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From Health Law Daily, April 17, 2013

Supplement manufacturer’s advertising claims regarding bone mineral density increases sent back to the district court for further review

By Danielle H. Capilla, JD

The U.S. District Court for the Southern District of Florida’s ruling that Garden of Life (GOL), a supplement manufacturer, was not in contempt of an earlier injunction regarding the advertising claims for its products was affirmed in part and vacated and remanded in part by the Eleventh Circuit (Federal Trade Commission v Garden of Life Inc., April 15, 2013, Marcus, S). GOL was barred from making misrepresentations in its advertisements after settling a case brought by the Federal Trade Commission (FTC) that alleged the manufacturer had made numerous unsubstantiated health claims regarding its supplements. The FTC asked the district court to hold GOL in contempt of the settlement after it made allegedly unsubstantiated claims on two new supplements, a children’s omega-3 supplement and an adult calcium supplement. The district court declined to find GOL in contempt of the injunction and the FTC appealed the decision to the Eleventh Circuit. The Eleventh Circuit found that the record surrounding representations of studies regarding the adult calcium supplement unclear and remanded it back to the district court to address whether GOL’s false description of bone density study results constituted a violation of the injunction.

Advertising. After GOL’s 2006 settlement with the FTC it hired an independent consulting firm, ISS, to evaluate the scientific evidence used to support its advertising claims. The head of ISS was a clinical pharmacologist with twenty years of experience evaluating drug and supplement advertising claims. In 2009 GOL began selling three new products, two calcium supplements and a children’s omega-3 supplement. Advertising for the omega-3 supplement indicated it supported brain development, health, vision, and positive mood and behavior. The calcium supplements had print advertisements that claimed in a six month randomized study, participants experienced a significant average increase of bone mineral density of 2.8 percent and 3.7 percent depending on compliance with the regimen. It was discovered that the clinical study results only found increases of half those amounts in a six-month period, and the numbers had been annualized by doubling them. ISS acknowledged the mistake and the advertising was withdrawn.

Omega-3 supplement. The FTC alleged that GOL violated the injunction when it failed to substantiate that the supplement benefited children’s cognitive development, mental focus, and mood and behavior. The support for this allegation came through an expert witness who offered the opinion that the GOL relied on insufficiently rigorous studies and that the populations studied were not representative enough. However, the head of ISS submitted various declarations describing the studies that were relied upon to make the advertising claims. Because the district court relied on one expert opinion over another, its finding that GOL had not violated the injunction was upheld.

Calcium supplements. The FTC alleged that the advertising for the calcium supplements violated the injunction by improperly comparing it to other supplements on the market and for improperly annualizing the average increase of bone mineral density attributed to the supplement. The district court properly found that GOL was not comparing the use of its calcium supplement to other supplements, but to individuals in the population who do not take any supplements; which was permissible and not banned by the injunction. However, the Eleventh Circuit found that the district court failed to discuss why the erroneous bone density increases were not a violation of the injunction and sent that claim back for further analysis.

The case number is 12-12382.

Attorneys: Michele Arington for Federal Trade Commission. Jeffrey S. Bucholtz (King & Spalding, LLP) for Garden of Life, Inc.

Companies: Federal Trade Commission; Garden of Life, Inc.

MainStory: TopStory SupplementNews AdvertisingNews AlabamaNews FloridaNews GeorgiaNews

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