The FDA has been more assertive this year with regards to health claims on food products. Here’s an example – the heavyweight bout with cereal giant General Mills:

Round 1: In May, the FDA asked General Mills to explain why its Cheerios packages carried a claim “Lower your cholesterol 4% in 6 weeks” which is more appropriate for a drug, not a food product.

Round 2: In June, the FDA received copies of 4 studies from General Mills substantiating the percentage reduction claims.

Round 3: It took several months to review, but in October the FDA sent its response to those studies. The bottom line – One study was OK, but that’s not enough for a health claim to be approved. Three studies  were not conclusive enough. This is the FDA’s summary:

In conclusion, in determining whether … to authorize the soluble fiber/coronary heart disease claim to include a statement about a specific percentage reduction in LDL cholesterol, FDA would need to consider the totality of the publicly available scientific evidence to support such a statement and also how to convey information in a way that is not misleading.

Round 4: On November 3rd, General Mills responded [PDF] with further clarifications.We won’t go into the details, although we’re sure the company firmly stands behind the research.

Round 5: Yesterday, the FDA published the letter it has sent in October. General Mills decided to respond immediately – a good PR tactic – by publishing its response and a press release:

“discussions with the U.S. Food and Drug Administration (FDA) regarding the cholesterol-lowering benefits of the soluble oat fiber in Cheerios continue.”

Ironically, as these discussions are going on, Cheerios is running a new promotion, with an even bolder claim of 10% reduction in cholesterol in just one month.

What you need to know:

The argument between the FDA and General Mills over what wording is to be allowed may seem like nit-picking to some, but you need to understand that a lot of money is at stake.

Manufacturers use health claims as a marketing tool to increase sales, and have been doing so since for ages. Up until 1991, it was pretty much a wild west when it came to health claims. Manufacturers would claim almost anything they liked. When the Nutrition Labeling and Education Act was passed in the early 1990’s, it seemed as though the claims would go away. The law provided the framework for the FDA to require standardized nutrition facts labels and ingredient list for virtually all packaged foods.

But pressure by food industry lobbies on Congress allowed the manufacturers to add health claims to packages as well. Thankfully though, the claims had to be thoroughly substantiated by scientific research and consensus. The language of the claims was also addressed in the law. There are certain things that can be said, while other can’t. And there’s a way to say it. In the Cheerios example, the FDA warned that the cholesterol reduction wording is more like that of a statin drug than of a food, and therefore out-of-bounds.

Nobody is arguing that Cheerios (the plain unsweetened version) is one of the better cereals out there, with a relatively low sugar count, and high fiber content. But the studies, funded by General Mills, showed that the control groups who ate other cereal products also reduced their cholesterol intake when both groups ate the cereals instead of some other non-fibrous meal. Hey, eating even Sugar Smacks daily, as “part of a healthy, balanced diet including regular exercise” will lead to better heart health.

Incidentally, just a few weeks ago Kellogg’s retracted it’s “Immunity” claims from packages of Cocoa Krispies.

What to do at the supermarket:

While the scientists on both sides of regulation battle it out, here’s the deal when it comes to breakfast cereals - best to ignore health claims. The information you need is on the nutrition facts panel and ingredient list. Look for:

- fiber at more than 3 grams per serving

- sugar at less than 6 grams per serving

- no artificial colors (Yellow 5, Red 40, etc…)

- no partially hydrogenated oils

All the other fortifications (B vitamins, etc..) are nice to have but very similar across the board.

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