Here Comes the FDA

Ah, the excitement of that new-administration smell. In my February Food Product Design editor’s page, written prior to the presidential inauguration (printed below), I suggested increased government oversight of food was on the way, particularly in labeling. But a particular, well-known incident regarding peanut butter has pushed food safety and plant inspections to the forefront. This week, President Obama ordered a “complete review” of the FDA saying, “we are going to make sure that we retool the FDA, that it’s operating in a highly professional fashion and, most importantly, that we prevent these things, as opposed to trying to catch them after they’ve already occurred.”

For anyone tempted to put profit before safety and quality—consider yourself warned.

   -Lynn A. Kuntz

The Regulatory Scene, Jelly Bean

The current hot topic in food regulation is speculation on changes the new Obama Administration might bring. The consensus predicts increased regulation in the industry, but movement in that direction may already be afoot, and not just on the federal level. Dec. 2008 saw a series of incidents signaling tighter government scrutiny:

A U.S. Court of Appeals said the packaging of Gerber’s gummy candy for tots, formerly named “Fruit Juice Snacks,” deceived consumers because it carries images of real fruit, despite corn syrup and sugar topping the ingredient list. The Court said consumers shouldn’t be “expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box.” According to the watchdog group Center for Science in the Public Interest, “The Court’s decision is a warning to all companies that try to make junk food look healthy by depicting nutritious fruits, vegetables, and whole grains on the labels of sugary, high-calorie snacks.”

MillerCoors decided to reformulate its Sparks alcoholic beverage, removing caffeine, taurine, guarana and ginseng, after a coalition of state attorneys general charged that the drink inappropriately combined stimulants and alcohol, and targeted underage drinkers. Federal regulatory authorities had approved Sparks’ formulation, labeling and marketing. The agreement followed a similar, earlier situation on a state level where Anheuser-Busch agreed to withdraw its Tilt and Bud Extra alcoholic energy drinks.

In the last one, which might raise a red flag for nutraceutical manufacturers and marketers, FDA sent a warning letter to Coca-Cola, claiming its Diet Coke Plus beverage was misbranded because its label carries a nutrient-content claim without meeting the necessary criteria. The FDA said the term “plus” should only be used to describe nutrient labeling and the label doesn’t reference the amount of nutrients in the beverage. Further, the letter stated, “The policy on fortification in 21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods such as carbonated beverages.” This regulation, along with 21 CFR 101.14, which prohibits health claims for foods that do not meet specific minimum nutrient levels, informally known as the “jelly bean rule” in the past, essentially forbid fortification of nutritionally bereft foods.

With the rise of nutraceuticals, the industry has been skirting the jelly bean rule for years. So, why Coke Plus and not the other sugar-water beverages? Coke apparently fell afoul of the FDA by carbonating their beverage, something specifically mentioned in the regulation. (A similar 7UP product may have escaped scrutiny due to the addition of 5% juice.) Whether this move signals a return to tighter enforcement of the jelly bean rule in 2009 remains to be seen. But it’s probably a sign of job security for lawyers versed in food law.