"The Tan Sheet" :: Nonprescription Pharmaceuticals and nutritionals

More Consumers Follow Green Instincts In Health Care Product Choices

e.crawford@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

More mainstream consumers want health care products to not only be safe and effective, but also “clean,” sustainable and “soulful,” says Hartman Group researcher Greg Prang. A connection between natural and health care sprang from the green movement, which positioned organic as healthier than manmade.

Regulatory News In Brief

Mon, 28 May 2012 00:00:00 -0400

Proposals to change supplement regs tabled in Senate; Senate wants firm sunscreen rule compliance date; 2012 sees rise in tainted sexual enhancement supplements.

FDA Recalls For May 16, 2012

Mon, 28 May 2012 00:00:00 -0400

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

Colgate Bids To Expand U.S. Toothpaste Lineup Through FDA Rulemaking

Mon, 28 May 2012 00:00:00 -0400

Colgate seeks regulatory approval for a version of its Colgate Sensitive Multi-Protection toothpaste in a formulation it already markets internationally. The request made in a citizen petition comes after Colgate’s plan to expand its U.S. toothpaste business failed when FDA did not give approval for Sensitive Pro-Relief.

CDER Benefit/Risk Assessment Tool Has Room For OTC Considerations

d.schiff@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

A new benefit/risk framework for drug reviews currently being tested in FDA requires incremental considerations to apply to OTC reviews, a CDER official says. Former NDAC chairman Brass says FDA’s model is compatible with a separate OTC assessment framework developed for industry.

CHPA Regulatory & Scientific Conference In Brief

d.schiff@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

OTC monograph finalization may never end, FDA exec suggests; agency official advises coloring inside the monograph lines; OTC adverse event reports fell about 19% in 2011; supplement AER practices can mitigate rising insurance rates.

Research & Development In Brief

e.crawford@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Iron, zinc do not boost long-term development; probiotics ease UTIs slightly, do not affect resistance; meta-analysis finds zinc shortens colds but linked to AEs; omega-3s may reduce Tourette’s symptoms.

Judge Knocks Down FTC Substantiation Bar In POM Wonderful Case

d.schiff@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

An FTC administrative law judge says the agency cannot require randomized controlled trials to substantiate nutrient claims. POM Wonderful calls the decision “a huge win,” but the firm still received a cease-and-desist order for its pomegranate juice and supplement claims.

Probiotics Industry Says FDA Regulatory Bar Is Set Too High

m.spicer@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Research on probiotics’ health benefits rapidly grows, but turning studies into label claims lags due to differences between industry, NIH and FDA about standards for claims substantiation. Attendees at a U.S.

PLx Pharma Proposes “GI-Safer” OTC Aspirin In New Drug Application

d.schiff@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The firm files a rare new drug application for an OTC product, a formulation of aspirin and phosphatidylcholine designed to be more tolerable to the gastrointestinal tract. The involvement of OTC veterans Peter Mann and Michael Valentino on PLx’s board suggests strong market potential.

In Brief

Mon, 28 May 2012 00:00:00 -0400

Takeda makes Brazilian OTC play; Valeant supplements Canadian portfolio; NAD cools Add Lib libido claims; Triu Naturals hedges on ERSP recommendation; Dr. Reddy’s launches lansoprazole; more news In Brief.

Children’s Sunscreens Boost EWG Recommendation Rate In 2012

r.nelson@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The Environmental Working Group says many children’s sunscreens have “safer, more effective ingredients than those in other products.” But the Personal Care Products Council questions EWG’s research, saying the group’s report “could confuse consumers and discourage them from using sunscreen.”

Perrigo Squares Off With Dr. Reddy’s In Lansoprazole Launch

d.schiff@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

FDA denied Perrigo’s petition that had sought to block Dr. Reddy’s ANDA for generic Prevacid 24HR because it used bioequivalence data for the proton pump inhibitor’s Rx version.

Weekly Trademark Review May 15, 2012

Mon, 21 May 2012 00:00:00 -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.

Anti-Aging Supplements Are Not Just For Boomers Anymore

e.crawford@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The average age of a supplement user is 53 years, but the fundamental concept that “healthy aging” is just for baby boomers and more mature consumers is no longer true, says marketing researcher Steven French.

Sponsors Should Hang Tight On “New Paradigm” Switch – CDER’s Leonard-Segal

d.schiff@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The director of FDA’s Division of Nonprescription Clinical Evaluation advises firms to wait to submit Rx-to-OTC switch applications until the regulations are revised to allow for expanded conditions of safe nonprescription use.

Function Before Age: OTC Design Needs User-Centered Approach

d.schiff@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

OTC health products designed for older patients should consider functional ability rather than strictly age in creating packaging and labeling, a packaging researcher says. Expanding OTC conditions of safe use likely will require additional education and monitoring of older consumers.

