By Todd Harrison, Venable01.05.18
Emerging case law on claims substantiation has clearly rejected the Federal Trade Commission’s prior consent decrees with Iovate and Nestlé, which required the companies to have two supporting placebo-controlled clinical trials on a particular product, or substantially similar product, in order to substantiate marketing claims for dietary supplements.
However, this standard was never the legal standard. Yet, the FTC, state attorneys general, and plaintiff class-action lawyers attempted to create the illusion that it was the law, rather than a negotiated settlement between FTC and the companies. So, what is today’s standard for claims substantiation? It is the same standard that has always applied: competent and reliable scientific evidence (CRSE), which never required drug-like clinical trials to support marketing claims.
More specifically, under the FTC guidance, “Dietary Supplements: An Advertising Guide for Industry” (FTC Guide), the relevant standard for “truthful and not misleading” claims for dietary supplements is the CRSE standard, which is defined 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.” 1
A ‘Flexible Standard’
Importantly, the FTC Guide does not require randomized clinical trials of dietary supplements and notes that “competent and reliable scientific evidence” is a “flexible” standard; there is “no fixed formula for the number or type of studies required.” Further, the FTC Guide notes that one should look to “the totality of the evidence” and that “studies on the precise formula used in the advertised product are not required.”2
Indeed, numerous federal courts have held that the CRSE standard is a flexible standard that requires careful analysis of the entire body of science, and it is not limited to only double-blind, placebo-controlled clinical trials. For example, the Seventh Circuit explicitly held that “[n]othing in the Federal Trade Commission Act … requires placebo-controlled, double-blind studies … [p]lacebo-controlled double-blind testing is not a legal requirement for consumer products.”3
Indeed, courts have expressly found that when analyzing competent and reliable scientific evidence for advertising claims, “the FTC Guidance makes clear that this standard is not the drug standard. Randomized clinical trials are not required.”2
Thus, in U.S. v. Bayer, the court rejected the FTC’s argument that competent and reliable scientific evidence could be met only through “human clinical trials that 1) are randomized, placebo-controlled, and double-blind; 2) use the specific product for which the claims are made; 3) are performed in the population at which the claims are directed; and 4) use validated methods and appropriate statistical methods to assess ‘outcomes.’”
Moreover, courts have specifically held that advertisers may support claims on a final product using testing of the products’ ingredients. For example, the Bayer court concluded that studies on the precise formula used in the advertised product were not required, and the court therefore found claims based on ingredient studies were properly substantiated.
Other courts have held that claims for a supplement were legally supported by CRSE where the marketer used an ingredient study to support claims for a final product that included additional ingredients.4
Time and again, U.S. federal courts have reiterated the fundamental principle that, when advertising dietary supplements, “placebo-controlled, double-blind testing is not a legal requirement for consumer products” and “something less may do.”1,5
Courts Reject Higher Standard
Despite the FTC’s efforts to impose a higher standard for CRSE, courts have consistently struck these attempts.
In 2012, the federal court for the District of Utah rejected the FTC’s allegations that an advertiser did not possess competent and reliable scientific evidence for its weight loss claims, including claims that users of the product “can eat all they want and still lose weight,” that the product “causes substantial weight loss,” and “causes weight loss for virtually all users.” The court explicitly rejected the FTC’s argument that the advertiser could only use randomized, double-blind, placebo-controlled clinical studies, and found the advertiser provided a reasonable basis for its claims based on clinical studies, as well as expert evaluations of those studies, in conjunction with animal and in vitro testing.4
In reaching this conclusion, the court explained that “[w]hile competent and reliable scientific evidence may consist of a single study under certain circumstances, [it] does not require that every aspect of an advertising claim be contained in one study. Nor does it preclude drawing inferences and correlations between different studies.”
Indeed, the Basic Research court held that a “study proffered by the FTC supporting a conclusion that disagrees with the supporting evidence proffered by [an advertiser] does not prove that [the advertiser] lacked a reasonable basis for the representation.” Applying this standard, the court concluded that the weight loss claims “are supported by competent and reliable scientific evidence.”4
In 2015, another federal court in U.S. v. Bayer explicitly rejected the FTC’s attempt to broaden the definition of “competent and reliable scientific evidence.” There, the court held that studies on the precise formula used in the advertised product are not required, and it can be “appropriate to extrapolate from the research to the claimed effect,” even if there “are significant discrepancies between the research conditions and the real life use being promoted.”
