Brownies Your Mother Never Made: FDA Issues Warning

The Food and Drug Administration has issued a warning letter to Baked World, a Memphis, Tenn., company marketing brownies laced with melatonin. The FDA notified this company that their product, first called "Lazy Cakes" then renamed "Lazy Larry," is in violation of the law for its production of brownies with this food additive while representing the brownie as just a brownie, and not something that contains a food additive, namely melatonin.

Melatonin is a naturally occurring compound that the FDA described as "... a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders." Their letter went on to say:

"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."

Clearly, the FDA is not happy with this company's loading brownies with melatonin and not even saying so.

For good reason. Melatonin has side effects that include nightmares and sleepwalking, daytime sleepiness and confusion, and headaches. It also can interact with medications taken commonly, like birth control pills, anti-coagulants and drugs used to treat diabetes and suppress immunity (taken for conditions like rheumatoid arthritis, colitis and lupus). And who knows what doses of melatonin a person might ingest from a "Lazy Cake" or "Lazy Larry"?

Melatonin can be a helpful supplement, used thoughtfully, with careful dosing and mindfulness of its side effects and interactions with medications. The issue is not melatonin, it is slipping it into a brownie that lures youth into yet another promised state of mental alteration and makes no mention of how.

These are not your mother's brownies. Let your kids and friends know about these "lazy" products. You might want to remind them that old-fashioned brownies are really good with milk or coffee -- and are a lot safer.

The opinions expressed here are solely my own as a psychiatrist and public health advocate. I receive no support from any pharmaceutical or device company. Visit Dr. Sederer's website at for questions you want answered, reviews, commentary and stories: www.askdrlloyd.com

 

Comments

[Jesse EngAmer]

03:08 PM on 08/08/2011

FDA wasting time and money again? Big surprise there.

While dangerous pharmaceuticals and harmful foods reach our plates every day due to shoddy work by the FDA, they still choose to waste time and resources regulating additives and supplements that people will take regularly and safely. Considering these brownies only have 4 mg of melatonin per serving and the recommended dose is 1-5 mg anyway, this is hardly a danger to society.

While Durbin and the FDA push this fiscally irresponsible, nanny-state assault on dietary supplements, contaminated foods continue to reach our plates and dangerous drugs reach our systems. The FDA and Durbin need to adjust their priorities if they truly intend to protect the American public.

[Willow712]

08:16 PM on 08/16/2011

I am one of these people that takes 4 mg of melatonin and falls asleep quickly. I would hate to eat two brownies and drive a car long distance. I would hate to eat these brownies and go to work ( I am a nurse). I do occasionally take melatonin. But I would need to know when I am ingesting it. And it IS a danger to society. There are enough people sleep deprived driving nowadays. I'd hate to see them eat a few brownies and drive to work.

[dbrockskk]

11:58 AM on 08/08/2011

I meant the melatonin pills, not the brownies.

[dbrockskk]

11:56 AM on 08/08/2011

must be me. I popped them like candy because they don't do a thing for me. I finally quit.

[NitramNos]

11:20 AM on 08/17/2011

I had the same experience. Melatonin had no perceivable effects on me.

[Elliot Klein]

09:41 PM on 08/06/2011

Definitely safer to stick with the hash brownies. Why mess with perfection?

[leftLibertarian]

01:58 PM on 08/06/2011

I prefer homemade brownies laced with dark chocolate and cannabis sativa with a cup of java.

[pc51]

05:57 PM on 08/06/2011

I'll be right over....

[porcinechic]

09:55 AM on 08/06/2011

I'd prefer to stick with the original laced brownies.

[messaiiina]

09:40 AM on 08/06/2011

Oh, please !! Our bodies make melatonin naturally, unlike the caffine in the coffee you recommend and which I would think would be worse for you. I've eaten these brownies and it says on the label clearly "For adult use only" and the ingredents list states there is melatonin in them and how much . The makers aren't trying to put anything over on anyone. People like you, who are always trying to start fires where there aren't any, shouldn't be allowed to hide their ignorance behind an "M.D" after their name.

[dwagner948]

05:03 PM on 09/03/2011

True enough, our bodies do make melatonin naturally, but ONLY when we are in the dark at night, and not when we are in a dark place in the daytime. Therein lies the problem with these brownies, i.e. eaten in the daytime they may cause drowsiness and impair driving ability. Indeed melatonin was first found to be a soporific during daytime nap tests. BTW the usual doses used for night-time sedation are supraphysiologic (most people make no more than 1 mg across the entire night), and even then are not all that effective for most people. Sorry, but this MD (sleep specialist) agrees with the FDA, which Congress made almost entirely toothless in this area in 1994 (thank you Senator Hatch).

[pc51]

08:21 PM on 08/05/2011

How much is in one of those brownies?