorneys are asking for up to 20% of settlement in fees.

Cold Sore Supplement From Germany Reaches US

 

Linpharma Bioactives is US marketer of Lyranda brand chewable lozenge made by German firm Weber & Weber International. Online claims include “acts as an antiviral, stopping viral reproduction.”

‘Inside Regulatory Affairs’ With AHPA's Robert Marriott

 
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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.