Accordingly, the Bayer court denied the FTC’s argument that supplement advertisers must possess double-blind, placebo-controlled clinical trials with results achieved at a statistically significant level before disseminating advertising claims for their products.
In September of this year, a third federal court rejected the FTC’s attempt to heighten the standard required for substantiating dietary supplement advertising claims.6 In FTC v. Quincy Bioscience, the U.S. Southern District of New York dismissed a case where the FTC alleged that advertising claims for a memory-enhancing dietary supplement were misleading.
In particular, the court rejected the FTC’s argument that claims were inappropriate because the advertiser’s clinical study did not yield a statistically significant improvement in the treatment group over placebo as a whole. Accordingly, the court held that “all that is shown is that there are possibilities that the study’s results do not support its conclusion,” and this alone does not suffice to support a case that an advertising claim is misleading.
Assessing Relevant Science
These cases demonstrate that dietary supplement health and safety claims do not only require placebo-controlled clinical study results on the finished product, and that something less may suffice. In this regard, the FTC has argued that a statistically significant outcome does not establish a product had a treatment effect. However, the opposite is also true; a product can have a meaningful and relevant treatment effect but not reach statistical significance.
In essence, the CRSE is not a static standard that requires statistical significance. Rather, it simply requires an assessment of the relevant scientific information by relevant experts to evaluate whether the product achieves the claimed benefits, a standard which “is sufficiently flexible to ensure that consumers have access to information about emerging areas of science.”2
To put it more simply, claim substantiation should be based on whether credible and properly qualified experts have a reasonable basis to conclude the claim is supported by the science, and such opinions cannot be defeated by the government or a private plaintiff by simply stating “our experts disagree.” If courts would simply adopt this common-sense position, we may finally see a downtick in questionable enforcement actions and plaintiff class-action lawsuits.
References
Todd Harrison
Venable
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
However, this standard was never the legal standard. Yet, the FTC, state attorneys general, and plaintiff class-action lawyers attempted to create the illusion that it was the law, rather than a negotiated settlement between FTC and the companies. So, what is today’s standard for claims substantiation? It is the same standard that has always applied: competent and reliable scientific evidence (CRSE), which never required drug-like clinical trials to support marketing claims.
More specifically, under the FTC guidance, “Dietary Supplements: An Advertising Guide for Industry” (FTC Guide), the relevant standard for “truthful and not misleading” claims for dietary supplements is the CRSE standard, which is defined 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.” 1
A ‘Flexible Standard’
Importantly, the FTC Guide does not require randomized clinical trials of dietary supplements and notes that “competent and reliable scientific evidence” is a “flexible” standard; there is “no fixed formula for the number or type of studies required.” Further, the FTC Guide notes that one should look to “the totality of the evidence” and that “studies on the precise formula used in the advertised product are not required.”2
Indeed, numerous federal courts have held that the CRSE standard is a flexible standard that requires careful analysis of the entire body of science, and it is not limited to only double-blind, placebo-controlled clinical trials. For example, the Seventh Circuit explicitly held that “[n]othing in the Federal Trade Commission Act … requires placebo-controlled, double-blind studies … [p]lacebo-controlled double-blind testing is not a legal requirement for consumer products.”3
Indeed, courts have expressly found that when analyzing competent and reliable scientific evidence for advertising claims, “the FTC Guidance makes clear that this standard is not the drug standard. Randomized clinical trials are not required.”2
Thus, in U.S. v. Bayer, the court rejected the FTC’s argument that competent and reliable scientific evidence could be met only through “human clinical trials that 1) are randomized, placebo-controlled, and double-blind; 2) use the specific product for which the claims are made; 3) are performed in the population at which the claims are directed; and 4) use validated methods and appropriate statistical methods to assess ‘outcomes.’”
Moreover, courts have specifically held that advertisers may support claims on a final product using testing of the products’ ingredients. For example, the Bayer court concluded that studies on the precise formula used in the advertised product were not required, and the court therefore found claims based on ingredient studies were properly substantiated.
Other courts have held that claims for a supplement were legally supported by CRSE where the marketer used an ingredient study to support claims for a final product that included additional ingredients.4
Time and again, U.S. federal courts have reiterated the fundamental principle that, when advertising dietary supplements, “placebo-controlled, double-blind testing is not a legal requirement for consumer products” and “something less may do.”1,5
Courts Reject Higher Standard
Despite the FTC’s efforts to impose a higher standard for CRSE, courts have consistently struck these attempts.
