FDA WARNING_LETTER - Before Brands Inc - October 20, 2020

The FDA issued a Warning Letter to Spoonfulone regarding their Puffs, Strawberry flavor product, following a review of its label and website in May, June, and August 2020. The FDA determined the product is an unapproved new drug under section 201(g)(1)(B) of the Act because its claims establish intent for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include "Help protect your child from developing a food allergy" and "The most complete food allergy protection system." As the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act, requiring prior FDA approval for interstate commerce.

Additionally, the product is misbranded food under section 403 of the Act. It includes unauthorized health claims, such as "74% supported SpoonfulOne to reduce the risk of developing a food allergy," which are not authorized by regulation or notification provisions. These claims are also impermissible for products intended for infants and toddlers under 2 years of age, and are inconsistent with the FDA's specific qualified health claim for ground peanuts and reduced risk of peanut allergy in infants with severe eczema and/or egg allergy. Furthermore, the product is misbranded because its ingredient statement uses the collective term "foundational food blend" instead of declaring each ingredient by its common or usual name in descending order of