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As fears escalate over the spread of coronavirus (COVID-19), scared consumers may be more susceptible to claims by companies offering cure-all remedies. The Federal Trade Commission (FTC) and Food and Drug Administration (FDA) are aware and looking out for consumers. The two agencies sent joint warning letters to seven companies – Vital Silver, Quinessence

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As previously reported on Keller and Heckman’s “The Continuum of Risk” blog, earlier this year, the U.S. Consumer Product Safety Commission (CPSC) announced that it was now reading the Child Nicotine Poisoning Prevention Act (CNPPA) to require nicotine e-liquid bottles to meet the “restricted flow requirement” in 16 C.F.R. § 1700.15(d), in addition to having

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The U.S. Food and Drug Administration (FDA) finalized its recommendations on September 6, 2017 on how to secure interoperable medical devices’ interactions with other devices and information systems. The FDA’s initial guidance, drafted in January 2016, was designed to help manufacturers develop safe, secure information exchange systems in connected medical devices. The updated guidance

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For all of you who know the U.S. Consumer Product Safety Commission (CPSC), you know that the agency distinctly does not have authority over tobacco or tobacco products. This arguably wasn’t always the case. Early on, the American Public Health Association petitioned the CPSC to regulate cigarettes containing more than 21 mg of tar. When

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Selling to consumers is generally a beneficial enterprise for all involved, but occasionally businesses will need to recall products, for a myriad of reasons. When that happens, different sets of rules apply depending on the type of product that is impacted. If your product falls under the U.S. Consumer Product Safety Commission’s (CPSC) jurisdiction, one

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The name of POM Wonderful, LLC (“POM”) will now forever be linked to some important advertising rulings that are not only of central significance to the food industry, but have broader advertising significance as well.  We are reminded of those actions today because POM’s advertising claims touting health benefits of pomegranate juice resulted in a ruling by the D.C. Circuit Court of Appeal upholding in part a January 2014 Federal Trade Commission (“FTC”) decision on POM’s health claim advertising, but rejecting one of the remedies of most concern to industry as a whole: a requirement that claims be supported by two (not one) well controlled, randomized clinical trials. 

A statement by FTC Chairwoman Edith Ramirez rejected the notion that the Commission would be precluded from requiring two clinical trials in other circumstances.  Chairwoman Ramirez explained that this court decision affirmed the January 2014 FTC decision that the marketers of POM Wonderful 100% Pomegranate Juice and POMx supplements deceptively advertised that the products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, and were clinically proven to have such benefits.  She noted that the court did not uphold the FTC order requirement for two randomized well controlled human clinical trials by POM in that case. However, she explained that the court did affirm the FTC’s order requiring POM to have at least one such study before making disease prevention or treatment claims, and held out the possibility that two might be warranted in other cases.

POM of course was not just the recipient of a claim about allegedly false advertising claims.  POM previously challenged successfully a competitor making “pomegranate” juice claims, resulting in an important 8 to 0 U.S. Supreme Court ruling in POM Wonderful LLC  v. The Coca-Cola Company, 133 S. Ct. 2224 (Jun. 12, 2014).  In that case, the Court ruled that regardless of whether a 100% juice product complies (or not) with Food and Drug Administration (“FDA”) labeling regulations under the federal Food, Drug and Cosmetic Act (“FDCA”), a competitor’s false advertising case under the federal Lanham Act could still proceed. 


Continue Reading POM-eled: POM Wonderful, The FTC and Competitor Challenges (Hint – It’s All About Consumer Deception)

On November 25, 2014, the Food and Drug Administration (FDA) released final regulations implementing nutrition labeling requirements for retail food establishments.  The regulations implement Section 4205 from the Patient Protection and Affordable Care Act, which requires chain restaurants and similar retail food establishments to provide consumers with more nutrition information.  From an advertising perspective, the