Drugs – Shehadeh Giannamore, PLLC

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District Court sides with Industry on Dietary Supplement Substantiation

FDA, FTC Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Structure-Function Claims, Substantiation

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. The 2007 Consent Decree prohibited Bayer from “making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses competent and reliable scientific evidence to support the claim.” The current decision originates from a motion for an order to show cause filed by the Department…

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Potential Changes to FDA Regulation of Homeopathic Drugs

FDA Drugs, FDA, Homeopathic, Labeling, OTC Drugs

On April 20, 2015 the Food and Drug Administration (FDA) heard testimony regarding homeopathic drugs and the Agency’s role in the regulation thereof. These two-day long hearings come after the FDA received over 1,500 public comments about the possibility of regulating homeopathic drugs in a manner consistent with over-the-counter (OTC) drugs. A primer for the public hearing can be found in the federal register, here. Homeopathy began in the 18th century, based off of teachings from a German scientist, Samuel Hahnemann. The main concept in homeopathy is that, “like cures like” (similia similibus curentur) meaning that disease causing substances can…

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US Marshals Seize Topical Products Deemed Drugs by FDA

FDA Disease Claims, Drugs, Enforcement, FDA

On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs from Stratus Pharmaceuticals, Inc. of Miami, Florida. Stratus purchased these unapproved prescription drugs, worth over $1.5 million, from Sonar Products, Inc. of New Jersey and marketed the topical products, deemed drugs by the FDA to consumers. The FDA conducted an inspection in late 2014 that revealed that Stratus was marketing these topical products without first acquiring the required FDA-approved drug applications, which is typically required when marketing drug products under the Federal Food, Drug and Cosmetic Act (“FFDCA”). The FDA found…

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Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

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

On March 31, 2015, Attorney Katherine Giannamore, of Shehadeh Giannamore, PLLC, was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of the industry’s premier sources for specialized, in-depth coverage and analysis of regulatory and market developments across the personal care and cosmetics industries. The full text of the article interview may be accessed here. The article focuses on cosmetics companies’ efforts to simultaneously promote their products effectively while abiding by all applicable laws and regulations. On this blog, we have previously discussed the challenges and…

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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 Stops Company from Marketing Unapproved New Drugs

FDA Disease Claims, Drugs, Enforcement, FDA, Injunction, Labeling, NDA, Warning Letters

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 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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FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

FDA, FTC Dietary Supplements, Disease Claims, Drugs, FDA, FTC, Labeling, Substantiation, Warning Letters

On September 23, 2014, the U.S. Food & Drug Administration ("FDA"), in conjunction with the Federal Trade Commission ("FTC"), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or prevent disease. According to the letter, Dr. Rima Laibow promoted Nano Silver as a "natural therapy" or "cure" for the Ebola virus. Additionally, Laibow's website contained claims referring to the product as…

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Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

FDA CGMP, dietary supplement marketing, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, manufacturing practices, permanent injunction, Structure-Function Claims, Warning Letters

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here. BioAnue received a warning letter from the…

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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…