Research · 10 min read
What a Health Claim Needs Behind It
Federal advertising law has a name for the evidence a company must hold before it says a product does something to your body. Knowing what counts, and what has never counted, changes how a sales page reads.
Key takeaways
- Substantiation must exist before an advertisement runs, and it must cover implied claims as well as stated ones.
- For health benefit or safety claims the standard is competent and reliable scientific evidence, defined by expert conduct, professional acceptance, and sufficiency in light of the entire body of evidence.
- Consumer anecdotes and surveys are never sufficient, and a practitioner's observation about their own patients is treated as anecdotal too.
- Naming a level of support creates a second claim, which can be deceptive even when the advertiser holds real evidence.
- Approval language placed beside an unrelated benefit claim can mislead through juxtaposition alone, and a company-owned site presented as independent commentary is the advertiser's own advertising.
The short answer
Before an advertisement runs, the advertiser is expected to already hold adequate substantiation for every objective claim it conveys, whether the claim is stated or implied.
For claims about health benefits or safety, the standard has a name: competent and reliable scientific evidence.
The Federal Trade Commission has defined that name in print, and the definition is short enough to carry around.
It also spells out what does not clear the bar. Customer stories, satisfaction surveys, a practitioner's observations, animal work, laboratory work and public health advisories are each addressed by name, and none of them is sufficient on its own.
Two principles, then one standard
The Commission's health advertising guidance reduces its own authority to two sentences.
Advertising must be truthful and not misleading. And before disseminating an advertisement, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to consumers acting reasonably.
The order matters. Substantiation is a precondition, not a defense assembled later.
The guidance then states the general rule for this field. Claims about the health benefits or safety of foods, dietary supplements, drugs and other health-related products require substantiation in the form of competent and reliable scientific evidence.
It also defines advertising broadly for its own purposes. The term covers more than television, radio, print and internet advertisements. It reaches packaging and labeling statements, brochures and digital content, social media and influencer marketing, press releases and interviews, trade shows and seminars, and promotion carried indirectly through healthcare practitioners or other intermediaries.
The definition, in the Commission's words
Competent and reliable scientific evidence is defined as tests, analyses, research or studies meeting two conditions. They must have been conducted and evaluated in an objective manner by experts in the relevant disease, condition or function to which the representation relates. And they must be generally accepted in the profession to yield accurate and reliable results.
There is a second half. The research must be sufficient in quality and quantity to substantiate that the representation is true. Sufficiency is judged on standards generally accepted in the relevant scientific fields, and in light of the entire body of relevant and reliable scientific evidence.
Read those two halves together and three demands fall out. The work has to be done by the right kind of expert. It has to meet the field's own standards. And it has to be weighed against everything else known, not just the parts that help.
As a general matter, the guidance says, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing.
There is no required number of such trials. Replication by independent researchers adds weight, because it reduces the chance that a single result reflects an undetected bias. But quality outranks quantity, and the guidance says numerous flawed and inadequate studies are unlikely to add up to competent and reliable scientific evidence.
Five things that are not substantiation
This list is the most useful part of the guidance for anyone reading a marketing page, because each item is something pages lean on constantly.
Customer experience. Anecdotal evidence about the individual experiences of consumers, including surveys of consumer experiences, is never sufficient to substantiate a claim about a health product. Even genuine experiences may be attributable to a placebo effect or to other factors unrelated to the product.
A clinician's impression. For the same reason, the guidance says a healthcare practitioner's observation about the effect of a product on patients is anecdotal and does not provide evidence of a causal relationship.
Association without causation. Epidemiological or observational studies can be valuable for showing an association, but they do not prove a causal link. The Commission will accept high-quality epidemiologic evidence only in the limited cases where experts in the field consider it an acceptable substitute and controlled trials are not otherwise feasible.
Animals and cells. Animal and laboratory studies may provide useful supporting or background information, but without confirmation by human trials they are not sufficient to substantiate health-related claims. The guidance says animal studies have only limited value in predicting effects in people, and that laboratory work on isolated cells may help identify a possible mechanism while remaining of limited predictive value.
