Question 1

Can I advertise that my food or drink reduces the risk of a disease?

Accepted Answer

Generally only where the FDA has authorized the claim, because the FTC treats FDA's significant scientific agreement standard as the principal guide to reasonable substantiation for an unqualified health claim. The Commission has not gone so far as to say that FDA authorization is the only way to substantiate disease treatment, prevention, or risk-reduction claims, as it explained in its analysis of a proposed consent order with POM.

Question 2

Does adding a hedge like “may” or “promising” fix a disease claim?

Accepted Answer

Rarely. In the Nestlé matter, the Commission said its experience and research show it is very difficult to adequately qualify a disease risk-reduction claim in advertising to indicate that the science supporting the effect is limited. The POM appeal showed the same problem, because the FTC argued there that modifiers like “promising,” “encouraging,” or “hopeful” in many cases served only to intensify POM's bullish spin on its clinical results. Advertisers remain generally free, the FTC added, to tell consumers about a promising body of emerging science if they include clear qualifying language that discloses the limits of the record and any contrary evidence.

Question 3

Do I need randomized controlled trials to back a health claim?

Accepted Answer

Not as a matter of FTC Act law, though a claim that a product treats or reduces the risk of a disease needs real clinical evidence. In POM, the initial decision stated that, as a matter of law, nothing in the Federal Trade Commission Act requires placebo-controlled, double-blind studies. That decision treated the appropriate level of substantiation as a question of fact determined by expert testimony. Even so, for a safe food not offered as a substitute for medical treatment, the decision still concluded that experts would agree the evidence must include clinical studies adequate to show that the product did treat, prevent, or reduce the risk of disease. The Commission's final order went further, providing that disease-related establishment or efficacy claims about POM products or any food, drug, or dietary supplement the respondents sell must be supported by at least two RCTs. Courts have not settled the question of how many studies are enough: in FTC v. Krotzer, the court quoted FTC v. Direct Marketing Concepts, Inc. for the point that, while it seems well-accepted that double-blind, placebo-controlled studies are necessary to substantiate health-related efficacy claims, it is not firmly accepted by the courts how many such studies must be offered.

Question 4

Does the standard FDA disclaimer protect an ad that makes disease claims?

Accepted Answer

No. The disclaimer belongs to structure/function statements, which must be accompanied by a disclaimer that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. In defending the POM order, the FTC argued that a barely legible version of that disclaimer did nothing to cure the deceptive message in the ads. The government has also taken the position, in a response to a motion for return of property, that an ingestible product labeled a “dietary supplement” is a drug if its distributor intends it to cure, mitigate, treat, or prevent disease, even if the labeling also includes disclaimers.

Question 5

Can I say my product is FDA approved if the FDA allowed a qualified health claim?

Accepted Answer

No. The Gerber complaint challenged claims that the formula qualified for or received approval for a health claim from the FDA. The resulting order barred misrepresenting that the FDA or any other governmental entity approved or authorized a covered product or any claim for one.

Question 6

How do I tell a health claim from a structure/function claim?

Accepted Answer

By whether the claim refers to a disease or health-related condition. Health claims characterize the relationship of a substance to one, while structure/function claims describe an effect on the body's structure or function without referring to a disease. The wording is not the whole test. In POM, the Commission majority found that an ad headlined “Drink to Prostate Health,” which also equated the juice to “good medicine,” conveyed that daily POM Juice treats prostate cancer. Commissioner Ohlhausen cautioned that finding implied disease claims too easily, without extrinsic evidence, may undermine the balance struck in regulating food, supplement, and drug advertising.

Question 7

If I follow FDA's labeling rules, can the FTC still challenge my advertising?

Accepted Answer

Yes. DSHEA changed how the FDA regulates supplement labeling but did not alter the long-standing FTC policies and enforcement practices relating to dietary supplement advertising. The FTC has also taken the position that FDA-defined terms in food advertising should be consistent with the FDA labeling definition. In the Metagenics calcium-supplement proceeding, the respondents argued that their claims were permissible under FDA law. Complaint counsel conceded, though, that the FDA's Calcium Rule was not dispositive of the issues in the proceeding.

Question 8

If the FDA authorizes a health claim for my food, will only my brand be able to use it?

Accepted Answer

Not on the POM record. There, an internal POM assessment of a possible FDA health claim noted that the claim would not be specific to POM, but rather generic to all pomegranate products meeting a minimum level of polyphenol content. The same assessment added that it was possible the FDA would extend the claim beyond pomegranates.

Health claim (FDA)

Definition

Key legal rules

Why these rules exist

Enforcement examples

In re Tropicana Products, Inc. (Pure Premium orange juice blood-pressure claims)

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

In re Gerawan Farming, Inc. (peaches and plums, “My Fruit My Body” campaign)

In re POM Wonderful LLC (pomegranate juice and supplements)

FTC v. Gerber Products Co. (Good Start Gentle infant formula)

In re Metagenics, Inc. (Bone Builder calcium supplement)

Exposure

FAQs

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