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The Tan Sheet
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     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • FDA Ignores OTC Firms’ Expertise On Drug Naming In Draft Guidance
    • Abstract: CHPA says FDA’s draft guidance on developing proprietary drug names ignores that OTC manufacturers assess risks for all aspects of their products, including names, prior to launch.
      PubDate: Fri, 26 Sep 2014 09:10:01 -040
  • Whole Food Supplement Sales Growing Twice As Fast As Overall Category
    • Abstract: Whole food supplement sales grew twice as fast as the overall supplement category in 2013, and could be the key to retaining and gaining sales in an industry that analysts predict will stagnate in the next few years as consumers opt for fortified “real” foods over supplements.
      PubDate: Fri, 26 Sep 2014 00:15:02 -040
  • ‘Sales Velocity,’ High Gross Margins Influence Investors
           Eyeing Supplement Deals
    • Abstract: Private equity and big pharma seek acquisitions and investment opportunities in the self-care space to round out their portfolios with stable investments. Small firms looking to be acquired can improve their options by offering a strong brand, high gross margins and sales velocity, an investment firm manager says.
      PubDate: Thu, 25 Sep 2014 00:15:01 -040
  • States Should Restrict Weight Loss, Bodybuilding Supplement Sales –
    • Abstract: “The lax federal regulatory scheme for dietary supplements leaves extreme gaps in federal oversight that should be filled by state governments,” according to a report by public health experts. State attorneys general have “bully pulpit” to expand on enforcement authorities exercised by both FDA and FTC, they say.
      PubDate: Thu, 25 Sep 2014 00:00:02 -040
  • Consumer Health Care Industry News Roundup
    • Abstract: FDA warns West Coast Labs of adulterated supplements; FTC warns firms in ‘Full Disclosure’ initiative; Mannatech expands in Singapore; and Youtheory hires Nick Bitz.
      PubDate: Wed, 24 Sep 2014 08:55:02 -040
  • SmartX “Brain Supplement” Firm Should
           Rethink Its Product Claims – NAD
    • Abstract: Cerebral Success submitted studies that did not test SmartX products or similar formulas, but were limited to findings on separate ingredients. NAD also said even when using the disclaimer “designed to,” an advertiser must provide reasonable support a product will “deliver the touted benefits to consumers.”
      PubDate: Wed, 24 Sep 2014 00:15:01 -040
  • OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance –
    • Abstract: The trade group recommends FDA write a separate proprietary name guidance for OTC drugs. FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on labeling, CHPA says in comments.
      PubDate: Tue, 23 Sep 2014 00:15:02 -040
  • Consumer Health Industry News Roundup
    • Abstract: Sigma-Tau launches colic-reliever; non-HFC propellant in Dr. Smith’s sprays; and upcoming supplement webinars.
      PubDate: Tue, 23 Sep 2014 00:00:05 -040
  • 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
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Heriot-Watt University
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