An official recommendation. Advertisers should not rely on public health recommendations, such as advisories from a medical organization, as substantiation. Such advisories reflect a judgment on the best available evidence; they are not a finding of a causal link. The guidance tells marketers to evaluate the evidence underneath the recommendation instead.
Naming your evidence raises the bar
There is a separate trap for pages that brag about their science.
When an advertisement refers to a specific level of support, the advertiser has to have that level of support. The claim about the evidence becomes its own claim, needing its own proof.
The guidance's example is a product advertised as based on Nobel Prize-winning research and proven effective by a large sum of federally funded work. The prize concerned an unrelated use of the ingredient, and the federal research examined safety rather than effectiveness.
Its conclusion is the sharp part. The specific claims about the level of support are deceptive even if the advertiser possesses other research that would qualify as competent and reliable scientific evidence of effectiveness.
In other words, a company can hold real proof and still mislead by describing that proof inaccurately.
The evidence has to match the product and the claim
The guidance calls this a common problem: an advertiser has valid studies, but the studies do not support the claim in its advertisement.
It lists the questions to ask of any cited study. How do the dose and the formulation compare with the advertised product? Is the ingredient or combination the same? Is it administered the same way? How well do the outcomes tested relate to the benefit advertised? Does the study population reflect the population the advertisement targets?
Where research conditions and real-life use diverge significantly, the advertiser must evaluate whether extrapolating is appropriate at all.
There is a matching rule about wording too. Claims that do not match what the research shows are likely to be deceptive, no matter how sound the research is. Advertisers should not exaggerate the extent, nature or permanence of an effect observed in a study.
The surrounding literature counts as well. Studies cannot be considered in isolation, and where a stronger body of contrary evidence runs against a claimed effect, the guidance says even a carefully qualified claim is likely to be deceptive.
Claims about approval are claims too
This is where health marketing and regulatory vocabulary collide, and it has its own section in the guidance.
Advertisers should be careful not to mischaracterize the extent to which a product or a claim has been reviewed, authorized or approved by the Food and Drug Administration. They should also not overstate any assessment that agency has made of the underlying science.
One example turns on a technical term. A banner reading that a product meets a qualified health claim uses regulatory language unfamiliar to most readers. The guidance says it likely communicates both approval of the product and a high level of supporting evidence. Using it in advertising is described as deceptive.
Another turns on juxtaposition. A device cleared for one narrow purpose is advertised as approved, alongside dramatic claims about a different outcome. The infomercial is deceptive because placing the approval reference beside those claims gives the impression that the agency found the product effective for them.
The lesson generalizes past those two cases. A true regulatory fact placed next to an unrelated benefit claim can create a false impression that neither statement makes on its own.
Borrowed articles and friendly websites
The last piece covers material a company did not write, and it is unusually relevant to how health products get sold online.
The Commission does not regulate the content of independently written and published books or articles. It does prohibit the deceptive use of such materials to market a product.
Whether the material falls within the Commission's reach turns largely on whether it was created, or is being used, by a marketer specifically to promote its product. Quoting a book's title and excerpts to describe a product's benefits makes those references advertising, and the marketer becomes responsible for substantiating what they convey.
Distance does not help. The guidance says that placing the material two clicks away from a company's own site does not insulate the marketer from responsibility for implied claims a reader takes from the indirect reference.
Its last example is the one to keep. An advertisement points to what appears to be an independent website discussing a surgical risk and naming the advertiser's product as a safer alternative. The advertiser created and owns that site. It is not independent literature, the advertiser is responsible for the claims on it, and it must clearly and conspicuously disclose the ownership.
How to use this while shopping
You will not see the evidence file. You can see how a page talks about it, which is enough to sort pages into rough piles.
Notice whether the page names a study or only a feeling about studies. Phrases about being backed by science, without a study behind them, are the claim rather than the support.
Notice whether the study described matches the thing being sold: same substance, same form, same dose, same kind of person, same outcome.
Notice whether an approval word is doing work near a benefit it does not cover.
Notice whether the supporting article was written by someone with no stake in the sale, and whether the page says so.
This will not tell you whether a company is complying with anything. It will tell you whether a page is making an argument or borrowing the appearance of one.
