FDA – 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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Cosmetic Products and the FDA

FDA color additives, Cosmetics, Disease Claims, FDA, imports, Labeling

FDA Regulation of Cosmetics Products Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food & Drug Administration (“FDA”) works in conjunction with the U.S. Customs and Border Protection (CBP) to monitor cosmetic products at the time of entry. Noncompliance with FDA regulations can result in a shipment being refused entry into the United States or a product being recalled from the market after entry. However, one may mistakenly assume that cosmetic products are subjected to the…

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FDA Imports: Tradeoff — Less Vigilance for More Diligence

FDA

The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved in food importing in a slow decline, resulting in delays for those dealing in FDA imports. Troubled by its inability to get Congressional funding to pay all of its bills, the FDA came up with an idea: have the importer and the food manufacturer pay for the inspections and re-inspections. With congressional approval, the Food Safety Modernization Act (2011) provides the FDA with the authority to charge such fees based on past costs (currently 2013) of inspections and re-inspections, and…

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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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FDA Clears Device via De Novo Process

FDA 510(k), CDRH, FDA, Medical Devices

On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy. Marketed under the name the DigniCap® Cooling System, the cooling cap is manufactured by Dignitana, a Swedish company making its first foray into the United States medical device market. After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer.…

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FDA “Natural” Food Labeling

FDA Beverages, Dietary Supplements, FDA, Food, Labeling, Rulemaking

On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the Agency should define the term “natural” and regulate its use in food labeling. The FDA has engaged the public’s input after receiving two Citizen Petitions requesting the agency take action on establishing a formal definition of the term “natural” for use in food labeling and one requesting asking that the agency prohibits the use of the term “natural” on food labels. The FDA also notes that this recent move is driven by recent private litigation surrounding the term “natural” in…

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What’s in a Name? Everything, for “Standard” FDA Food Labeling

FDA

FDA Particular words mean everything to the U.S. Food and Drug Administration (FDA). It takes great pains and uses specific words to proclaim its position, and clarify what it names something, especially when it comes to setting a standard. Most of us who have dealt with or follow FDA activities are well aware of FDA rules, such as those set forth in 21 CFR. What many do not know or realize is that the FDA has set standards for what is in, and what is not in, a commonly named food, such as mayonnaise, or tomato paste. These standards are…

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FDA Bans Trans Fats

FDA Beverages, FDA, Food, imports, Labeling, Nutrition Facts, Rulemaking

FDA Issues Final Determination Concerning Partially Hydrogenated Oils The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs). FDA recently issued its final decision on how it would categorize PHOs. Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats. This change in categorization now puts PHOs under the regulations that govern food…

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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…