The Tan Sheet
   Full-text available via subscription Subscription journal
     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • FDA Warning On Gerber Formula Claims Strikes Familiar
           Chord With FTC Complaint
    • Abstract: An FDA warning letter to Nestle Infant Nutrition says Gerber Good Start Gentle’s labeling and the product’s website omit or obscure required disclaimers, rendering qualified health claims as unauthorized, and mischaracterize the product’s formulation.
      PubDate: Fri, 21 Nov 2014 15:00:00 -050
  • Dr. Reddy’s Moves Quick On First Generic Allegra-D 12 Hour
    Extended Release
    • Abstract: Generics of fexofenadine-only Allegra and fexofenadine/pseudoephedrine Allegra-D 24 Hour launched soon after the branded product’s switch in 2011, Dr. Reddy’s abbreviated NDA for a generic of Allegra-D 12 Hour Allergy & Congestion is the first approved by FDA.
      PubDate: Fri, 21 Nov 2014 00:05:01 -050
  • Oral Health Concerns Prompt Lawmakers To Ask FDA For Microbead Exam
    • Abstract: Members of Congress urge FDA to investigate reports suggesting plastic microbeads’ use in toothpaste poses health risks. Legislation to ban the ingredients has focused on environmental impact, but adding a consumer health dimension could generate support.
      PubDate: Thu, 20 Nov 2014 00:05:02 -050
  • Ibuprofen ‘Regulatory History’ Pre-empts Failure-To-Warn
           Claims In State Court – CHPA
    • Abstract: FDA regulations and decisions on ibuprofen labeling indicate the agency would not approve warnings plaintiffs seek for Motrin, preventing J&J/McNeil from making the changes without violating federal law, which pre-empts state laws, according to CHPA’s amicus brief in the firm’s appeal of a verdict in Massachusetts.
      PubDate: Wed, 19 Nov 2014 00:05:00 -050
  • Imidazoline Childproof Packaging Deadline Extended Six Months, Potentially
    • Abstract: The Consumer Product Safety Commission followed its staff’s recommendation to extend the deadline for six months, through May 10, 2105, and to consider requests for additional six-month extensions on a case-by-case basis.
      PubDate: Tue, 18 Nov 2014 00:05:01 -050
  • Consumer Health Products Industry News Roundup
    • Abstract: Solgar recalls children’s supplement; and GMP warnings follow inadequate responses.
      PubDate: Tue, 18 Nov 2014 00:00:03 -050
  • Sunscreen Innovation Act Starts Clock Ticking On FDA Review Of TEAs
    • Abstract: Congress passes legislation to provide an alternative process for reviewing UV filters to be added to the OTC drug sunscreen monograph. The bill’s passing during Congress’ lame duck session reflects not only bipartisan support, but also lobbying by the personal care product industry and consumer health advocates to impose deadlines on FDA for long-sought changes to the sunscreen monograph.
      PubDate: Mon, 17 Nov 2014 00:10:00 -050
  • Dietary Supplement GMP Warning Letters
    • Abstract: FDA warning letters also include the latest example of an own-label supplement distributor failing to address compliance with the 2007 supplement GMP final rule.
      PubDate: Mon, 17 Nov 2014 00:04:10 -050
  • House Energy And Commerce
    • Abstract: Senior Democratic members Henry Waxman and John Dingell are retiring, and a senior Republican, Ralph Hall, lost his re-election bid in the primaries.
      PubDate: Mon, 17 Nov 2014 00:04:05 -050
  • Hatch, Alexander Expected To Helm Health Panels In Senate
    • Abstract: Orrin Hatch, the supplement industry’s chief congressional ally and veteran of major pharmaceutical legislative initiatives, is in line to head the Finance Committee with Republican control of the Senate. The HELP Committee – with jurisdiction over public health – could be Lamar Alexander’s first chair opportunity.
      PubDate: Mon, 17 Nov 2014 00:03:57 -050
  • Weekly Trademark Review Nov. 11, 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, 17 Nov 2014 00:03:52 -050
  • FDA Recalls For Nov. 12, 2014
    • Abstract: Recalls reported by FDA for OTC drugs, nutritionals and personal care products.
