USDA Organic Labeling

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The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural products. These standards do not address food safety or nutrition, as these issues are within the regulatory oversight of FDA or other USDA programs. The statutes under which the National Organic Program operates are found here. When a company wants to use organic labeling or label a product in a way that promotes the use of to organic ingredients, they…
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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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FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

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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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FDA Inches Closer to New Nutrition Facts Panel Rules

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On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that would make significant changes to food labeling requirements, particularly nutrition facts panels. Per the Administrative Procedure Act, the FDA is currently reviewing the 264,723 comments that it received regarding the proposed rule and changes to nutrition facts panels that appear on all FDA-regulated food products. The proposed rule can be found here. As soon as the rule is finalized, it will be implemented in sixty (60) days’ time. For existing products, manufacturers will have two (2) years to comply with…
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Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

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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

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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 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 Publishes Food Allergen Labeling Guidelines

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On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its "Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The draft guidance represents current thinking on the topic as previously discussed through the release of the October 2006 "Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance." The guidance provides the FDA's answers to commonly asked questions concerning the notification process for those seeking exemptions from the labeling of food allergens and updates the responses in the 2006 document. You…
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