Beware the Jellybean

Functional foods is a lucrative market—over $30 billion in the United States—but one that might be fraught with legal landmines. The FDA again has gone after food companies that the agency believes have crossed the legal line, issuing warning letters to Unilever (for Lipton Green Tea 100% Natural Naturally Decaffeinated) and Cadbury Adams Dr Pepper Snapple Group (for Canada Dry Sparkling Green Tea Ginger Ale).

According to the warning letters, Lipton Tea’s transgressions were:

1) Including a link to its websites (making those websites “labeling”) that promote the product “for conditions that cause it to be a drug” that is “intended for use in the cure, mitigation, treatment, or prevention of disease” under the Federal Food, Drug, and Cosmetic Act. (The website discussed studies showing a cholesterol lowering effect from tea or tea flavonoids.)

2) Unauthorized nutrient content claims using the term “antioxidant” in several ways that do not meet current regulations, saying “The use of a term, not defined by regulation, in food labeling to characterize the level of a nutrient misbrands a product.”

The FDA warned Canada Dry about:

1) Labeling that “bears a nutrient content claim that is not authorized by regulation” (again concerning the product’s use of the term “antioxidants”).

2) Fortifying a carbonated beverage while “21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods such as carbonated beverages” (The infamous “jellybean rule”).

It’s not just the government who’s getting tough with functional foods either. The September 2010 Scientific American Magazine ran an editorial, “Snake Oil in the Supermarket,” which tarred the segment with a broad brush, saying in part, “consumers are getting a rotten deal. Although health claims for foods may appear to be authoritative, in many cases science does not support them and the government does not endorse them.”

These are just the latest in a series of indications that functional food and beverage purveyors have to scrutinize the concept, the carrier and the communication of any benefits to stay on the side of the regulatory angels and maintain consumer confidence in the industry. Most of the information is set out in the CFR, albeit the language occasionally has a Jabberwocky feel to it. Crossing the line—intentionally or not--may seem a bold move, but likely will cause the government and the slithy pundits to give you some unpleasant surprises.

So, remember when fortifying foods (with apologies to Lewis Carroll):

Beware the Jellybean, my friend!

The laws that bite, the claims that catch!

Beware the soda pop to shun

The frumious Fed’s dispatch!