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The Tan Sheet
   Full-text available via subscription Subscription journal
     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • Herbalife Rebuts FDA Deputy Commissioner’s View Of ‘Safe And
           Effective’ Statement
    • Abstract: The beleaguered firm can add FDA’s foods and veterinary medicine chief, Michael Taylor, to the list of regulatory officials who have questioned some aspect of its business. Taylor says a Herbalife TV ad and an online video “mischaracterize FDA’s role with regard to dietary supplements” and should be halted.
      PubDate: Fri, 19 Dec 2014 00:05:00 -050
  • Mature Supplement Market Demands Segmented Marketing
    • Abstract: “No matter how you look at it, it’s a mature category,” and “utilizing segmented marketing is vital,” it says Natural Marketing Institute President Maryellen Molyneaux.
      PubDate: Fri, 19 Dec 2014 00:00:02 -050
  • Teens Dousing Smoking, But Initiating Nicotine Use With Electronic
           Delivery Devices
    • Abstract: Researchers with the Monitoring the Future survey say e-cigarettes could serve as a point of entry into the use of nicotine. “For these youth, e-cigarettes are a primary source of nicotine and not a supplement to tobacco cigarette use,” the researchers say.
      PubDate: Thu, 18 Dec 2014 00:05:01 -050
  • Industry News Roundup
    • Abstract: NCCIH debuts at NIH; Gravity in Hantain’s orbit; SDC Nutrition in Costa Rica, Cayman Islands; Mannatech in Spain; and Food Advisory Committee nominations.
      PubDate: Thu, 18 Dec 2014 00:00:13 -050
  • Downward Trend In Teen Abuse Of Cough/Cold OTCs Continues
    • Abstract: The percentage was highest among high school seniors, 4.1%, while 3.7% of sophomores and 2% of 8th-graders reported they had within the previous 30 days used OTC drugs to get high, according to Monitoring the Future survey results.
      PubDate: Thu, 18 Dec 2014 00:00:06 -050
  • For J&J OTC Sales, Tylenol Arthritis Label
           Approval Could Bring Relief Closer
    • Abstract: FDA’s approval positions J&J/McNeil to return Tylenol 8HR Arthritis to the market with new packaging to interest consumers while also sustaining their connection with the iconic brand. The latest label design for the product features different color schemes and text fonts than the most recent previous changes.
      PubDate: Wed, 17 Dec 2014 00:00:04 -050
  • Harkin, Hatch Swing At FDA Pitch To Evaluate NDIs Under Food Additive
    • Abstract: The staunch industry allies explain their concerns about the potential for regulating new dietary ingredients as food additives in a letter to FDA Commissioner Hamburg. They point out DSHEA includes “an essential exclusion of dietary ingredients from the statutory definition of food additives.”
      PubDate: Tue, 16 Dec 2014 00:05:24 -050
  • FDA Gets Senate Funding, House Scolding In Fiscal 2015 Appropriation
    • Abstract: An omnibus spending agreement gives FDA about a 1.3% increase from its fiscal 2014 appropriation. But the Office of the Commissioner still stands to lose $20 million if FDA does not finalize draft guidance on evaluation and labeling of abuse-deterrent opioids by June 30, 2015.
      PubDate: Mon, 15 Dec 2014 00:02:28 -050
  • Weekly Trademark Review Dec. 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 Dec 2014 00:02:18 -050
  • Homeopathic Claims Have FTC Searching For Remedy To Regulatory Conflict
           With FDA
    • Abstract: FTC shuts down the second marketer this year for making fraudulent claims for human chorionic gonadotropin weight-loss products. Enforcing against other homeopathics’ claims that violate advertising regulations, however, is on hold until FTC resolves its differences with FDA’s regulatory oversight of the products.
      PubDate: Mon, 15 Dec 2014 00:02:11 -050
  • Consumer Health New Products Roundup
    • Abstract: Daily iodine supplementation for premenstrual discomfort; immune system support from Hyperbiotics; Emerald Resources hammers natural in testosterone booster; Cetaphil line reaches babies; SuperNutrition gets HeartSmart; and Iovate Nature’s Food at GNC in U.S.
      PubDate: Mon, 15 Dec 2014 00:01:57 -050
  • Industry News Roundup
    • Abstract: DASCA facilitates DEA’s steroid scheduling; U.K. ad authority sneezes at hay fever claim; Nutroganics acquires Wholesoy; hemp migraine relief distribution lit; Clif’s cashew recipe trips some customers; ONHA sponsors GrassrootsHealth nutrient research; baby wipe recall reaches 4M units; and Nasdaq reprieve for Rock Creek.
