The FDA has written to HBB LLC, a manufacturer of melatonin brownies that they are unsafe and could be seized. The brownies contain melatonin, a naturally occurring hormone known to regulate our sleep-wake cycle. Their makers say they are good for relieving stress.

They used to be called “Lazy Cakes”, however, after public officials and lawmakers expressed concern, the name was changed to “Lazy Larries”.

The brownies contain a logo of what appears to be a very calm and relaxed SpongeBob SquarePants lookalike. The company says they can be bought in some shops, or online through them.

The FDA (Food and Drug Administration) says it may seize the products if the company continues producing and selling them. Melatonin is not a safe food additive, the FDA stressed. It described the brownies as “adulterated”.

The FDA has more authority over a food product than a supplementary dietary pill. Legally, supplement makers have to make sure their goods are safe.

In a letter to the manufacturer, the FDA wrote:

“Specifically, it contains melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under section 409 of the FDCA [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170.

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 FDA says the product cannot be classed as a dietary supplement for the following reasons:

  • It is sold next to snack foods
  • Potential purchasers are directed to www.mylazycakes.com. A cake is a food
  • According to the manufacturer’s web site, the ingredients are the same as the purchaser’s mother uses to make brownies. A brownie is a food (not a supplement)
  • The product contains sugar, four oil, cocoa, egg, salt – ingredients for a brownie, not a dietary pill.
  • The product is presented and packaged as a brownie, not a supplement pill.

The FDA wrote:

“Any substance added to a conventional food, such as your “Lazy Larry” product must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin. We are not aware of any information to indicate that melatonin is the subject of a prior sanction [see 21 CFR Part 181]. As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.”

The manufacturer has said the brownies are dietary supplements.

In the letter, the FDA tells the manufacturer that it is not aware of any data that establish the safety of melatonin for use in foods. In fact, it mentions scientific literature which has raised safety concerns about melatonin use, such as its effect on blood glucose, as well as the reproductive, ocular, neurological and cardiovascular systems.

The FDA also wrote:

“Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Melatonin is not approved for use in any food, including brownies. Therefore, your “Lazy Larry” product is adulterated within the meaning of section 402(a)(2)(C) of the FDCA [21 U.S.C. § 342(a)(2)(C)]. You should take prompt action to correct this violation and prevent its future recurrence. Failure to do so may result in enforcement action without further notice. The FDCA authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products.”

The Agency has given the manufacturer 15 days to respond. The manufacturer is asked to explain what steps it will take to remediate the “violation” and to make sure it does not happen again.

Written by Christian Nordqvist