Do I need significant scientific agreement before I can say a food or supplement reduces disease risk?

It is the benchmark for unqualified diet-disease claims. The Commission regards the standard as the principal guide to reasonable substantiation for an unqualified health claim. FDA authorizes health claims by regulation only when that agreement exists.

Does significant scientific agreement mean every scientist has to agree?

No, full consensus is not required. A filing in the POM matter quotes the FTC's Enforcement Policy Statement on Food Advertising as saying the Commission does not require food advertisers to establish scientific consensus, and that FDA has indicated its standard does not require a full consensus among scientists.

If my evidence is promising but not conclusive, can a disclaimer fix a disease claim?

Not reliably. The Commission's experience and research show that it is very difficult to adequately qualify a disease risk-reduction claim in advertising to indicate that the supporting science is limited. In POM, though, the Commission said it would have considered the ads in light of disclaimers like those described in Pearson, such as "the evidence in support of this claim is inconclusive," and that without them the ads were deceptive and misleading.

Is a claim illegal just because it lacks significant scientific agreement?

Not on that basis alone, according to the D.C. Circuit in Pearson v. Shalala (as quoted in Respondents' pretrial brief in the POM matter), which rejected the argument that health claims lacking "significant scientific agreement" are inherently misleading. The Commission, for its part, has not read Pearson to stop it from finding that claims are misleading because they lack substantiation, even if they are evaluated as potentially misleading rather than actually misleading.

Can the FTC require me to get FDA authorization before I make disease claims?

It has done so in consent orders, though not in the litigated POM case. In the Nestlé order, the Commission determined that requiring FDA pre-approval before URTI risk-reduction claims was reasonably related to enforcing the order. In POM, the Commission rejected an FDA pre-approval requirement and imposed a two-RCT requirement instead. It also said that ruling does not foreclose pre-approval in an appropriate future case.

If FDA has authorized a claim, can I use my own words, and does that protect me?

Within limits, and the protection depends on the order. In the Nestlé analysis, the Commission said that if FDA has approved a claim, the company may use a variety of words and images to communicate it, but an ad whose net impression is risk reduction still needs an FDA-authorized claim based on significant scientific agreement. Dannon's proposed order would likewise not prohibit representations that FDA regulations specifically permit in labeling.

HealthLegal test

Significant scientific agreement

Berkeley Robinson, Managing Attorney at Robinson Law Firm PLLC

Author

Berkeley Robinson, Esq.

Managing Attorney, Robinson Law Firm PLLC

Berkeley has served as the go-to counsel for many scaling businesses in a transactional and litigation management capacity. Before becoming an attorney, Berkeley grew sales teams, ran online marketing campaigns, and did everything else an entrepreneur does—and still does today as the founder of two online businesses.

Definition

In health-claim law, significant scientific agreement means significant agreement, among experts qualified by scientific training and experience to evaluate such claims, that a health claim is supported by the totality of the publicly available scientific evidence. Source: Complaint Counsel’s Post-trial Brief, In re POM Wonderful LLC (quoting 21 U.S.C. § 343(r)(3)(B)(i))

The FTC treats the same standard as the principal guide to what experts in the field of diet-disease relationships would consider reasonable substantiation for an unqualified health claim. Source: In re POM Wonderful LLC, Opinion of the Commission (quoting Enforcement Policy Statement on Food Advertising)

Key legal rules

Significant scientific agreement is the yardstick for judging whether an unqualified diet-disease claim is supported. Two rules put it to work:

FDA authorizes a health claim by regulation only when significant scientific agreement supports it, and the Commission regards that standard as the principal guide to reasonable substantiation for an unqualified diet-disease claim—so it is likely to reach the same conclusion as FDA on whether such a claim is adequately supported. Source: Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC), quoting a federal court opinion on a supplement maker's First Amendment challenge
The absence of an FDA determination that a health claim is scientifically valid is a significant factor in the Commission's assessment of the adequacy of substantiation, and food marketers should not expect to circumvent FDA's petition process for health claims simply by limiting the assertion of unapproved or unreviewed claims to advertising. Source: Complaint Counsel's Appeal Brief, In re POM Wonderful LLC, Docket No. 9344 (F.T.C.)

For the sake of space, this page lists only the primary rules related to this term that most businesses should follow. More may apply to your situation, and your unique facts affect how they apply.

Send us a message through our online form to talk through yours.

Send a message

Response within 24 hours

Why these rules exist

Consumers cannot readily check a diet-disease claim for themselves, and the Commission has treated claims "whose truth or falsity would be difficult or impossible for consumers to evaluate by themselves" as requiring a high level of substantiation. Source: Opinion of the Commission, Part V.B (F.T.C. Jan. 10, 2013) Respondents' pretrial brief in the POM matter described FDA's practice this way: the agency has declined to approve health claims that rest on credible but inconclusive evidence. Source: Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version]

A hedge in the ad does not reliably repair the problem, because reasonable consumers may read an ad as promising risk reduction even when it says the science is limited, as the Commission explained in the Nestlé consent order analysis. Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.) The standard is also limited from the other side. In Pearson v. Shalala, as quoted in Basic Research's motion to compel in the POM matter, the D.C. Circuit held that the agency had to give "some definitional content" to the phrase. Source: Basic Research, LLC's Motion to Compel (quoting Pearson v. Shalala, 164 F.3d 650, 660 (D.C. Cir. 1999)) It concluded that potentially misleading claims could be remedied by "prominent" disclaimers. Source: In re POM Wonderful LLC, Opinion of the Commission

Enforcement examples

In re Nestlé HealthCare Nutrition, Inc. (BOOST Kid Essentials and other nutritional drinks)

Nestle' HealthCare Nutrition, Inc.; Analysis of Proposed Consent Order to Aid Public Comment; Letter to Commenter Thomason (Jan. 12, 2011)

The Nestlé consent order addressed complaint allegations that the company made unsubstantiated representations that its products prevent upper respiratory tract infections (URTIs). Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.) The order reaches BOOST Kid Essentials, any drink product containing probiotics, and any nutritionally complete drink other than infant formula, medical foods, and products not sold primarily through conventional retail channels. Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.)

