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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  [14 journals]
  • FDA Sounds Off On Unapproved Ear Drops Through Enforcement Notice
    • Abstract: FDA says firms marketing unapproved and misbranded prescription otic products containing one or more of antipyrine, benzocaine, chloroxylenol, hydrocortisone, pramoxine and zinc acetate will be subject to enforcement actions including seizure, injunction and/or criminal proceedings.
      PubDate: Thu, 02 Jul 2015 00:05:01 -040
       
  • People News Roundup: Herbalife, Mead Johnson, Capstone
    • Abstract: Director of Herbalife Washington office; MJN adds Cup as CFO; Kundu heads Capstone; Another Young heads Young Living; and more news in brief.
      PubDate: Thu, 02 Jul 2015 00:00:06 -040
       
  • TriCalm Firm Appeals For Relief From NAD Decision On
           Itch Claims
    • Abstract: “NAD has shown it believes its opinion of what is scientifically appropriate (despite having no bona fides in the area) trumps that of accomplished medical professionals,” Cosmederm Bioscience argues. NAD rejects the firm’s support for all TriCalm ad claims challenged by Cortisone-10 marketer Chattem.
      PubDate: Wed, 01 Jul 2015 00:05:00 -040
       
  • Industry Roundup: Nicotine Exposure ANPR, Athena Petition Denied,
           Supplement Warning Letters
    • Abstract: Comments sought for nicotine-exposure ANPR; Supreme Court denies Athena petition; spiked products and drug claims; and GMP problems.
      PubDate: Wed, 01 Jul 2015 00:00:03 -040
       
  • GMO Bills Differ On Labeling, All Agree On Pre-empting State Laws
    • Abstract: H.R. 1599 would create a structure for codifying GMOs in foods and supplements and make labeling voluntary, but opponents say it keeps consumers in the dark while pre-empting state laws. S. 809 and H.R. 1699, meanwhile, would require labeling for genetically engineered products.
      PubDate: Tue, 30 Jun 2015 00:00:03 -040
       
  • ‘Vast Weight’ Of Evidence Fails To Tip Scale Against Joint
           Health Claims
    • Abstract: A U.S. circuit court affirms a ruling that consumers from California, Illinois, New York, Ohio and Pennsylvania did not adequately plead falsity of the allegedly misleading marketing claims by GNC and Rite Aid.
      PubDate: Mon, 29 Jun 2015 00:02:00 -040
       
  • Consumer Health New Products Roundup: IBgard,
           Gel-V Hot, VisiVite R.B.I.
    • Abstract: IBgard supplement for IBS symptoms in Canada; Caffeine, brown seaweed nutrient in Gel-V Hot; Eye supplement line reformulates; and more new products in brief.
      PubDate: Mon, 29 Jun 2015 00:01:33 -040
       
  • Athena Appeal Decision Could Open ‘Floodgate’ For False Claims
           Litigation
    • Abstract: Lower court decisions that Athena Cosmetics’ RevitaLash products is an unapproved drug competing unfairly against Allergan's Latisse drug could have broader implications if the Supreme Court denies the firm's request for review. Already beleaguered by class actions following FDA warnings, firms could face more opportunistic lawsuits if federal courts are left to determine a product's intended use and regulatory status.
      PubDate: Mon, 29 Jun 2015 00:01:21 -040
       
  • Weekly Trademark Review June 23, 2015
    • Abstract: OTC drug, personal care product and nutritional 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, 29 Jun 2015 00:01:10 -040
       
  • First Amendment Suit: FDA Draws Line At Amarin's Heart Disease Claim
    • Abstract: Amarin Pharmaceuticals’ marketing plan for its Rx fish oil drug Vascepa, including noting the qualified heart health claim allowed for omega-3 supplements, could “establish precedent that would return the country to ... when companies were not required to prove that their drugs were safe and effective for each of their intended uses,” FDA argues.
      PubDate: Mon, 29 Jun 2015 00:01:03 -040
       
  • Infant Formula Selenium Rule Agrees With Manufacturers’ Routines
    • Abstract: FDA issues a final rule on a range for selenium in infant formulas, denying industry requests to broaden the range to accommodate products currently outside the agency’s 2-7 mcg per 100 kilocalorie range. The rule finalizes a proposal from 2013 and takes effect in June 2016.
      PubDate: Fri, 26 Jun 2015 00:10:09 -040
       
  • Supplement Firms Have ‘Continuous Monitoring’ Burden To Show
           Product Safety
    • Abstract: Former FDA supplement programs head Bill Frankos says the industry bears the burden for monitoring product safety in the marketplace because FDA does not have the same vested interest it has for drugs and medical devices stemming from pre-market approval of the products.
      PubDate: Thu, 25 Jun 2015 00:00:35 -040
       
