Category Archive: FDA

Dec 06

FDA Untitled Letters: FDA Warnings with a Twist

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 …

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Nov 03

FDA Regulation of Aromatherapy and Essential Oil Products

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 …

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Jun 07

Cosmetic Products and the FDA

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 …

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Apr 20

FDA Imports: Tradeoff — Less Vigilance for More Diligence

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 …

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Jan 21

District Court sides with Industry on Dietary Supplement 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 …

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Jan 11

FDA Clears Device via De Novo Process

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 …

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Jan 11

FDA “Natural” Food Labeling

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 …

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Sep 10

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

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 …

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Jun 30

FDA Bans Trans Fats

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 …

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May 04

FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations

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 …

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