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OTC/Nutritional News From "The Tan Sheet": J&J Personnel Changes, Vitacost Brand Overhaul, PPI Fracture Study

 

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Deja Vu All Over Again: McNeil Recalls Motrin Product

McNeil Consumer Healthcare’s voluntary recall of 12 million bottles of its Motrin product marks the third consecutive year the Johnson & Johnson business ended the year recalling an OTC drug product.

In a Dec. 21 statement on the Motrin website, McNeil said it is recalling from retailers 59 lots of Motrin IB coated caplets and tablets in 24-count containers and coated caplets in 24+6-count packages -- each product contains 200 mg ibuprofen. The firm said testing of samples showed some caplets may not dissolve as quickly as intended when the products near their expiration date. The lots are being recalled "since there is a chance they could experience a similar problem as they approach expiration,” the J&J business said.

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This Week In OTCs And Nutritionals: 'Tis The Earnings Season

Big names across the realm of OTC drugs and nutritionals are reporting quarterly sales and earnings this week, including GlaxoSmithKline, Mead Johnson, Merck, Perrigo, Procter & Gamble, USANA Health Sciences and Vitamin Shoppe. Check out "The Tan Sheet" Oct. 31 for coverage of these companies and more.

In the meantime, our Oct. 24 issue reviewed Johnson & Johnson's third quarter results, reported Oct. 18. See the full story below.

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This Week In OTCs And Nutritionals: Switch, GMPs, Abbott

The Oct. 24 issue of “The Tan Sheet” reports on researchers’ recommendations for sponsors of OTC switch applications based on questions FDA has asked in previous switches, as well as additional news in the OTC sector from firms including Johnson & Johnson and Help Remedies.

We also note that for the first time, FDA submitted GMP warning letters with language explaining the agency considers own-label dietary supplement marketers responsible for their contract manufacturers’ violations. Plus, we look at how Abbott Laboratories’ nutrition business gains importance with the firm’s plan to spin off its research-based branded pharmaceuticals business.

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This Week In OTCs And Nutritionals: The Supplement Industry Challenges Research And CHPA Workshop Features Quality Control, Switch Discussions

The supplement industry takes one on the chin, but keeps fighting after several studies spotlight the risks of supplements and suggest additional regulation may be needed. Supplement firm Herbalife also asks FDA to meet the industry half-way in the debate about what the new dietary ingredient notification process covers.

On the OTC side, FDA and drug industry leaders brainstorm best practices to improve quality control and ways to facilitate switch at the Consumer Healthcare Products Association’s Product Quality & Operations Workshop.

This news preview is brought to you by "The Tan Sheet," your source for the most in-depth news and analysis from the world of OTC drugs and nutritionals. For information on a 30-day free trial subscription, click here.

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"The Tan Sheet" News Roundup: P&G Pares Exec Ranks, Afexa Bidding War, Saw Palmetto Study

 

This news roundup is brought to you by "The Tan Sheet," your source for the most in-depth news and analysis from the world of OTC drugs and nutritionals. For information on a 30-day free trial subscription, click here.

Also, check out "The Tan Sheet" on Twitter and Facebook.

OTC News Roundup: J&J Unloads Monistat Line

In today's roundup:

Insight picks up Monistat from J&J/McNeil ... Think tank is latest to tout OTC Lipitor ... Virginia plant sold, will continue making Pfizer OTCs

This Week In OTCs And Nutritionals: Tough-Pill-To-Swallow Edition

As the dietary supplement industry continues digesting FDA’s expectations that significantly more new dietary ingredients notifications are necessary, the agency also dishes out some news on serious adverse event reports that the industry could find hard to swallow, this week’s issue of “The Tan Sheet” reports.

FDA’s Division of Dietary Supplement Programs suggests that supplement firms should be submitting to the agency more of the reports on adverse events the firms are receiving from consumers and other parties. Meanwhile, industry champion Sen. Orrin Hatch makes clear he agrees with stakeholders that FDA’s draft guidance on NDI notifications oversteps regulations established by DSHEA.

In this issue, we also report on an attorney’s caution about functional food advertising claims due partly to increased enforcement in the area.

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This Week In OTCs And Nutritionals: Class In Session Edition

 
“The Tan Sheet” this week reports on a GlaxoSmithKline-backed study that shows educating consumers about the safety and efficacy of nicotine-replacement therapies could lower their concerns about the products’ prices.

We also report that Pfizer would need to learn a lot about consumers’ safe self selection if the firm wants to switch its high cholesterol treatment Lipitor to OTC, and dietary supplement industry trade groups want to learn more about how FDA will calculate the user fees authorized by the Food Safety Modernization Act.

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Education About NRT Safety Overcomes Smokers’ Cost Barrier – Study
Drug firms could educate consumers about the safety and efficacy of nicotine-replacement therapies to show the products’ value, according to recent research.

Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles
Pfizer would face major hurdles in research on consumers’ safe self-selection for FDA to approve an OTC switch of the firm’s cholesterol treatment Lipitor.

Supplement Industry Questions FDA's Calculations For Food Safety User Fees
Good manufacturing practice compliance becomes more critical for dietary supplement firms as FDA sets the first user fees to cover agency costs for follow-up inspections of facilities and imports and work on mandatory recalls.

This Week In OTCs And Supplements: Rumblings And Grumblings About NDI Guidance Continue

 

Industry concerns are adding up regarding the new dietary ingredient notification draft guidance released earlier this month. In the latest issue of "The Tan Sheet," industry stakeholders say the guidance sets the evidence bar too high and worry that combinations of old ingredients to create a new molecular entity could trigger NDI notification requirements. FDA stands by its earlier statement that several firms already met the burden of proof – showing it is possible.

This issue also looks closer at social media in OTC marketing and the growing momentum to once again allow consumers to pay for OTCs with pre-tax health savings accounts without obtaining a prescription.

[For more blow-by-blow coverage of the NDI guidance and other news impacting the dietary supplement and OTC industries subscribe to "The Tan Sheet." Click here for a free 30-day trial subscription.]