Spectrum Organic Products, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Spectrum Organic Products, Inc. regarding their "Organic All Vegetable Shortening" product, found to be misbranded under the Federal Food, Drug, and Cosmetic Act. The product's label bears several nutrient content claims that do not meet regulatory requirements.

Specifically, the claims "[c]holesterol free" and "naturally cholesterol free" are used, but the product contains 6g of saturated fat per tablespoon, exceeding the 2g limit for "cholesterol free" claims (21 CFR 101.62(d)(1)(ii)). The claim "[l]ess saturated fat than butter" is made without the required comparative information (21 CFR 101.62(c)(4) and 101.13(j)(2)). The claim "good source of ... monounsaturated fat" is also cited as a violation because a Daily Reference Value (DRV) has not been established for monounsaturated fat, precluding the use of "good source" for this nutrient (21 CFR 101.54(c)).

Furthermore, the label includes "0 Grams Trans Fat" but fails to bear the required disclosure statement for products with more than 4g of saturated fat per serving, such as "See nutrition information for saturated fat content" (21 CFR 101.13(h)).

The FDA requires prompt corrective action