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FDA Regulation of OTC Sunscreen Products

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Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing to wear sunscreen on a daily basis throughout the summer months, it is imperative that the sunscreen on the market is safe and effective. With that in mind, on November 26, 2014, Congress enacted the Sunscreen Innovation Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen with the U.S. Food & Drug Administration (“FDA”). The Sunscreen Innovation Act does not relax the FDA’s scientific standards for evaluating safety and effectiveness of sunscreen ingredients. It…
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FDA Stops Company from Marketing Unapproved New Drugs

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On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. The permanent injunction prohibits Laclede from selling and distributing unapproved new drugs or misbranded drugs and devices. According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs.…
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FDA Guides on General Wellness and Low Risk Devices

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On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health (CDRH) to deal with inquires from manufacturers asking whether or not their products qualify as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are defined in section 201(h) of the FDCA as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ...intended…
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Court Issues Injunction after FDA Warning Letter Issues Persist

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On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration ("FDA") regulations and mandated standards (Current Good Manufacturing Practices or “CGMPs”). According to the FDA, the steps taken by the manufacturer in response to an FDA warning letter and FDA inspections did not bring the facility back into compliance with the CGMPs, prompting FDA to move forward with the action for injunction. In the case against the company, the judge signed a consent decree of permanent injunction, which requires…
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Overview of FDA’s Final Menu and Vending Labeling Rules

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Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling rules). The full text of the menu and vending labeling rules can be found here. The menu labeling rule applies to restaurants if they are part of a chain of 20 or more locations, doing business under the same name, and offering more or less the same menu items. The 1990 Nutrition Labeling and Education Act established nutrition labeling on…
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FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

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On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District of Michigan against Scotty’s Incorporated, a manufacturer of ready-to-eat sandwiches. The FDA alleges that Scotty’s violated the Hazard Analysis and Critical Control Points (HACCP) food safety management system, which according to FDA must be followed under federal law. Scotty’s had previously received a Warning Letter in 2009 for failing to have adequate processes and controls in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the…
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FDA Food Allergen Labeling

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When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, peanuts, and soybeans are all common ingredients considered “major food allergens” that can potentially cause life-threatening consequences for consumers with allergies. The U.S. Food and Drug Administration notes that each year in the United States, food allergies cause 30,000 visits to the emergency room, 2,000 hospitalizations, and 150 deaths. Because of these health concerns, food allergen labeling has emerged as…
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FDA Imports: Foods and Cosmetics

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Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As it turns out, importing food and cosmetics into the United States is not as simple as putting it in boxes and shipping it to the supermarket or local drug store. The U.S. Food and Drug Administration (FDA) is guided by a comprehensive statutory scheme that governs food and cosmetics produced in foreign countries and imported into the United States. Understanding the issues surrounding FDA imports, including how the importation of foods and cosmetics are affected by federal regulations, is important…
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FDA Approval Required for Company Enjoined from Marketing Products

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On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As we previously reported, Ascend had been targeted in connection with the marketing and sale of certain products, deemed drugs by the FDA, without first obtaining formal FDA approval. As explained in FDA’s announcement of the injunction, the Company is now enjoined from marketing these products until they first secure FDA approval and post bond to recover the seized products. As…
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Court Finds FDA Exceeded Authority in Device Reclassification

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On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being sold on the market in an effort to require the device to obtain further approval. The medical device that was the subject of the controversy was an absorbable surgical mesh, designed for use in knee replacement surgeries, called the Collagen Scaffold. In 2008, the device manufacturer obtained clearance from the FDA, through the 510(k) process, to market the Collagen Scaffold.…
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