The New Year starts with a bang as FDA reveals new enforcement against an ingredient banned from use in supplements and as several companies embrace new brands and strategies in an attempt to start 2012 on the right foot.
Just in time for New Year’s diet resolutions, FDA announces the seizure of products adulterated with ephedrine alkaloids – a move that sends a strong deterrence message. An agency official acknowledges other products likely contain the illegal and undeclared diet aid and that FDA will seek these as part of its enforcement against spiked supplements.
Meanwhile, ProPhase Labs’ CEO Ted Karkus discusses the firm’s plans for 2012 and beyond, including several line extensions for Cold-EEZE and new products that use the state-of-the-art delivery technology available to ProPhase through a joint venture with the Australian delivery technology firm Phosphagenics Ltd. Prestige Brands also hopes to expand its offerings in 2012 by closing the acquisition of 17 brands from GlaxoSmithKline, including BC and Goody’s brands.
Finally, we also take a look back at the most read topics of 2011, including how Johnson & Johnson handled quality control problems, the mystery of Pfizer’s consumer division’s future and the future of Rx-to-OTC switches.
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Rx-to-OTC Switch
Somaxon Could Seek Buyer For Silenor Sleep Aid, OTC Marketing Rights – Somaxon reconsiders its options and might sell the sleep aid Silenor, despite a “clear path” to switch OTC, after the firm’s stock fell from $10.60 per share to 42 cents per share. Procter & Gamble would have first crack at exclusive OTC marketing rights if Somaxon sells Silenor.
Dietary Supplements
Ephedra Back On Regulatory Radar As Supplement Adulterant – FDA acknowledges that enforcement activity on ephedra has been a lower priority than other adulterants since the agency banned ephedrine alkaloids in supplements in 2004. “The presumption was that it was banned and people were abiding by the law,” says FDA supplement official Daniel Fabricant.
Supplement Industry Waits For “Friendlier” MedWatch Form – FDA changes MedWatch form 3500A to accommodate medical device firms’ needs, but will not make changes to facilitate reporting AERs for drug, supplement or food products. The agency and supplement industry stakeholders agree 3500A is not ideal for supplement AERs.
Regulatory
MedWatch Plus Stalled As FDA Prioritizes Food, Animal Drug AER System – FDA is delaying work on the web-based MedWatch Plus system for receiving drug, dietary supplement and medical device adverse event reports to focus on improving a portal for adverse events linked to human and animal food and veterinary drugs. The Food Safety Modernization Act required improvements to the agency’s Safety Reporting Portal, which was implemented in May 2010, according to FDA officials.
Enforcement News In Brief – FDA warns Nenningers Naturals based on Twitter flu prevention claim; Global Sweet Polyols earns warning due in part to dog in facility; Yogi Tea warned for insufficient QC review documentation; more Enforcement In Brief.
OTCs
CEO Karkus Talks Cold-EEZE Turnaround At “Lean, Mean” ProPhase Labs – In an interview, ProPhase Labs CEO Ted Karkus talks about the ongoing turnaround of Cold-EEZE zinc lozenges, ProPhase’s flagship brand, as well as efforts to launch new products and restore relationships with retailers.
Prestige Acquires 17 Glaxo OTC Brands, Enters Analgesics Market – Prestige Brands acquires GlaxoSmithKline’s BC and Goody’s analgesic brands as part of $660 million deal for 17 North American OTC lines, also including Beano gas treatment, FiberChoice supplement and Sominex sleep aid.
Court Rules Studies Don’t Support Cirrhosis – Acetaminophen Link – A few observational case studies are not enough to prove prolonged therapeutic use of Tylenol (acetaminophen) was sufficient to cause a plaintiff’s liver damage, a New York state court ruled in a case brought against McNeil Consumer Healthcare. The appellate division of New York’s Supreme Court ruled the Supreme Court properly determined that the Johnson & Johnson division “met its burden by demonstrating that there was no evidence linking acetaminophen to cirrhosis,” Judge John Leventhal wrote in the unanimous Nov. 22 opinion.
Research & Development
Research & Development In Brief – PPIs linked to community-acquired pneumonia; Vitamin D deficiency linked to heart health; Lacidofil provides multiple benefits; more Research & Development In Brief.
Business & Finance
J&J’s Problems, Pfizer’s Options And Switch Outlook Top “The Tan Sheet” Topics In 2011– Readers of “The Tan Sheet” in 2011 showed the most interest in stories about Johnson & Johnson’s OTC quality issues, Pfizer’s consumer business maneuvers and Rx-to-OTC switch outlooks. Other hot topics included omega-3 drug development, supplement GMP strategies and state pseudoephedrine laws.
In Brief – Shareholder suit against Johnson & Johnson, including CFO Caruso, may proceed; Novartis pauses OTC production at Nebraska plant; Mead Johnson finds Enfamil powder clear of bacteria after stores pull the product; John Gay leaves NPA after two years as executive director and CEO; more news In Brief.
-- Elizabeth Crawford (e.crawford@elsevier.com)
