FDA WARNING_LETTER - Premier Organics Inc.

The FDA issued a Warning Letter to Premier Organics Inc. regarding their Artisana Coconut Butter Whole Coconut Flesh 16 oz. product, based on a June 2014 review of the product label and website (www.artisanafoods.com). The product is deemed misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 343) and 21 CFR Part 101.

The product is misbranded because its label bears implied nutrient content claims, "The Art of Healthy Foods" and "healthy food," in connection with statements about "life-essential fatty acids, enzymes, vitamins and minerals." However, the product does not meet the "healthy" nutrient content claim requirements of 21 CFR 101.65(d)(2), as it contains 16g of saturated fat per 32g serving, exceeding the 1g per RACC and 15% of calories from saturated fat limits for "low saturated fat" foods.

Additionally, the website labeling claims "good source of essential amino acids." This is a nutrient content claim (21 CFR 101.13(b)(1)), but there is no Daily Value (DV) for amino acids, making the claim unauthorized under 21 CFR 101.54(c). Even if interpreted as "good source of protein