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Description
Of those letters, 94 were based on an on-site inspection of the company, 27 were the result of records requests sent under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), six stemmed from testing product samples, and the remainder were generally based on review of product labels, registration materials, and/or websites
NDGA, nordihydroguaiaretic acid
S1 (April): 1028
Several serious adverse events, such as pneumonia, anal abscess, and Clostridium difficile infection, have been reported, but the incidence of these events was extremely rare [77]
