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The Tan Sheet
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     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • NSAIDs Could Cut Cancer, Heart Attack Risk, But Experts Defer On Advising
           Proactive Use
    • Abstract: Some NSAIDs could reduce incidence of and deaths from cancers and from heart attack and stroke, but it is unclear if the increased risk of bleeding from using the drugs outweighs the benefits, according to recent studies.
      PubDate: Wed, 27 Aug 2014 00:30:00 -040
       
  • Drug Claims For Supplements Put Enforcement Bulls Eye On Firms
    • Abstract: FDA advises Ad-Med Biotechnology/A.M.S. Bioteck, EnerHealth Botanicals and Human Science Foundation about marketing unapproved new drugs due to disease claims.
      PubDate: Wed, 27 Aug 2014 00:00:04 -040
       
  • “Mender” Supplement Firm Hopes To Reopen After Mending Its
           Violations
    • Abstract: BioAnue Labs says it temporarily stopped selling its products, which FDA warned are unapproved new drugs due to claims the firm made. BioAnue’s website and others associated with the firm continue to advertise supplements under brands that include a common disease name and terms that refer to treating the condition.
      PubDate: Tue, 26 Aug 2014 00:30:01 -040
       
  • Consumer Health Care New Products Roundup
    • Abstract: Carmex keeps up appearances with TriPLEX; Arcadia, ZoomEssence collaborate; Northstar readies Snorenz re-launch
      PubDate: Tue, 26 Aug 2014 00:00:05 -040
       
  • All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill
    • Abstract: Senate HELP Committee leaders release a draft bill that expands on changes proposed in the House’s Sunscreen Innovation Act by requiring deadlines for FDA review of all OTC ingredient TEAs. In a draft bill, Chairman Tom Harkin and other HELP members propose setting “reasonable” deadlines for TEA reviews.
      PubDate: Mon, 25 Aug 2014 00:45:01 -040
       
  • Industry News Roundup
    • Abstract: Reckitt looks to “friend” consumers on Facebook; InterHealth acquires 7-Keto; regulators interested in adverse event reporting; CRN tool reveals enforcement trends; FDA food advisors take on risk assessments; and more consumer health care product industry news.
      PubDate: Mon, 25 Aug 2014 00:01:25 -040
       
  • Continuous Manufacturing A Focal Point For FDA Emerging Technologies Team
    • Abstract: Agency officials encourage the pharmaceutical industry to switch from batch to continuous manufacturing, and promise to help with the transition. The Emerging Technologies Team is a part of a 12-year initiative CDER Director Janet Woodcock has led to improve pharmaceutical manufacturing.
      PubDate: Mon, 25 Aug 2014 00:01:18 -040
       
  • Executive Decisions Roundup
    • Abstract: Alternaturals CEO; Skinvisible staffs for direct-selling; PureFormulas VP; Cyanotech COO; and more executive news from around the nutritional supplement and OTC drug industries.
      PubDate: Mon, 25 Aug 2014 00:01:06 -040
       
  • Suppliers Ready Microbead Alternatives As Political Storm Brews State Bans
    • Abstract: Personal care product manufacturers are under pressure to reformulate items containing plastic microbeads as states take steps to ban the ingredients due to environmental concerns. Ingredient suppliers are promoting alternative offerings, emphasizing built-in value to offset premium pricing.
      PubDate: Mon, 25 Aug 2014 00:00:17 -040
       
  • House Members, Trade Group At Odds Over CPSC Report On Phthalate Risks
    • Abstract: A Consumer Product Safety Commission report identifies cosmetics, food and pharmaceuticals among top sources of exposure to phthalates for vulnerable populations. House Democrats ask FDA to act on the findings, but the American Chemistry Council questions the report and expresses concern about its influence on CPSC rulemaking.
      PubDate: Mon, 25 Aug 2014 00:00:11 -040
       
  • Capsugel, Cardax Collaborate To Target Consumer Astaxanthin Demand
    • Abstract: The firms are collaborating to develop consumer health astaxanthin products using Capsugel’s proprietary lipid multi-particulate delivery technology and Cardax’s “nature-identical” synthetic astaxanthin. They also need a retail commercialization partner to make the product available in the mass market.
      PubDate: Fri, 22 Aug 2014 00:00:04 -040
       
  • U.K. Supplement Retailer’s “Suitable” Customer Advice
           Likely Unsuitable In U.S.
    • Abstract: Holland & Barrett ads clarify store clerks’ advice “would be in relation to nutrition and supplements, rather than general or individual health advice,” the UK advertising regulator says. While some US retailers train staff about supplement claims, they do not have as much room for advising customers as the UK agency allows in its ruling on a challenge.
      PubDate: Thu, 21 Aug 2014 00:30:01 -040
       
