Do immune health claims attract regulatory attention?

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Immunity claims aren’t always straightforward. Dietary supplement brands face strict rules around what they can and cannot say, and while some brands may feel they have the scientific substantiation to make a claim, they may still run the risk of regulatory action.

The COVID-19 pandemic sparked a flurry of warning letters from FTC, FDA, and the National Advertising Division (NAD; part of BBB National Programs) after a number of immunity brands broke the rules. Megan Olsen, senior vice president and general counsel at the Council for Responsible Nutrition (CRN; Washington, DC), says that while the industry has generally been good about understanding the advertising rules, some companies have overstepped.

“During the pandemic, we saw companies wanting to talk about promising research around ingredients they sell and the effect on COVID-19, and we saw some warning letters about those types of actions,” Olsen explains. “Companies do want to talk about the ingredients they sell, but they have to be reminded to be careful.”

With consumer interest in immune health products still high, it makes sense for brands to want to position their products for immune health. But those who stray too far with their health claims may find themselves on the receiving end of an FDA warning letter. Here are some of the ways brands can ensure their immune health claims stay within the bounds of what the law permits.

Structure-Function Claims Are Permitted

Brands may be able to use claims that discuss structure and function. Mary Engle, executive vice president of policy at BBB National Programs, says claims such as “supports the immune system” are health-related structure-function claims, which may be permissible when supported by reliable evidence.

“FDA has specifically commented on the claim ‘supports the immune system’ and stated that it does not necessarily constitute a disease claim,” Engle says. “A claim that a product ‘supports’ the immune system could convey consuming a product is one of many factors that contributes to a healthy immune system. However, use of the term ‘boosts’ may raise the bar for the type of scientific substantiation needed.”

Disease-Treatment Claims Are Off-Limits

While structure-function claims and “support” claims are generally permitted, brands cannot state or imply that a nutritional product treats or cures a disease. Katie Bond, partner at Lathrop GPM LLP (Washington, DC), says that any claim to treat or prevent the cold, flu, RSV, or any other illness is risky.

“A claim like ‘fewer school absences this winter’ would normally be risky,” Bond explains. “Likewise, imagery of a person coughing and sneezing without a product, but healthy with it, would normally entail risk.”

Bond says brands can be surprised to learn that a truthful claim may nonetheless be prohibited. Furthermore, the difference between structure-function and disease-treatment claims isn’t necessarily intuitive; in many cases, regulators make a judgement call.

New entrants to the market can be easily caught off-guard by these rules, Bond says. “This past summer, Nature’s Way, which makes a variety of elderberry products, challenged a competitor’s advertising that included claims like ‘shorten the duration of the common cold.’ This prompted the competitor to voluntarily discontinue its claims before the case was heard.”

Substantiation Always Helps

While “supports a healthy immune system” is a low-risk type of claim, it never hurts to have scientific substantiation to back it. John Villafranco, partner at Kelley Drye & Warren LLP (Washington, DC), says that while immune support claims are relatively safe, substantiation is always required to support immune health claims.

“FTC requires competent and reliable scientific evidence to support health claims generally,” Villafranco says. “In simple terms, that means a quality and quantity of evidence that experts in the field agree is sufficient to support the claim. While FDA does not generally review substantiation, a claim that a dietary ingredient promotes or supports immune health should be substantiated.”

Villafranco says the COVID-19 pandemic served as a reminder that context can make otherwise-permissible claims impermissible. FTC issued hundreds of warning letters to otherwise-acceptable claims that were made in the context of COVID-19.

“When the statement implies a benefit to consumers suffering from COVID-19, whether describing symptoms or including context on a label, the claim can be classified as illegal,” Villafranco explains.

He says companies have been, and continue to be, named as parties in litigation and enforcement actions relating to COVID-19 claims. These companies are also singled out in Truth in Advertising (TINA) press releases and received unfavorable recommendations from NAD.

“There’s also a pending class action suit in the Southern District of California concerning immunity claims made in connection with Sambucol,” Villafranco notes. “Some of the relevant claims at issue include claims that Sambucol is the only elderberry supplement that can ‘guarantee consistent immune-supporting properties in every serving,’ and that the supplements ‘arm you with some of the best protection nature has to offer.’”

When in Doubt, Perform Legal Review

Immune health claims are an area where it’s easy for brands to stray beyond the bounds of the law. When making claims for an immune health product, your brand could be at risk of an FTC warning letter, an NAD challenge, or a lawsuit. Immune health brands have come under additional scrutiny since the COVID-19 pandemic, making this area one where brands should invest in proactive policing of their own claims. Spotting your own problem claims before NAD or FTC do could save you considerable time and money.