"The Tan Sheet" :: Elsevier Business Intelligence

U.K. Packages All Electronic Cigarettes Under Medical Regulation

m.spicer@elsevier.com — Mon, 17 Jun 2013 00:20:08 -0400

The U.K. pharma regulator requires all electronic cigarettes to be licensed as nonprescription medicines beginning in 2016, noting concerns about product quality. Meanwhile, FDA considers allowing e-cigarettes to be marketed as nicotine replacement therapy on a case-by-case basis.

Plan B One-Step OTC Proposal Leaves Plaintiffs, Judge Korman Wary

d.schiff@elsevier.com — Mon, 17 Jun 2013 00:20:04 -0400

The Center for Reproductive Rights and other plaintiffs suing FDA say the agency’s plan to approve only Teva’s Plan B One-Step for universal OTC sales, but not less-expensive generic emergency contraceptives, would not provide sufficient access for all women.

Capsugel Flexes Breadth Of Capabilities In Development Collaborations

d.schiff@elsevier.com — Mon, 17 Jun 2013 00:10:17 -0400

Amit Patel, president of Capsugel’s Dosage Form Solutions business unit, says the firm is able to work more closely with customers in the product development process since it is no longer a subsidiary of Pfizer. Capsugel announced the launch of its Lipidex integrated technology platform June 5.

PASS Presses FDA To Repair TEA Process, Facilitate Sunscreen Reviews

Mon, 17 Jun 2013 00:10:12 -0400

The Public Access to SunScreens Coalition plans to work with FDA, lawmakers and stakeholders to facilitate review of sunscreen active ingredients. The group proposes user fees as one method of ensuring FDA has resources to complete sunscreen ingredient evaluations, some pending as time and extent applications since 2002.

Church & Dwight Claims Marketplace Advantage With Value Pricing

e.crawford@elsevier.com — Mon, 17 Jun 2013 00:05:18 -0400

Church & Dwight relies on a recession-resistant portfolio, innovation, increased marketing and expanded distribution to continue growing despite reduced consumer spending. CEO James Craigie cautions competitor P&G against a price war, and promises to “hold our price caps.”

In Brief

Mon, 17 Jun 2013 00:05:14 -0400

FTC pressed to investigate Herbalife; P&G denies leadership “vacuum”; infant formula makers rebuff BPA ban bill; FDA unleashes nine tainted supplement alerts; Bio-Botanica warned about drug claims; Teeter Creek failed to quantify supplement ingredients; Metaugus ingredient comes up short; CDER planning office renamed.

Daily Sunscreen Use “Significantly” Slows Skin Aging – Study

Mon, 17 Jun 2013 00:05:09 -0400

The first human data validating the long-held notion that regular sunscreen use can help prevent skin aging was published in the Annals of Internal Medicine June 4. The Australian study found “significantly” less photoaging among daily sunscreen users versus a control group after 4.5 years.

Digital Media Sharpens Colgate-Palmolive’s Consumer Insights

Mon, 17 Jun 2013 00:00:33 -0400

Colgate allotted more than 15% of its ad spend in 2012 to digital media, which the firm identified as crucial to staying competitive in key markets and reaching consumers in developing regions like India, where traditional ad platforms are less effective, Chief Marketing Officer Nigel Burton says.

Weekly Trademark Review June 11, 2013

Mon, 17 Jun 2013 00:00:32 -0400

OTC drug, personal care product and nutriotional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

FDA OTC Drug Recalls For June 12, 2013

Mon, 17 Jun 2013 00:00:30 -0400

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

New Products In Brief

l.gillespie@elsevier.com — Mon, 17 Jun 2013 00:00:29 -0400

Goody’s liquid shot launches; “First” omega-3 tablet launches; Nestle’s BOOST Nutrition Bar targets seniors; Gold Bond powder spray from Chattem; OptiFlow first U.S. product with DSM’s Fruitflow; more New Products In Brief.

