Melatonin Cakes and the Backlash on Dietary Supplements

May 31, 2011

lazy cakes1Melatonin-filled brownies called Lazy Cakes have come to the attention of Congress. Will the FDA use them as another excuse to over-regulate dietary supplements?


Two Massachusetts towns, Bedford and Fall River, are moving to ban the sale of “relaxation” brownies called Lazy Cakes after children who tried the cakes were rushed to the hospital, where it was extremely difficult to wake them up. The chocolate treats are filled with melatonin and are being sold in food markets and night clubs. In Arizona, a two-year-old boy given a few bites of a relative’s Lazy Cake was hospitalized after becoming withdrawn and falling deeply asleep.

The brownies contain nearly 8 milligrams of the supplemental sleep aid, so one piece has significantly more than the usual amount prescribed for adults—and who has only one brownie? Melatonin is a hormone produced naturally by the body. Standard doses in the Unites States (where it is available over the counter) and in Europe (where a prescription is typically required) range from 0.3 mg to 3 mg.

The Massachusetts towns want to ban their sales largely because of their appeal to children. Purple packaging features Lazy Larry, a cartoonish brownie with a big grin on its face.

Now Sen. Dick Durbin (D-IL) has written to the FDA, asking the agency to clarify its authority to regulate foods that contain additives, such as baked goods that contain high doses of melatonin, and to clarify the difference between dietary supplements and food.

Existing laws already give the FDA all the tools they need to regulate supplements, and we already have regulations in place that explain the difference between dietary supplements and food and that regulate them accordingly. The FDA does not need more regulations. The drug-based paradigm is not a good paradigm for food and supplements!

Lazy Cakes are clearly not a dietary supplement because the law says that dietary supplements cannot be “represented for use as a conventional food or as a sole item of a meal or the diet.” Brownies are clearly represented as food and cannot be mistaken for something else.

Since Lazy Cakes are not dietary supplements the FDA must regulate them as food. Ingredients that are intentionally added to food—in this case, melatonin—are food additives. Food additives require pre-market approval based on data demonstrating safety submitted to FDA in a food additive petition.

A substance is exempt from pre-market approval if it is GRAS—that is, Generally Recognized as Safe by qualified experts under conditions of use. Since these Lazy Cakes contain significantly more than the usual amount prescribed for adults, the ingredient was not used in a way that is GRAS! Lazy Cakes, therefore, are already subject to FDA enforcement under existing law.

FDA might be trying a repeat performance of their actions after DSHEA was introduced. David Kessler, who was then FDA commissioner, ordered FDA not to enforce DSHEA because he was convinced that the worst elements of the dietary supplement industry would then come to the fore, causing Congress to repeal the law. This of course did not happen.

With the way the agency has handled (or not handled) the Lazy Cakes situation, it would appear FDA is trying to allow bad food products to tarnish the dietary supplement industry—perhaps in the hope that Congress will repeal DSHEA. But the agency’s inaction is no excuse—there are already enough laws in place to make sure that dietary supplements and foods are safe.

Melatonin-laced cakes are clearly a terrible idea. Children should not take melatonin, especially during the day, and they shouldn’t eat chocolate at night. Melatonin does not belong in brownies!

Everyone should be justly concerned about companies that make misleading claims about their products. We should point out, however, that the worst offenders are Big Food companies who make confusing claims about their food products.

36 responses to “Melatonin Cakes and the Backlash on Dietary Supplements”

  1. Kassandra says:

    Ever get the feeling that TPTB don’t WANT us to be healthy? It’s a growth industry, in more ways than one.

    • Sandy B says:

      Kassandra,
      You are 100% correct. Just look around at the obesity/disease epidemic in American and realize that your physical condition is a result of what you put into your mouth, primarily, and the chemicals, etc you are exposed to in the environment, and the connection is clear–sickness is the goal of TPTB. It’s really obvious to everyone, even the most dense. Most of the people I know are now taking a defensive posture and beginning to garden organically, not buy anything they know or suspect is genetically engineered (that’s almost impossible when buying from a store). They’re refusing vaccines. They’re becoming highly aware that TPTB have allowed our food and environment to become highly toxic. I thought the public would never wake up to the unfolding nightmare, but they finally are. With more aware people, we have a chance to fight back. We do, after all, out-number the elite PTB.

