OverTheCounterToday

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: Storm Edition

 
As the East Coast prepared for Hurricane Irene, "The Tan Sheet" found a storm of news brewing in the OTC drug and nutritional supplement industries. Public Citizen wants FDA warn consumers of about the increased risk of “potentially fatal” fractures, infection and magnesium deficiency while taking OTC proton pump inhibitors. The Consumer Healthcare Products Association and Personal Care Products Council warn of a storm of disappointed consumers facing a shortage of sunscreen products in summer 2012 if manufacturers do not have more time to comply with FDA's final rule. And FDA battens down the hatches and defends its assessment of the time required to file a new dietary ingredient notification

Public Citizen Urges FDA To Add Sweeping Warnings To PPI Labels
Public Citizen petitions FDA to add several warnings to all proton pump inhibitors, including OTCs – which the agency previously determined do not pose the same level of risk as prescription versions.

FDA Defends Estimate For NDI Notification Preparation
Supplement firms already should have compiled the information for a new dietary ingredient notification when they substantiated the safety of the ingredient, FDA says.

Industry Needs More Time To Comply With Sunscreen Testing, Labeling Rule
A “shortage of sunscreen products” could occur in summer 2012 unless FDA allows manufacturers six additional months to comply with the testing and labeling requirements imposed in a recent final rule, trade groups say.

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OTC/Nutritional News Roundup: Earthquake Edition

 
Just as a 5.8 magnitude earthquake shook much of the East Coast the OTC drug and dietary supplement industries were moving and shaking too. Sanofi shakes up the Indian OTC market with the acquisition of Universal Medicare, Public Citizen pushes to shake FDA into warning on proton pump inhibitors and the Consumer Healthcare Products Association rumbles a caution about a possible sunscreen shortage.

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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: The Dog Days Of Summer

 

Industry resistance to FDA’s draft dietary ingredient guidance continues to simmer as summer's sweltering days drag on, and the agency says it will wait out the heat before responding to the mounting complaints until after the comment period ends Oct. 3, according to a story in the latest issue of “The Tan Sheet.”

“The Tan Sheet” also looks at how some firms are trying to beat the heat. Desert Labs, for example, is launching a cold product – Ice Cube Diet – and cooling its claims to avoid increasing enforcement in the hoodia supplement market. Companies in the prebiotics market, on the other hand, could flourish in the heat in part because prebiotics do not require refrigeration, unlike most probiotics, which makes them well suited for diverse medical foods.

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FDA Regulation Of Homeopathics Does Not Pre-empt Damages Claims – Court
A federal judge rejected an argument that FDA’s regulation of homeopathic drugs pre-empts a state consumer protection law.

FDA NDI Notification Draft Guidance Contradicts Final Rule – Ullman
FDA contradicts its final rule on new dietary ingredient notifications with its draft guidance requiring notifications for all supplements containing an NDI, food and drug attorney Marc Ullman contends.  

NuMe Among Firms With Gut Feeling About Burgeoning Prebiotics Space
Prebiotics could grow from a currently “nonexistent” market to surpass the flourishing probiotics category in both revenues and supporting science, the chief executive of a prebiotics developer says.

OTCS

• OraSure Plans To File Over-The-Counter HIV Test Application By Year End

DIETARY SUPPLEMENTS

• Desert Labs Seeks To Overcome Hoodia Market’s Reputation
• NDI Notification Draft Guidance Seminar In Brief

IN BRIEF

• GSK touts smoking-cessation brands' allure
• Prestige pulls Compound W from kids' TV
• Phytosterols claim rule comments accepted
• Petition seeks FSMA warehouse exemption
• FDA gives OKs for Superba GRAS, NDI
• Sunsweet brings Function Drinks aboard Sales & Earnings In Brief

SALES & EARNINGS IN BRIEF

• NBTY moves to "everyday low" pricing
• Vitacost absorbs loss as it preps expansion
• Economic woes weign on Reliv
• ProPhase inches toward profitability
• Acquisitions boost Atrium sales

REGULATORY

• Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations

RESEARCH & DEVELOPMENT IN BRIEF

• Phytosterols boost Rx cholesterol treatment
• Combination of analgesics works best
• Prenatal folic acid does not cause asthma
• Vitamin D could decrease mortality

PEOPLE

• People In Brief

-- Elizabeth Crawford (e.crawford@elsevier.com)
 

 

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.

OTC/Nutritional News Roundup

 
In this week's roundup...

Supplement firms contemplate FSMA user fees ... Oklahoma battle brews over local PSE laws ... Circulation journal looks at CVD benefits of functional foods

This Week In OTCs And Nutritionals: Table Of Contents

 

Johnson & Johnson and Tylenol are back in the headlines in this week's issue of "The Tan Sheet," but this time the news is not about recalls. Rather, the firm's McNeil Consumer Healthcare subsidiary makes waves by lowering the maximum daily dose of the Extra Strength painkiller to improve the product's safety profile.

FDA's new dietary ingredient draft guidance also continues to make headlines as industry claims it is a "radical departure" from the Dietary Supplement Health and Education Act of 1994 and that the agency underestimates the cost of compliance.

Merck KGaA's appointment of a new consumer business head and Colgate-Palmolive's launch of a toothpaste to compete with whitening products also catch our eye this week.

[Stay updated about the goings-on in the OTC pharma and nutritional industries featured in "The Tan Sheet" with a  free 30-day trial subscription by clicking here.]

McNeil Lowers Recommended Maximum Dose For Extra Strength Tylenol
McNeil Consumer Healthcare lowers the maximum daily dose indicated on labels of Extra Strength Tylenol, the first in a series of dosing changes for the firm’s acetaminophen-containing products

Merck KGaA Appoints Novartis, J&J Veteran As Consumer Division Head
Merck KGaA appoints a pharma industry veteran without OTC sector experience, Udit Batra, to head its Consumer Health Care unit

FDA Final Rule For OTC Inhaler Labeling Requires Death Warning
FDA disagrees with industry comments regarding the health risks of using OTC asthma inhalers, rejecting suggested language for the final monograph covering asthma and bronchodilator drugs