FDA User Fee Liberation Likely Hinges On Senate Appropriations Panel

c.dombrowski@elsevier.com — Mon, 17 Jun 2013 00:00:28 -0400

House leadership plans a comprehensive bill to undo sequestration for the government as a whole, but Republican Robert Aderholt, who chairs the House subcommittee that originates appropriations for FDA, says he is willing to work with Senate appropriators in conference on a fix specific to the agency’s user fees.

Spiked Supplement Penalties May Predict Stronger Enforcement Approach

e.crawford@elsevier.com — Mon, 10 Jun 2013 00:05:00 -0400

FDA and DoJ imposed a financial penalty and a prison sentence on the founder of NovaCare LLC, who pleaded guilty to spiking supplements. Industry stakeholders say the penalties could be a sign of coming enforcement strategy as FDA runs out of patience with spiked supplements.

USPlabs Crafts DMAA Defense As Shield Against Further Damage

l.gillespie@elsevier.com — Mon, 10 Jun 2013 00:01:52 -0400

USPlabs’ compliance with FDA’s request to cease marketing DMAA-containing products came following lengthy and detailed responses to the agency that could shield the firm from class action lawsuits and state investigations.

Tamper-Resistant Pseudoephedrine Sparks Pharmacies’ Interest

m.spicer@elsevier.com — Mon, 10 Jun 2013 00:01:11 -0400

Ohio and West Virginia chain Fruth Pharmacy begins replacing the 30 mg PSE products available in its stores with Acura Pharmaceuticals’ Nexafed product. Meanwhile, DEA says Westport Pharmaceuticals should not make an extraction-proof claim for its Zephrex-D PSE product.

Court Order Could Convolute Emergency Contraception Market

d.schiff@elsevier.com — Mon, 10 Jun 2013 00:00:51 -0400

A federal appeals court mandates full OTC sales of two-tablet levonorgestrel products, as requested in a 2001 citizen petition. The order delineates two-dose emergency contraceptives from Teva’s Plan B One-Step product, which did not exist at the time of the petition.

Weekly Trademark Review June 4, 2013

Mon, 10 Jun 2013 00:00:00 -0400

In Brief

Mon, 10 Jun 2013 00:00:00 -0400

Hatch floats OTCs, supplements for HSAs; Omega Protein sentenced in EPA case; Brazilian Tylenol recalled for bottle defect; Earthborn Products lacked domestic contact info for AERs; FDA warns Meta Labs on ingredient labeling; more news In Brief.

P&G Reorganization Identifies Potential CEOs, Prioritizes Reaching Consumers

e.crawford@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Procter & Gamble reorganizes into four industry-based units, with the goal of getting closer to consumers and becoming more agile, CEO Lafley says. Each unit leader and two other executives now have direct lines of communication to Lafley and could be positioned to take over the helm.

Research & Development In Brief

e.crawford@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

NSAID use increases heart failure risk; probiotics help prevent clostridium difficile-associate diarrhea; citicoline slows glaucoma progression; and aspirin safely prevents VTE.

People In Brief

l.gillespie@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Taylor Wallace departs CRN; Glanbia makes management moves; Lord takes HFMA chair; Masotes manages Herbalist & Alchemist’s sales; more People In Brief.

FDA Budget Could Face 5% Cut In Fiscal 2015

d.gingery@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

An Office of Management and Budget memo says federal agencies should reduce net discretionary spending from the initial fiscal 2015 estimate and provide options for additional cuts. Across-the-board cuts and “new user fees to offset existing spending” are not allowed in fiscal 2015 requests.

Congress Targets Sequester-Proof User Fees For FDA

d.gingery@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Rep. Sam Farr says Congressional Budget Office scoring problems prevent releasing FDA’s fiscal 2013 user fees from being held in the budget sequester, but an amendment will be proposed to ensure the agency’s fiscal 2014 fees are included in its appropriations.

