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FDA cites Maine firm for issues with lip balm and skin cream.
February 5, 2015
By: Christine Esposito
Editor-in-Chief
The US FDA has sent a warning letter to Chaga Mountain, Inc., a small Maine-based business. Through an inspection conducted between Sept. 23, 2014 and Oct. 1, 2014, and a review of Chaga Mountain’s website, FDA said it found serious violations of the Federal Food, Drug and Cosmetic Act and its implementing regulations. Through the review of the firm’s website in November 2014, FDA says Chaga Skin Cream and Lip Balm—as well as Chaga Mushroom Tincture/Extract Alcohol Free and two tea products—were being sold with natural ingredients including natural essential oils which the firm’s website promotes for conditions that cause the products to be drugs. The FDA also took issue with the company for adulterated dietary supplements and misbranded dietary supplements. The letter was dated Jan. 20, 2015.
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