Outcome. Part I of the proposed order bars representations that a covered product prevents or reduces the risk of URTIs unless FDA regulations under the Nutrition Labeling and Education Act specifically permit the representation in labeling. Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.) In practical terms, the company could not claim URTI risk reduction unless FDA had issued a regulation based on a finding of significant scientific agreement. Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.) The test follows the ad's net impression rather than its wording, so an ad that conveys URTI risk reduction needs an FDA-authorized claim whatever words or images it uses. Source: Nestle' HealthCare Nutrition, Inc.; Analysis of Agreement Containing Consent Order to Aid Public Comment A commenter suggested changes, and the Commission answered that Part I requires the company to meet in advertising the same standard it already must meet for labeling; it then issued the Decision and Order in final form without the suggested modifications. Source: Letter from Donald S. Clark, Sec'y, FTC, to Lee Thomason re Nestlé HealthCare Nutrition, Inc., File No. 0823145 (Jan. 12, 2011)

In re POM Wonderful LLC (pomegranate juice and pomegranate extract products)

In re POM Wonderful LLC, Opinion of the Commission (Jan. 10, 2013)

The complaint alleged that POM advertised that certain doses of its juice and extract products treat, prevent or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, without a reasonable basis to substantiate those claims. Source: Opinion of the Commission, Part I (F.T.C. Jan. 10, 2013) Complaint Counsel's post-trial brief contended that, instead of pursuing FDA-authorized health claims of reduced risk of heart disease or prostate cancer, the company decided it was more advantageous to do targeted research for marketing purposes or to publicize what it already had. Source: Complaint Counsel’s Post-Trial Brief, In re POM Wonderful LLC

Outcome. The Commission concluded that the respondents violated Sections 5(a) and 12 of the FTC Act. Source: Opinion of the Commission, Part I (F.T.C. Jan. 10, 2013) Complaint Counsel had asked for a remedy that would require FDA pre-approval of future disease claims. The Commission rejected it and required at least two randomized controlled trials instead. Source: Opinion of the Commission, Part X.B (F.T.C. Jan. 10, 2013) The Final Order therefore contains no FDA pre-approval provision. Source: Opinion of the Commission, Part I (F.T.C. Jan. 10, 2013) The Commission said its ruling does not foreclose imposing that remedy in an appropriate case. Source: Opinion of the Commission, Part X.B (F.T.C. Jan. 10, 2013)

In re The Dannon Company, Inc. (probiotic dairy drink and yogurt)

The Dannon Company, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

According to the FTC complaint, Dannon represented in various advertisements that drinking DanActive reduces the likelihood of getting a cold or the flu, and the complaint alleged those claims were unsubstantiated. Source: The Dannon Company, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Outcome. Part I of the proposed consent order would bar representations that a covered product reduces the likelihood of getting a cold or the flu unless FDA regulations under the NLEA specifically permit the representation in labeling. Source: Analysis of Proposed Consent Order To Aid Public Comment (The Dannon Company, Inc.) Part VI, meanwhile, would leave Dannon free to make any representation for any product that FDA regulations specifically permit in labeling. Source: The Dannon Company, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Exposure

A company that makes disease risk-reduction claims without adequate support can end up under an order barring those claims unless FDA has authorized them. The Nestlé consent order bars URTI risk-reduction representations unless FDA regulations under the NLEA specifically permit them in labeling. Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.) The Commission determined that requiring FDA pre-approval would facilitate compliance and was reasonably related to enforcing that order. Source: In re Nestlé HealthCare Nutrition, Inc., Analysis of Proposed Consent Order to Aid Public Comment (F.T.C.) Dannon's proposed order carried a similar bar on representations that a covered product reduces the likelihood of getting a cold or the flu. Source: Analysis of Proposed Consent Order To Aid Public Comment (The Dannon Company, Inc.)

In the litigated POM matter, the Commission found violations of Sections 5(a) and 12 of the FTC Act and issued a Final Order. The order requires at least two randomized controlled trials before any representation about a product's effectiveness in the diagnosis, treatment, or prevention of any disease. Source: Opinion of the Commission, Part X.B (F.T.C. Jan. 10, 2013) It reaches beyond the challenged products to any other food, drug, or dietary supplement products sold by POM and the other Roll entities. Source: Opinion of the Commission, Part X.B (F.T.C. Jan. 10, 2013)

FAQs

1.D09344 - Complaint Counsel’s Post-trial Brief. Complaint Counsel’s Post-trial Brief, In re POM Wonderful LLC (quoting 21 U.S.C. § 343(r)(3)(B)(i))See also Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version]. Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC), quoting a federal court opinion on a supplement maker's First Amendment challenge
2.Opinion of the Commission, By Commissioner Maureen K. Ohlhausen. In re POM Wonderful LLC, Opinion of the Commission (quoting Enforcement Policy Statement on Food Advertising)
3.Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version]. Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC), quoting a federal court opinion on a supplement maker's First Amendment challengeSee also Opinion of the Commission, By Commissioner Maureen K. Ohlhausen. In re POM Wonderful LLC, Opinion of the Commission (quoting Enforcement Policy Statement on Food Advertising)See also Opinion of the Commission, By Commissioner Maureen K. Ohlhausen. Opinion of the Commission, Part V.B (F.T.C. Jan. 10, 2013)