Senators Push FDA For SPF Cap, Spray Sunscreen Review

l.nardella@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Nine Democrats led by Senator Jack Reed ask FDA to resolve sunscreen issues that remain in regulatory limbo. FDA needs to clarify “misconceptions about misleadingly high SPF labels beyond 50, where the increase in UV protection is relatively small,” the senators suggest.

Full OTC Status For Two-Dose Emergency Contraceptives – Appellate Court

d.schiff@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Unrestricted OTC sales of generic versions of the original two-dose Plan B emergency contraceptive must be allowed immediately, according to a June 5 appellate court order. The U.S.

In Brief

Mon, 03 Jun 2013 00:00:00 -0400

Abbott maintains diversified businesses course; citizen petition not germane to Plan B One-Step, DoJ says; Matrix noni and silver claims flagged by FDA; FDA warns e-commerce firm on claims; FDA finalizes imported food reporting rule; and Euromonitor predicts Indonesian growth spurt.

Weekly Trademark Review May 28, 2013

Mon, 03 Jun 2013 00:00:00 -0400

People In Brief

l.gillespie@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Williams stars in Clear Eyes campaign; industry veteran Brown joins Innovus as CFO; Mannatech makes promotions, addition; Loew heads Sanofi’s European commercial operations; Bayer HealthCare moves Schubmehl to CIO; more People In Brief.

New Products In Brief

Mon, 03 Jun 2013 00:00:00 -0400

US Organic Group offers organic OTC anti-itch balm; Nordic Natural expands ProEPA line; Clearblue pregnancy test tracks time since ovulation; Nutrition 21 touts Nitrosigine as superior arginine; Culturelle probiotics go chewable; more New Products In Brief.

Bausch + Lomb Buy Vaults Valeant Into Consumer Eye Care Space

l.gillespie@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Bausch + Lomb retains its name and becomes a division of Valeant in the $8.7 billion acquisition expected to close in the 2013 third quarter.

Warnings Not To Give Young Children Cough/Cold OTCs Still Go Unheeded

e.crawford@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Four in 10 parents said they administered OTC cough and cold products to children younger than 4 years even though labeling says not to use in this age group, according to a national poll. The finding suggests more education is necessary to reduce confusion and noncompliance.

California Safer Consumer Products Compliance Costs Will Vary Widely

r.nelson@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

The state toxic substances authority says “a simple single-chemical alternatives analysis” could cost $2,000 to $3,000, a moderately complex analysis with existing data “would be in the tens of thousands of dollars” and one “of greater complexity requiring extensive testing” could run in the hundreds of thousands.

Research & Development In Brief

e.crawford@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Phytosterols with red yeast rice do not lower LDL; cognitive risk for children of iodine-deficient moms; glucosamine linked to intraocular pressure; and calcium lowers women’s mortality risk.

Colgate Targets High-End Oral Care Segments For U.S. Growth

l.nardella@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Colgate-Palmolive looks to gain U.S. oral care market share with high-end mouthwash and toothbrush innovations. The firm expects to build awareness quickly for Colgate Total Pro-Shield mouthwash, while preparing to launch a toothbrush that makes brushing “exciting,” says North America chief Noel Wallace.

Perrigo Campaigns For Rational OTC Shopping Over Brand Loyalty

d.schiff@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

The online “Store Brand Meds” campaign launched by Perrigo in early 2013 encourages consumers to “Make store brands your brand,” by emphasizing lower price points and equivalent active ingredients. Overcoming consumer connections to brands such as Tylenol is a challenge, however.

FDA Recalls For May 29, 2013

Mon, 03 Jun 2013 00:00:00 -0400

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

Potential OTC Contraception Market Could Attract Switch

m.spicer@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

A report showed 62.2% of 2,046 women surveyed favor OTC sales of contraception pills, representing a potential U.S. market of around 11 million. The results also could reflect consumer interest in making the drugs available OTC under conditions of safe use.

Sen. Baucus Agenda Still Ambitious: Tax Reform, Deficit Reduction, ACA

Mon, 03 Jun 2013 00:00:00 -0400

The Finance Committee chairman will leave the Senate following the 2014 elections with a history of working productively with the drug industry on major legislation such as health reform, the Medicare Modernization Act and PDUFA reauthorizations.

