OverTheCounterToday

FDA's Year In A Nutshell: More Salmonella-Related Recalls

 
  

FDA announces hazelnut recalls due to salmonella suspicion: 2009 may very well be remembered as the year FDA went nuts, as it dealt first with tainted peanut butter, then pistachios and finally hazelnuts.

Teva acquisition item correction: In a Dec. 28 OverTheCounterToday post since removed, we said Teva had acquired a majority stake in Japanese company Taisho Pharmaceutical Co. Ltd. Teva has in fact purchased a share in generics firm Taisho Pharm. Ind. Ltd. We regret the error.

Happy New Year!: "The Tan Sheet" and "The Rose Sheet" wish our readers a happy and healthy 2010!

FDA Targets Nestle Nutrient Claims; Mead Johnson Becomes Acqusition Target

FDA nutrient claims action against Nestle broadcasts medical foods warning: "The Tan Sheet" reports...

Mead Johnson shares valued at more than $7.3 bil. with split-off complete: Bristol-Myers Squibb says...

This Week In Cosmetics & Personal Care: Table Of Contents

Industry Looks For New Year Resolution Of Issues With Calif. Cosmetics Law
The Personal Care Products Council is optimistic that issues hindering industry's compliance with the California Safe Cosmetics Act (SB 484) will be resolved early next year.

Unilever Halts Palm Oil Purchases From Alleged Forest Destroyer
Unilever - the world's largest buyer of palm oil -has suspended its purchases from PT SMART due to allegations that the Indonesian supplier illegally destroyed areas of forest to harvest palm oil.

Gillette Downsizes Tiger Woods' Marketing Role
Procter & Gamble/Gillette says it will curtail its use of golf superstar Tiger Woods in promotions.

This Week In OTCs And Supplements: Table Of Contents

Our final issue of 2009 includes more analysis on developments in areas crucial to the growth or the regulation of the OTC drug and dietary supplement markets: GSK signs an exclusive OTC licensing deal for a novel cold sore drug ingredient, Ovos looks to launch its cognitive supplement in the U.S. contingent upon FDA's go-ahead, and FDA collaborates with other agencies on an import tracing analysis center.

NanoBio's OTC Route For Cold Sore Med Pays Off With GSK Deal
Privately held biotech company NanoBio's novel cold sore treatment is deviating from the Rx market path most new molecules follow by aiming straight for the OTC market with the help of GlaxoSmithKline.

Ovos Plots Vivimind Cognitive Supplement Launch, Awaits FDA Reply
Ovos Natural Health plans a 2010 U.S. launch of its Vivimind cognitive health supplement, contingent upon FDA's go-ahead.

FDA Could Beef Up Food Safety Enforcement Through Inter-Agency Center
FDA expects its work in the Customs and Border Protection's new import tracing analysis center to generate information the agency can assimilate into its own supply-chain tracing capabilities.

Sanofi To Buy Chattem, Plans Allegra OTC Switch

[For news and analysis of the consumer health product markets, to track the deals and understand the regulatory landscape, subscribe to "The Tan Sheet" here. We'll have more to come on this deal and what it means for the OTC marketplace].

Sanofi-Aventis gave itself an early Christmas present with the announcement it plans to buy U.S. consumer health products company Chattem for $1.9 billion.

Closure of the deal will mark a major player debuting in the U.S. consumer health market, with Sanofi bringing significant financial muscle to build on Chattanooga, Tenn.-based Chattem's business. Sanofi's will be the fifth largest consumer health business in the world, the firm says. Chattem's revenue in 2008 was $454.9 million

Sanofi CEO Chris Viehbacher sees the Chattem buy as a platform for Rx-to OTC switches and simultaneously announced plans to switch the antihistamine Allegra (fexofenadine) via the new U.S. consumer business. Allegra would compete most directly with JNJ's Zyrtec and Merck's Claritin.

Sanofi also plans to leverage existing Chattem brands globally. Key Chattem brands include Gold Bond skin care, Selsun Blue dandruff shampoo, the Icy Hot pain relief line and ACT mouthwash.

Chattem leadership, including CEO Zan Guerry, will be retained to head Sanofi's consumer business, the firm says.

Sanofi plans to make the cash tender offer of $93.50 a share in January and close the deal in the first quarter.

