In recent weeks, Lazy Cakes “Relaxation Brownies” have had the opposite effect on some public officials who are upset that the products in cartoon packaging may appeal to children but contain adult doses of the dietary supplement ingredients melatonin, valerian root and passion flower used to promote relaxation and sleep.
Each Lazy Cakes brownie contains roughly 8 milligrams of melatonin. The typical amount of melatonin recommended to support sleep in adults is usually not more than 3-5 milligrams. Melatonin is not usually recommended for children as a sleep aid.
So far, Mayors in two Massachusetts cities have sought to ban the brownies based on reported cases of children who were hospitalized when they became extremely lethargic after eating the brownies. Other municipalities and at least one state quickly followed suit and now U.S. Senator Dick Durbin has asked the Food and Drug Administration (FDA) to step in and rule on the safety of foods containing dietary supplement additives.
This controversy raises an important question. Are Lazy Cakes a food or a supplement? The answer determines how they are regulated by the FDA. Food ingredients must be generally regarded as safe and gain approval as a food additive. (The FDA has not approved melatonin as an additive in foods.) Because Lazy Cakes brownies are labeled and marketed as dietary supplements, and not subject to the requirements of foods, they are not required to have approval to include melatonin.
The Council for Responsible Nutrition issued a statement regarding the growing controversy. “Conventional food products, including cakes and brownies that are fortified with a dietary ingredient such as melatonin, are not dietary supplements despite being labeled that way; they are mislabeled conventional foods,” said CRN president and CEO Steve Mister.
At the time of this writing, the Food and Drug Administration had not yet made a determination on whether Lazy Cakes qualified as a food or supplement. However, the precedent already set by the agency suggests that Lazy Cakes may soon be a recipient of a warning letter.
Update: On July 28, 2011, the FDA issued a warning letter to the makers of Lazy Cakes, (also marketed as Lazy Larry brownies) stating that their product was in violation of FDA regulations regarding approved food additives. The warning stated that the product should be classified as a food and not a supplement. And since melatonin is not an approved food ingredient or additive, it’s inclusion in the cakes is considered an adulteration and therefore a violation. They cited several factors that led to their classification of the cakes as a conventional food:
- It is marketed alongside snack foods
- It’s website refers to the product as a conventional food (cake)
- The product is described as having “the same ingredients your mother uses to make brownies,” which is a conventional food.
- The appearance and packaging of the product is a brownie
- The product was represented as a conventional food by use of the word “cakes” in the product name and “brownie” as the statement of identity.
The FDA gave the makers of Lazy Cakes/Lazy Larry 15 days from the receipt of the warning letter to provide the specific steps it has taken to correct the violation and to assure that similar violations do not occur in the future.
The maker of the brownies says it will make “all necessary changes to market and sell the product as a supplement”.
Industry experts say the FDA may be issuing more warning letters to other products, particularly liquid supplements that many believe are marketed as conventional foods but labeled as supplements to get around food regulations which require pre-approval for all ingredients. The FDA has said that these products should be clearly labeled as “Dietary Supplements” and displayed in stores alongside other supplements, not conventional foods.
Melatonin is a hormone made by the pineal gland in the brain that helps control sleep and wake cycles. Natural melatonin levels decline with age -- with some older adults making only very small amounts. Melatonin is found in some foods but only in very small amounts.
In addition to promoting restful sleep, scientific evidence suggests that Melatonin has powerful, immune-supporting antioxidant properties. The typical adult dose of melatonin supplements to support relaxation and sleep is between 0.3 and 5 milligrams. Melatonin may be recommended for adults in higher doses of 10 to 20 mg to support the immune system and protect against cellular damage caused by free radicals. CNCA strongly suggests that you consult your healthcare provider before taking more than 3 mg of melatonin a day.
Video: Lazy Cakes Controversy News Coverage:
Food Safety News
Sources: ( from update )
Natural Products Insider