OverTheCounterToday

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

 

This news roundup is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs And Nutritionals: Plan B Pediatric Analysis, Class Action Claims, Supplement Industry Year Ahead

This week, "The Tan Sheet" examines FDA's review of Teva Pharmaceutical Industries' Plan B One-Step levonorgestrel product, and its determination that the emergency contraceptive does not raise pediatric safety concerns. The agency's Pediatric Advisory Committee is meeting this week to discuss Plan B and other drugs.

Our Jan. 30 issue also features coverage of the Food and Drug Law Institute's Food Week, including a discussion of what makes functional food and supplement companies vulnerable to class action lawsuits.

"The Tan Sheet" additionally checks in with supplement industry leaders on what to expect in 2012, and looks back at 2011 via the full-year financial results from Johnson & Johnson, Novartis, Procter & Gamble, and more.

 

This blog is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

OTC/Nutritional News From "The Tan Sheet": Omega-3s And Depression, USP Floats Probiotics Standards, California Limits DXM Sales

This news roundup is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here. No credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

 

Exclusive OTC/Nutritional Coverage From "The Tan Sheet": PGT Healthcare

"The Tan Sheet" offers ongoing coverage of PGT Healthcare, the global consumer health joint venture between Procter & Gamble and Teva Pharmaceutical Industries. Above, Teva CEO Shlomo Yanai (left) and P&G Vice Chairman, Global Business Units Dimitri Panayotopoulos seal the deal Nov. 3.

Our contribution to "Health News Daily" on Nov. 15 took a closer look at what the firms hope to accomplish through PGT. Keep reading for a full version of that story, and check back with "The Tan Sheet" on Nov. 21 for an extended version.

 

Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here.

Also, follow "The Tan Sheet" on Twitter and Facebook.

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.

[“The Tan Sheet” is your weekly full-course meal with ingredients from throughout the OTC drug and nutritional product industries. Sign up here for a free 30-day trial subscription.]

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: NDI Guidance Could Be Summer Blockbuster

Just when the supplement industry thought it was safe to go back in the new dietary ingredient water, FDA's top supplement official says more enforcement activity is likely once the NDI notification guidance hits theaters -- er, dockets -- as is expected next week.

But will the guidance prove a smashing success with the industry that has waited years for it? Or will it bomb? This week's issue of "The Tan Sheet" has the story.

Our June 27 edition also shines a light on what FDA thinks about spray sunscreens and checks in with several ingredient companies making moves in the functional foods arena.

 

["The Tan Sheet" is rated "E" for essential market insight covering the OTC pharma and nutritional industries. Snap up a free 30-day trial subscription here.]

 

TOP STORIES

Low NDI Notice Compliance Sets Stage For Enforcement – FDA’s Fabricant
The volume of noncompliant supplement ingredients on the market likely will prompt an uptick in enforcement after FDA releases its NDI notification guidance, which will draw attention to the problem, dietary supplement program chief Daniel Fabricant says.

FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status
FDA could exclude increasingly popular spray sunscreens from the final monograph unless firms submit sufficient safety and efficacy data, according to an advanced notice of proposed rulemaking.

Ingredient Supplier Interest In Functional Foods Shows No Sign Of Let-Up
Market research firm Mintel says the consumer market for functional foods and beverages has hit a lull, but at the product development level the segment continues expanding with new ingredients and applications.  

Today's Bill Of Fare: Regulatory Enforcement

 
Over the weekend, the New York Times offered up a menu of stories on health claims for foods. The fare included a main course here about health benefit claims in products across numerous categories of functional foods, and an après-dinner treat here on the use of melatonin in brownies and other desserts, which may run afoul of FDA's regulations on using dietary supplement ingredients in foods.

“The Tan Sheet” also has reported on FDA’s regulation of health benefit claims for food products, here, and on the agency’s enforcement against food products containing ingredients common in supplements but unapproved as food additives, here. 

["The Tan Sheet" serves a weekly feast of nutritional product and OTC drug news and analysis. Click here to sign up for a free 30-day trial.] 

-- Malcolm Spicer (m.spicer@elsevier.com)

Kind-Of-A-Big-Deal Week For OTCs And Nutritionals: Table Of Contents

Not to take away from our sister site, The IN VIVO Blog, but lately the OTC/nutritionals world has generated enough deals to warrant our own Deals of the Week feature.

As you'll read in the March 28 issue of "The Tan Sheet," Procter & Gamble and Teva Pharmaceutical Industries joined forces to create what could prove a monster platform for Rx-to-OTC switches and new consumer health products.

Elsewhere, Walgreens gained a strong electronic retail presence in OTC drugs and supplements with its $409 million acquisition of drugstore.com, while NBTY announced it expanded into production of liquid nutritionals with its recent purchase of Vitarich Laboratories.

Not a deal, per se, but still a big deal for pharma and supplement firms everywhere, the Supreme Court ruled unanimously that shareholders of Matrixx Initiatives could proceed with their lawsuit against the Zicam maker, which the Court says should have been more forthcoming with adverse event reports linked to its intranasal products.

"The Tan Sheet" has all these stories, plus an exclusive interview with Prestige Brands CEO Matthew Mannelly and in-depth stories on how OTCs are dealing with shifting demographics and private label competition.

 

[To deal with the ever-changing realities shaping the OTC and nutritionals industries, check out "The Tan Sheet." The first step to your no-obligation, complimentary issue starts here.]

 

TOP STORIES

P&G/Teva Joint Venture Lays Foundation For Switches, Product Launches
Procter & Gamble and Teva Pharmaceutical Industries combine their consumer businesses in a joint venture that creates a leading platform for Rx-to-OTC switches and new consumer health products.

Supreme Court's Matrixx Decision Expands Firms' Disclosure Burden
The Supreme Court's decision in a complaint shareholders brought against Matrixx Initiatives lowers the threshold for when firms need to disclose information, but also aims to prevent an "avalanche of trivial information."

Prestige CEO Mannelly Sees Change In Retail "Headwinds" Giving Brands More Shelf Space
In a year-and-a-half of heading Prestige Brands Holdings, Matthew Mannelly has been a change agent for the consumer health products firm. 

FDA Expands Phytosterol Heart Health Claim In Proposed Rule

FDA significantly overhauls a health claim linking phytosterols to a reduced risk of coronary heart disease, expanding the variety of enriched conventional foods and dietary supplements that can make the claim.

"The Tan Sheet" explores how the proposed rule in the Dec. 8 Federal Register opens the door for a CHD phytosterol claim for foods such as orange juice, low-fat dairy foods, bread and cereal, by allowing firms to make the claim on nonesterfied phytosterols. It also redefines phytosterol, establishes new methods specification standards to justify the claim as well as set a new daily dietary intake and a minimum amount per serving of phytosterols that must be present for products to qualify for the claim.

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