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The Tan Sheet
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     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • FDA Recalls For Sept. 10 And 17, 2014
    • Abstract: Recalls reported by FDA for OTC drugs, nutritionals and personal care products.
      PubDate: Mon, 22 Sep 2014 00:04:09 -040
  • Weekly Trademark Review Sept. 16, 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, 22 Sep 2014 00:03:51 -040
  • Aleve PM Enters Nighttime Pain-Relief Market After
           160-Count Label Approved
    • Abstract: Bayer HealthCare business on Sept. 15 announced the product with 220mg naproxen sodium and 25mg diphenhydramine HCL is available at U.S. retailers. Its NDA was approved in January, but Bayer waited for FDA’s OK on 160-count labeling before launching the product.
      PubDate: Mon, 22 Sep 2014 00:03:46 -040
  • Bayer’s Early R&D To Get Boost After Material Sciences
    • Abstract: Germany’s diversified big pharma firm will become a bit more focused, with the goal of aiding its faster growing segments.
      PubDate: Mon, 22 Sep 2014 00:03:39 -040
  • FDA Talks Drug Safety With China, But Visas Still Elusive For Staff
    • Abstract: The agency is unable to place more inspectors in China even as Howard Sklamberg, deputy commissioner for global regulatory operations and policy, visits Beijing.
      PubDate: Mon, 22 Sep 2014 00:02:01 -040
  • Continuous Manufacturing Teed Up As Disrupting Force In Pharma Sector
    • Abstract: The question studied over the past decade – whether the industry should adopt continuous manufacturing – has been answered, and the new question is how best to implement it? Pharma firms have drafted a survival guide as they take advantage of continuous manufacturing and realize how it can transform an industry rooted in batch processing.
      PubDate: Mon, 22 Sep 2014 00:01:55 -040
  • Natural Product Expo East Roundup
    • Abstract: Enzymedica launches women’s health supplements; C.S. BioScience offers homeopathic toothpaste; MegaFood’s on-the-go whole food powder supports immunity; Nutritional Products International’s bulk pricing; Aiya’s Matcha To Go’s mix; and Honeydrop relies on therapeutic benefits of honey.
      PubDate: Mon, 22 Sep 2014 00:01:47 -040
  • Steroid-Spiked Supplement Bill Lingers In Roiling Senate Climate
    • Abstract: Time for passing the legislation is running short with Congress leaving to focus on campaigns and with multiple issues already claiming priority for congressional action. The mid-term elections also could diminish the bill’s chances, as well as change control of the Senate and create large turnover in the House.
      PubDate: Mon, 22 Sep 2014 00:01:20 -040
  • California DTSC’s Draft Work Plan Includes Personal Care, But Few
    • Abstract: “Beauty, personal care and hygiene” as one of seven product categories could be priorities in the next round of product selections in California’s Safer Consumer Products program. PCPC welcomes the direction DTSC appears to be taking toward more active industry engagement over the next three years.
      PubDate: Mon, 22 Sep 2014 00:00:44 -040
  • To Curb PSE Diversion, Retailers Lead By Example With Emphasis On
           Tamper-Resistant Products
    • Abstract: An HHS agency’s 2013 drug use survey shows the number of meth users rising by 155,000 after changing little the previous two years. Acura Pharmaceuticals notes the survey and Tennessee data showing that making only tamper-resistant, single-ingredient PSE products available affects the diversion rate.
      PubDate: Fri, 19 Sep 2014 00:15:04 -040
  • Short Window For Senate, House To Agree On TEA Review Deadlines For FDA
    • Abstract: The Senate approves by unanimous consent legislation to speed reviews for all OTC ingredient TEAs. But the House version addresses only sunscreen TEAs, and any agreement the two chambers make on the legislation likely will have to wait for the lame duck session.
      PubDate: Thu, 18 Sep 2014 00:10:02 -040
  • “The Tan Sheet” Q&As: Inside Information From Consumer
           Health Experts
    • Abstract: In exclusive Q&As, experts provide an inside look at their businesses and organizations and candid insight about what drives their decisions and what should be important to companies in the OTC drug and dietary supplement industries.
      PubDate: Wed, 17 Sep 2014 15:40:00 -040
  • E-Cigarette Workshops Aim To Fill Information Gaps Prior To FDA Regulation
    • Abstract: The first of three workshops, Dec. 10-11, will focus on device designs, liquid nicotine and other ingredients, aerosol constituents, packaging, constituent labeling and environmental impact. The workshops are not for commenting on a proposed rule deeming cigars, pipe tobacco and electronic nicotine delivery devices subject to FDA’s authority.
