Making immune health claims in the time of COVID-19? Be careful.

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It’s no secret that immune health and wellness products have fared especially well with consumers during the COVID-19 pandemic. Market researchers have reported seeing unprecedented dietary supplement sales gains in the U.S. in the initial weeks of the pandemic as consumers turned to supplements to support their health. Immune health ingredients such as vitamin C and elderberry have become clear winners during the pandemic, with near-term sales spikes to make any supplement marketer’s head spin. With so much consumer demand for immune health products today, companies, both on the retail end and on the ingredient supply end, are seeing value in lasering in on their immune health product portfolios-and advertising their immune health products. Caution should be taken, however, in how a company frames its products or ingredients especially during the time of this pandemic. Nutritional Outlook hosted a webcast on May 29 titled “COVID-19 and Immune Health Claims: What NOT to Say (Do’s and Don’ts),” during which attorneys discussed why companies need to tread the immune health space very carefully especially during this time.

(Another speaker at the event was pharmacist and author David Foreman, who discussed the many ways in which consumers can be misled by deceptive immune health marketing. Click here to read more about his presentation.)

Who’s Watching?

During the webcast, two speakers-attorney Katie Bond, a partner at the law firm of Amin Talati Wasserman LLP, and Megan Olsen, vice president and associate general counsel for the Council for Responsible Nutrition (CRN; Washington, DC)-stressed that dietary supplement claims are being heavily scrutinized amidst the pandemic by regulators at both the federal and the state level. Olsen said that since the beginning of this year, when news about the COVID-19 crisis began spreading globally, FDA, either alone or in conjunction with the FTC, has issued more than 60 warning letters, a vast majority of which involve products illegally marketed as dietary supplements. The products run the gamut, including both ingestible and topical products, and ranging from vitamins and cannabidiol (CBD) to herbal products, zinc, colloidal silver, and elderberry.

State attorneys general are also closely watching this space. Oregon regulators even enacted an emergency rule to deal with products making illegal COVID-19 claims, said Olsen. And then there are other groups like the National Advertising Division of the BBB National Programs and the consumer advocacy group Truth in Advertising (TINA) who are actively scrutinizing supplement claims.

Types of Claims

Bond and Olsen discussed the types of product claims that can run companies into trouble.

First and foremost, of course, are blatantly illegal disease claims. It goes without saying that disease-treatment claims are not allowed within the realm of dietary supplements and that no one should be claiming that their natural product or ingredient can treat or prevent COVID-19. Yet, FDA and FTC warning letters demonstrate that companies are making express claims that their products can prevent, treat, mitigate, diagnose, or cure COVID-19.

FDA has prioritized going after such egregious disease claims, the low-hanging fruit, said Olsen. “Looking at the warning letters that FDA has put out over the last year, I will say that all the warning letters did appear to include at least an explicit mention of coronavirus or COVID-19,” she said. “I don’t think this is surprising. FDA has limited resources, so they truly are trying to go after the products that are likely the most harmful to consumers because they actually talk about their effect on coronavirus and COVID-19.”

While many responsible companies know to refrain from making such express disease claims, they can run into trouble when it comes to “softer,” implied claims, both attorneys said. These are claims or other advertising or marketing elements that, “by implication, suggest that the product can have an effect on coronavirus or COVID-19, either [preventing you from getting it] or treating it,” said Olsen. “Companies…are making those softer claims that are still disease claims nonetheless, talking about, ‘Hey, we can help boost your immune system in these times of a global health crisis.’”

She continued: “Companies, even if they may not be getting on FDA’s radar” with disease claims, “could still be making implied claims about coronavirus and about how a product could help you during these very difficult and scary health times, could find themselves the subject of scrutiny by other organizations or class action attorneys.”

So, what has FDA said is allowed to be said about immune health products? Said Olsen: “FDA [says] an immune health claim can be appropriate when you are simply talking about ongoing support for your immune system, not suggesting that it’s going to stop you from getting diseases or [issues] threatening your health in other ways.”

Ahead are some of the takeaways from Bond and Olsen’s presentations.

Don’t make disease claims or mention COVID-19.

Companies should not say that their supplement product can address any identifiable characteristics or signs/symptoms of the disease. “I think it’s fairly obvious to say you can’t talk about coronavirus or COVID-19,” said Olsen. “But companies should also be very careful that they’re not saying or implying through the context of their ads that their product could have an effect on a respiratory illness. Or some of the things I’ve seen are talking about inflammation and the anti-inflammatory effects of a product, because my understanding at least with coronavirus is that there’s concern about inflammation within cells and how that affects your immune system. And so, just be careful that you aren’t moving into those territories where you’re suggesting that the product not only would have an effect on the actual disease itself but the signs or symptoms of the disease.” Firms should avoid “anti-inflammation” and “antiviral” claims, she said.

Companies should also refrain from saying that a product could help mitigate adverse effects of any COVID-19 pharmaceutical treatment.

