The FTC has long required that if an advertiser makes a specific, verifiable claim, the advertiser needs to have adequate substantiation for the claim before it is made. One of the more interesting and recognizable examples of this rule came on December 1, 2015, when the FTC announced a proposed settlement with Tommie Copper for its claims that its products—copper-infused compression clothing—relieve pain.  Tommie Copper's advertisements claimed that its copper-infused compression clothing provides pain relief from a number of conditions.  In fact, the company proclaimed that its products provide pain relief comparable to, or better than, drugs or surgery.  For example, its infomercials featured Montel Williams declaring "Tommie Copper truly is pain relief without a pill."  The advertisements also claimed relief from chronic pain and pain caused by multiple sclerosis, arthritis, and fibromyalgia, relying on some purported customer testimonials.

But, based on the 2015 proposed settlement, it appears that Tommie Copper did not have much support for these lofty claims.

The settlement, which will cost Tommie Copper at least $1.35 million, served as a reminder that before making any advertising claim, the advertiser must have adequate substantiation for the claim.  And the bar is higher for medical claims.  As the proposed settlement explains, before the company can make health-related claims related to chronic or severe pain, diseases, drugs, and surgery, it must have "competent and reliable scientific evidence" to support the claims.  FTC v. Tommie Copper, Inc., 7:15-cv-09304-VB, Dkt. 4-1 (S.D.N.Y. Dec. 1, 2015).

The proposed settlement specifically defined "competent and reliable scientific evidence" as "human clinical testing . . . based on standards generally accepted by relevant medical experts" that is "(1) randomized, double-blind, and placebo-controlled; and (2) . . . conducted by researchers qualified by training and experience to conduct such testing."  Id.  The proposed settlement also prohibits the use of other health-related claims without substantiation from tests, analysis, research, or studies conducted by qualified persons in a manner that is generally accepted in the profession to be accurate and reliable. Id. The monetary judgment in the proposed settlement is a whopping $86.8 million, although Tommie Copper need only pay $1.35 million now.  The remainder of the judgment is suspended based on, among other things, the company's representations regarding its finances.

Though the facts and circumstances of every advertisement will determine what amount and type of substantiation is required, this settlement shows the FTC will require "competent and reliable scientific evidence" when making health-related claims to consumers.

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