Although actual snow flurries have been scarce in the nation's capitol this winter, 2012 has started with a flurry of activity. First, the U.S. military bans sales of the stimulant DMAA on its bases after two soldiers died and regulators in Canada and New Zealand restrict acess.
Elsewhere in the supplement realm, industry champions Sens. Orrin Hatch and Tom Harkin call on FDA to withdraw the new dietary ingredient draft guidance, citing its conflict with Congress's intent in the Dietary Supplement Health and Education Act.
Finally, FDA posts comments on its self-selection draft guidance, this one from Merck, which mined its studies on the unsuccessful switch of the statin Mevacor to rebut FDA's argument that purchase decisions are "an unreliable surrogate" for self-selection.
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Dietary Supplements
U.S. Military Investigates Supplement Ingredient DMAA, Bans Sales - DoD suspends DMAA sales at military stores after regulators in Canada and New Zealand restricted access and as some U.S. firms change how they market and label the ingredient. These moves and the potential for an FDA review could lead to enforcement against DMAA similar to the 2004 ban against ephedra’s use in supplements.
Food Groups Petition FDA To Withdraw User Fee Notice - Food industry groups request revocation of the food safety fees notice because FDA determined the amount of fees to be collected “in a manner contrary to the method specified by” FSMA. While other supplement groups also question the fees, CRN “didn’t have any concerns with it.”
New Products In Brief - Vitamin Shoppe’s True Athlete line enters the sports nutrition ring; Metagenics makes “smart multi”; antacid supplement features ProDigestive enzymes; Wellesse targets bariatric surgery patients; C3* drink tackles stress; more New Products In Brief.
Regulatory
Nanotech Is “More Than Just Tiny,” Requires FDA Regulation – Lawsuit- Environmental advocacy groups ask FDA to regulate the use of nano-sized particles, particularly in sunscreens and other personal care products, according to a lawsuit seeking an agency response to their 2006 citizen petition that made the same request.
Park Doctrine Influence Could Wane In Upcoming Cases, Attorney Argues - As penalties increase under the responsible corporate officer doctrine, attorney Allison Burroughs says to expect increased scrutiny. A DoJ Consumer Protection Branch official says pharma execs will be held responsible because of the role the industry plays in consumers’ daily lives.
FDA’s Office Of Regulatory Affairs Scrutinizes Recalls Process - ORA sets a 2012 priority of improving the efficiency of the recall process to help reach its overall enforcement and compliance goal of preventing public health emergencies.
OTCs
N.J. Lawmakers To Consider Age Restriction For DXM - The state legislature’s Law and Public Safety Committee in November unanimously passed the bill to require photo identification for purchases of products containing dextromethorphan and impose a fine of up to $750 on employees and retail establishments for violations.
People
People In Brief - Bristol-Myers exec to head Teva; GSK’s Witty now Sir Andrew; ISPE names Berg president; more People In Brief.
News in Brief
In Brief - FDA proposes amending ANDA-blocking petition reg; Sara Lee snaps up Tea Forté; testing by FDA, CDC find no bacteria in Enfamil formula powder; USP offers draft probiotics standards; more news In Brief.
On The Hill
Hatch, Harkin Call For Withdrawal of NDI Draft Guidance - Sens. Hatch and Harkin ask FDA to craft a new document to replace the current NDI notification draft guidance, recommending the agency “provide needed clarification” on what constitutes an NDI.
Appropriations Negotiators Allow NIH Translational Science Center Launch- NIH receives more than $500 million to finance the National Center for Advancing Translational Science, created in the consolidated fiscal 2012 appropriations bill. Members of Congress cautioned that NCATS’ work to speed up drug development should not inhibit private efforts in the same arena.
--Carolyn B. Phenicie (c.phenicie@elsevier.com)