Find Wall Street Journal's coverage here.

"The Rose Sheet" Interviews NPA Head John Gay

Read this complimentary story from "The Rose Sheet" on the Natural Products Association's evolving standard and certification program for personal care. Not a subscriber? Follow the provided link to claim your 20% new member discount to "The Rose Sheet" today (offer valid through Dec. 30): http://www.windhover.com/ezine/html/RSPC_LP.html?utm_source=blogoffer

NPA Seal On Nearly 300 Natural Products; New CEO Gay Is Ready For 2010

The Natural Products Association has certified nearly 300 personal-care products since the introduction of its standard in May 2008, and the organization expects more manufacturers to pursue its seal as the economy picks up in 2010.

The group's standard and certification program "has been received very well," NPA vice president of Scientific and Regulatory Affairs Daniel Fabricant told "The Rose Sheet" Dec. 9.

He noted that almost 100 of the 300 certifications to date have gone to ingredients.

"We're really excited about that because I think one thing we want to do is shake up the supply chain and make it easier to make a natural product," he said.

8 Crazy Nights (Of OTCs, Nutritionals And Personal Care)

Season's greetings! We can't get enough Hanukkah pop written and performed by Utah's senior senator. Here it is, but be careful -- it's catchy. Sen. Hatch is keeping busy on the supplement front, too, in this edition of Over the Counter Today.

Hatch, Chaffetz stand in opposition to USADA initiative: For the Olympic testing agency, the path to pre-market regulation of supplements will have to go through the industry's staunchest congressional supporters.

Rep. Gordon announces retirement: The Tennessee Democrat, who has had a hand in nanotech and meth legislation, will not run for re-election in 2010.

Alberto Culver grows skin-care portfolio in U.K. to match hair biz: The beauty and personal-care firm continues its European expansion with the acquisition of Simple Health & Beauty Ltd.

This Week In OTCs And Supplements: Table Of Contents

In the Dec. 14 issue of "The Tan Sheet," we size up the challenge for Matrixx Initiatives to rebuild its Zicam brand and the potential for some liquid nutritionals to be subject to conventional food regs rather than dietary supplement regs. We also report tobacco firm Reynolds American Inc. sizes up the smoking cessation market with its acquisition of nicotine replacement therapy maker Niconovum.

To Rebuild Zicam, Matrixx Can Tap Into Brand's History, Pharmacists' Regard
Matrixx Initiatives' best chances for rebuilding the Zicam brand appear to be reminding consumers why they initially chose the firm's products and tapping pharmacists' insight on the efficacy of zinc-containing cold remedies.

FDA Supplement Beverage Guidance May Open Can Of Regulatory Worms
An FDA draft guidance has the potential to make defining a beverage as a dietary supplement much tougher.

Tobacco Firm Reynolds Enters NRT Market With Niconovum Buy
Tobacco giant Reynolds American Inc.'s purchase of Swedish NRT firm Niconovum will put the company in the business of serving both smokers and quitters.

Roundup At The Acquisition Corral

Our roundup today takes an international spin with OTC industry acquisition news from South America and Europe, and turns a domestic loop with reports that OTC and personal care product firm Combe is on the market.

Selling to smokers coming and going: "The Tan Sheet" reports...

Brazil's Hypermarcas continues takeover samba: Reuters reports...

Combe-ing the market for buyers: According to the Wall Street Journal...

This Week In Cosmetics & Personal Care: Table Of Contents

 

Study Finding Musks In Newborns Warrants Updated Fragrance Labeling Law - CSC
The Campaign for Safe Cosmetics says a new study finding fragrance chemicals in infant umbilical cord blood supports closing a "loophole" in federal packaging law that allows marketers to omit fragrance ingredients from labels.

Dermatologists Expect FDA Sunscreen Rule "Soon," End Product Seal Program
The American Academy of Dermatology says its seal of approval for products offering sun protection is no longer necessary with FDA's final sunscreen rule imminent.

Mintel Examines East/West Divide For Beauty You Eat, Drink, Swallow
Beauty foods, drinks and supplements in Asia, particularly in Japan, frequently boast ingredients with specific skin benefits, while nutricosmetics in the West generally are marketed via a different, "softer" approach, according to Mintel International's Lynn Dornblaser.