Does an ad have to name a disease to make a disease claim?

Not if the ad as a whole still points to a disease. After an FTC warning letter, Golden Sunrise replaced “COVID-19 virus” with terms such as “the virus” and “viral,” and the court still found it clearly a reasonable inference that the later ads implied the product treated COVID-19.

Can a mild phrase like “promotes healing” amount to a disease claim?

It can, when a reader who has the condition would take the phrase to mean the condition itself will heal. In Grove Laboratories, the Commission forbade a hemorrhoid product's use of “promotes healing,” reasoning that a person suffering from hemorrhoids would assume the medication would lead within a reasonable period to the healing of hemorrhoids.

Is a general health claim like “supports prostate health” a disease claim?

Not by itself. In POM Wonderful the Commission agreed that claims about general health benefits for heart, prostate, or erectile function are not the equivalent of claims to treat, prevent, or reduce the risk of the corresponding diseases. The administrative law judge's reasoning was that the meaning of “health” is not so limited as to include only treatment, prevention, or reduction of the risk of disease. Context can still turn health wording into a disease claim, because the Commission looks at the overall net impression of the whole ad.

Does calling a claim “structure/function,” or adding the standard FDA disclaimer, protect it?

No on both counts: the FDA's regulatory distinctions between “structure/function” and “health” claims under DSHEA do not apply to Section 5 of the FTC Act. The disclaimer fares no better, since the FTC staff's Dietary Supplements Guide says its inclusion is not likely to negate explicit disease claims in the ad and will not cure the fact that the claims are not substantiated.

Can we tell customers about early-stage research?

Generally yes: an advertiser may assert a health-related claim backed by medical evidence falling short of an RCT if it includes an effective disclaimer disclosing the limitations of the supporting research. Vague qualifiers are a poor substitute for that disclosure. The FTC's appellate brief in POM Wonderful, quoting its Dietary Supplements advertising guide, says terms such as “may” or “helps” are unlikely to be adequate.

Do I need two randomized trials to make a disease claim?

Not as a universal rule, because Chairwoman Ramirez and Commissioner Brill have said the proper level of substantiation for establishing liability is a case-specific factual determination. For claims that a food or supplement treats or prevents a serious disease, though, the Commission found in POM Wonderful that the proper level of substantiation is RCTs. The D.C. Circuit later modified POM's order to require at least one RCT before the disease claims covered by that provision. The court went no further than that, finding inadequate justification for a blanket requirement of at least two such studies as a precondition to any disease-related claim.

Can a food or supplement be treated as a drug?

Yes, because the FTC Act defines “drug” by intended use, including “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.” In Golden Sunrise, a court found that a supplement treatment appeared to be a drug covered by Section 12 because it was intended to cure, mitigate, treat, or prevent disease. A CBD case followed the same logic: the FTC's complaint alleged that calling products “dietary supplements” was false because disease claims rendered them unapproved new drugs under the Food, Drug, and Cosmetic Act.

Are claims the FDA has approved exempt from an FTC disease-claim order?

In some orders, yes. The Whole Leaf Organics order, for example, does not prohibit a drug representation approved in labeling under an FDA monograph or an approved new drug application.

HealthLegal test

Disease claim

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

A disease claim is an express or implied representation that a product is effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease. Source: Final Judgment and Order for Permanent Injunction and Other Equitable Relief, Part I (Prohibited Representations: Disease Claims) Orders also reach claims that a product “reduces the risk of any disease.” Source: Order, Part IV (Ban on Disease Claims) (Mar. 31, 2015)

Key legal rules

Several rules govern how a disease claim is read and what a business must have behind it:

An advertisement is deceptive if it contains a representation or omission of fact that is likely to mislead a consumer acting reasonably under the circumstances, and that representation or omission is material to a consumer’s purchasing decision. Source: Opinion of the Commission, Part III (F.T.C. Jan. 10, 2013)
In determining what claims an advertisement conveys, the Commission examines the entire advertisement and assesses the overall “net impression” it conveys. Source: Opinion of the Commission, Part IV (F.T.C. Jan. 10, 2013) Where an ad conveys more than one meaning, only one of which is misleading, a seller is liable for the misleading interpretation even if non-misleading interpretations are possible. Source: Opinion of the Commission, Part IV (F.T.C. Jan. 10, 2013)
A statement about a product's effect on a normal “structure or function” of the body may convey an implied disease claim, and the advertiser must then be able to substantiate that claim even if the ad contains no express reference to disease. Source: Complaint Counsel's Memorandum in Opposition to Respondents' Motion for Summary Decision, Part III.B.4 (quoting FTC, Dietary Supplements: An Advertising Guide for Industry)
For claims that a product can treat or prevent disease, the Commission has long required “competent and reliable scientific evidence,” typically consisting of “well-controlled human clinical studies.” Source: Brief of Respondent Federal Trade Commission, Statement of Facts, Part A (The Legal Framework) The relative safety of the product does not alter the requirement that the scientific evidence establish causality. Source: Opinion of the Commission, Part V.B (F.T.C. Jan. 10, 2013)
If an advertisement represents that a particular claim has been scientifically established, the advertiser must possess a level of proof sufficient to satisfy the relevant scientific community of the claim’s truth. Source: Opinion of the Commission, Part V.A (F.T.C. Jan. 10, 2013)
An advertiser may assert a health-related claim backed by medical evidence falling short of an RCT if it includes an effective disclaimer disclosing the limitations of the supporting research. Source: POM Wonderful, LLC v. FTC, No. 13-1060 (D.C. Cir. Jan. 30, 2015) Advertisers cannot use fine print to contradict other statements in an advertisement or to clear up misimpressions the advertisement would otherwise leave. Source: Complaint Counsel's Memorandum in Opposition to Respondents' Motion for Summary Decision, Part III.B.4 (quoting FTC, Dietary Supplements: An Advertising Guide for Industry)

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.

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Why these rules exist

The FTC has explained that products sold for their medical benefits are credence goods, meaning buyers cannot easily tell whether they work before or even after buying them. Source: POM Wonderful, LLC v. FTC, FTC Opposition Brief (D.C. Cir.) The medical harm the rule guards against is that unfounded disease claims may lead consumers to forego other treatments that have been validated by scientific evidence, or to self-medicate for potentially serious conditions without medical supervision. Source: POM Wonderful, LLC v. FTC, FTC Opposition Brief (D.C. Cir.)

A product's safety does not remove that risk, because consumers who rely on a claim may forgo important diet and lifestyle changes that are known to reduce the risk of diabetes, heart disease, or arthritis. Source: Statement of Chairwoman Edith Ramirez and Commissioner Julie Brill, In the Matter of GeneLink, Inc. and foru International Corporation (Jan. 7, 2014) Unsubstantiated disease claims also harm honest competitors that spend resources on studies of the existing science and conform their advertising to it. Source: Statement of Chairwoman Edith Ramirez and Commissioner Julie Brill, In the Matter of GeneLink, Inc. and foru International Corporation (Jan. 7, 2014) The pull runs the other way too, because Commissioner Wilson agreed that the Commission should be careful to avoid an unduly high standard of substantiation that risks denying consumers truthful, useful information. Source: Concurring Statement of Commissioner Christine S. Wilson (Dec. 17, 2020) For that reason she cautioned that the stringent substantiation requirement should be imposed sparingly. Source: Concurring Statement of Commissioner Christine S. Wilson (Dec. 17, 2020)

Enforcement examples

In re POM Wonderful LLC (pomegranate juice and supplements)

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

The complaint alleged that POM Wonderful and its co-respondents advertised that daily doses of POM Juice, POMx Pills, or POMx Liquid treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, without a reasonable basis. Source: Opinion of the Commission, Part I (F.T.C. Jan. 10, 2013) One print ad said drinking eight ounces of POM Juice a day “can help prevent . . . heart disease” and pictured the bottle with a noose around its neck. Source: Opinion of the Commission, Part IV.A (F.T.C. Jan. 10, 2013)

