Warning Letters – Shehadeh Giannamore, PLLC

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FDA Untitled Letters: FDA Warnings with a Twist

FDA Claims, FDA Enforcement, FDA Warning Letters, Labeling, Marketing, Untitled Letters, Warning Letters

The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled Letters require the recipients to take immediate action once a letter has been issued. FDA Untitled Letters: Why It Matters? Many businesses may be well versed when it comes to handling FDA Warning Letters, but when it comes to FDA Untitled Letters recipients of Untitled Letters may not fully understand how to respond. Accordingly, there are a few things to…

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FDA Regulation of Aromatherapy and Essential Oil Products

FDA Aromatherapy, Claims, Essential Oils, FDA regulation, Warning Letters

Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal regulations must be a key consideration for marketers and distributors of these products. On September 22, 2014 the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Young Living for alleged violations of the Federal Food, Drug & Cosmetic Act (FDCA) in connection with the marketing of their aromatherapy essential oils. According to the FDA, these violations stemmed from the Company’s claims of curing and treating diseases with the usage of Young Living Essential Oil aromatherapy products, causing…

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FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations

FDA Enforcement, FDA, Inspection Violations, Tobacco Control Act, Tobacco Retailer Inspections, Tobacco Warning Letter, Warning Letters

The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months for compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) by issuing countless tobacco warning letters in connection with tobacco retailer inspection violations. The FDA has the authority to regulate tobacco products under the FD&C Act as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act, which was enacted on June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate tobacco products. The FDA has…

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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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Court Issues Injunction after FDA Warning Letter Issues Persist

FDA CGMP, Dietary Supplements, Enforcement, FDA, Injunction, Recalls, Warning Letters

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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FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

FDA FDA, Food, HACCP, Warning Letters

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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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…