FDA WARNING_LETTER - Quest Nutrition, LLC.

On July 29, 2015, the FDA issued a Warning Letter to Quest Nutrition, LLC, following a June 2015 review of the labels for their Quest Protein Chips BBQ Flavor, 1 1/8 oz product. The FDA determined the product was misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and 21 CFR Part 101.

The primary violation was that the product label bore nutrient content claims without meeting the regulatory requirements. Specifically, the claim "Quest has finally made delicious crispy chips healthy" and "Baking alone doesn’t make it healthy" in connection with "a whopping 21g of protein per bag" constituted an implied "healthy" nutrient content claim. However, the product did not meet the requirements of 21 CFR 101.65(d)(2) because the fortification of snack foods with protein blend and calcium carbonate to meet the 10% RDI/DRV for protein and calcium was inconsistent with the fortification policy in 21 CFR 104.20.

Additionally, the claim "With only 5g of total carbs" was identified as an unauthorized nutrient content claim, as the FDA has not defined such claims for carbohydrates.

Quest Nutrition, LLC was required to respond within 15 working days