Outcome. The Commission found that this ad conveyed to at least a significant minority of reasonable consumers that drinking eight ounces of POM Juice daily prevents heart disease. Source: Opinion of the Commission, Part IV.A (F.T.C. Jan. 10, 2013) It then concluded that the proper level of substantiation for the disease efficacy claims was randomized controlled human trials. Source: Opinion of the Commission, Part V.B (F.T.C. Jan. 10, 2013) Because Respondents failed to proffer even one RCT supporting the claims it found, the Commission did not decide how many trials liability would require. Source: Opinion of the Commission, Part I (F.T.C. Jan. 10, 2013) As fencing-in relief, its final order required at least two RCTs for disease-related establishment or efficacy claims about the challenged products or about any food, drug, or dietary supplement Respondents sell. Source: Opinion of the Commission, Part I (F.T.C. Jan. 10, 2013) On review, the D.C. Circuit modified Part I of the order to require POM to possess at least one RCT before making the disease claims covered by that provision. Source: POM Wonderful, LLC v. FTC, No. 13-1060 (D.C. Cir. Jan. 30, 2015) The court found inadequate justification for the Commission's blanket requirement of at least two such studies as a precondition to any disease-related claim. Source: POM Wonderful, LLC v. FTC, No. 13-1060 (D.C. Cir. Jan. 30, 2015)

In re A & O Enterprises Inc. (iV Bars intravenous vitamin therapy)

In re A & O Enterprises Inc., Docket No. C-4670, Complaint

The complaint alleged that iV Bars claimed its intravenous vitamin cocktails could be used to treat consumers suffering from serious diseases, including cancer, congestive heart failure, multiple sclerosis, diabetes, fibromyalgia, and neurodegenerative disorders. Source: Complaint, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 2019) The complaint also alleged that the cocktails and the intramuscular treatments are “drugs” within the meaning of Sections 12 and 15 of the FTC Act. Source: Complaint, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 2019) As to support, the complaint alleged that the disease treatment claims rested on anecdotal stories of iV therapy patients and on studies of individual active ingredients given in different doses, formulations, routes of administration, or regimens than those advertised. Source: Complaint, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 2019)

Outcome. As proposed, the order broadly prohibited express or implied health benefit, efficacy, safety, or side effects claims for the intravenous therapies, unless the representation is non-misleading. Source: Letter to Jann Bellamy, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 13, 2019) The proposed order further provided that the required substantiation must include a randomized, double-blind, and placebo-controlled human clinical trial when experts generally require such testing. Source: Letter to Elizabeth de Laperouse, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 13, 2019) Before accepting the proposed order, the Commission required the respondents to send notices to consumers who may have relied on the challenged claims. Source: Letter to Center for Inquiry, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 13, 2019) After considering the public comments, the Commission issued the Decision and Order in final form without modification. Source: Letter to Center for Inquiry, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 13, 2019)

FTC v. Health Research Laboratories, LLC (heart, blood-pressure and diabetic nerve-pain supplements; contempt)

Order on Facial Ambiguity of Section II.H of the Stipulated Final Judgment and Order (July 31, 2020)

The FTC and the State of Maine contended that four products (Neupathic, Black Garlic Botanicals, BG18, and The Ultimate Heart Formula) were marketed with unsubstantiated claims that they cure, treat, or mitigate diabetes, diabetic neuropathy, cardiovascular disease, atherosclerosis, and hypertension. Source: Order on Facial Ambiguity of Section II.H of the Stipulated Final Judgment and Order, Part I (July 31, 2020) One mailer, they said, told readers that black garlic “can help reverse plaque build-up in arteries – not just slow it down.” Source: Plaintiffs' Motion for an Order to Show Cause, Statement of Facts, Part II.C (Dec. 17, 2019) For Neupathic, they argued that claims about relief of diabetic nerve pain, placed next to unqualified testimonials, amounted to a representation that the product cures, mitigates, or treats diabetic neuropathy. Source: Plaintiffs' Motion for an Order to Show Cause, Statement of Facts, Part II.G, and Legal Discussion, Part III (Dec. 17, 2019)

Outcome. The court held that the judgment's “cures, mitigates, or treats any disease” provision was facially ambiguous and did not, on its face, clearly and unambiguously cover representations about those conditions. Source: Order on Facial Ambiguity of Section II.H of the Stipulated Final Judgment and Order, Part IV (July 31, 2020) The reason was that the defendants' narrower reading of “any disease,” tied to the heading of that section of the judgment, was also reasonable. Source: Order on Facial Ambiguity of Section II.H of the Stipulated Final Judgment and Order, Part IV (July 31, 2020)

FTC v. Golden Sunrise Nutraceutical, Inc. (herbal supplement “plans of care” marketed for COVID-19 and cancer)

Order Granting Temporary Restraining Order (hearing Aug. 5, 2020)

