Lice – just say the word and people start scratching their heads. This week, in an order that compounded that phenomenon, the FTC entered into a settlement with two marketers of the bed bug and head lice treatment Best Yet!, requiring them to obtain FDA pre-approval for any head lice treatment claims in the future. Earlier this year, however, the FTC refused FTC staff’s request to apply this remedy in the POM Wonderful case, despite finding that POM made deceptive claims that its pomegranate juice-based product treated, prevented, or reduced the risk of heart disease, prostate cancer, and erectile dysfunction. At least one Commissioner thinks the use of this remedy is lousy.
This past September, the FTC sued several marketers of Best Yet!, challenging ads that marketed the product as a natural, organic, and non-toxic treatment for head lice and bed bugs. Specifically, the FTC took issue with claims that Best Yet! is effective at treating and preventing head lice and bed bugs, and that it was developed for the U.S. Army at the request of the U.S. Department of Agriculture. Finding that head lice infestation is a medical condition with significant health consequences, the FTC decided to subject all future head lice treatment claims made by the defendants to FDA pre-approval. In contrast, bed bug treatment claims will only need to be supported by competent and scientific reliable evidence.
Chairwoman Ramirez and Commissioner Brill issued a statement explaining why they thought FDA pre-approval was appropriate. These commissioners noted that: the POM decision preserved the Commission’s right to apply the pre-approval remedy in the future; lice infestation is a medical condition covered by an FDA Monograph; and the consequences of a false claim were high, warranting this type of aggressive remedy.
Commissioner Ohlhausen voted against the settlement. Although she expressed support for the enforcement action as a whole, Commissioner Ohlhausen dissented from applying the “onerous level of substantiation required to obtain FDA preapproval.” Disagreeing with the conclusion that a head lice infestation is a serious condition, she noted that it is not life threatening and cannot lead to disease. Further, because the FTC in this action challenged claims about the product’s efficacy, rather than its safety, the only potential harm would be a longer infestation or transmission to other consumers. The dissent expressed further concern that marketers will consider this to be a signal of a policy shift, in that the FTC would tie all substantiation requirements to FDA standards. According to Ohlhausen this outcome could unnecessarily result in the chilling of health-related claims, effectively depriving consumers of useful information. Indicative of the level of disagreement at the Commission on this issue, the majority and Commissioner Ohlhausen can’t even agree on whether it’s “pre-approval” (majority view) or “preapproval” (Ohlhausen view).
Commissioner Wright voted to approve the settlement but issued a separate statement indicating that he believes FDA pre-approval should play a very limited role in FTC orders and should be used in narrow circumstances. He did not indicate further exactly what those circumstances might be.
The Commission previously required FDA pre-approval in cases that settled involving cold and flu claims. Thus, in settled cases involving cold and flu remedies and lice infestations, the Commission requires FDA pre-approval, but in a litigated case involving cancer and heart disease the Commission does not. Moreover the Commission appears deeply divided on whether and when this remedy is appropriate. Trying to make sense of all of this could make you crazy as a bed bug.