Why FTC Advertising Compliance Matters
FTC advertising compliance protects your brand, supports consumer trust, and prevents costly legal consequences.
The Federal Trade Commission closely monitors health claims, digital advertising, and marketing materials across all platforms. Even a single false impression or misleading statement can expose companies to regulatory scrutiny and damage long-term business growth.
The FTC imposes multimillion-dollar penalties for practices such as false advertising, false claims, and deceptive marketing.
Liability includes injunctions, corrective advertising, and disgorgement, each of which can impact investor confidence and revenue.
FTC rules apply to all health-related claims, including environmental claims, establishment claims, product benefits, and comparative claims.
Enforcement covers websites, social media, funnels, influencers, apps, ads, and any content affecting commerce.
Noncompliance undermines consumer trust. It affects purchase decisions and can slow business expansion.
Marketers need competent and reliable scientific evidence to support all health, safety, or efficacy claims their ads convey to consumers expressly or by implication. And they need it in hand before the ad is disseminated. For most disease-related representations – especially claims as serious as Zika prevention or risk reduction – that means well-controlled human clinical testing.
What Is FTC Advertising Substantiation?
FTC advertising substantiation is the legal requirement that all health-related claims—including those for dietary supplements, wellness services, and other health-related products—must be truthful, not misleading, and supported by evidence before they are marketed. Under the Federal Trade Commission (FTC) and the FTC Act, companies must be able to substantiate health-related claims with the type of reliable scientific evidence standard the agency expects. This often includes well-designed studies, controlled human clinical trials, expert-driven analysis, and data collected in an objective manner.
Because both express and implied claims carry the same legal weight, businesses must ensure that all advertising materials communicate a truthful claim and avoid deceptive labeling claims that could mislead reasonable consumers. The FTC frequently evaluates various factors to determine if a company has met its substantiation obligations. These factors include consumer surveys, expert opinions, and available research. In short, advertisers must be able to substantiate claims before making them, especially in industries where unsupported statements may create significant safety risks for the public.
FTC defines “competent and reliable scientific evidence” 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.
Without this level of substantiation, even seemingly valid claims can be flagged as deceptive—triggering FTC warnings, investigations, or enforcement actions.
How We Ensure Your Healthcare Advertising Claims Are Compliant
Creating compliant advertising and marketing claims requires more than quick edits—it requires a rigorous, structured, and evidence-based workflow. Our approach helps healthcare, wellness, and dietary supplement health brands make truthful claims that align with the reliable scientific evidence standard the FTC expects. We work to eliminate deceptive labeling claims, strengthen substantiation, and ensure everything is communicated clearly to reasonable consumers.
To achieve this, we review and audit all advertising or marketing materials, assess how they communicate express and implied claims, and verify whether your scientific evidence truly supports your health-related claims. This includes analyzing controlled human clinical trials, research quality, expert affidavits, real-world data, and the overall strength of your developing substantiation. When needed, we refine language, implement clear and conspicuous disclosure practices, and guide your team through compliant claim development. Our workflow includes:
Advertising claims review (express + implied)
Review & audit of marketing materials (ads, website, funnels, social media, emails)
Scientific substantiation evaluation to ensure evidence supports health related claims
Compliance audits for websites, social media, funnels, and digital advertising
FTC investigation defense & settlement negotiation
Mobile medical app and telehealth advertising compliance
Health and wellness product labeling review
Guidance on testimonials, endorsements, and material connections
Risk assessment for product launches
Ongoing monitoring programs
Drafting compliant disclosures and claims
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Who We Serve
Healthcare companies face more regulatory scrutiny than almost any other industry. This is especially true when advertising health benefits, product performance, or environmental claims. We help brands stay compliant, minimize risk, and confidently promote health claims and other products while meeting all FTC expectations. Here are some of the healthcare and medical practices we serve:
Health apps & mobile medical apps
Dietary supplements
OTC products
Medical devices
Cosmetics
Integrative health, wellness, and functional medicine
Coaching companies & health influencers
Biotechnology startups
Recent FTC Enforcement Examples
FTC enforcement actions reveal exactly what the agency considers unfair or deceptive acts and which practices trigger penalties. These cases show how important it is to have trustworthy scientific proof, to back up claims properly, and to steer clear of false statements or misleading messages that could confuse consumers.