Golden Sunrise sold supplements through “plans of care,” and its homepage stated that the plans “are intended to treat, modify, reverse, or cure a Serious or Life-threatening disease or condition.” Source: Order Granting Temporary Restraining Order, Background (hearing Aug. 5, 2020) After an FTC warning letter, the company replaced “COVID-19 virus” with terms such as “the virus,” “viral,” or “the viral pandemic.” Source: Order Granting Temporary Restraining Order, Background (hearing Aug. 5, 2020) The FTC alleged that the revised materials still represented that the Emergency D-Virus plan can effectively treat COVID-19. Source: Order Granting Temporary Restraining Order, Background (hearing Aug. 5, 2020)

Outcome. The court found it clearly a reasonable inference that the advertisements following the warning letter implied that Emergency D-Virus was an effective treatment for COVID-19. Source: Order Granting Temporary Restraining Order, Analysis, Part I.A (hearing Aug. 5, 2020) It also held that all of the representations were material because they concern consumer health. Source: Order Granting Temporary Restraining Order, Analysis, Part I.A (hearing Aug. 5, 2020) The court granted the FTC's motion for a temporary restraining order in its entirety. Source: Order Granting Temporary Restraining Order, Background (hearing Aug. 5, 2020)

In re Marc Ching (Whole Leaf Organics; Thrive and CBD supplements)

Decision and Order, In re Marc Ching (Whole Leaf Organics) (Consent Agreement and Settlement Order, issued Oct. 16, 2020)

In a proposed stipulated preliminary injunction, the FTC asserted that the Whole Leaf Organics website claimed that Thrive treats, prevents or reduces the risk of COVID-19 and that CBD-EX, CBD-RX, and CBD-Max treat cancer, and that the efficacy of these products was scientifically or clinically proven. Source: [Proposed] Stipulated Preliminary Injunction, FTC v. Ching, No. 2:20-cv-3775 (C.D. Cal.), Findings ¶ 2.b

Outcome. The Commission's consent order barred any representation, express or implied, that a covered product treats, prevents or reduces the risk of COVID-19, treats cancer, or cures, mitigates, or treats any disease in humans, unless the representation is non-misleading and backed at the time by competent and reliable scientific evidence. Source: Consent Agreement and Settlement Order (F.T.C. issued Oct. 16, 2020), Provisions I, V, VI and Attachment A The order defined that evidence as human clinical testing that is randomized, double-blind, placebo-controlled, and conducted by qualified researchers. Source: Consent Agreement and Settlement Order (F.T.C. issued Oct. 16, 2020), Provisions I, V, VI and Attachment A

Exposure

The FTC's complaint in Golden Sunrise invoked Section 13(b) of the FTC Act to ask the court for injunctive relief and ancillary relief, including restitution and disgorgement. Source: Complaint (FTC v. Golden Sunrise Nutraceutical, Inc.) ¶ 86 (July 30, 2020) Commissioner Wilson has stated that the Supreme Court's decision in AMG Capital Management, LLC v. FTC ended the Commission's use of Section 13(b) to obtain equitable monetary relief. Source: Dissenting Statement of Commissioner Christine S. Wilson, Notice of Penalty Offenses Concerning Substantiation of Product Claims (Mar. 31, 2023) Earlier stipulated orders show the scale of relief that was available before that decision. In one order, judgment in the amount of $391,335 was entered against the defendants, jointly and severally, as equitable monetary relief. Source: Final Judgment and Order for Permanent Injunction and Other Equitable Relief (Grey Defence), Part VI (Monetary Judgment) (Sept. 12, 2016) In another, a $993,416 judgment was entered against an individual defendant as equitable monetary relief. Source: Stipulated Order for Permanent Injunction and Monetary Judgment Against Quantum Wellness Botanical Institute, LLC and Fred Auzenne, Part VI (Feb. 10, 2020) That order required him to pay $60,000, after which the remainder of the judgment was suspended. Source: Stipulated Order for Permanent Injunction and Monetary Judgment Against Quantum Wellness Botanical Institute, LLC and Fred Auzenne, Part VI (Feb. 10, 2020) The suspension is lifted if the court finds that he failed to disclose a material asset or made a material misstatement or omission in his financial representations. Source: Stipulated Order for Permanent Injunction and Monetary Judgment Against Quantum Wellness Botanical Institute, LLC and Fred Auzenne, Part VI (Feb. 10, 2020)

