FTC Compliance for Healthcare Businesses

FTC Compliance Attorneys for Healthcare Businesses in Texas

The Federal Trade Commission (FTC) has broad authority over marketing and advertising, including for medical spas and other healthcare businesses. While there aren't specific regulations tailored solely to med spas or wellness services, the general principles of truth in advertising apply.

Call today to talk to our healthcare compliance attorneys to help ensure your marketing and advertising materials are in compliance with the FTC.

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What Are the FTC Requirements For Advertising Health and Wellness Services?

Healthcare claims are material to a patient’s decision to seek out your services. You should be prepared to back that claim with reliable scientific evidence.

Here are some general FTC guidelines for marketing and advertising health and wellness services such as Med Spas, Cryotherapy, and IV Hydration Therapy:

  • Make truthful and substantiated claims: The FTC mandates that advertisers must have solid evidence to support their claims before promoting any product or service. This is particularly crucial for healthcare-related offerings, which require reliable scientific evidence.
  • Include clear and conspicuous disclosures: Any limitations, conditions, or qualifications on claims must be clearly and conspicuously disclosed. This includes information about potential risks, side effects, and the need for additional treatments. A disclaimer that directly contradicts the core message of your advertising is ineffective.
  • Avoid deceptive pricing: Advertising must accurately reflect the price of services, including any additional fees or charges.
  • Make sure endorsements and testimonials are authentic: If using endorsements or testimonials, they must reflect the honest opinions of the endorser and not be misleading. If the person giving the endorsement or testimonial was compensated in any way, the endorsement or testimonial must disclose this fact.
  • Avoid unfair competition: Advertising should not make false or misleading comparisons to competitors.

How the FTC Evaluates Healthcare Advertising Claims

The FTC focuses on claims that are likely to affect consumers' choices. This means that even if a statement is technically true, it can still be misleading if it creates a false impression about the product or service.

In determining whether an advertisement is deceptive, the FTC engages in a three-step review to assess:

  1. What claims are conveyed in the ad;
  2. Whether those claims are false or misleading; and
  3. Whether the claims are material to prospective consumers

What Is A Claim?

A “claim” is an assertion of the truth of something. An advertisement includes a claim if the FTC finds that consumers acting reasonably under the circumstances would interpret the advertisement to contain that message. The FTC’s analysis also involves an examination of the net impression of the entire advertisement, including both visual and aural imagery.

A claim may include more than one meaning or interpretation.

Liability can be found for a false claim, even if only one interpretation of the claim is determined to be false while other interpretations for the same claim are determined to be substantiated.

When Is A Claim False Or Misleading?

Unsubstantiated claims are considered to be false or misleading. The level of substantiation required depends on the whether the advertiser is making an efficacy or establishment claim.

This is how the FTC distinguishes between “efficacy claims” and “establishment claims”:

  • An efficacy claim only suggests that a product successfully performs the advertised function.
  • An establishment claim ups the ante by suggesting that a product's effectiveness or superiority has been scientifically established.

What Evidence Is Required to Substantiate Healthcare Claims?

Your advertisements may be determined to be false or misleading if you do not possess the level of scientific evidence that is needed to substantiate your healthcare claims.

Healthcare claims regarding the general health benefits of a product or service would be considered an efficacy claim. The level of scientific evidence required to substantiate an efficacy claim includes tests, analyses, research, or studies conducted by qualified persons in accordance with the standards established by the applicable profession.

Healthcare claims regarding disease treatment, prevention, or risk reduction typically involve establishment claims. The level of scientific evidence required to substantiate an establishment claim includes one or more randomized, double blind, placebo-controlled, large-scale clinical trials.

When Is A Claim Material?

Claims or omissions are material if they significantly involve health, safety, or other areas with which the reasonable consumer would be concerned.

Texas Medical Board Advertising Guidelines

The Texas Medical Board (TMB) also bans false, deceptive, or misleading advertisements “designed to attract public attention to the practice of a physician”.

Per the TMB, “any advertisement shall be deemed by the board to be false, deceptive, or misleading” if it:

  • Contains or implies material false claims or misrepresentations of material facts which cannot be substantiated;
  • Omits material facts;
  • Makes a representation likely to create an unjustified expectation about the results of a healthcare service or procedure;
  • Advertises or assures a permanent cure for an incurable disease;
  • Compares a healthcare professional's services with another healthcare professional's services unless the comparison can be factually substantiated;
  • Advertises professional superiority or the performance of professional service in a superior manner if the advertising is not subject to verification;
  • Contains a testimonial that includes false, deceptive, or misleading statements, or fails to include disclaimers or warnings as to the credentials of the person making the testimonial;
  • Includes photographs or other representations of models or actors without explicitly identifying them as models and not actual patients;
  • Causes confusion or misunderstanding as to the credentials, education, or licensure of a health care professional;
  • Plus other prohibited claims, solicitations, and representations.

While the TMB regulations do not wholly forbid testimonials, physicians should be very careful when consider the use of testimonials in their advertising. The Texas Occupations Code prohibits all healthcare providers from using testimonials in their advertising.

Medical Device Advertising and the FDA

If your med spa or healthcare business uses medical devices, you must also comply with U.S. Food and Drug Administration (FDA) regulations for advertising those devices. Advertising must accurately reflect the device's intended use as cleared or approved by the FDA.

It's important to note that the FDA's regulations are complex and subject to change. Consult with the health law and regulatory attorneys at Hendershot Cowart P.C. to help ensure full compliance.

What Are the Consequences of False or Misleading Health Claims?

The FTC has broad authority to regulate advertising and protect consumers from deceptive practices. If a company makes false or misleading health claims, the FTC can take several actions:

  • Cease and Desist Orders: The FTC can order a company to stop making false or misleading claims.
  • Civil Penalties: The FTC can impose significant financial penalties on companies that violate the law.
  • Consumer Redress: The FTC can seek monetary relief for consumers who have been harmed by deceptive practices.
  • Corrective Advertising: The FTC may require a company to run corrective advertising to undo the harm caused by the deceptive claims.

In 2018, the FTC brought an action against a Texas-based IV hydration bar for marketing various cocktails as treating, curing, and mitigating the effects of various diseases. The company was ordered to stop making false and unsupported health claims and had to send a notice to customers that its cocktails aren’t scientifically proven to treat any disease.

Ensure Your Advertising and Marketing Efforts Are in Compliance

Both the FTC and FDA have demonstrated a strong commitment to protecting consumers from false and misleading health claims. Companies that engage in such practices face significant risks to their reputation, finances, and operations.

Take FTC marketing rules seriously to protect your brand and ensure that you avoid legal scrutiny and enforcement actions. Talk to our healthcare compliance attorneysto help ensure your marketing and advertising materials are accurate and transparent to protect both your clients and your business.

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