- Aura Labs, for an Instant Blood Pressure app.
- Withdrawal Ease and Recovery Ease, for “home opiate detox” products ($6.6 million judgment).
- Mars Petcare, for dog food, claims about an extended dog lifespan.
- NextGen Nutritionals, for claims that HCG could create weight loss of up to 80 pounds in 40 days
- CellMark Biopharma, for claiming that “CellAssure” could treat the side effects of cancer treatment.
- Health Research Laboratories, for claims about treating Alzheimer’s and dementia
- Prevagen, for claims about treating memory loss.
- Avrom Lasarow, for marketing a “mole detective” family of healthcare apps.
- Various companies make claims about preventing Zika.
The above are just some of the actions the FTC has taken regarding health claims. The FTC emphasizes the importance of identifying and reviewing any claims before entering the market. This is where FTC legal counsel can be very helpful. Once a healthcare company falls under the FTC’s enforcement focus, the FTC is likely to impose significant enforcement powers, and the legal costs will probably increase rapidly in response.
FTC Requirements for Health & Advertising Claims
When you make health claims in your marketing materials, the FTC expects you to back them with competent and reliable scientific evidence—not assumptions or outdated studies. This framework exists to prevent unfair or deceptive acts and protect consumers from false or misleading claims, whether express or implied. Here’s what the Federal Trade Commission considers essential.
The FTC’s “Truthful, Non-Misleading” Standard
The foundation of all FTC advertising law is simple: your advertisement must be truthful and must not mislead consumers. That includes both what you say and what you leave out. Even if you never intend to deceive consumers, the agency still evaluates how a reasonable consumer will interpret the ad, especially in the context of health claims that influence real purchasing decisions.
The FTC Advertising Substantiation Health Claims Requirement
Before you promote product benefits, you must be able to substantiate them with reliable evidence. As the FTC explains in the FTC Policy Statement Regarding Advertising Substantiation, the underlying requirement is that advertisers have a reasonable basis for advertising claims before they are disseminated. Failure to have a reasonable basis for the claims is an unfair and deceptive act or practice in violation of the Federal Trade Commission Act (FTCA). In many cases, this means competent and reliable scientific evidence, clinical studies, replication, detailed records, and a claims substantiation file that clearly backs each specific claim you make.
Express vs. Implied Claims
Express claims are the things you explicitly promise — the words right there on the page. Implied claims are the messages consumers take away from your images, layout, product name, or general impression. The FTC uses a comprehensive evaluation to determine whether such claims create a false impression or deceive consumers.
Disclosures Must Be Clear & Prominent
A disclosure is only effective if people notice and understand it. That’s why the FTC requires disclosures to be clear, conspicuous, and placed close to the specific claim they qualify. Tiny font, vague wording, or disclaimers buried in footers don’t count, and phrases like “results may vary” are rarely enough to fix misleading claims.
What the FTC Looks for When Evaluating Substantiation Health Claims
In reviewing and evaluating health claims, the FTC applies a two-step process: identify all express and implied claims that the ad conveys to consumers and assess the scientific evidence to see whether it is adequate to support the claims that are being made.
In assessing the implied claims, the FTC looks to the “net impression” conveyed by all elements of an ad, including the text, product name, and depictions. The FTC also requires that disclosure of any necessary qualifying information be presented clearly and prominently so that it is actually noticed and understood by consumers.
According to the FTC, well-controlled clinical studies are the most reliable form of evidence, and “replication of research results in an independently conducted study adds to the weight of the evidence.”
Among other things, advertisements must ensure that necessary qualifying information is presented clearly and prominently. For instance, advertisements should disclose whether subjects in a trial engaged in regular exercise and followed a restricted-calorie diet as part of their study regimen, and clarify that users should adhere to the same regimen to expect similar results.
