Wednesday, December 15, 2010

Dannon fined for making health claims for its yogurt product

The Dannon Company will pay a $21 million fine and stop making exaggerated health claims for two very popular Dannon products under an agreement with the federal government and attorneys general from 39 states.

Dannon will stop claiming that one daily serving of Activia yogurt relieves irregularity and that its DanActive dairy drink helps people avoid catching colds or flu, the Federal Trade Commission announced on Wednesday.

"These types of misleading claims are enough to give consumers indigestion," says FTC Chairman Jon Leibowitz. "Companies like Dannon shouldn't exaggerate the strength of scientific support for their products."

The move signals a more aggressive federal watchdog roll over deceptive advertising practices by major marketers under the Obama administration
The FTC charged that Dannon's ads were deceptive because it did not have substantiation for its claims. The commission also charged that Dannon's claims that Activia and DanActive were clinically proven were false.

The FTC complaint and settlement can be downloaded from the FTC website at:

Here are some tips on substantiation of product claims:

Wednesday, December 8, 2010

Court held that FDA can only regulate e-cigarettes as tobacco products

A federal appeals court ruled yesterday that the FDA can only regulate electronic cigarettes (e-cigarettes) as tobacco products and not as drug-delivery products, and therefore cannot block their import.  The ruling will allow e-cigarette maker Sottera Inc. to resume importing its NJOY products.

The FDA and other public health organizations had argued e-cigarettes should be regulated as drug-delivery devices. That would require proving that they are safe and effective as a stop-smoking aid using expensive clinical trials.

A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency's authority over tobacco.  Congress passed the Tobacco Act in 2009 to give the FDA authority to regulate tobacco products -- but not to ban them.

"The liquid nicotine in each e-cigarette is derived from natural tobacco plants."  Therefore the products are a "tobacco product" as defined by the Tobacco Act. 

However, one of the three judges on the panel appeared to be willing to reconsider this issue again if the FDA were to issue its own interpretation of "tobacco product" through the rule making process.   Also, the FDA may appeal this ruling in the Supreme Court.  In the mean time, the ruling says that the FDA can only regulate e-cigarettes as tobacco products, provided that they do not make any drug or therapeutic claims. 

The case is Sotera, Inc. v. FDA, case  no. 10-5032.  A copy of the opinion can be downloaded here.