  2. Suzanne says:

    There are already enough laws in place to make sure that dietary supplements and foods are safe.
    The worst offenders are Big Food companies who make confusing claims about their food products.

    • And if kids are being rushed to the hospital, you know there’s going to be lawsuits. Let the lawsuits crash Lazy Larry. There are enough laws in place already.

    • Rhee says:

      That is exactly right. We don’t need anymore laws or control.

      • Elaine says:

        Agreed completely!! Now how to we make “the law makers” use the same common sense. Truth is, to me, that this was put out in the public for a situation like this to eventually happen so they could use it it justify the actions they intended to take, anyway. Create the problem, get a reaction, and then “they” come up with the sollution they wanted all along. I’m sick of this BS…they do it over and over again. And it is HOW they keep taking our rights away. The more “control” we give them, the more “control” they have!

  3. Jim says:

    As long as the FDA is run by the pharmaceutical industry, you can expect anything. The corruption is so flagrant that there’s no attempt to hide it anymore. I wonder how much money it takes from big pharma to get these bureaucrats to sell their soul. I wouldn’t their karma, for sure!

    • Beware of greed & crime. It hurts the victims and the abusers. Our bodies require a balance of physical, mental & emotional achievement for good balance. That’s why there is so much suicide in wild weathly lifestyles and crazy poor terrorist & criminals. We’re all victims of commercialization and politics and mostly because we are so trustworthy and naive. Our impulsive and indulgent society wants everything NOW. But watch ourselves grow and see what good patience and health can do. We must all take the time to be educated, aware, deliberate and methodical as we manage our instincts for proper health. Last week I heard that poli-tics was “many blood suckers” which sounded correct. It’s a travesty how our society has focused on self versus others. Let’s get back to by the people, for the people, to the people. Thank you Lord for our heritage and please help us get back to our founders basic principles!! Grandpa George

    • Mrky says:

      Jim I do agree with you, FDA is practicly getting pay for doing nathing – there is so much corruption in food and restaurant business that praticaly there is no inspection of any kinde, I’m talking abot quality and hygiene of food control. Many people that I know are not eating out any longer to avoid health causing problems.
      They intraduse the clasification of restaurant A, B, and C category which is just lots of bull,,,,

  4. Chris says:

    I don’t want them to start regulating more than they are, because the FDA is failure If they do, then they should definitely make it illegal to put Statin drugs in fast food before they start. They should not put Lithium in the water as has been talked about to ‘reduce suicide’.

  5. Mimi says:

    What a stupid, stupid idea for a snack. What’s next? Testosterone Tacos? Progesterone Pizza?
    Melatonin is a hormone to be administered in case specific amounts -not consumed en mass. Typical of our country, however: If a little is good, a crap load must be better.

    • Dr. Mike says:

      Hey!! Testosterone Tacos!! Mimi, I think you just gave me my next big idea!! Now to get on the phone with the guys from Taco Hell . . .

  6. Pamela says:

    Ok, I have a problem with everything ABOUT this Lazy Cake product. The LAST thing we need in this country is a product that celebrates laziness. Melatonin is NOT a food additive, it’s a nutritional supplement that people need as they get older. It’s not a one size fits all supplement. People need different amounts at different ages and children don’t need any at all, they make plenty on their own. Which explains why children are rushed to the hospital. 8 mg per brownie is an insane amount! There is no excuse for that amount to be in one brownie. My personal feeling is this should be taken off the market. And don’t even let me start on the labeling and marketing of it.
    I could cheerfully throttle the person who thought this up. We don’t have enough battles to fight with the FDA and Codex over keeping access to our supplements, this moron has to come in with a marijuana brownie substitute that is laced with unbelievably high levels of melatonin that a. nobody NEEDS and b. sends parents rushing to the hospital with their children. What would make sense is to ban the product but since when does the FDA do anything that makes sense? My fear now is they’ll bypass common sense and just ban melatonin.

    • Jill says:

      I agree, not to mention, the first time I saw this travesty was sitting at the counter at a gas station! Can you imagine someone buying one ‘for the road’ and not realizing the profound and rapid effect of drowsiness that can overtake you with melatonin!
      I take melatonin in CORRECT doses AS NEEDED because I am an educated consumer and understand the product’s usefulness and effects. The company behind this product will make the FDA nervous, and they are liable to get out their hatchet– declaring melatonin evil and banned! Irresponsible jerks!

