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The Tan Sheet
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   Full-text available via subscription Subscription journal
     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • Flonase Switch Approved, Branded Nasal Allergy Spray
           Market Will Grow In 2015
    • Abstract: Glaxo says Flonase Allergy Relief (fluticasone propionate 50 mcg spray) is the “first OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms.” The firm has not learned from FDA whether Flonase Allergy Relief will launch with market exclusivity.
      PubDate: Thu, 24 Jul 2014 14:00:03 -040
       
  • “Crash” Claim Put 5-Hour Energy On
           Collision Course With State AGs
    • Abstract: Living Essentials accuses two attorneys general of seeking money from the firm prior to filing lawsuits alleging ads for 5-hour ENERGY misled consumers. NAD and CARU also warned the firm about claims similar to those at issue and advertising practices.
      PubDate: Thu, 24 Jul 2014 00:00:03 -040
       
  • Alli Labels In U.S. Add Seizure Advisory Similar To
           E.U. Change
    • Abstract: GSK also recently posted to the alli brand website statements on why language was added to the Drug Facts panel for the orlistat 60 mg product. FDA contacted Glaxo in November 2013 requesting a supplement NDA for the label change, FDA’s Division of Nonprescription Clinical Evaluation said.
      PubDate: Wed, 23 Jul 2014 00:00:02 -040
       
  • U.K. E-Cigarettes Can Make Smoking Alternative Claim, But Not Healthier
    • Abstract: NJOY ads “implied that the product was favorable to smoking tobacco cigarettes,” but “there may be a number of reasons why a friend might suggest the product as an alternative to smoking tobacco cigarettes,” U.K. advertising watchdog says.
      PubDate: Tue, 22 Jul 2014 00:00:05 -040
       
  • Wellness Drink Firm Trips Over FTC Endorsement Disclosure Bar
    • Abstract: TriVita agrees to settle with FTC regarding claims it made for its “anti-inflammatory” drink Nopalea. The Scottsdale, Ariz.-based firm will pay $3.5 million in consumer refunds and is barred from making unsubstantiated claims about its products and using employees in testimonials.
      PubDate: Mon, 21 Jul 2014 00:02:05 -040
       
  • In Brief: Novartis, Abbott Earnings; Using mL Cuts Mis-Dosing; Labels Need
           Proprietary Blend, Capsule Ingredients
    • Abstract: Novartis consumer up 5%; adult products drive Abbott Nutrition growth; medication errors drop when mL is unit of measurement; ingredients of proprietary blends must be labeled; include capsule ingredients on labels; and Herbalife defends nutrition clubs.
      PubDate: Mon, 21 Jul 2014 00:01:42 -040
       
  • Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning
           Letters
    • Abstract: About 13% of the 156 warning letters FDA sent to dietary supplement firms from 2011 through June 2014 cited firms for failing to report serious adverse events or for not providing on product labels a domestic address or phone number at which to receive AERs. The citation total has climbed steadily from 2011.
      PubDate: Mon, 21 Jul 2014 00:01:32 -040
       
  • New Products In Brief: Dr. Cocoa Ships,
           Beano + Dairy Defense,
           Resveratrol By SOBO
    • Abstract: Dr. Cocoa ships to retailers; Beano + Dairy Defense from Prestige; Resveratrol in SOBO cream.
      PubDate: Mon, 21 Jul 2014 00:00:22 -040
       
  • Dietary Supplement GMP Warning Letters
    • Abstract: Quality control personnel must be trained in all their responsibilities under the dietary supplements good manufacturing practices final rule and firms must document that those employees are completing their responsibilities, FDA says in recent warning letters. The agency also notes that retroactive testing of ingredients is not compliant with the June 2007 rule.
      PubDate: Mon, 21 Jul 2014 00:00:15 -040
       
  • Weekly Trademark Review July 15, 2014
    • Abstract: 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.
      PubDate: Mon, 21 Jul 2014 00:00:07 -040
       
  • Revised House Sunscreen Bill Promotes Review Transparency, Feasibility
    • Abstract: The latest House version of the Sunscreen Innovation Act would institute reasonable deadlines for FDA review of TEA sunscreen ingredients and require the agency to issue guidance detailing standards for applications seeking GRASE status. The Energy and Commerce Committee advanced the bill.
      PubDate: Mon, 21 Jul 2014 00:00:00 -040
       
  • Causation Disclaimers Should Be In Adverse Event Reports Submitted To FDA
    • Abstract: Dietary supplement firms should use a script for receiving AERs and establish review protocols to ensure serious events are reported to FDA, recommends attorney Claudia Lewis. She detailed best practices for supplement AERs at a recent American Conference Institute conference.
      PubDate: Fri, 18 Jul 2014 00:00:04 -040
       
  • OTC Emergency Asthma Inhaler NDA Survives, Needs Additional Studies
    • Abstract: FDA’s request for additional data on Armstrong’s NDA for Primatene HFA – a breath-triggered, epinephrine inhalation aerosol – shows the agency’s interest in expanding consumers’ choices for OTC emergency asthma inhalers beyond the one currently available, racepinephrine with a battery-powered atomizer.
      PubDate: Thu, 17 Jul 2014 00:00:00 -040
       
