Editor's Page: Don’t Be Lazy

Demand and sales for functional food are up. According to a new Leatherhead report, global functional food and drink sales are even outpacing conventional food and drink sales, by about 4%. Consumers like the notion of getting added-value ingredients in their food and drink. It’s convenient; hopefully it’s tasty. What’s not to love?

Well, a lot if you are FDA and watching some companies cross the line of which ingredients are allowed in conventional food. Melatonin has been the headliner in this scene, starting with “Slow Your Roll” beverage Drank. You can also have your cake and eat melatonin, too, thanks to Lazy Cakes “Relaxation Brownies” (now renamed “The Original Lazy Larry”), Kush Cakes, or Lulla Pies cookies.

FDA sent Drank a warning letter informing that melatonin is neither an approved food additive nor Generally Recognized as Safe (GRAS)-and therefore forbidden in conventional food or beverage. Surprisingly, however, melatonin baked goods have not faced the same wrath. That is, until this July, when FDA finally sent a warning letter to the makers of Lazy Cakes.

Scrambling for options, melatonin-food companies like Drank and Lazy Cakes have attempted to turn around and call themselves dietary supplements instead. (Melatonin, while not allowed in food, is a grandfathered ingredient permitted in supplements.) This has cast an unfairly negative light on the dietary supplements industry, with U.S. Senator Dick Durbin (D-IL) and his new legislative bill (see page 14 for more detail) stating that the industry is allowing such products to “masquerade as dietary supplements.”

However, the supplements industry does not support such products. By and large, the industry has spoken out against Lazy Cakes and Drank, stating that they cannot be marketed as supplements either.

Thankfully, FDA agrees, and in the recent Lazy Cakes warning letter, the agency ruled that the product markets itself as a conventional food and as such is misbranded. Pointing to evidence, the agency said that Lazy Larry’s website makes reference to the word cake; that the website says that the product has “the same ingredients your mother uses to make brownies;” that the other ingredients-sugar, flour, oil, cocoa, egg, and salt-are ingredients used in conventional brownies; and, last but not least, that the product’s appearance and packaging represent the product as a brownie.

The warning letter states: “Your ‘Lazy Larry’ product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321 (ff)]. The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321 (ff)(2)(B)]. Your use of the term ‘dietary supplement’ in the statement of identity, and your use of a ‘Supplement Facts’ panel for nutrition labeling do not make your product a dietary supplement, because your ‘Lazy Larry’ product is represented for use as a conventional food.”

Marketers who wish to bring functional food to market should do their homework before positioning their products, cautions Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “I think manufacturers and product developers just need to be really conversant in the laws, or they need good legal counsel when they’re doing product development. One of the things we’ve seen with FDA is that they like their nice little buckets. They like to be able to look at a product and say, ‘This is a drug. This is a cosmetic. This is a food. This is a dietary supplement.’ Even though the marketplace or the consumer demand may come up with some creative ideas-‘Wouldn’t it be great if we could sell this as a food? What if we put this in a cupcake or a sandwich?’-you’ve got to ask yourself, ‘Will that still fit into a nice box that meets all the requirements?’”

He concludes, “Consumer interest in a product or a delivery form is only half the question. If you can’t sell it legally, then you can’t sell it.”

Got that? Don’t be lazy. Do your homework.