The FTC also addresses claims based on consumer experiences or expert endorsements. Overstating the qualifications of an expert can be considered deceptive and misleading. For example, referring to someone as a “leading clinician in joint health” is deceptive if the expert has not conducted sufficient trials to support this endorsement. Furthermore, the expert’s connection to the company affects the “weight and credibility” of the endorsement. Even if the expert is adequately qualified, his or her position with the company must be disclosed.
Additionally, the FTC does not guarantee that following its guidance will not result in enforcement action; instead, it encourages industry to avoid puffery and overstating results of studies that are not supported by the data, methods, and results.
Common Mistakes That Trigger FTC Investigations
Even well-meaning companies fall into traps that raise red flags under the FTCA. These mistakes often happen when marketing moves quickly, teams rely too heavily on agencies, or claims are modeled after competitors who may not be compliant. One oversight in your claims development process can lead to unexpected FTC penalties, reputational damage, or long-term legal consequences.
No substantiation.
Misleading testimonials.
Inadequate disclosures.
Unauthorized disease claims.
Overreliance on marketing agencies.
Misuse of “clinically proven.”
Unverified expert endorsements.
App-store claims not reviewed.
Repurposing animal studies as human evidence.
Why Choose Cohen Healthcare Law Group for FTC Advertising Compliance?
You need more than surface-level advice when dealing with the Federal Trade Commission; you need a partner who understands the science, the law, and the realities of launching products in fast-moving markets. With decades of experience handling FTC enforcement actions, minimizing legal consequences, and guiding companies through every aspect of advertising claims substantiation, we combine deep legal expertise with practical, business-minded solutions.
We help you advertise confidently while protecting your brand, your growth, and your ability to deliver authentic consumer benefit. Here are some reasons why you should choose Cohen Healthcare Law Group for your FTC concerns:
Decades of FTC, FDA, and healthcare advertising law experience.
Specialization in health claims substantiation and reliable scientific evidence.
Fast turnaround for marketing campaigns and new product launches.
Compliance across websites, ads, funnels, and digital platforms.
Experience with startups and large enterprises.
Practical guidance focused on outcomes.
Litigation, investigation, defense & negotiation support.
Reach out to us today to get expert guidance on your healthcare advertising claims.
FAQs
Healthcare advertising is complicated — but it doesn’t have to be confusing. Here are clear, direct answers based on years of real-world FTC investigation defense experience, helping healthcare practitioners with their advertising claims.
It means you must have solid scientific evidence—often including expert analysis or controlled human clinical trials—to support any health-related claims you make about dietary supplements or other healthcare products. Before you advertise, the FTC expects you to meet the reliable scientific evidence standard so your claims are truthful and not misleading to reasonable consumers.
Your claim is substantiated when you have the level of evidence the FTC would consider adequate: high-quality studies, expert evaluations, and credible data that support the exact benefit you’re promoting. If you’re unsure, a legal review can help determine whether your evidence meets FTC Act standards and whether your advertising materials communicate your claims in a compliant, objective manner.
An implied claim is any objective product claim conveyed through your promotional materials, even if you never state it directly. The FTC evaluates how ordinary consumers interpret the overall net impression, including imagery, layout, product names, and marketing techniques that may suggest a claimed benefit or even a drug claim.
Yes—because influencers must provide clear and conspicuous disclosures when they receive payment, free products, or any material connection. Without proper clarity tailored to the intended audience, influencer posts can become deceptive advertising, especially in dietary supplement advertising and promotions for over the counter drugs.
The FTC expects evidence that aligns with standards generally accepted in relevant scientific fields, such as well-designed studies or expert-supported data. For stronger claims—particularly those close to a drug claim—the agency may require randomized controlled human clinical trials to support the claimed benefit.
Brands should review their promotional materials at least twice yearly to catch significant limitations or shifts in evidence. Regular audits also help companies avoid deceptive advertising and stay ahead of FTC enforcement efforts, especially when promoting wellness benefits or claims tied to a relevant disease.
