FDA WARNING_LETTER - Summit Beverage Group, LLC - May 07, 2014

On October 17, 2014, the FDA issued a Warning Letter to Summit Beverage Group, LLC, following an inspection from April 23 to May 7, 2014. The inspection and subsequent review of product labeling and website revealed serious violations of the Federal Food, Drug and Cosmetic Act.

Three products (AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + white tea (infused camucamu), and AMAZON urucu water (infused with pomegranate)) were deemed "unapproved new drugs" due to therapeutic claims on their labels, such as "protecting against cancer" and "healing connective tissue." These products are not generally recognized as safe and effective for these uses and lack FDA approval. The AMAZON coconut water + rooibos tea (infused with acai) product was also cited as misbranded because it lacked adequate directions for layperson use.

Additionally, several products were identified as "misbranded foods." Violations included unauthorized nutrient content claims (e.g., "Packed with antioxidants," "Rich in phytonutrients and flavonoids") that did not meet regulatory requirements (21 CFR 101.54(g), 21 CFR 101.54(b)). The Cell-nique Super Green Pomegranate product was misbranded for an unpermitted "low calorie" claim, incorrect nutrition facts format (21 CFR 1