  • J&J’s 7.7% OTC Sales Growth Drives Consumer Business
           Turnaround
    • Abstract: Johnson & Johnson reports second-quarter OTC sales increased 7.7% to $1 billion, helping the firm’s overall consumer business sales grow 2.4% to $3.74 billion. CEO Alex Gorsky says J&J has a broad approach, including collaborations with other firms, for greater consumer sales growth.
      PubDate: Wed, 16 Jul 2014 00:00:46 -040
       
  • FDA Targets Acetaminophen Safety Evaluation In Plan To Mine OTC Use Data
    • Abstract: An RFP to provide FDA with direct access to data on consumers’ OTC use identifies the public health impact of potential changes in dosing information on acetaminophen product labels as one reason for the planned data evaluation. Access to the data also will increase FDA’s ability to perform regulatory impact studies, particularly to assess the impact of Rx-to-OTC switches.
      PubDate: Tue, 15 Jul 2014 00:00:05 -040
       
  • FDA Recalls For July 9, 2014
    • Abstract: Recalls reported by FDA for OTC drugs, devices, nutritionals and personal care products.
      PubDate: Mon, 14 Jul 2014 00:01:26 -040
       
  • In Brief: Ad, Social Media Claims Scrutinized; Unilever Slims Down;
           Perrigo Generic Advil Congestion Ready
    • Abstract: NAD refers RDK Global advertising to FTC; social media claims trigger FDA warning; Perrigo to launch equivalent of Advil product; Unilever divests Slim-Fast; class-action complaint against Nu Skin; Herbalife makes friends on Capitol Hill; and child-proof liquid nicotine bill introduced.
      PubDate: Mon, 14 Jul 2014 00:01:19 -040
       
  • Safety Problem Plus GMP Warnings Equal Increased Likelihood Of DoJ Action
    • Abstract: Triceuticals agrees with DoJ to a consent decree of permanent injunction against distributing adulterated supplements. DoJ says a consumer of a Triceuticals product experienced headache, confusion and kidney failure resulting in hospitalization due to vitamin D toxicity.
      PubDate: Mon, 14 Jul 2014 00:01:12 -040
       
  • Weekly Trademark Review July 8, 2014
    • Abstract: 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.
      PubDate: Mon, 14 Jul 2014 00:01:08 -040
       
  • New Products In Brief: Rhoto Eye Drops, First PLUS Vitamins, ForsLean Soft
           Extracts
    • Abstract: Cool Max added to Rhoto Eye Drops line; Fruit PLUS boosts nutrition level; and Sabinsa’s ForsLean gets real.
      PubDate: Mon, 14 Jul 2014 00:00:57 -040
       
  • Recall Plans Show Value In Quick Product Removal, FDA Satisfaction
    • Abstract: Dietary supplements make up a substantial portion of food and drug recalls, suggesting all firms should have a plan in place for removing product from the market quickly if a safety signal or other problem arises, a food and drug attorney recommends.
      PubDate: Mon, 14 Jul 2014 00:00:47 -040
       
  • Pharma Hopes EU Commission Policy Report Will Lead To Real Dialogue
    • Abstract: The European Commission's latest policy document dedicated to making the pharma industry a better global competitor advocates a new, co-operative approach, but lacks detail. The industry, though, believes the document offers hope for constructive debate in key areas.
      PubDate: Mon, 14 Jul 2014 00:00:15 -040
       
  • FTC-L’Oreal Settlement Should Reverberate Across Industry –
           Attorneys
    • Abstract: The recent action against L’Oreal sends a signal to industry that FTC is paying attention to their claims. In an interview with “The Rose Sheet,” attorneys from Edwards Wildman Palmer discuss the case’s implications and whether it heralds a new FTC focus on cosmetics.
      PubDate: Mon, 14 Jul 2014 00:00:10 -040
       
  • Zephrex-D Solo Show In W.Va. Could Move
           Tamper-Resistant PSE To Starring Role
    • Abstract: With CVS selling only Zephrex-D at its W.Va. stores, Walgreens planning to make a similar change and pseudoephedrine diversion to make meth also a problem in other states, other manufacturers of single-ingredient PSE products could feel pressure to start using tamper-resistant formulations.
      PubDate: Fri, 11 Jul 2014 00:00:00 -040
       
  • Industry Suggests Increase In Spiked Supplements Reflects FDA Investment
           In Testing, Targeted Selection
    • Abstract: The number of products marketed as supplements and identified as tainted in 2013 grew 136% from 2011 – the year after FDA announced it would take “swift and strong” enforcement action. Trends in recalls and public notifications likely reflect FDA’s investment in testing products, a strategy in need of updating, supplement industry trade groups say.
      PubDate: Thu, 10 Jul 2014 00:00:03 -040
       
 
 
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