Now more than ever consumers are paying attention to their health and wellness. Not surprisingly, many businesses see this as an opportunity to promote the health and wellness benefits of their products, but they must be careful.

• Of cases opened through the U.S. self-regulatory truth-in-advertising body, the National Advertising Division (NAD), in recent years, a significant percentage have been health-related advertising claims.
• Health-related claims are also a priority for the Federal Trade Commission (FTC), as recently made clear by the new guidance on health-related claims released at the end of 2022, the Health Products Compliance Guidance.
• In May 2023, the FTC put almost 700 marketing companies on notice: if you can’t back up or substantiate your product claims, you could face civil penalties to the tune of $50,000 per violation. Specifically, the FTC calls out that claims “about the health or safety benefits of a product” must be backed by competent and reliable scientific evidence. 

Although all businesses can, of course, promote and advertise the benefits and unique features of their products, all messages conveyed by the advertising must be supported by a reasonable basis. Failure to adequately support a health or wellness claim can quickly get a business into trouble, resulting in scrutiny from law enforcement or a challenge from a competitor in an independent industry self-regulation forum such as NAD.

1. You must have a reasonable basis for all messages reasonably conveyed by your ads.

It is not enough to support the claim that is expressly being made in your ads. Consumers may take away additional messages based on the context of the ad. Both express and implied claims must be supported. This is true even if you did not intend to convey those implied messages.

2. General claims that cross over into health or disease claims must be substantiated by competent and reliable scientific evidence.

Pay particular attention to whether you are communicating a health or disease prevention benefit. All claims must be substantiated by a reasonable basis, but for health and disease claims that means the claim needs competent and reliable scientific evidence as substantiation. Randomized, placebo-controlled studies on human beings that reach statistical significance and yield clinically meaningful results are the most reliable evidence that a product will provide a claimed health benefit and almost always will be needed for claims that a product can cure, mitigate, or treat a disease.

3. If your scientific support is limited, qualify your claim accordingly.

If the scientific evidence you have is reliable but does not quite rise to the level of being able to support a health claim, you may still be able to use it, provided you disclose the limitations of the evidence or qualify the claim to fit the evidence. Be careful though, because the evidence you are relying on must still be reliable, and the disclosure of the limitations must be clear, conspicuous, and not contradict the claim.

4. Ensure your claims are substantiated. Adherence to regulatory guidelines is only half the battle.

Many products in the health and wellness space are subject to specific regulations by the FDA, EPA, or another federal regulatory body. Complying with regulatory requirements, however, is only the first step. You must still ensure that your advertising claims, including those on the product label and packaging, are truthful and accurate.

5. When highlighting a product’s unique features, ensure comparative express or implied claims are truthful and substantiated.

You are free to highlight the unique features of your product. But if you do so in a way that implies a health or wellness benefit, then all the requirements of substantiating a health claim, as discussed above, still apply. Similarly, if in promoting the features of your product you convey a message that your product is superior, or as good as, other products, those comparative claims must be substantiated as well (typically through head-to-head comparison testing).

6. Tests to substantiate a claim must be conducted under consumer-relevant conditions.

Products should be tested in the way consumers use the product. For example, testing a product in a petri dish is unlikely to be sufficient to evaluate a product, whether it is for a device’s germ-killing properties or a pill or potion’s effect on the body since a petri dish does not simulate actual use conditions.

If your competitors are not following these rules, consider bringing a challenge to BBB National Programs’ NAD. Learn more about the various case tracks for an NAD challenge.