Melatonin Brownies Known As "Lazy Larries" Are Unsafe, Says FDA

[HuckleB]

http://www.medicalnewstoday.com/articles/232137.php

"...

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 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."

..."


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I haven't seen anything that indicates that melatonin is truly unsafe, but I think it's interesting that a food product manufacturer must prove the safety of said ingredient, while the supplement seller does not.

:crazy:

[HysteryDiagnosis]

1. Better round up the cherries then.

http://www.google.com/url?sa=t&source=web&cd=3&sqi=2&ved=0CC4QFjAC&url=http%3A%2F%2Fwww.choosecherries.com%2FUploads%2FDocuments%2F8590234737041963308.pdf&rct=j&q=natural%20sources%20of%20melatonin&ei=25c4TumCI6Ti0QHF8oW7Aw&usg=AFQjCNG2xbUdyX7E7CUWdyJ6AtN-Bn4QvA&cad=rja


Cherries are believed to be one of the most concentrated sources of melatonin.
Bananas, corn and oats supply melatonin but in considerably smaller amounts.
Beyond the benefits of helping to reset the body’s internal time clock to treat
jet lag, melatonin also may be helpful for late-shift workers trying to adjust to a new
schedule. Increasing melatonin also has been shown to help with sleep-onset
insomnia in older adults with a melatonin deficiency.

“During adulthood, blood levels of melatonin begin to decline and by age 60,
levels can be significantly lower, which may account for the sleep disturbances that
often occur with aging,” Reiter said. “If eaten regularly, tart cherries may help
regulate the body’s natural sleep cycle and increase sleep efficiency, including
decreasing the time it takes to fall asleep.”
Increasing melatonin may do more than promote a restful sleep. Melatonin is
a potent antioxidant that has been extensively studied in recent years for its role in
reducing inflammation and fighting free radicals in the body, which is linked to
increased cancer risk.

A new study published in the journal Free Radical Research that was
conducted by Reiter and colleagues at the University of Granada in Spain found that
melatonin neutralizes the oxidative and inflammation process caused by aging,
thereby suggesting that melatonin may play a role in delaying the effects of aging.
Based on the findings of this study, the authors suggest that daily melatonin
intake in humans from the age of 30 or 40 could potentially help delay illnesses
related to aging.

[laconicsax]

7. It isn't used as an additive in cherries.

The OP is about its use as an additive. The FDA guidelines state that additives must be proven safe to be allowed in foods. I think that's a sensible policy.

Do you agree that food additives should be proven safe before they're allowed?

[abelenkpe]

2. uh O really?

My uncle uses melatonin all the time to combat insomnia. :(

[HysteryDiagnosis]

3. Jet Lag as well, or so I've read. n/t

[HuckleB]

4. It's not that it is unsafe, it's that the food manufacturer hasn't proved that it is safe.

Melatonin supplement makers don't have to prove that the product is safe, or so it appears.

[saras]

5. The problem isn't melatonin as such, but using it in "fake hash brownies"

"I think it's interesting that a food product manufacturer must prove the safety of said ingredient, while the supplement seller does not."

This actually makes since, as many food buyers have no interest what's in their food, and expect it to not have surprise ingredients. Supplement buyers (presumably) know what they're getting and why they're getting it, which includes understanding potential problems. In addition, many supplements with recognized mainstream medical value are harmful if used incorrectly or by the wrong people. There's just no avoiding that risk except by banning supplements entirely. This is exactly why the FDA is objecting - because the brownies look too much like food and not enough like medicine. Melatonin in pill form has been available, and ignored, for decades.

The food manufacturer DOES have to tell you exactly what is in their food, so that people who have special issues with food (like life-endangering allergies, for example) can make their own decisions.

[HuckleB]

6. It makes no sense whatsoever.

If you're going to sell a product, then you need to prove that it's safe. This should be basic. The fact that there are different sets of rules for pharmaceuticals, food stuffs and supplements is simply wrong headed. This is bad policy at its absolute worst.

[saras]

8. You can't. It's that simple. "Safe" is an abitrary point, ususally decided by insurance companies.

Medicines are not safe. Period. This includes over-the-counter medicines. If they are powerful enough to have an effect, they are powerful enough to be dangerous.

Power tools are not safe. Period. It is, in general, impossible to make them safe while still able to do any useful work.

I could go on for hours...

OF COURSE there are different standards for different products. Different products do different things in different contexts.

Are you suggesting that no medicine should be marketed, even for extreme conditions, unless it is as safe as celery? Or that every plant that anyone in the world eats needs to be tested for safety to the same degree that a vaccine for an annoying but not fatal disease needs to be?