    • Susan says:

      Question is, who really is the culpret that started, and made this product in the first place? Could it have been somone who intended on making trouble for the natural supplement world? Hmmmm… Just food for thought.

  7. Darren McCauley says:

    If we don’t buy these experimental products that are harming our families then they won’t stock them on the shelfs…

  8. Joe Battaglia says:

    Why isn’t there a link to this companies website here, so we can pepper the imbeciles who make these “idiot-brownies” a message to let them know that as healthful consumers of legitimate supplements, we totally DISAGREE with their deceptive, moronic products…just like we do with big pharma, and agri-biz-GMO cretins.

  9. Monty says:

    To top it off – Lazy Cakes are made with non other than hydrogenated oils.
    These trans fat baby’s are GMO specials.

  10. Billy Jack says:

    Th government doesn’t have to go after this one. I see multi-million dollar lawsuits coming. Anyone selling these brownies is a target for lawyers. The market will regulate itself. Also, I see Family and Children’s Services going after the adults who allowed kids to eat the brownies. Lots of trouble on the way for brownie sellers.

  11. Kathy says:

    Fluoride in the water has made the people stupid. HFCS have made the people fat. GMO’s have made the people sick.
    If the govt. regulates the stuff that we need it will damn them too.

  12. anonymous says:

    “Necessity is the plea for every infringement of human freedom. It is the argument of tyrants, it is the creed of slaves”.
    NO system is ever perfect. There will be ways for certain people to sneak through the loopholes and literally get away with murder.
    However, what is the impact to the do-good-ers as the over-regulation continues to strangle our freedom in other productive and good areas?
    Whose idea was it to start these high-powered melatonin brownies anyway? Sounds like someone planned this. I mean, who in their right mind would use 8 mg of melatonin in a single brownie? Not anybody without strategies in mind, most likely.
    Call me a conspiracy theorist, I say if you don’t think about this critically, that ignorance is not always the road to bliss.
    Who would do this but someone with an objective in mind? Come on, think about it.

  13. anonymous says:

    CORRECTION: “Necessity is the plea for every infringement of human freedom. It is the argument of tyrants, it is the creed of slaves”. Paul Revere, Jr., House of Commons
    I think that just about sums it up. Well said!
    No amount of loophole-closing can ever tighten the noose enough…so why bother, unless you are on a power trip? Greed knows no bottom.
    Thanks for suing our government, ANH you are doing a great thing! Freedom is priceless. We need to follow….suit. Class action. All of us acting together. Because the misery to come will be a price we will never forget, if we remain silent now…

  14. Sepp says:

    I believe that our real problem here is the prohibition mentality that informs lawgiving efforts.
    Let’s ask the more basic question: What justifies laws regulating or prohibiting *anything* unless it’s a clear danger to life and limb of the unsuspecting. Where is the “buyer beware” mentality that has successfully brought us through millennia? Why is it important that anything and everything must be controlled and why do we selectively prohibit not only nutrients, but drugs, activities, technical stuff, that we consider “unsafe”?
    Are we so weak that we can’t live in a world where there is the least bit of danger? Do we really want to live a fully controlled life where laws prohibit anything that has a remote possibility of harming anyone?
    Let us shine the light on and seriously question that prohibition mentality.

  15. Stephanie says:

    You are talking about thse “Lazy Brownies” and talking about children eating them, well I seen these the other day at my gas station and it CLEARLY STATES “NOT INTENDED FOR CHILDREN”. So why are you going on about children eating these when if you read the label it tells you to keep it away from children. Also it states that an adult should only eat part of the brownie not all of it. So if you follow the directions on the label there should be no problem. Stop this nonsense with saying such things are a risk when everything in our lives is a risk. I wish I had the time to analize food and make up wrongful information about the product. Maybe there is something wrong with these I did not try them BUT READ THE LABEL it clearly states NOT INTENDED FOR CHILDREN and adults to only eat part of the brownie.
    Don’t pick on petty stuff like this. There are many other things more serious out there to dwell on than something like this.