  • Industry Roundup: GMP Woes, KY DXM Sales, Pharmascience Expands
    • Abstract: Herbal firm crosses GMP, claims line; Kentucky makes 8 to age-restrict DXM sales; and Pharmascience receives $4.8 million for Quebec for $55M expansion.
      PubDate: Wed, 24 Jun 2015 02:05:00 -040
       
  • Loss Of Martha Stewart License Puts A Crimp In
           Inergetics’ Style
    • Abstract: Nutritional product firm Intergetics has “substantial doubt about its ability to continue as a going concern,” according to an SEC filing. Martha Stewart Living Omnimedia ended Inergetics’ license for a six-product supplement line after the firm fell behind on paying fees.
      PubDate: Wed, 24 Jun 2015 01:55:01 -040
       
  • Class Action ‘Extortion’ Demands Defense From First Step In
           Litigation – Attorneys
    • Abstract: Companies targeted in class actions should challenge litigants throughout the process, from when a complaint is filed to when a judge is deciding, say lawyers during a Council for Responsible Nutrition webinar. Firms fearful of high damage fees too often will settle when they have other options.
      PubDate: Tue, 23 Jun 2015 00:05:01 -040
       
  • Documenting Slack Fill Reasons Can Fill In Blanks During Litigation
    • Abstract: OTC and supplement firms that must include slack fill in products should document reasons why as a defense in future class action cases, says attorney Elizabeth Chiarello. Transparent packaging and fill lines also protect companies, she says.
      PubDate: Tue, 23 Jun 2015 00:00:03 -040
       
  • J&J Bullish On OTC Drug Pricing, Consumer Regard For Its Brands
    • Abstract: Brand strength, not price cuts, drives J&J OTC product sales, says Worldwide Group Chairwoman Sandra Peterson. The firm has returned 80% of its recalled brands to store shelves and will restart Tylenol Arthritis distribution later this year, leaving one “substantive” product to re-launch.
      PubDate: Mon, 22 Jun 2015 00:05:00 -040
       
  • Weekly Trademark Review June 16, 2015
    • Abstract: OTC drug, personal care product and nutritional 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, 22 Jun 2015 00:02:51 -040
       
  • Allegra-D Joins ‘Common Cold’ Club In OTC
           Antihistamine Market
    • Abstract: Allegra-D has competed in the OTC antihistamine space without including “relief of nasal congestion due to the common cold” in its indications since its 2011 launch through Sanofi’s Chattem business.
      PubDate: Mon, 22 Jun 2015 00:02:00 -040
       
  • Merck KGaA ‘Consumer Centric’ Model Boosts Product Lines,
           Shapes R&D
    • Abstract: Merck KGaA launches additional OTC products from brands associated with doctors or behind-the-counter sales or that currently are Rx to yield double-digit organic growth. The German firm is soliciting consumer feedback to shape its R&D and improve its understanding of factors driving the OTC market.
      PubDate: Mon, 22 Jun 2015 00:02:00 -040
       
  • China Hunts GMP Gaps Before International Pharma Inspection Convention
    • Abstract: The China Food and Drug Administration presses on with efforts to join the international pharmaceutical inspection convention and co-operation scheme (PIC/S) and has launched a feasibility study to this end.
      PubDate: Mon, 22 Jun 2015 00:01:59 -040
       
  • P&G Streamlining Could Cut $12 Billion Beauty Slice To Coty
    • Abstract: Coty could growing its global beauty presence significantly by acquiring P&G's Wella and Clairol hair-care businesses, CoverGirl and Max Factor makeup lines and prestige fragrance licenses in a deal rumored to be in the works.
      PubDate: Mon, 22 Jun 2015 00:01:40 -040
       
  • All PSE Formulations Deserve Equal Marketplace Billing – CHPA
    • Abstract: “Any product containing PSE – single ingredient or otherwise – can be potentially diverted into the manufacture of methamphetamine,” says Carlos Gutierrez, CHPA’s head of state government affairs.
      PubDate: Mon, 22 Jun 2015 00:01:30 -040
       
  • Abbott On Same Page With Mylan About Perrigo, Teva
    • Abstract: Abbott Labs it supports Mylan’s rejection of Teva’s acquisition offer and its hostile takeover bid for Perrigo.
      PubDate: Mon, 22 Jun 2015 00:01:20 -040
       
  • Tamper-Resistant PSE On Big Pharma Stage: Bayer Licenses Acura’s
           Formulation
    • Abstract: Bayer gains exclusive worldwide license to Acura Pharmaceuticals’ Impede technology for use in a pseudoephedrine-containing product resistant to extraction to make methamphetamine. The deal is Acura’s first licensing, and the first move toward tamper-resistant PSE by a major pharma firm.
      PubDate: Tue, 16 Jun 2015 11:30:01 -040
       
 
 
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