Added Bond: “You mention coronavirus, you mention COVID-19 in the context of your product sales and marketing, and that alone is going to really increase your risk of getting one of these letters…For example, saying ‘COVID-19 defense product.’ These are all a bad idea in terms of risk.” Don’t make claims like “natural prevention for coronavirus,” “natural virus remedies,” or “COVID-19 defense product” either, she said.

Don’t make implied claims linking your product to COVID-19.

Bond highlighted one warning letter FTC sent to a company. The company said in its marketing that a social media influencer would be using the company’s product daily while traveling during this time. “The FTC took the position that is implying that it’s going to apply some kind of disease treatment or prevention of coronavirus. Again, a very bad idea. Very risky,” she said. Making indirect references to the current pandemic by saying things like “These are the times you need to protect yourself” is also risky, she said.

Don’t use words like boost, defend, or protect.

When regulators “see that kind of language, they up the ante,” said Bond. “They think that that kind of language conveys to the consumer that this is going to boost, defend, or protect you against” a certain disease. In the past, she said, regulators would flag this language related to illnesses like cold or flu, but now they are specifically looking for these claims in association with COVID-19. Bond added: “You put these words with any kind of reference to COVID-19…it’s just incredibly risky.” And the FTC will certainly demand a “very well-controlled clinical test in humans” to substantiate such a claim.

Even the word build can be risky, she said. She pointed out that in a warning letter, FTC flagged a company’s claim that “Many mushrooms can help build your immune system. I take reishi frequently simply for general health.”

On the other hand, she said, using words like immune support is generally more acceptable. “An ‘immune support’ claim is pretty vague, pretty fluffy, and in general, they’re not going to require something like a well-controlled clinical trial to make that kind of claim. They’re going to allow something lesser, maybe even something like a good in vitro study on a biomarker of immune function, that in many cases is going to be good enough.”

Another risky word is therapeutic, said both Bond and Olsen, due to its association with medical terminology. Instead of using that term, they suggested using a word like effective.

What if words like defense or protect are part of your product’s name? This could cause a company to be looked at more closely, said Olsen, and so she advised that companies be extra careful to make sure that their other claims are compliant with the law.

Watch your website, blog, newsletter, and social media behavior.

Specifically, watch what you’re linking to. “The FTC as well as the FDA have taken issue with companies providing a link to an article on COVID-19 and then, in the same breath, on the same website, or in the same social media, linking to where products can be purchased,” said Bond.

Other advice from Bond: Don’t use the words coronavirus or COVID-19 as a tag on a product website. She said, “Be sure you have an eye on how you’re optimizing your website, what meta tags you’re using, keywords, AdWords, hashtags, domain names, all of that. In the very technical sense, FTC and FDA typically do not treat a meta tag or a keyword alone as an advertising claim…That being said, if it links up to something deceptive, they will go ahead" and enforce against it.

Be careful when citing research studies.

“I know there have been a number of studies that have come out or are ongoing about how certain vitamins, for example, could have an effect on coronavirus or COVID-19,” said Olsen. “But be very, very careful if you want to cite the research to consumers, because especially in a lot of these studies, the study title itself will talk about coronavirus and COVID-19, and that could be a red flag to regulators that you’re moving over into disease claim territory.”

Watch how you show up in Internet searches.

Said Olsen: “Maybe the product itself, when you look at the ad or look at the page where you can buy the product, says nothing about coronavirus, but FDA and FTC are looking at the fact that, ‘Did your ad pop up when I searched for ‘How do I support my immune system?’'”

If you’re a dietary supplement company, can you still talk about your company’s charitable works associated with COVID-19?

In a nutshell, yes, said the speakers, as long as you are not suggesting something like your product is being used in a COVID-19-related clinical study.

Ingredient suppliers should also exercise caution.

While it’s true that regulators tend to focus more of their claims scrutiny on consumer-facing product marketers, ingredient suppliers can and have in the past gotten in trouble with regulators for making unscrupulous product claims. And if a finished-product marketer starts making disease claims based on claims the ingredient supplier has made, those claims could be traced back to the ingredient supplier. Conversely, ingredient suppliers should also keep track of how the companies they sell their ingredients to are making claims about a supplier’s ingredient, to make sure they are compliant.

Retailers should also be cautious.

Some FDA warning letters of late carbon-copied retailer Amazon.com because the product that was the subject of the warning letter was sold through the Amazon Associate Program. “Now, the letters don’t actually accuse Amazon of doing anything wrong here, but it seems to be FDA’s signal that because of the serious nature of these claims, they really are looking at retailers to hold them accountable for the types of claims that they’re making money off of because companies are selling these products through these platforms or in their stores.”

The Stakes Are High

Regulators are not only scrutinizing supplement claims in a big way during the pandemic, they are so concerned that they’ve even created consumer education websites to tell consumers about products that have received warning letters, said Olsen.

Expect this kind of scrutiny to continue, said both Olsen and Bond. As more state attorneys general start to take their own actions toward regulating this space, they will also trigger more class action lawsuits not just for disease claims but also implied claims that plaintiffs will argue run afoul of legal structure-function claim rules.

If you missed this webcast, you can still watch it for free On Demand at https://www.nutritionaloutlook.com/no_s/covid19_immunehealth