Regulatory News In Brief
This article was originally published in The Tan Sheet
Executive Summary
FDA extends FSMA comment period
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FDA extends FSMA comment period The agency extends to Nov. 30 the deadline for comments on the burden of Food Safety Modernization Act user fees on small businesses. FDA’s notice for comment requested input on whether a reduction in fees for small businesses is appropriate and how to define small business under FSMA. The agency originally published the request Aug. 1 with a 78-day comment period. In an Oct. 5 guidance, FDA delayed submitting invoices for the fees until the agency creates a process to apply for waivers. Supplement industry leaders have noted FSMA-authorized user fees could be significant, particularly for small businesses. For fiscal 2012, FDA set the user fee rates at $224 an hour for domestic investigations and $325 when foreign travel is required (Also see "Food Safety User Fees On Hold Until FDA Creates Waiver Process" - Pink Sheet, 10 Oct, 2011.). Insight recalls nasal spray Insight Pharmaceuticals recalls one lot of Nostrilla nasal decongestant spray that could be contaminated with bacteria, the firm says Oct. 19. An internal investigation found Burkholderia cepacia in the product. The bacteria may cause a serious infection in consumers with compromised immune systems or chronic lung conditions, the Langhorne, Pa., firm said. The contaminated lot was distributed nationwide through pharmacies and retail outlets. No illnesses linked to the products have been reported, the firm said. Algonot warned for product claims FDA warns that dietary supplement firm Algonot’s website includes claims that make its Algonot-Plus, CystoProtek, ProstaProtek and NeuroProtek unapproved new drugs. The claims include “designed to give long-term relief from arthritis” and “may reduce symptoms of gut and brain inflammation and nerve damage.” FDA’s Sept. 16 letter also cites consumer testimonials and supportive research posted on the Sarasota, Fla., firm’s website as evidence of the products’ intended uses. Unapproved claims translated from Spanish Normidex’s dietary supplements are unapproved new drugs because they make illegal claims, including “anticancer” and “eliminating diabetes.” The claims, included on product labeling and in promotional materials, were translated from Spanish, FDA’s Los Angeles district office says in an Oct. 11 letter to the San Diego firm. Additional products are misbranded because they fail to include supplement fact boxes, a list of dietary ingredients or warning about iron overdose, among other violations. FDA also noted good manufacturing practices violations. |