Injunctions can go well beyond the claim at issue. In Daniel Chapter One, a district court order permanently enjoined the defendants from advertising, promoting, offering for sale, selling, or distributing any dietary supplement. Source: Order, Part IV (Ban on Disease Claims) (Mar. 31, 2015) The same order permanently enjoined them from representing, expressly or by implication, that any product or service cures, treats, mitigates, prevents, or reduces the risk of any disease. Source: Order, Part IV (Ban on Disease Claims) (Mar. 31, 2015) The court's memorandum opinion found that the defendants had intentionally and knowingly violated the earlier FTC order from April 2, 2010 until May 24, 2012. Source: Memorandum Opinion, Daniel Chapter One (Mar. 31, 2015) The United States had asked for a final order that includes injunctive relief, equitable monetary relief of $1,345,832.43, and a civil penalty award of $3,528,000, and the court granted its motion. Source: Memorandum Opinion, Daniel Chapter One, Part I (Background) (Mar. 31, 2015)

The Commission cannot obtain civil penalties for first-time violations of Section 5 of the FTC Act. Source: Dissenting Statement of Commissioner Christine S. Wilson, Notice of Penalty Offenses Concerning Substantiation of Product Claims (Mar. 31, 2023) Penalties become a concern once an order exists. The Commission's February 2019 letter on the iV Bars order described civil penalties of up to $41,484 per violation should the respondents violate it. Source: Letter to Center for Inquiry, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 13, 2019) The same letter said the respondents would be subject to the final Decision and Order for 20 years. Source: Letter to Center for Inquiry, In re A & O Enterprises Inc., Docket No. C-4670 (F.T.C. Feb. 13, 2019)

Parties and nonparties bound by an order may be held in civil contempt if the movant demonstrates by clear and convincing evidence that they had notice of the order, that the order was clear and unambiguous, that they could comply, and that they violated it. Source: Plaintiffs' Motion for an Order to Show Cause, Statement of Facts, Part II.G, and Legal Discussion, Part III (Dec. 17, 2019) In the Health Research Laboratories matter, the FTC and Maine sought compensatory sanctions of $2,133,263, measured by the net revenues of three products, jointly and severally from the company and its owner. Source: Plaintiffs' Motion for an Order to Show Cause, Statement of Facts, Part II.G, and Legal Discussion, Part III (Dec. 17, 2019)

Owners and officers face personal exposure. To impose non-monetary injunctive relief against an individual, the FTC must show either that the individual participated directly in the business entity's deceptive acts or practices or that he had the authority to control them. Source: Brief of Respondent Federal Trade Commission, Argument, Part IV A showing of knowledge is necessary only when the FTC seeks equitable monetary relief against an individual. Source: Brief of Respondent Federal Trade Commission, Argument, Part IV Orders can also reach beyond the products at issue: the POM Wonderful order applies to the challenged products and to any other food, drug, or dietary supplement sold by POM and the other Roll entities. Source: Opinion of the Commission, Part X.B (F.T.C. Jan. 10, 2013) The order in the administrative law judge's initial decision in that matter provided for termination in twenty years. Source: Initial Decision, In re POM Wonderful LLC, Part III.H.4.f (May 2012) Orders can also require a company to tell past customers its claims were untrue. The Whole Leaf Organics order required a notice stating that “some of the things we said in our advertising about Thrive aren’t true.” Source: Consent Agreement and Settlement Order (F.T.C. issued Oct. 16, 2020), Provisions I, V, VI and Attachment A

FAQs

1.Final Judgment and Order For Permanent Injunction and Other Equitable Relief. Final Judgment and Order for Permanent Injunction and Other Equitable Relief, Part I (Prohibited Representations: Disease Claims)
2.Daniel Chapter One: United States District Court Order Requiring the Defendants To Pay $1.345 Million In Equitable Monetary Relief For Consumer Redress and $3.5 Million In Civil Penalties; Permanently Prohibiting the Defendants From Marketing or Assisting Others To Market Dietary Supplements; Permanently Prohibiting the Defendants From Representing That Any Product or Service They Market Will Cure, Treat, Mitigate, Prevent, or Reduce the Risk of Any Disease; and Imposing Other Relief - March 31, 2015. Order, Part IV (Ban on Disease Claims) (Mar. 31, 2015)
3.Opinion of the Commission, By Commissioner Maureen K. Ohlhausen. Opinion of the Commission, Part III (F.T.C. Jan. 10, 2013)