Lafley Back At P&G Helm As McDonald’s Tenure Ends At Four Years

Mon, 27 May 2013 00:00:00 -0400

Procter & Gamble turns to its former leader, previously replaced by Bob McDonald in 2009, after facing investor and analyst pressure to shake up management. Lafley’s return as CEO “provides us with new hope,” one market analyst says.

Regulatory News In Brief

Mon, 27 May 2013 00:00:00 -0400

FDA distinguishes supplements from medical foods; super fruits are not drugs, FA explains; Sunland resumes production; Bayer voluntarily nixes Alka-Seltzer claims; FDA cites inflammation as drug claim; three Florida supplement makers warned for drug claims; and FDA warns Michigan e-commerce firm on claims.

Pending Calif. Consumer Products Reg Inconsistent, Unfair – Trade Groups

r.nelson@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

The Personal Care Products Council and the Consumer Healthcare Products Association fault the latest and likely last draft of California’s Safer Consumer Products regs for its lack of a weight-of-evidence approach to decision making and inadequate trade-secret protections, among other shortcomings.

Weekly Trademark Review May 21, 2013

Mon, 27 May 2013 00:00:00 -0400

Monster Lawsuits Test State Preemption Of FDA

l.gillespie@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

San Francisco City Attorney Dennis Herrera wants Monster to lower its products’ caffeine levels, “provide adequate warning on labels” and “cease targeting minors” in advertising. Monster preemptively sued the city in April, attempting to stop Herrera from pursuing the demands.

EWG Supports Nano-Engineered Mineral Sunscreens In 2013 Report

l.nardella@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

Sunscreens containing zinc oxide and titanium dioxide nanoparticles rate relatively highly in the Environmental Working Group’s annual Sunscreen Guide, though the advocacy group says greater transparency is needed regarding products with nano-engineered ingredients.

FDA Undermined Switch Process With Past Plan B Deviations – CRR

d.schiff@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

The Center for Reproductive Rights says FDA should not be granted a stay of a judge’s order to approve OTC emergency contraceptives. CRR says FDA forfeited the authority to argue in defense of the regulatory approval process given its previous departures from that process in reviewing Plan B One-Step.

In Brief

Mon, 27 May 2013 00:00:00 -0400

Bayer buys herbal firm; NBTY notes bright spots, hires international leader; Neptune prepares to rebuild; P&G suit targets CAO’s tooth whiteners; CSPI supports restricting St. John’s wort; Coppertone schools parents; Hillary Clinton will speak at NACDS Total Store Expo.

Most U.S. Sunscreens Not So Hot, Reflecting FDA Failures – EWG

l.gillespie@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

Sunscreen products earned low marks in EWG’s 2013 guide because FDA’s regulation of the category is not rigorous enough, the group says. But the Personal Care Products Council cautions that consumers may get the wrong message from EWG and choose to not use sunscreen.

Supplement Firms Cannot “Contract Out” GMP Responsibility – FDA

d.schiff@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

The agency’s Florida district office, in three recent warning letters, says although a firm may contract out certain supplement manufacturing operations, “it cannot, by the same token, contract out its ultimate responsibility to ensure that” its products are not adulterated.

N.Y. Supplement Marketing Restriction Bill Raises Specter Of Copycats

m.spicer@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

Stakeholders fear legislation proposed in New York to restrict sports supplement sales to consumers 18 and older and to require additional labeling could inspire copy-cats in other states. Trade groups say DSHEA already covers the proposed legislation’s goals.

Actavis’ Warner Chilcott Buy Brings Switch Options In Diversified Portfolio

e.crawford@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

Actavis’ acquisition of Warner Chilcott creates a women’s health powerhouse with Rx-to-OTC switch potential. UBS analysts expect $400 million in cost synergies and an “even more robust than previously disclosed” pipeline and diverse product portfolio that complements Actavis’ existing products.