Dannon Settles Class Action Challenging "Clinically" and "Scientifically" Proven Health Claims For $45 Million

The Dannon Company recently settled a Northern District of Ohio class action which challenged the company's claims that its Activia and DanActive yogurts were clinically or scientifically proven to help regulate the body's digestive system. The settlement is being characterized as one of the largest settlements of a food false advertising case and highlights the importance of ensuring that a marketer's level of claim support matches the advertised claim.

Dannon advertised these two yogurts as using "probiotic" bacteria to help regulate the human digestive system. Dannon claimed that the products' efficacy was "clinically" and "scientifically" proven. While Dannon had evidence supporting the products' efficacy in digestive health, the litigation focused primarily on its use of the clinically or scientifically proven type of establishment claims. Establishment claims such as these usually trigger enhanced substantiation obligations because they promote a certain level of support beyond the advertiser's typically reasonable basis substantiation obligation.

Even though Dannon continues to stand behind their advertisements and denies any wrongdoing, a settlement was reached which included injunctive language and a potential payment of $45 million dollars. According to attorneys involved in the action, it may be the largest food product settlement ever obtained, which is particularly noteworthy given that there was no physical harm reported by consumers.

Under the settlement terms, in addition to the payment, Dannon must also reword the phrasing on their advertising and labels. Under the settlement, the company is required to:

- Change phrases like "clinically" and "scientifically proven" to wording more like "clinical studies show" or "there are a number of clinical studies that show."

- Qualify claims that the product "helps regulate the digestive system" with the explanatory statement that the product "helps with slow intestinal transit when eaten daily for two weeks, as part of a balanced diet and healthy lifestyle" or words to a similar effect

- Dannon must remove the word "immunity" from DanActive labels and ads and add a qualifier at the end of "helps strengthen your body's defenses" and/or "helps support the immune system" that states that these statements are true "when eaten as part of a balanced diet and healthy lifestyle."

- Place the correct genus, species, and strain designation when referring to the probiotic strain.

- Include a section on their website that specifically states that the yogurts are a food product and not intended as treatments or cures for any medical disease/disorder.

The message to marketers is clear: be sure that your advertised claims are properly substantiated. When making an establishment claim (i.e., clinically proven), advertisers should consider that regulators typically take the position that such claims require two well-controlled studies that support the claim. This obligation is particularly true when it comes to food labeling and advertising. Not only can the results be potentially dangerous but they can also be costly.

To learn more about Olshan's food and drug practice, click here.

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