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.  

In 2020, BBB National Programs’ National Advertising Division (NAD) saw a 50% increase in competitor challenges to health-related advertising. And of those cases opened through NAD’s marketplace monitoring, more than a third were for the truth and accuracy of health-related claims. At the federal level, the FTC and FDA sent hundreds of warning letters to—and sued several—companies that crossed the line and made express or implied claims that their products could prevent, treat, or cure COVID-19.  

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.  

Recently, NAD and Faegre Drinker Biddle & Reath LLP presented a webinar event providing guidance on how to stay out of trouble when making health and wellness claims. Below we share six of the key takeaways discussed.

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.   

When considering what implied claims consumers may take away from your ads, pay attention to the context of the entire ad. For example, a claim that a product boosts the immune system in a context that reminds consumers of the pandemic and the threat it poses to their health conveys a very different message than an immunity boosting claim made in isolation. 

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.  

Regardless, you will need studies or tests conducted and evaluated in an objective manner by persons qualified to do so, using procedures that yield accurate and reliable results, and which experts in the relevant area agree are sufficient to support the claim. The bar for supporting a health-related claim is high because consumers rely on such claims to make important decisions that impact their health.    

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.  

For example, if you conducted a randomized, placebo-controlled study on a subset of the population that can benefit from your product, you might still be able to make the claim if you specify that subset in your claim. However, you will need to be careful to make sure that your ad does not impliedly convey the message that your product can provide that benefit to a wider population unless you have other reliable evidence that it does. 

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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.   

Conversely, if your product is not regulated, that does not mean you have free rein—all advertising must be truthful and not misleading.   

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. 

These rules apply to all advertising. Following these rules should keep your advertising off the radar of the FTC and your competitors. If your competitors are not following these rules, consider bringing a challenge to BBB National Programs’ NAD. It can be effective at leveling the playing field and promoting truthful advertising practices across an industry. 

Learn more about the various case tracks for an NAD challenge. Questions about advertising challenges? You can always reach out at NAD@bbbnp.org.