  • Hi-Tech CEO Could Face Jail For Violating Court Order To Recall Weight
           Loss Products
    • Abstract: A federal judge soon will decide whether Hi-Tech Pharmaceuticals CEO Jared Wheat goes to jail for failing to recall weight loss products marketed with false claims. Wheat has a history of run-ins with FDA, FTC and DEA for marketing supplements adulterated with drugs and making false claims for products.
      PubDate: Thu, 21 Aug 2014 00:00:02 -040
       
  • Carlyle Group Gives NBTY Helm To Former Coca-Cola Executive Cahillane
    • Abstract: Steven Cahillane, who left his post as president of Coca-Cola Co.’s Americas division in 2013, is moving to NBTY to replace Jeffrey Nagel after the supplement manufacturer and retailer reported flat sales for its most recent earnings period and after net income dropped nearly 12% during the firm’s previous fiscal year.
      PubDate: Wed, 20 Aug 2014 00:00:04 -040
       
  • Consumer Health Care New Products Roundup
    • Abstract: P&G Meta for nutritionals; Colgate Lasting White Mouthwash; Aviva advances hair nutrition advance; Bayer brings Berocca to U.S.; and more new product news.
      PubDate: Tue, 19 Aug 2014 00:00:05 -040
       
  • FDA Proposal For Increased Sunscreen Safety Testing On NDAC Agenda
    • Abstract: FDA’s Nonprescription Drug Advisory Committee will consider proposed tests for evaluating the safety of sunscreen ingredients that sponsors want to add to the OTC monograph. The committee will not consider the safety or efficacy of specific ingredients pending review via TEAs.
      PubDate: Mon, 18 Aug 2014 14:05:01 -040
       
  • Weekly Trademark Review Aug. 12, 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. Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled by “The Tan Sheet” from Official Gazette of the U.S.
      PubDate: Mon, 18 Aug 2014 00:02:10 -040
       
  • Business & Finance News Roundup
    • Abstract: NBTY sales flat; ProPhase legal costs climb; taxes trip Mannatech to a loss; and more business and finance news.
      PubDate: Mon, 18 Aug 2014 00:02:04 -040
       
  • N.Y. Sen. Gillibrand Seeks Federal Action On Personal-Care Microbeads
    • Abstract: A federal interagency task force should include microbeads and microplastics from personal-care products on its list of Great Lakes contaminants, New York Senator Kirsten Gillibrand asserts in a letter to EPA Administrator Gina McCarthy.
      PubDate: Mon, 18 Aug 2014 00:01:53 -040
       
  • Regulatory News Roundup
    • Abstract: E-cigarette “Love” claim misleading; time for proprietary names comment; more supplement adulterations, contaminations.
      PubDate: Mon, 18 Aug 2014 00:01:48 -040
       
  • Consumer Health Care Industry News Roundup
    • Abstract: PuraMed migrane re-launch; Skinvisible direct sales; RegiMEN ad campaign; Axxess Pharma hires social media firm; and more industry news.
      PubDate: Mon, 18 Aug 2014 00:01:18 -040
       
  • As Healthy Eating Bites Into Supplement Sales Growth, Basic Drivers
           Provide Traction
    • Abstract: In the first half of 2014 U.S. vitamin product sales have been flat, around 1% to 1.5% monthly growth compared to 6% to 8% in the first half of 2013, according to market research. Factors contributing to the drop include increased competition from fortified foods, imports and specialized product offerings.
      PubDate: Mon, 18 Aug 2014 00:00:02 -040
       
  • Perrigo Growth Trajectory Traverses Manufacturing, Licensing Headwinds
    • Abstract: Perrigo firm omitted from its fiscal 2015 guidance revenues from generic guaifenesin expectorants because raw material sourcing has not met manufacturing specifications and continue to hold up production. The firm’s plans for launching store brand OTC nasal corticosteroids also are in limbo.
      PubDate: Fri, 15 Aug 2014 00:30:01 -040
       
  • Between A Rock Creek And A Hard Place: Firm Stops Supplement Sales,
           Weathers Litigation
    • Abstract: Rock Creek Pharmaceuticals faces investor and consumer class-action complaints on top of ending sales of its nutritionals following an FDA warning. Moreover, the company name is known more in connection with federal officials’ investigation of the former governor of Virginia than for its products.
      PubDate: Fri, 15 Aug 2014 00:00:04 -040
       
  • Without User Fees, OTC Monograph Changes Have Low Priority At FDA
    • Abstract: FDA’s work on time and extent applications and monograph updates is not supported by user fees, unlike its work in evaluating NDAs for some OTC drugs and for Rx products. The difference shows in the stalled process for approving new monograph ingredients, says the acting head of FDA’s OTC drugs office.
      PubDate: Thu, 14 Aug 2014 00:00:54 -040
       
 
 
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