      PubDate: Mon, 15 Dec 2014 00:01:20 -050
  • Sunscreen TEAs Could Illuminate How Deadlines Influence FDA’s
    • Abstract: CHPA says FDA’s work on sunscreen TEAs under deadlines already set will give an idea of the impact from changes Congress imposed for FDA’s TEA process. But the industry will not know whether the changes benefit introducing other new OTC ingredients until FDA establishes and follows process deadlines.
      PubDate: Mon, 15 Dec 2014 00:00:01 -050
  • DoJ Aims To ‘Do Something About’ Crime In FDA-Regulated
    • Abstract: In a frank warning at a FDLI meeting, DoJ Director of Consumer Protection Michael Blume says the agency’s role is clear once it takes on a case investigated by FDA or FTC. Blume notes the dietary supplement category “has become something of an emphasis for us in the department.”
      PubDate: Fri, 12 Dec 2014 00:00:03 -050
  • Supplement Space Exit Strategy: Bankruptcy Traffic Could Accelerate
    • Abstract: Gaspari Nutrition, acquired by Allegro Nutrition, sought Chapter 11 protection after its debt load outstripped its revenue outlook. Natrol threw in the towel and filed after federal judges consolidated multiple class action claims accusing the firm of false advertising for its joint relief products.
      PubDate: Thu, 11 Dec 2014 00:05:00 -050
  • Dietary Supplement GMP Warning Letters
    • Abstract: Failing to establish specifications and conduct ingredient identity tests continues to trip up supplement manufacturers, and non-compliant firms’ responses to FDA continue to omit documentation about their stated corrective actions.
      PubDate: Thu, 11 Dec 2014 00:00:02 -050
  • Industry Wants To Up Its Ante As California Deals Safer Product Reg Cards
    • Abstract: Stakeholders weigh in on the California Department of Toxic Substances Control’s draft work plan for advancing the state’s Safer Consumer Product regulations. Industry groups request more opportunities for providing input and seek visibility into DTSC’s internal processes.
      PubDate: Wed, 10 Dec 2014 00:05:14 -050
  • Executive Decisions Roundup
    • Abstract: Another Coca-Cola exec pops up at NBTY; Hussain helms Glaxo pharma globally; China TCM office veteran returns; T-Bird tabs Huang as COO; and Lee named Calif. DTSC director.
      PubDate: Wed, 10 Dec 2014 00:00:14 -050
  • FDA Program Alignment For Boosting Specialization Also Stretches Funding
    • Abstract: Officials from FDA’s centers for Food Safety & Applied Nutrition, Drug Evaluation and Research and Veterinary Medicine discuss the ORA/centers alignment effort that Commissioner Margaret Hamburg announced earlier in 2014 to streamline agency efforts and improve efficiency.
      PubDate: Tue, 09 Dec 2014 06:00:00 -050
  • FDA’s Suggested Acetaminophen Allergy Warning Tracks Industry Change
    • Abstract: The recommendation in a draft guidance covering single- and combination-ingredient acetaminophen products marketed under the tentative final monograph for internal analgesics mirrors a warning that some OTC manufacturers already are using on their products.
      PubDate: Mon, 08 Dec 2014 00:02:51 -050
  • Industry News Roundup
    • Abstract: ‘Heal yourself’ claim nicked by FDA; Urban Moonshine’s error of omission; new tech needs old school substantiation; O2 plans big for InboxFitness; Migranade sprouts spray division; ChromaDex cashes in NeutriSci shares; GoodSense sponsors runDisney; Walgreens joins flu tracking crowd; Qualitas algal omega-3 reaches market; Islet cooks cannabidoil in business plan; and Food Advisory Committee candidates sought.
      PubDate: Mon, 08 Dec 2014 00:02:39 -050
  • Weekly Trademark Review Dec. 2, 2014
    • 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, 08 Dec 2014 00:02:32 -050
  • Dietary Supplement GMP Warning Letters
    • Abstract: Dietary supplement manufacturers’ responses to FDA reports of good manufacturing practices problems not only are inadequate, but in some instances prompt the agency to warn of checking for corrective actions in later inspections, according to recently posted warning letters.
      PubDate: Mon, 08 Dec 2014 00:02:28 -050
  • REACH Update: Draft Community Rolling Action Plan 2015-2017
    • Abstract: The European Chemicals Agency’s Community Rolling Action Plan proposes adding 65 chemicals to the list of substances flagged for member-state review over the next three years under the EU’s REACH program. Newly listed cosmetic substances would include zinc oxide, benzyl alcohol, propyl acetate and phenol.
      PubDate: Mon, 08 Dec 2014 00:02:11 -050
  • Merck KGaA Hoists Consumer Health Flag High, Stays The Course For Growth
    • Abstract: The German’s firm’s consumer health division hosts a day-long debate on major pressures and influences facing the OTC and nutritional products sector. "We really want to stick to” the consumer products business, Merck Consumer Health CEO Uta Kemmerich-Keil says.
      PubDate: Thu, 04 Dec 2014 00:00:02 -050
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