In Brief

k.carra@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

Pernix, SEEK prep new cough med; FDA warns Quadex over herpes reference; NuMe progresses on prebiotic program; Creative Edge Nutrition expands; Reaction Nutrition records lacking; more news In Brief.

Sales & Earnings In Brief

Mon, 21 May 2012 00:00:00 -0400

Cold-EEZE marketing boosts retail reorders; Prestige Brands growth refutes Genomma bid; Mannatech incentivizes new recruits; advertising adds to ChromaDex’s net loss; more Sales and Earnings In Brief.

People In Brief

Mon, 21 May 2012 00:00:00 -0400

Former FDA official Sundlof contracts with EAS Consulting; Boiron USA veteran becomes CEO; Perrigo hires pricing director and environmental head; DeFrancesco investor relations VP for Watson; more People In Brief.

Advisory Panel Endorses OraSure In-Home HIV Test

rebecca.kern@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

An FDA advisory committee endorses OraSure’s OraQuick in-home HIV test in a unanimous vote. If approved, OraQuick would be the first OTC test for HIV that untrained users can perform entirely in the home.

California GMO Labeling Initiative Threatens Supplements

e.crawford@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

A California ballot initiative to require labeling of genetically modified foods would be a “nightmare” for supplement manufacturers, says NAI CEO Mark LeDoux. CRN President Steve Mister advocates educating consumers about GMO.

DSM Makes Waves In Omega-3 Fish Oil With Ocean Nutrition Pick-Up

d.schiff@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The Dutch ingredients company hopes to expand Ocean Nutrition Canada into a global omega-3 fish oil supplier for foods and supplements, as well as a source for pharma ingredients. With expiring IP on the Martek algal DHA process, DSM could be seeking a hedge.

FDA Execs Prefer Novel Switch Model Sans Intervention

d.schiff@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

Leaders at FDA’s drug center appear more closely aligned with the OTC industry than with medical professionals’ groups on consumer access to innovative switches. CDER Director Woodcock says the clinical community has resisted switches – and been proven wrong – before.

FDA Recalls For May 9, 2012

Mon, 14 May 2012 00:00:00 -0400

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

In Brief

Mon, 14 May 2012 00:00:00 -0400

FDA softens disclaimer for green tea QHC; Formulife/Purus covers spectrum of violations; NAD refers Schick case to FTC; Genomma drops Prestige Brands board bid.

Sales & Earnings In Brief

Mon, 14 May 2012 00:00:00 -0400

Vitamin Shoppe shrugs off DMAA warnings; Teva grows OTCs, transitions CEO; Reckitt’s Mucinex still ahead of private label; DSM nutrition still up from Martek acquisition; more Sales & Earnings In Brief.

Alacer Sale Underscores Value-Add Of Best Practices

m.spicer@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Best practices help establish a firm’s appeal as an acquisition target, illustrated by the case of Pfizer’s acquisition of Emergen-C maker Alacer.`

FDA Needs More Aggressive Globalization Strategy – Sen. Brown

d.gingery@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The Ohio Democrat says FDA should be more creative in dealing with globalization problems than asking for funds to put more inspectors in China. Commissioner Hamburg says the agency is aggressive but lacks tools and resources to fully address globalization issues.

New Products In Brief

d.schiff@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Abbott’s Revigor fuels EAS sports nutrition line; Tahitian Noni rebrands as Morinda Bioactives and gets “Fit”; Nordic Naturals tries veggie omega-6 with Nordic GLA oil; Solgar’s minnows sweeten fish oil proposition; Mannatech puts “Real Food” in NutriVerus powder; more New Products In Brief.

Korea’s National Assembly Passes Long-Awaited OTC Drug Bill

p.chang@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Confronted with mounting public anger, the National Assembly approves the OTC bill as both ruling and opposition parties gear up for the presidential election.

Perrigo Feels Ill Effects Of Mild Cold Season, Excess OTC Capacity

d.schiff@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The private labeler lowered its full-year revenue guidance, noting weak cough/cold/flu OTC sales. Perrigo built up excess capacity to take advantage of recalled Johnson & Johnson OTCs, and now is shifting some capacity in response to a Novartis plant shutdown.

Weekly Trademark Review May 8, 2012

Mon, 14 May 2012 00:00:00 -0400

FDA Toots Its Own Horn On Safety Of Marketed Drugs, Imports

c.dombrowski@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

FDA’s Global Engagement report describes the agency’s actions to protect the international supply chain. Meanwhile, the Advances in FDA’s Safety Program for Marketed Drugs report notes label changes and safety studies mandated under its post-market drug safety program.

