OverTheCounterToday

This Week In OTCs And Nutritionals: Table Of Contents

 
The July 25 edition of "The Tan Sheet" continues coverage of the OTC industry's biggest story of the past two years -- Johnson & Johnson's OTC manufacturing issues and recalls. Our cover story looks into the report produced by a special committee of J&J directors, in response to a shareholder lawsuit, that identifies root causes behind the company's quality control lapses. On the inside of this week's issue, we take a look at J&J's second-quarter results and the encouraging signs for its consumer business.

"The Tan Sheet" also has follow-up coverage of FDA's new dietary ingredient notification draft guidance -- what it might mean for probiotics supplements and how FDA might go about enforcing the guidance.

Of course, there's plenty more as well, including news from Procter & Gamble, Abbott Nutrition and the U.N.'s Codex Alimentarius Commission.

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TOP STORIES 

J&J Directors Find Root Causes But Little Blame For OTC Quality Issues
A report by a Johnson & Johnson special committee finds organizational and middle management changes at the firm were the root causes of manufacturing and quality control lapses in the OTC drug business.

International Panel’s Nutrient Value Guideline May Boost Supplement Exports
Dietary supplement firms soon could export products internationally without having to reformulate to accommodate local nutrient value regulations.  

NDI Notification Enforcement Ramp-Up Likely To Target “Low-Hanging Fruit”
Legitimate supplement firms should not need phased-in enforcement of the new dietary ingredient notification regulations, says Anthony Young, general counsel to the American Herbal Products Association.  

J&J Reclaims Consumer Unit Growth In Second Quarter

After more than a year of product shortages stemming from extensive OTC recalls, Johnson & Johnson's consumer business reported positive growth in the second quarter, with global sales up 4% to $3.79 billion.

True, that growth was attributable to international sales (U.S. consumer fell 8.5%) and without the benefit of currency exchange rates, consumer actually dipped 1.8% compared to the year-ago quarter. Still, the reported numbers represent the first quarter of consumer growth since first quarter 2010, just before J&J recalled 45 SKUs of Tylenol, Benadryl and other pediatric OTC liquids.

In today's "Health News Daily," we look a little closer at J&J's second-quarter earnings report, where the pharma firm stands in returning the recalled OTCs to market and how financial analysts view the consumer unit's gradual recovery.

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.]

OTC/Nutritional News Roundup: License Plate Bingo Edition

 

Join "The Tan Sheet" in a game of license plate bingo and see how many states you can find that are sources of OTC and nutritional industry news. This week, Mississsippi officials praise the state's law requiring a prescription for OTC purchases of pseudoephedrine and Maryland considers taxing OTCs.

["The Tan Sheet" is your source for nonprescription pharmaceutical and nutritional industry news from the 50 states and around the world. Click here for a free trial.]

 

This Week In OTCs And Supplements: FDA, Industry Rumble Over NDI Guidance

FDA unloaded its draft guidance on new dietary ingredient notifications over the Indpendence Day break, setting off a war of words with the supplement industry.

"The Tan Sheet" this week offers perspectives on both sides of the issue -- why FDA's top supplement official believes the guidance is reasonable for firms and essential to public health, and why industry stakeholders see potential for an onerous pre-market clearance process.

Elsewhere in the supplement arena, our July 11 issue looks at the agency's inspection priorities and facility targets under its good manufacturing practices program.

Also, we've got analysis of Pfizer's plans to exit the nutritionals business and an exclusive interview with the CEO of Hyland's, who reflects on what Johnson & Johnson's OTC recalls have meant for homeopathic remedies.

[For the best rock 'em, sock 'em coverage of dietary supplements and OTC pharmaceuticals, check out "The Tan Sheet." A free 30-day trial subscription can be yours by clicking here.]
 

TOP STORIES

NDI Guidance Protects Public Health And Allows Innovation – FDA's Fabricant
Present and former top FDA officials with oversight of dietary supplements defend the draft guidance on new dietary ingredient notifications, saying the document serves important public health priorities and will not be onerous to industry.

Pfizer Will Unload Nutrition Division, Keep Consumer Product Unit
Pfizer will divest or spin off its nutrition unit but the firm will keep its consumer product business and look into future OTC switches.

Finished Product Manufacturers Top FDA’s GMP Inspection Targets
Finished product manufacturers are FDA's "first priority" for dietary supplement good manufacturing practice inspections, with contract manufacturers a close second, according to an agency official.

This Week In OTCs and Nutritionals: Senatorial Edition

 
It is fitting that "The Tan Sheet"'s Fourth of July issue has such a focus on the goings-on in the nation's capital, particularly of the Senate.

Supplement industry champion Sen. Orrin Hatches faces a possible primary fight with Rep. Jason Chaffetz, an industry veteran, to keep hold of his D.C. office. Sen. Dick Durbin, however, introduces a bill that could be devastating to the supplement industry by requiring broad labeling changes. And Sen. Tom Harkin, speaking to an industry convention in Las Vegas, warned industry should be concerned about an NDI notifications guidance that does not respect the intent of the Dietary Supplement Health and Education Act. (FDA published a draft guidance on NDI notifications after our issue went to press. We noted the guidance here on our Over The Counter Today blog.)

["The Tan Sheet" is your source for essential nonprescription pharmaceutical and nutritionals industry news, in the Senate and beyond. Vote aye for your free trial here.]

 

FDA Unleashes New Dietary Ingredient Notification Guidance

Right on schedule, FDA's long-awaited guidance for new dietary ingredient notifications and related issues emerged over the holiday weekend and is posted here.

The bulk of the guidance addresses practicalities of submitting an NDI notification to FDA -- how and when to submit, which data to include and what to expect from the agency's response. FDA also addresses a number of lingering questions, including whether synthetics, nanoscale materials and previously authorized investigational new drugs can be considered NDIs (typical answer: "It depends").

"The Tan Sheet" will have plenty to say about the guidance in the coming days and weeks. In the meantime, check out our recent related coverage here and here.

 

[Want a free 30-day trial subscription to "The Tan Sheet," your source for the best news and analysis from the world of dietary supplements and OTC drugs? Click here.]

 

- Dan Schiff (d.schiff@elsevier.com)