FTC guidance for sellers & marketers of Health Products Unlocked

FTC guidance for sellers & marketers of Health Products Unlocked

FTC Health Products

Introduction:

In this blog, we’ll aim to summarize the principles that help advertisers comply with FTC laws (deceptive claims/facts) for OTC drugs, food, homeopathic products, supplements, health equipment, and more.

Overview of Regulatory Framework: FTC Authority over Advertising Health Products:

The responsibility of the Federal Trade Commission (FTC) is to prevent unfair/deceptive acts and practices in marketing or selling health-related products.  To summarize:

  1. Advertising must be truthful and not misleading; and
  2. Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to consumers acting reasonably.
  3. “Advertising” refers to a wide variety of marketing techniques (social media, digital content, brochures, influencer marketing, etc).
  4. Anyone participating in deceptive marketing is potentially liable under FTC law.
  5. The FTC can seek a variety of remedies for deceptive advertising up to legally bringing courts in to ban companies from certain activities.

Coordination between the FTC and FDA:

The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products. The agencies coordinate their enforcement and regulatory efforts under a Memorandum of Understanding – often called the “FDA-FTC Liaison Agreement” – that governs the basic division of responsibilities between them. The FDA has primary responsibility for claims that appear in labeling, including the package, product inserts, and other promotional materials available at the point of sale. The FTC has primary responsibility for claims in all forms of advertising. Due to the shared jurisdiction, the two agencies work closely to ensure that their enforcement efforts are fully consistent and feasible.

What are the differences between the FTC and FDA Laws?

While both the FTC and the FDA require truthful and accurate marketing of dietary supplements and other health-related products, there are some key differences in the agencies’ legal frameworks and approaches that marketers should be aware of.

  • FTC advertising law applies to all products and claims
  • The FTC doesn’t pre-approve “health” claims, as that term is defined by FDA labeling laws
  • The FTC doesn’t require notification for “structure/function” claims

How to apply FTC law to advertising Health-Related Products:

To determine whether advertising complies with FTC law, it is necessary to first identify all claims communicated to reasonable consumers through advertising materials. Once the claims are identified, the FTC evaluates the scientific evidence on which the company relies to determine whether the claims are adequately supported. We can assist you by helping you;

  1. Identify Claims and Interpreting Ad Meaning Express and Implied Claims
  2. When to disclose qualifying information
  3. How to disclose clearly

How to substantiate health-related product claims?

Marketers must ensure that their claims are adequately supported in addition to conveying them clearly and accurately. Advertisers must have a reasonable basis for their product claims under FTC law before running an ad. What constitutes a reasonable basis is highly dependent on the claims made, how they are presented in the context of the entire advertisement, and how they are qualified. The FTC’s substantiation standard is stringent, especially when it comes to health claims. It is intended to give consumers confidence in the accuracy of information presented in advertisements. A variety of factors influence the amount and type of substantiation required, including:        

Need help with NHP or Dietary Supplement FTC-FDA compliance of Health Products

  1. The type of product
  2. The type of claim
  3. The benefits of a truthful & cost or feasibility of developing substantiation for the claim
  4. The consequences of a false claim
  5. The amount of substantiation that experts suggest is reasonable

Claims based on traditional use:

Several health-related products, such as botanical supplements, homeopathic medicines, and other alternative products, have a long history of use as traditional medicine in the United States or elsewhere to treat specific conditions or symptoms. Under FTC law, claims for products based on traditional use must be substantiated with competent and reliable scientific evidence, just like any other product.

At the same time, FTC law does not prohibit advertising that is sufficiently qualified to be truthful and not misleading. Advertising that merely describes the traditional or historic use of a product and is carefully qualified to avoid any misleading implications about the product’s efficacy or health benefits may be permissible.

Avoid Misleading Messages in your Health Product labeling:

To avoid communicating a misleading message about the product’s efficacy or the scientific basis for any health benefit, an advertiser who wants to describe a product’s historic or traditional use should take the following steps: Guidance for Health Product Compliance

⊲ The advertiser should identify the historic or traditional use and make sure that its product is consistent with that use – for example, that it contains the same ingredients and formulation, the same strength or dose, the same form of administration, and the same indications for use. If there is a significant difference between the traditional use of the product and the marketed product, a “traditional use” claim isn’t appropriate. ⊲ A claim that suggests a health-related benefit for which there isn’t competent and reliable scientific evidence must communicate the lack of scientific evidence. To avoid any deceptive implication, a disclosure that there is no scientific basis for the traditional use should stand out and be near the claim. To be effective, it may need to be incorporated into the claim.

⊲As with all claims, marketers shouldn’t undercut a disclosure about the lack of science with additional positive statements, consumer endorsements, images, or other elements of the ad suggesting the product is effective.

⊲ Given the inherent difficulty of discussing the traditional use of a product while also effectively communicating that there is no scientific basis for its efficacy, an advertiser should consider conducting a copy test or other consumer research to confirm that consumers understand the limited nature of the claim. The FTC will look closely at how consumers perceive a traditional use claim and whether they assume the claim means the product is effective and backed by more evidence than the marketers have. An ad that, despite a disclosure, conveys more substantiation than a marketer has, is deceptive.

The Quality of the Evidence:

The scientific community has generally accepted several basic principles as enhancing the validity of test results. Whether designing and conducting their research or relying on research conducted by third parties, marketers should ensure that the research upon which they rely for any health-related claim complies with these basic principles.

  1. Control Group
  2. Randomization
  3. Double Blinding
  4. Statistically Significant Results
  5. Clinically Meaningful Results

Other Advertising Issues:

In addition to the principles of ad meaning and substantiation discussed above, several other issues commonly arise in the context of health-related advertising. These include the use of consumer testimonials and expert endorsements; claims based on alternative medicine or traditional use; the effect of DSHEA disclaimers in advertising; claims about FDA approval or compliance; and the relevance to FTC advertising law of the FDA’s “third-party literature” exemption.

  • Claims based on consumer testimonials or expert endorsements
  • Claims based on traditional use
  • Use of the DSHEA Disclaimer in advertising
  • Mischaracterizations of FDA Approval
  • Third-party literature

Conclusion:

Marketers of health-related products, including dietary supplements, should be familiar with FDA and FTC requirements that labeling and advertising claims be truthful, not misleading, and substantiated. In general, the FTC requires that health-related claims be supported by competent and reliable scientific evidence proving that the representations are true. Marketers of any health-related product should take two important steps to ensure FTC compliance:

1) Consider what explicit and implied messages your advertisements are likely to convey to consumers.

2) Carefully review the support for each claim to ensure it is scientifically sound, adequate, and relevant, and qualify your claims as needed.

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