The Snake Oil Wars: P&G Is the FDA's Latest Target for Misleading Health Claims

A lawsuit against Procter & Gamble (PG) for making science-y claims about its Align digestive health diet supplement is the latest in a string of actions against companies who advertise the health benefits of their products with the legal disclaimer that the product has "not been evaluated by the Food and Drug Administration."

That phrase is fast becoming code for "don't believe a word of this." Snapple, Vitaminwater and Nestlé (NESN)'s Boost Essentials have all been the subject of recent legal action for claiming that their products have drug-like benefits without drug-like clinical trials proving so.

The law actually encourages advertisers to make these claims. Even though the FDA has sweeping powers to ensure the safety of drugs and food, it has almost no power over the "diet supplement" industry. The Dietary Supplement Health and Education Act of 1994 specifically removes FDA authority from pills and "health" products, like Align.

Thus advertisers in that category didn't have much to worry about if they stretched the truth -- until now. P&G claimed Align was "clinically proven to naturally defend against 5 signs of digestive imbalance." Among the allegations in the class action suit on Align are:

Procter & Gamble's advertising claims that Align has a "Money Back Guarantee" [which] is likely to deceitfully induce a placebo effect on consumers, irrespective of any actual probiotic effect.

There are no proper clinical studies that provide substantiation, clinical or otherwise, for Align's digestive health claims.

• POM Wonderful is suing the FTC in a kamikaze action claiming it has a free speech right to make health claims without FDA approval.
• Coca-Cola (KO) is currently defending a suit that claims Vitaminwater does not prevent eye disease, as it advertising has suggested.
• The judge in the Snapple suit -- which claims its "natural" slogan is a crock because the drinks contain high-fructose corn syrup -- has asked the FDA to determine whether HFCS is natural or not.
• And Nestle was forced by the FTC to get FDA approval for any further claims it makes about its "probiotic" Boost drink for kids. (Interestingly, Align is also a "probiotic" product.)

If the courts start to come down against advertisers in these cases we could be looking at the end of Wild West diet supplement advertising, where makers said whatever they wanted about their snake oil as long as there was an asterisk leading to a footnote -- as there is on Align's site -- that says:

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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