Published on January 6th, 20140
Eat a Brownie and Relax?
Better do some reading before you pursue these ZZZZs though. Melatonin-laced foods have faced several challenges, including whether they are safe and marketed in a truthful manner.
Concerns about dosage
Currently, melatonin is the only hormone in the United States that can be obtained without a prescription. It is sold in pill form as a dietary supplement and in foods dosed with it. It is also found naturally in many foods. But there has been concern about the amount of melatonin people may be getting from the products. Improper dosages of melatonin have been linked to a slow down of the central nervous system, which could lead to difficulty in breathing, and it has been linked to hallucinations among other side effects.
However, many studies are contradictory and note that more research needs to be conducted to determine exactly how effective melatonin actually is. Some studies have shown that there was not much of a difference in results when melatonin or a placebo was given to those with and without sleeping disorders, while other studies have found that some people who have trouble sleeping could benefit from taking melatonin at the right time of the day because it helped them fall asleep quicker. A recent study showed that although there may be some short-term benefits of melatonin intake for those with sleep-related disorders, these were largely erased after a six-month period. And, studies also cautioned about adverse effects of melatonin on those taking other medications, as well as effects on children and pregnant woman as a result of hormone interactions.
In recent years, the FDA has taken regulatory action against melatonin-laced food products. In 2011, the FDA cracked down on HBB, LLC, a Memphis, Tenn.-based company that manufactures melatonin products for falsely labeling its line of Lazy Larry brownies as dietary supplements. The FDA said the company was really selling the brownies as conventional food products. According to the FDA, selling melatonin baked into “conventional food” such as brownies is not quite the same as selling melatonin in capsule form. In its warning letter to HBB, the FDA also said that there is neither scientific research nor enough common usage to show that melatonin is safe in foods. The FDA has not approved melatonin as a food additive or deemed it safe. As a dietary supplement, it doesn’t need FDA premarket approval, and the onus is on the manufacturer to make sure it is safe. Companies can’t just slap a dietary supplement label on it to avoid stricter FDA oversight but also try to sell it as a safe additive in conventional foods, the FDA warned.
In 2011, a consumer brought a proposed class action lawsuit against HBB in California claiming the company failed to inform consumers of the potentially harmful effects of the high dosage of melatonin contained in the brownies. The case was dismissed. But it isn’t over. Though the Ninth Circuit appellate court recently affirmed the lower court’s dismissal, it also ruled that it would allow for an amended complaint to be filed.
At the time the case was brought, HBB’s warnings were hidden in the fine print on the back of the package. The warnings for some of the side effects of melatonin are now listed on the front of the packaging. However, there is no explicit warning for the high levels of melatonin in the brownies.
Foods appeal to children
HBB is particularly shrewd when it comes to marketing its products. In 2011, under scrutiny from lawmakers and public officials who questioned the safety of the brownies, the company simply changed its name from Lazy Cakes to Lazy Larry. When complaints mounted over how appealing a brownie cartoon and clear packaging revealing the chocolate inside would be to children, HBB was ready with a new solution. It repackaged the brownies into colored packages so as to not reveal the chocolate and removed the brownie cartoon. Oh yeah, and changed the name to Mellow Munchies for good measure.
Mellow Munchies are available for sale on the company’s website. HBB is also offering rebates to third parties who buy on their website, so keep an eye out for some Mellow Munchies at your local stores. But make sure to figure out how much melatonin you are consuming through all sources and whether such an amount is safe.