    • Onyx Panthyr says:

      @Stephanie
      But you’re asking people to actually READ the label and make their own decisions! How could you honestly ask people to go out of their way to do that?? Everything needs to be all nicely prepackaged correctly for them so they don’t need to think for themselves and can just grab it and go! /sarcasm
      But seriously, you have **excellent** points and I agree with you fully. People need to take some responsibility themselves.

    • Jill says:

      Stephanie, I would agree with you if all consumers of such products were as educated and aware as you are. Unfortunately, the marketing and product mascot are intended to elicit positive responses from young people, not everyone (children and adults alike) understands the strong effects of melatonin, and since when do children always listen to their parents (especially if unsupervised) and when do adults not eat a whole brownie?
      I would disagree that this is ‘petty’, since buying them at a gas station likely on the way back to your car, without knowing exactly what you’re ingesting, could literally create a disaster. I take melatonin for insomnia and fall fully asleep within 20 minutes!
      Beyond that, the FDA rarely needs big reasons to regulate herbs and supplements into oblivion. This has the potential for a nightmare if left to its own devices.

  16. Lydia Freund says:

    This product got to market with a label that said, Not for Children. Just like ephedra-packed “Energy drinks” and extra-caffiene drinks, and alcohol and cigarettes. If you let your kids eat stuff that is labelled hazardous for children, let them drink alcohol, let them smoke cigarettes, then they will get sick! DUH! And the package was obviously meant to appeal to the “pot-brownie” generation, trying to take a cue from that style of graphics. I grant you the product is not really food, but was labelled as food, and labelled as not for children. American don’t like to read – or be responsible for what their children do.

  17. Barbara Talbert says:

    If the FDA goes after this one( the lazy cake brownies) they might have to admit that chimeric organisms added to a food is an additive and is unsafe as recently many highly regarded professors have begun to challenge the GRAS status of GMO foods. The FDA would have alot of trouble proving that plants that produce pesticide in vitro are safe. Common sense tells you that they are not.

  18. Janis says:

    Melatonin does NOT belong in food! Again the FDA NOT doing their job to protect the public, allowing a product like this to come on the market. It’s a crime that stuff like this is allowed to come out, but real cures and healing methods are suppressed and doctors are even harrassed at gun point by the FDA! Yes, I am outraged …. can you tell? When is it all this madness going to end? I agree with someone who posted about reading labels, since when do Americans actually take responsiblity for themselves? ….. most don’t ….

    • Jose G. says:

      But you shouldn’t be outraged. This is a A+ product. Try it. Plus, it’s not like children can actually die from overdosing on melatonin, that’s even more outrageous than that FDA are not doing their “job”. The FDA should have no say in a supplemental product. That’s what it is, if you take away the ingredients and put them side by side, “chocolate supplement made with Melatonin, RoseHips, Valerian Root & Passion Flower.” That’s a lot of what a supplemental pill would look like without chocolate(of course). Now, the quantity of Melatonin ingested by this product is completely up to the individual. Firstly, you should always read the servings label. Secondly, it is no longer targeted towards children. This is not a public health danger. I can decide to buy a bottle of melatonin at Walgreens and take 50 pills, therefore, your argument is invalid.

  19. Felisa says:

    You are right most Americans don’t take responsibility for themselves it was taken away or it was made easy not to have any responsibility. And when you try to teach them or wake them up, entlighten them they don’t want to hear it. They are sooooo dumfoundet they still believe and trust the government and FDA. It is sooo sad but real

  20. kim w h says:

    My wife was the first one in with a “wellness” ammendment sent directly to Dick Durbin, he needs to get a grip. My wife also worked to get the narcotic oxycoden off the market in Ca and in the Fed courts……I guess what, it failed……drugs killing Jounior High Kids is stil available.

  21. Johnny Schembra says:

    Blood test is the only way to know. Though, I’ve read that men with very low testosterone levels usually do not wake up with a morning erection. That’s not to say every man who doesn’t wake up with one has low testosterone levels, though. Was this answer helpful?

  22. Jose G. says:

    I support Lazy Larry Brownies.

  23. […] a good crisis go to waste, in 2011 Sen. Durbin used a troubling but isolated incident—the sale of melatonin-filled brownies called “Lazy Cakes”—to ask the FDA to clarify its authority to regulate foods that contain additives, such as the […]

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