FDA WARNING_LETTER - Hampton Creek Foods - June 30, 2015

The FDA issued a Warning Letter to Hampton Creek Foods, Inc. on August 12, 2015, following a review of labels and website labeling for their Just Mayo and Just Mayo Sriracha products in June 2015. The FDA concluded these products violate section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

Key violations include: 1. **Misbranded Nutrient Content Claims:** The "cholesterol free" claim on Just Mayo and the website statement "You'll never find cholesterol in our products" are misbranded under 403(r)(1)(A) of the Act. These claims do not meet 21 CFR 101.62(d) requirements because the products contain more than 13 grams of total fat per 50 grams (approximately 36 grams), and the labels fail to disclose the total fat level in immediate proximity to the cholesterol claims. 2. **Unauthorized Health Claim:** The website's "Your Heart Matters" statement with a heart symbol implies a health claim about reducing heart disease risk due to cholesterol absence, misbranding the products under 403(r)(1)(B). Both products contain 36 grams of fat per 50 grams, disqualifying them from making such health claims per 21 CFR 101.14(