The Heated Debate over FTC Claims Substantiation and the Definition of “Competent and Reliable” Scie

Substantiation of health claims has been under scrutiny by the Federal Trade Commission (FTC) since its 1972 decision in the Pfizer case, which established the reasonable basis requirements for substantiation.[1] For claims relating to health and safety, FTC defines the reasonable basis requirement as “competent and reliable scientific evidence.”[2] Just recently, the flexible definition of “competent and reliable” scientific evidence returned to haunt FTC as it is once again faced with defining the level of substantiation required to adequately support health benefit claims. On September 27, 2010 FTC filed an administrative complaint against POM Wonderful LLC (“POM”) charging POM with deceptive advertising by making claims that POM Wonderful 100% Pomegranate Juice and POMx supplements prevent or treat heart disease, prostate cancer, and erectile dysfunction.[3]  FTC asserted that these claims were not supported by sufficient scientific evidence.[4]

FTC case law defines “competent and reliable” scientific evidence in only general terms as:

“tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[5]

In the recent POM case, FTC retroactively elevated its standard of substantiation by requiring that POM possess two double blinded, randomized controlled trials (“RCTs”) and obtain FDA pre-clearance on certain claims.[6] FTC asserts that it is “axiomatic that only RCTs can establish that a product is proven to treat, prevent or reduce the risk of a specific disease.”[7] Perhaps, FTC thought it had created a de facto substantiation standard when it entered into consent decrees with Iovate Health Sciences Inc. and Nestle HealthCare Nutrition,[8] ordering RCTs and FDA pre-approval for drug claims. Requiring this level of evidence constitutes an unusual discretion on the part of FTC, especially considering the fact that the FTC Act requires only that claims be truthful and not misleading, not that they meet FDA requirements.

On May 21, 2012, the FTC’s own Chief Administrative Law Judge (“ALJ”) D. Michael Chappell rejected major FTC arguments that POM must conduct double-blinded studies and that POM is only allowed to make certain claims if those claims have been pre-cleared by the FDA.[9] The ALJ stated that “precedent does not support implementing FDA pre-approval” and described the requirement as constituting “unnecessary overreaching.”[10] In regards to requiring double blinded studies the ALJ said that:

for health benefit claims…made in connection with a food, or food-derived product that is safe, and that is not being offered as a substitute for medical treatment, double-bind, randomized, placebo-controlled clinical trials, such as those required by the FDA, are not required. However,…claims that a food or food-derived product treats, prevents, or reduces the risk of a disease,…competent and reliable evidence must include clinical studies, although not necessarily double-blind, randomized placebo-controlled clinical trials.[11]

In another recent case, FTC tried to impose the same two-study standard against the Garden of Life, LLC (GOL), again without the requisite statutory authority. FTC charged GOL with making misleading claims linking GOL’s supplements to cancer treatment and making unsubstantiated representations about the cognitive benefits of their supplements.[12] The U.S. District Court for the Southern District of Florida ruled that GOL performed adequate due diligence and met the requirement of “competent and reliable” scientific evidence. GOL’s expert found that the supplements offered the documented benefits; however, FTC’s expert said the evidence on the supplements was flawed and unsupported. The court’s ruling acknowledged that a disagreement between experts does not inevitably render either scientific opinion wrong and that “competent and reliable” does not mean uncontroverted proof.

FTC’s attempt to create higher threshold substantiation standards similar to those for pharmaceuticals has met with resistance; it has been rejected as unreasonable and inapplicable to making health benefit claims when marketing a product. The recent POM and GOL decisions are good news for companies making health benefit claims backed by peer-reviewed, and published scientific research because the companies can feel confident in making claims that are substantiated in accordance with FTC’s current authorized standard of “competent and reliable” scientific evidence.

However, the reality is that FTC has not codified what it constitutes “competent and reliable” scientific evidence, but as these cases show, FTC may have to begin to create a bright line rule on the level of substantiation needed for claims related to health and safety. Otherwise, FTC will continue to apply substantiation standards in an ad hoc and potentially arbitrary fashion, leaving companies, who are substantiating that their representations (i.e., the claims) are true, at risk for being charged with violations of the Act.

The current industry trend of advertising the health benefits of food products is continuing at a high rate because consumers desire foods that confer something more than traditional nutritive or hedonistic value. What is clear is that companies making health benefit claims will continue to be under strict scrutiny by FTC. It is extremely important for FTC to act under its authority and be clear about the substantiation required because companies must develop regulatory strategies in order to realize the ultimate success of their products.

Over two years have passed since the FTC filed the complaint against POM and the litigation continues.  Both FTC and POM recently presented interesting oral arguments in front of five FTC Commissioners on August 23, 2012. The Commissioners should make a decision by the beginning of October, 2012. If the decision goes against POM, it can challenge FTC’s ruling in a Court of Appeals; this would definitely be considered “big league” litigation in the world of FTC advertising cases. Awaiting the final outcome of the case will have industry on the edge of their seats. Clearly, there are a number of potential obstacles to crafting a truthful and meaningful claim.

Let the experts at Burdock Group provide you with the assurance you need to be confident that your product claims are substantiated with the appropriate type and level of scientific evidence and, are in compliance with regulations.

References

[1] Pfizer Inc., 81 F.T.C. 23, 86 (1972)

[2] Novartis Corp., 127 F.T.C. 580, 725 (1999).

[3] FTC Press Release, FTC Complaint Charges Deceptive Advertising by POM Wonderful, Sept. 27, 2010, http://www.ftc.gov/opa/2010/09/pom.shtm ; See Docket No. 9344, In the Matter of POM Wonderful LLC and Roll Global LLC [hereinafter POM Wonderful]; FTC File No. 082-3122, http://www.ftc.gov/os/adjpro/d9344/120521pomdecision.pdf.

[4] Id.

[5] Novartis, supra note 2; See also Interstate Bakeries Corporation, Docket C-4042. http://www.ftc.gov/os/2002/04/wbibdo.pdf. ; In the Matter of Ciba-Geigy Corp. and Ciba Self-Medication, Inc., corp, Docket No. 9279.

[6] Pfizer, supra, note 1.

[7] Riette van Laack, FTC v. Pom Wonderful: the Battle Continues,  July 16, 2012, http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/07/ftc-v-pom-wonderful-the-battle-continues.html

[8] Nestlé Healthcare Nutrition, Inc., C-4312 (July 14, 2010); FTC v. Iovate Health Sciences USA, Inc., No. 10-CV-587 (W.D.N.Y. July 29, 2010).

[9] POM Wonderful, supra note 3.

[10] Id.

[11] POM Wonderful, supra note 3.

[12] FTC v. Garden of Life, Inc. and Jordin S. Rubin, No. 12-12382 (11th Cir. May 12, 2012).