Sources
- Health Products Compliance GuidanceThe two principles of truth-in-advertising law and the requirement of adequate substantiation before dissemination for all objective claims conveyed expressly or by implication; the general rule that health benefit and safety claims require competent and reliable scientific evidence; the guidance's own broad definition of advertising, including social media, influencer marketing and promotion through healthcare practitioners; the full two-part definition of competent and reliable scientific evidence; that randomized controlled human clinical testing is generally required and that no specific number of trials is; that replication adds weight while flawed studies do not add up; that consumer anecdotes and satisfaction surveys are never sufficient; that a practitioner's observation is anecdotal; the limited circumstances in which epidemiological evidence is accepted; that animal and in vitro work is insufficient without human confirmation; that public health recommendations are not substantiation; the specific-level-of-support rule and its worked example; the relevance questions about dose, formulation, administration, outcome and population; that claims must not exaggerate the extent, nature or permanence of an observed effect; the totality-of-the-evidence rule; the section on mischaracterizations of FDA approval and its two examples; the third-party literature section including the two-clicks-away and company-owned-site examples; and the division of responsibility with the Food and Drug Administration under their memorandum of understanding.
- 16 CFR Part 255 — Guides Concerning Use of Endorsements and Testimonials in Advertising (§ 255.2(a))That an advertiser must possess and rely upon adequate substantiation, including competent and reliable scientific evidence where appropriate, for claims made through consumer endorsements in the same manner as if it had made them directly, and that consumer endorsements themselves are not competent and reliable scientific evidence.
- 15 U.S.C. § 52, "Dissemination of false advertisements"That it is unlawful to disseminate, or cause to be disseminated, any false advertisement for the purpose of inducing, or which is likely to induce, the purchase of food, drugs, devices, services or cosmetics, and that doing so is an unfair or deceptive act or practice within the meaning of section 45 of that title. The word services was added to both paragraphs by the 1994 amendment, which is why a marketed service and not only a marketed product falls inside this section.
Frequently asked questions
What exactly is “competent and reliable scientific evidence”?
The Federal Trade Commission defines it as tests, analyses, research or studies meeting two conditions. They must have been conducted and evaluated in an objective manner by experts in the relevant disease, condition or function to which the representation relates. They must also be generally accepted in the profession to yield accurate and reliable results. It adds that the research must be sufficient in quality and quantity to substantiate that the representation is true. That sufficiency is measured against standards generally accepted in the relevant scientific fields, in light of the entire body of relevant and reliable scientific evidence.
Do customer reviews count as evidence that a product works?
Not under this standard. The Commission's health guidance states that anecdotal evidence about individual consumer experiences is never sufficient to substantiate claims about the effects of a health product. That holds for surveys of consumer experiences too, because genuine experiences may still be attributable to a placebo effect or other factors unrelated to the product. The Endorsement Guides make the same point in a single line: consumer endorsements themselves are not competent and reliable scientific evidence.
Does a doctor saying it works in their patients count?
The guidance addresses this directly. It says a healthcare practitioner's observation about the effect of a health product on patients is anecdotal and does not provide evidence of a causal relationship. Individual experiences are not a substitute for scientific research.
Is one study enough?
There is no required number. The guidance says randomized, controlled human clinical trials are generally the type of substantiation experts would require. It adds that replication in an independently conducted study adds to the weight of the evidence, and that quality matters more than quantity. It also says studies cannot be considered in isolation, and that where a stronger surrounding body of evidence runs contrary to a claimed effect, even a qualified claim is likely to be deceptive.
Can an advertisement be deceptive even when the company does have good research?
Yes, in at least two ways described in the guidance. If the advertisement claims a specific level of support that the evidence does not match, those claims are deceptive even where the advertiser holds other research that would qualify. And if the research does not fit the advertised product, dose, population or outcome, valid studies still will not support the claim being made.
Who covers advertising and who covers labeling?
The Commission's guidance describes a memorandum of understanding with the Food and Drug Administration governing the basic division. The Administration has primary responsibility for claims that appear in labeling, including the package, product inserts and other promotional materials available at point of sale. The Commission has primary responsibility for claims in all forms of advertising. The guidance adds that the agreement does not limit the Commission's jurisdiction or prevent it from acting on deceptive labeling claims.