FDA plans OTC overhaul… 32 Spray April 2014 From p. 14 remains sterile throughout use. Rinosoro nasal decongestant fluid for adults and children dispenses a sodium chloride solution in an easy-to-use, continuous jet spray. Both nasal sprays utilize packaging from Coster. Happy Feet From arthritis to blisters to ingrown toenails, hurting feet present a huge public health concern, according to the American Academy of Orthopaedic Surgeons (AAOS), which states that 43.1 million U.S. residents suffer from foot problems…that’s one in every six people. Help is on the way with Tinactin Chill Liquid Spray, which relieves the itching, burning and cracking of athlete’s foot and ringworm. It sprays on to provide a quick, convenient, no-touch application that leaves no powder residue and helps prevent infection from recurring. New Odor-Eaters Spray Powder with Tolnaftate Antifungal absorbs sweat, destroys odor and helps prevent most athlete’s foot. It’s three advanced, long lasting odor and wetness fighters dry fast and clear to stop odor all day. The 4oz. package is topped by the travel-friendly Twist-To-Lock Vail accessory on VX valve from Aptar Beauty + Home. Reckitt Benckiser’s Scholl brand in the UK relaunched Scholl Fresh Step Shoe Spray to help soothe and cool the symptoms of Athlete’s Foot using non-prescription Tolnaftate. It helps eliminate odor and dries with no residue. Also relaunched was Scholl Fresh Step Anti-Perspirant Foot Spray, specially developed The U.S. Food & Drug Administration (FDA) plans to overhaul the way it approves OTC medical products, a move that will change how tens of thousands of personal care items and medicines reach U.S. store shelves. The products—from pain relievers to sunscreens to antifungal medicines—have for decades been approved through a time-consuming process that hampers manufacturers’ ability to later modify their ingredients. Revamping the approval path would have big implications for the over-the-counter medical products industry, which in 2012 recorded $29.3 billion in annual U.S. sales, according to the Consumer Healthcare Products Association, which represents OTC producers. The industry could introduce new forms of products more quickly as researchers discover better ingredients. The current approval framework was created in 1972 and now needs a complete revision to become a more agile and responsive process, the agency said. As we go to press, the FDA planned to hold a public hearing March 25–26 to consider ideas from the community. At issue are the tens of thousands of drugs and products created through “monographs”—essentially, recipes of ingredients that go into drugs. That monograph process is distinct from the one in which most prescription drugs get tested and approved by the FDA. “The current system isn’t working well for the public or for us,” Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation, said. “We would like monograph drugs to have the same safety framework as prescription drugs.” The agency said it is contemplating certain specific changes that include improving the FDA’s ability to quickly require new warnings or label changes as safety issues emerge based on new science. In addition, the agency said it hopes to allow innovative changes in products more quickly. It also wants to include new dosing limits for children based on the most recent science. For example, the FDA still allows a 500-milligram over-the-counter Tylenol pill, generically called acetaminophen, to be sold despite liver toxicity issues. The FDA said it agrees the highest over-the-counter Tylenol pill should be just 325 milligrams, but contends that the current regulatory framework doesn’t allow such changes to be made quickly. Johnson & Johnson, the maker of Tylenol, contends that when used as directed, Tylenol has a favorable safety profile. David Spangler, Senior VP for Policy at the Consumer Healthcare Products Association, said the group generally supports the idea of making the approval process more efficient. He estimated there are more than 100,000 OTC medical products on the market. Source: The Wall Street Journal Finding Relief Over The Counter
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