Melatonin Brownie Maker Finally Sees FDA Censure

Incense Specialities Inc., the brand that markets the melatonin-containing brownie popularly known as “Lazy Cakes” (and since renamed “Lazy Larry”), received an FDA warning letter on July 28.

In the letter, FDA informs the company that melatonin is not an approved food additive, nor is it a Generally Recognized as Safe (GRAS) ingredient; therefore, any food product containing melatonin is considered adulterated.

Moreover, FDA stated that the product and its marketing cause the product to be classified as a conventional food and not a dietary supplement-despite the company’s attempts to rebrand the product as a dietary supplement. (Melatonin is an ingredient allowed in dietary supplements.)

As evidence of the product being classified as a conventional food, the agency states that Lazy Larry’s website makes reference to the word cake; that the website says that the product has “the same ingredients your mother uses to make brownies;” that the other ingredients-sugar, flour, oil, cocoa, egg, and salt-are ingredients used in conventional brownies; and, last but not least, the product’s appearance and packaging represent the product as a brownie.

The warning letter states: “Your ‘Lazy Larry’ product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321 (ff)]. The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321 (ff)(2)(B)]. Your use of the term ‘dietary supplement’ in the statement of identity, and your use of a ‘Supplement Facts’ panel for nutrition labeling do not make your product a dietary supplement, because your ‘Lazy Larry’ product is represented for use as a conventional food.”

The dietary supplements agency has largely supported FDA efforts to enforce against products “masquerading” as dietary supplements in order to escape food laws.

Additionally, products such as bakery items containing melatonin have sparked a legislative bill proposed recently by Senator Richard Durbin (D-IL). Read more industry responses to Durbin’s bill here and here.