FDA IT Systems In Senate Appropriators’ Crosshairs

c.dombrowski@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The Senate Appropriations Committee approves a $3.9 billion spending plan for the agency in fiscal 2013, providing a $12.5 million boost in direct funding over President Obama’s proposed budget, with the extra funds slated for the food and animal drug programs.

J&J’s Path Forward – An Interview With Alex Gorsky

d.cassak@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

In a conversation shortly before taking the helm at Johnson & Johnson, CEO Gorsky discusses deal strategies, emerging markets, his experience overseeing both the device and pharma businesses and the value of J&J’s consumer health product portfolio.

Supplement AER Under-Reporting Marks Tip Of Compliance Iceberg – FDA

m.spicer@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

FDA’s dietary supplement program chief raised eyebrows at a botanical products conference citing low estimates on rates of compliance with the good manufacturing practices final rule and the new dietary ingredient notification requirements, as well as adverse event reporting.

Regional Firms Must Compete With Multinationals At Home And Away

e.crawford@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Regional firms have to face multinationals coming into small and emerging markets, says an Alkaloid AD Skopje exec, but they need to venture into new markets themselves. While multinationals have the benefit of large budgets and proven strategies, smaller companies can more effectively identify and predict key local behavior.

People In Brief

Mon, 07 May 2012 00:00:00 -0400

Doctor’s Best co-owner Halvorsrude dies; Capsugel’s Zambetti continues as IADSA chairman; EHPM elects Legge chairman; Elway debuts as Neptune Krill Oil ambassador at SupplySide; Post takes F3 Nutrition’s head post; more People In Brief.

Emerging Markets Compound Stagnation In Developed Economies

e.crawford@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

The rapid growth of emerging markets – key regions for many OTC firms – is a major contributor to the industrialized world’s economic stagnation, an HSBC analyst says. Emerging market growth hinders recovery in developed markets by driving up commodity and oil costs, breaking the link in the traditional boom-bust economic cycle.

Herbalife Shakes Off Market Dive After Investor Scare

d.schiff@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

David Einhorn’s questions during Herbalife’s Q1 earnings call sowed market doubt about the firm, whose stock dropped about 20% May 1. But analysts called the panic behind the sell-off “unwarranted” given the firm’s strong Q1 performance and sound fundamentals.

Weekly Trademark Review May 1, 2012

Mon, 07 May 2012 00:00:00 -0400

FDA Considers Cuts And Initiatives For Fiscal 2014 – Hamburg

d.gingery@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

Commissioner Hamburg tells FDA’s Science Board that in the early stages, both cuts and expansions are on the table as the budget process begins in preparation for the fiscal year starting October 2013.

Regulatory News In Brief

Mon, 07 May 2012 00:00:00 -0400

Caffeine claims for avitae cross the line; Essiac Tea in hot water with FDA; studies are claims for Nature’s Pearl supplement; “Statin Support” label makes CoQ10 a drug; more Regulatory News In Brief.

Senate Appropriators Call For Botanical Identity Testing Guidance

m.spicer@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

A Senate FDA appropriation report says the guidance would enhance the agency’s ability to inspect and assess industry practices for manufacturing botanical dietary supplements. A National Center for Natural Products Research official says most botanical ingredients lack standard identity tests.

Judge Likely To Order Lower Age Restriction For Emergency Contraceptives

b.sandburg@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

A federal judge seems inclined to order FDA to make emergency contraceptives available OTC to women younger than 17, but he did not say whether the use would be limited to Teva’s Plan B One-Step, or would include all nonprescription levonorgestrel products.

Sales & Earnings In Brief

Mon, 07 May 2012 00:00:00 -0400

Pfizer’s divested nutrition unit up 9% in Q1; Church & Dwight battles tough environment, toothbrush recall; Cyvex grows but fish meal trends sink Omega Protein; Reliv pins U.S. turnaround hopes on LunaRich launches.

Genomma Refuses To Raise Price, Drops Prestige Bid

e.crawford@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

Genomma drops its unsolicited offer because it was unwilling to meet Prestige’s demand for a higher price. The Mexican firm said it secured funding and met other milestones Prestige insisted on.

In Brief

Mon, 07 May 2012 00:00:00 -0400

Okla. and Ala. limit PSE sales while Colo. and Hawaii consider NPLEx; Abbott, Biocon team on Indian nutrition R&D; Bunge leaves Solae stake to DuPont; Valeant buys AcneFree; more news In Brief.

DMAA Warnings Shed Light On FDA NDI Enforcement

e.crawford@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

FDA’s warning letters to 10 marketers of DMAA-containing products might have a silver lining for the supplement industry as they suggest the agency may be flexible on its controversial interpretation of some provisions in the new dietary ingredient notification requirement.