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FDA Warning Issued Regarding Weight Loss Products

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On April 7, 2014, the U.S. Food and Drug Administration ("FDA") released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was to alert the public that the product contained potentially harmful active pharmaceutical ingredients, which had not been listed on the label for the product and was the subject of a FDA warning letter. The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk…
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FDA Seizes Topical Creams Deemed Drugs

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On May 16, 2014, the U.S. Food and Drug Administration ("FDA"), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The products seized by the FDA included those marketed for the treatment of inflamed hemorrhoids, colitis and other inflammatory conditions (Hydrocortisone Acetate Suppositories, 25 mg) and skin thickening conditions such as dermatitis and eczema (Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%). The FDA announcement can be found…
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FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids

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On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured for Blunt Force Nutrition in North Carolina and is sold in retail stores, gyms, and on the internet. The FDA alleges that despite being labeled as a dietary supplement, Mass Destruction contains synthetic anabolic steroids, which makes it an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDA’s announcement may be found here.…
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FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

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On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating that the products are safe for long-term use and effective in preventing illness and infection. You can read the FDA’s announcement here. The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above,…
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J&J Company Pleads Guilty to Misbranding for Off-Label Marketing

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On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen Pharmaceuticals, Inc. (JPI), a Johnson & Johnson company, pled guilty to misbranding the drug Risperdal (risperidone) in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), arising from its off-label marketing of the drug. Under the plea agreement, the Company is required to pay a $400 million criminal fine. It will also be required to pay civil penalties under a separate settlement concerning Risperdal. The cases resulting in these settlements originated from qui tam, or “whitstleblower,” lawsuits filed under…
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FDA Approves Botox Cosmetic for New Intended Use

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On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered via intramuscular injection. You can read the announcement here. The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA…
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FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs

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On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and other federal laws. The products, sold online and in retail stores, include dietary supplements, over-the-counter (OTC) drugs, and unapproved prescription drugs. You can read the announcement here. Also, a list of the warning letters is available at this link. The FDA issued the warning letters as part of an initiative to remove illegal diabetes products from…
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Supreme Court to Review Design Defect Case against Generic Drug Company

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On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for the First Circuit, in Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. 2012), where the Court found that the Federal, Food, Drug, and Cosmetic Act (“FDCA”) does not preclude a state law design defect claim against a generic drug manufacturer. You can find the documents in the case here. Mutual is a Pennsylvania company that…
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FDA Approves Orphan Drug to Treat Aplastic Anemia

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On February 21, 2013, the U.S. Food and Drug Administration (“FDA”) granted orphan drug status to an aplastic anemia treatment. Aplastic anemia is a rare condition where bone marrow does not produce sufficient blood cells or platelets. The treatment, placental expanded (PLX) cells, is sponsored by Pluristem Therapeutics, Inc. You can read more about the requirements for obtaining orphan drug status here. Pursuant to the Orphan Drug Designation program, the FDA provides incentives for the development of products that will diagnose or treat rare diseases. Orphan drug status qualifies a drug sponsor to receive tax credits for clinical testing of…
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Marshals Seize Supplements with Undeclared Drug Ingredients

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On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be tainted dietary supplements, believing the products to be unsafe, as they may contain an undisclosed active pharmaceutical ingredient. Marshals noted that several of the products that were seized contain sibutramine hydrochloride (sibutramine), which is the active ingredient in Meridia, an obesity drug. Meridia was pulled from the market in the United States in December of 2010, after clinical trials determined…
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