FDA Untitled Letters: FDA Warnings with a Twist

FDA Untitled Letters: FDA Warnings with a Twist

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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 Regulation of Aromatherapy and Essential Oil Products

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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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