      PubDate: Wed, 17 Sep 2014 11:00:00 -040
  • Weight Loss Products Provide More Targets In FDA War On Spiked Supplements
    • Abstract: FDA finds four weight loss products that contain potentially dangerous undeclared ingredients, including DMAA and sibutramine. The agency also continues to warn about bee pollen with undeclared ingredients.
      PubDate: Wed, 17 Sep 2014 10:35:00 -040
  • FTC Requests Drug Claim Support For Bayer Probiotic Supplement
    • Abstract: On behalf of the FTC, DoJ alleges Bayer violated a 2007 settlement to substantiate supplement claims and asks a court to require the firm to provide two RCTs for dietary supplement claims for Phillips’ Colon Health. Trade groups rally behind the firm, arguing the requirement is unfair and illegal.
      PubDate: Tue, 16 Sep 2014 00:15:03 -040
  • Consumer Health Care Industry News Roundup
    • Abstract: House Passes Stronger Enforcement On Steroid-Spiked Supplements; Sipes Directs CDER Regulatory Policy; Pharmavite Hires Kellogg, NBTY Execs; and ‘Turtle Power’ Behind Colgate Kids Mouthwash
      PubDate: Tue, 16 Sep 2014 00:00:03 -040
  • Weekly Trademark Review Sept. 9, 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, 15 Sep 2014 00:01:54 -040
  • J&J Baby Social-Media Campaign Underscores “Safety
           Promise” Post-Reformulation
    • Abstract: Currently comprising 16 informative YouTube videos, and with 25 more coming before year-end, Johnson’s Baby’s biggest social-media campaign to date has generated 2.3 million views online and sparked a dialogue among millennial moms about Johnson’s products and baby-care issues, the company says. The initiative follows a reformulation announced by J&J in 2011 that removed formaldehyde-releasing preservatives and other controversial ingredients from the line in accordance with consumer demand.
      PubDate: Mon, 15 Sep 2014 00:01:39 -040
  • Global Nutrition & Health Alliance Aims To Elevate Supplement
    • Abstract: Newly formed alliance wants to educate consumers and health care providers about the value of healthy nutrition, including the use of dietary supplements, with initial focus on Omega-3 and Vitamin D.
      PubDate: Mon, 15 Sep 2014 00:00:36 -040
  • Dietary Guidelines Should Endorse Regular Vitamin Use – CRN
    • Abstract: “Using a multivitamin-mineral to fill nutrient gaps is a prudent way to make sure that Americans meet their targeted nutrient intakes,” says CRN science chief Duffy MacKay. The Dietary Guidelines Advisory Committee meets Sept. 16-17 for the final time before submitting its report to HHS and USDA.
      PubDate: Fri, 12 Sep 2014 00:10:01 -040
  • Senators Optimistic As Sunscreen Bill Heads For HELP Committee Markup
    • Abstract: Ahead of a Sept. 17 committee markup of the Senate’s Sunscreen Innovation Act, bill sponsors and stakeholders held a briefing on Capitol Hill to generate support for the legislation, which has already passed in the House. The bill, S. 2141, has 15 co-sponsors and is expected to advance through committee to the Senate floor.
      PubDate: Fri, 12 Sep 2014 00:00:04 -040
  • J&J Looks To Expand Consumer Business After Consent Decree
           Obligations End
    • Abstract: J&J is “very excited about the possibility of consumer becoming a bigger part of our business,” CFO Caruso says, noting it hopes to grow the business organically and through acquisitions. But J&J first must complete its obligations under a consent decree related to manufacturing quality problems.
      PubDate: Thu, 11 Sep 2014 00:10:00 -040
  • Executive Decisions Roundup
    • Abstract: Schnedar heads CDER compliance office; Vitamin Shoppe shops for a CEO; Perrigo adds AER chief; Langowski joins CVS as exec VP; and more Executive Decisions.
      PubDate: Thu, 11 Sep 2014 00:00:03 -040
  • New Consumer Health Products Roundup
    • Abstract: Mentholatum launches new scent for chest rub; Wellmune WGP in four Emergen-C drinks; “revolutionary” digestive supplement; NatureSmart relies on ‘Star Wars’ to win gummy battle; and more new products.
      PubDate: Wed, 10 Sep 2014 12:55:01 -040
  • Flaws In TEA Process Delay Reviews, Monograph Changes – FDA
    • Abstract: The significant time and resources necessary to amend the monograph are one reason for FDA’s slow response to time and extent applications to add ingredients to the OTC sunscreen monograph, agency officials say. Another reason may be flaws in data required in the application process.
      PubDate: Wed, 10 Sep 2014 00:45:01 -040
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