FDA WARNING_LETTER - North Dallas Honey - January 15, 2013

The FDA inspected North Dallas Honey Company from September 2012 to January 2013, reviewing product labels for Nature Nate's Natural 100% Pure Raw & Unfiltered Honey, Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey, and Norcal Honey Co. Pure Raw & Unfiltered Honey, along with the company's website, www.naturenates.com. The FDA concluded that the products are promoted for conditions that cause them to be unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, violating section 505(a). This was due to therapeutic claims on the Spanish website (e.g., for food poisoning, arthritis, allergy relief) and product labels (e.g., "Allergy relief"). Additionally, the products are misbranded foods. Nutrient content claims, such as "high in...antioxidants" on the Spanish website, do not comply with 21 CFR 101.54(g) regarding required nutrient naming. Implied "health benefits" claims on labels do not meet 21 CFR 101.65(d)(2) for using the term "health." Furthermore, Nature Nate's 100% North Dallas Honey Co. Pure Raw & Unfiltered Honey lacks required Nutrition Facts information per 21 CFR Part 101.9, and other products' Nutrition Facts panels are improperly formatted (21 CFR 101.9(d)(1)(i)). The company's October 2012 response was deemed inadequate as unlawful claims persisted. The FDA requires prompt corrective actions within fifteen working days to prevent further regulatory action.