In 2012, the federal court for the District of Utah rejected the FTC’s allegations that an advertiser did not possess competent and reliable scientific evidence for its weight loss claims, including claims that users of the product “can eat all they want and still lose weight,” that the product “causes substantial weight loss,” and “causes weight loss for virtually all users.” The court explicitly rejected the FTC’s argument that the advertiser could only use randomized, double-blind, placebo-controlled clinical studies, and found the advertiser provided a reasonable basis for its claims based on clinical studies, as well as expert evaluations of those studies, in conjunction with animal and in vitro testing.4
In reaching this conclusion, the court explained that “[w]hile competent and reliable scientific evidence may consist of a single study under certain circumstances, [it] does not require that every aspect of an advertising claim be contained in one study. Nor does it preclude drawing inferences and correlations between different studies.”
Indeed, the Basic Research court held that a “study proffered by the FTC supporting a conclusion that disagrees with the supporting evidence proffered by [an advertiser] does not prove that [the advertiser] lacked a reasonable basis for the representation.” Applying this standard, the court concluded that the weight loss claims “are supported by competent and reliable scientific evidence.”4
In 2015, another federal court in U.S. v. Bayer explicitly rejected the FTC’s attempt to broaden the definition of “competent and reliable scientific evidence.” There, the court held that studies on the precise formula used in the advertised product are not required, and it can be “appropriate to extrapolate from the research to the claimed effect,” even if there “are significant discrepancies between the research conditions and the real life use being promoted.”
Accordingly, the Bayer court denied the FTC’s argument that supplement advertisers must possess double-blind, placebo-controlled clinical trials with results achieved at a statistically significant level before disseminating advertising claims for their products.
In September of this year, a third federal court rejected the FTC’s attempt to heighten the standard required for substantiating dietary supplement advertising claims.6 In FTC v. Quincy Bioscience, the U.S. Southern District of New York dismissed a case where the FTC alleged that advertising claims for a memory-enhancing dietary supplement were misleading.
In particular, the court rejected the FTC’s argument that claims were inappropriate because the advertiser’s clinical study did not yield a statistically significant improvement in the treatment group over placebo as a whole. Accordingly, the court held that “all that is shown is that there are possibilities that the study’s results do not support its conclusion,” and this alone does not suffice to support a case that an advertising claim is misleading.
Assessing Relevant Science
These cases demonstrate that dietary supplement health and safety claims do not only require placebo-controlled clinical study results on the finished product, and that something less may suffice. In this regard, the FTC has argued that a statistically significant outcome does not establish a product had a treatment effect. However, the opposite is also true; a product can have a meaningful and relevant treatment effect but not reach statistical significance.
In essence, the CRSE is not a static standard that requires statistical significance. Rather, it simply requires an assessment of the relevant scientific information by relevant experts to evaluate whether the product achieves the claimed benefits, a standard which “is sufficiently flexible to ensure that consumers have access to information about emerging areas of science.”2
To put it more simply, claim substantiation should be based on whether credible and properly qualified experts have a reasonable basis to conclude the claim is supported by the science, and such opinions cannot be defeated by the government or a private plaintiff by simply stating “our experts disagree.” If courts would simply adopt this common-sense position, we may finally see a downtick in questionable enforcement actions and plaintiff class-action lawsuits.
References
- Available at http://bit.ly/2BaNVCD
- U.S. v. Bayer Corp., No. 07-cv-01(JLL), 2015 WL 5822595, at *4 (D.N.J. Sept. 24, 2015) (citing the FTC Guide).
- FTC v. QT, Inc. 512 F.3d 858 (7th Cir. Jan. 3, 2008).
- Basic Research, LLC v. FTC, No. 2:09-cv-0779, 2014 WL 12596497 (D. Utah Nov. 25, 2014).
- Bayer Phillips colon Health Probiotics Sales Practices Litigation, No. 11-cv-03017, 2017 WL 1395483 (Apr. 18, 2017).
- FTC v. Quincy Bioscience Holding Co., Inc., No. 17-cv-124 (LLS), 2017 WL 4382312, at *1 (S.D.N.Y. Sept. 28, 2017).
Todd Harrison
Venable
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
