Drug – Shehadeh Giannamore, PLLC

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FDA Warns of Marketing Cosmetics with Drug Claims

FDA Cosmetics, Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning Letters

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) governs the regulation of drugs and cosmetic products. The Act defines a cosmetic, in part, as something designed for the, “cleansing, beautifying, promoting attractiveness, or altering the appearance [of a person].” By contrast, the Act defines a drug, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," or “intended to affect…

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FDA Approval Required for Company Enjoined from Marketing Products

FDA Disease Claims, Drug, Drugs, Enforcement, FDA, FDA Approval, Injunction, Labeling, Marshalls, NDA, Seizure

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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FDA Seeks Injunction against Company for Misbranding Drug Products

FDA Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Warning Letters

On June 25, 2014, the U.S. Department of Justice ("DOJ"), in response to a request made by the U.S. Food and Drug Administration ("FDA"), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company's president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District Court for the Central District of California, related to Laclede's illegal distribution of over-the-counter (OTC) vaginal drug products that did not have the required FDA approval. News pertaining to this action can be found here. The unapproved products that were subject to the complaint against…

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FDA Seizes Topical Creams Deemed Drugs

FDA Disease Claims, Drug, Drugs, Enforcement, Labeling, NDA

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 Approves First Drug Specifically Formulated to Treat Pediatric Tumors

FDA Accelerated Approval Program, Drug, Drugs, FDA, Pediatric, post-marketing studies

On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by Novartis, Afinitor Disperz is a new dosage form of the existing anti-cancer drug Afinitor. While approved by the FDA in November 2010, Afinitor was for use only in patients three years of age and older. With this new approval, Afinitor Disperz is recommended for use by patients ages 1 and older. This approval is significant in that Afinitor Disperz is…

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FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

FDA Dietary Supplements, Drug, Drugs, FDA, Recalls

On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of the Company’s products. Tadalafil is the active ingredient in Cialis, the popular drug approved by the FDA to treat Erectile Dysfunction (“ED”). Because of the presence of the undeclared pharmaceutical ingredient, the FDA warns that the Company’s products are considered unapproved new drugs under the…