      PubDate: Mon, 17 Nov 2014 00:03:47 -050
  • FDA Will Face Reforms, Oversight In Republican Congress – Analysts
    • Abstract: Election gains will embolden Republicans to put FDA in Congress’ oversight “crosshairs,” as members of key Senate and House panels scrutinize how the agency is using its resources. Reforms could also come soon as part of the ongoing 21st Century Cures initiative.
      PubDate: Mon, 17 Nov 2014 00:02:54 -050
  • Decree Sends SciLabs To Supplement Manufacturing Sideline
    • Abstract: The Irvine, Calif., firm, which makes supplements distributed under the brand All Pro Science, and CEO Paul Edalat in federal court entered a consent decree of permanent injunction with FDA and DoJ to prevent the distribution of adulterated supplements.
      PubDate: Mon, 17 Nov 2014 00:01:09 -050
  • Epidemiologist, “Coalition Builder” Mayne To Lead CFSAN
    • Abstract: Susan Mayne will succeed Michael Landa at the CFSAN helm in January 2015. Supplement industry stakeholders are encouraged FDA filled the post ahead of Landa’s retirement after feeling the impact of vacancies in CFSAN offices regulating the industry.
      PubDate: Mon, 17 Nov 2014 00:00:59 -050
  • Consumer Health Care New Products Roundup
    • Abstract: “Mainstream wellness” from hemp in cannabidiol; relaxation wins at beverage contest; BodyLab shakes out J-Lo line; homeopathic formulation targets migraines; and AirWare launches skin care line;.
      PubDate: Mon, 17 Nov 2014 00:00:31 -050
  • House Ways And Means
    • Abstract: Dave Camp’s retirement clears way for a new committee chairman.
      PubDate: Mon, 17 Nov 2014 00:00:10 -050
  • Senate HELP
    • Abstract: Lamar Alexander is expected to be chairman with Republican takeover of the Senate; former chairman and key supplement industry ally Tom Harkin is retiring.
      PubDate: Mon, 17 Nov 2014 00:00:06 -050
  • Elections Change Congressional Committees: Senate Finance
    • Abstract: Supplement industry champion Orrin Hatch is expected to chair the panel following the Republican takeover of the Senate. Long-time senator and Health Subcommittee Chairman John Rockefeller is retiring.
      PubDate: Mon, 17 Nov 2014 00:00:01 -050
  • Consumer Health Care Industry News Roundup
    • Abstract: SciLabs on supplement manufacturing sideline; magnesium transdermal absorption claims doused in U.K.; and authorization needed for U.K. Joint Restorer claims.
      PubDate: Fri, 14 Nov 2014 08:30:00 -050
  • H.I.G.’s Capstone Puts Customers First With Custom Formulations
    • Abstract: The private equity firm’s H.I.G. Growth Partners capital investment affiliate merges two of its businesses, Integrity Nutraceuticals and Cornerstone Research & Development, into Capstone Nutrition.
      PubDate: Fri, 14 Nov 2014 00:10:01 -050
  • FTC Actions On Supplement Claim Substantiation Put Industry On Alert
    • Abstract: Substantiation “is not defined by one study or two studies and by whether the FTC likes that study or not,” attorney Todd Harrison says at CRN’s annual convention. Scott Bass, an attorney who worked on writing DSHEA, says “FTC has declared, at least informally, ‘We don’t care about FDA law.’”
      PubDate: Thu, 13 Nov 2014 00:00:08 -050
  • Vitamin Shoppe Hones Innovation As Tip Of Spear For Growth
    • Abstract: “We're not seeing as many new and unique products as we were four years or five years ago,” CEO Tony Truesdale says. The manufacturer and retailer is adding health and wellness devices to its stores and continues with plans to open 60 stores in both 2014 and 2015.
      PubDate: Wed, 12 Nov 2014 00:00:03 -050
  • McNeil Styles Rogaine Sales Boost With 5% Minoxidil
           Product For Women
    • Abstract: Launching Women’s Rogaine with a higher concentration of minoxidil follows FDA’s approval in February of McNeil's supplemental NDA for women’s use of the 5% formulation. With previous testing of the 5% concentration using male subjects only, 2% has been the formulation limit approved for women.
      PubDate: Tue, 11 Nov 2014 00:05:02 -050
  • FDA Recalls Nov. 5, 2014
    • Abstract: Recalls reported by FDA for OTC drugs, nutritionals and personal care products.
      PubDate: Mon, 10 Nov 2014 00:02:54 -050
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