Immune' claims and COVID-19 - Regulatory Affairs ...
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‘Immune’ claims and COVID-19
Katie Bond, JD, and Brian Fries, JD
Products such as elderberry, echinacea, and vitamin C have long been marketed
for added support for the immune system. Although regulators have
occasionally targeted claims for preventing or treating colds, flu, or other
diseases, marketing products with “immune support” claims has generally
proven to be a safe harbor for companies. As long as products include one or
more ingredients with valid in vitro or other efficacy evidence, “immune
support” claims have tended to be low risk for companies.
This article will examine whether, in an unprecedented global pandemic, such
products can still be launched and marketed. The short answer is that they can
be, but that context matters and careful execution is key. Regulators are
scrutinizing the product category and taking action. Companies need to be
aware of the enforcement and other challenges and avoid the same pitfalls. To
that end, the authors review federal and state enforcement, self-regulatory
actions, and class actions that are reshaping the landscape for foods and dietary
supplements marketed for the immune system. They will also provide pointers
for crafting low-risk claims in a post‒COVID-19 market.
©2021 Regulatory Affairs Professionals Society
June 2021
Federal and state regulatory action
Even before the pandemic-related shut-down began in the US, the Federal
Trade Commission (FTC) and US Food and Drug Administration (FDA) began
issuing warning letters targeting advertising and labeling claiming products
could be used to treat or prevent COVID-19. This swift action around warning
letters was in keeping with the agencies’ past responses and actions around
outbreaks such as Zika and Ebola.1,2 The regulatory response to COVID-19 has
been similar to those responses, only on a larger scale and at a more sustained
level as the pandemic continued.
On 9 March 2020, the FTC and FDA announced their first round of warning
letters, targeting seven companies that were marketing products, including
teas, essential oils, and colloidal silver for treating or preventing COVID-19.3 The
letters identified sweeping claims that expressly mentioned “COVID” or
“coronavirus,” such as:
• “The most powerful antivirus essential oils to provide defence [sic]
against coronavirus,”
• “Wellness!! Vital Silver!!! Simple!!! Go on the offense [sic] this year
against viruses including the Coronavirus – it’s simple,” and
• “. . . with epidemics similar to CoronaVirus that are highly mutated and
drug resistant, we need to use therapeutic benefits of essential oils to
target the virus itself not just the specific gene type #coronavirus.”4-6
Between April and November 2020, the FTC announced eight additional rounds
of warning letters, issued either by both agencies or by the FTC alone, targeting
hundreds of additional companies and individuals selling a variety of products. 7
Even since the last official press announcement, in November 2020, both
agencies have continued to issue warning letters.8-10 In general, the original
theme has remained the same, with letters mostly targeting hard-hitting
advertising or labeling that expressly mentions “COVID” or “coronavirus,” or
fighting respiratory illness. For instance, a December 2020 FDA warning letter
flagged claims such as “The time to start boosting [children’s] immune system is
now . . . because of the coronavirus” and “Research demonstrates that
probiotics are safe and effective for fighting the common cold and influenza-like
respiratory infections.”11
Some of the FTC and FDA warning letters have targeted softer advertising that
used hedge language such as “may prevent COVID,” or other more subtle forms
of advertising. For instance, one warning letter identified claims such as the
following that appeared under a “Coronavirus” webpage tab: “products below
are worth considering in supporting your immune system and helping your body
fight off viruses.”12 As another example, a warning letter identified a social
media post that included the following text: “A recent article by the New York
Post states New York’s largest hospital system is giving vitamin C to treat
seriously sick COVID-19 patients” and “Our organic liposomal vitamin C boasts a
90% absorption rate while most are around 20%.”13 Although the article was
seemingly authentic, the agencies objected to its use in promoting a vitamin C
supplement given an alleged implied disease treatment message. In another
letter, the agencies made clear that “traditional use” claims, normally allowed if
June 2021
truthful and for nondisease states, would not be tolerated in the context of
COVID-19. The agencies specifically identified claims like the following as
deceptive: “Colloidal silver is an ancient remedy commonly utilized for its . . .
anti-viral activities.”14
In addition to the many warning letters, in October 2020, the FTC entered into a
settlement with a company and its owner over product, containing vitamin C
and botanicals, that was being touted as “the perfect way to strengthen your
immunity against pathogens like ‘Covid-19.’”15 The order does not impose
monetary redress, but bars the respondents from disseminating any future
claims for treating or preventing any disease unless the claims are supported by
“randomized, double-blind, and placebo-controlled” human clinical testing.15 In
July 2020, the FTC also filed a lawsuit against a company that allegedly marketed
a $23,000 “Emergency-D Virus” plan as “FDA accepted” for treating COVID-19.16
That lawsuit followed a warning letter to the same company and, several days
after the complaint was filed, the court granted a temporary restraining order
barring the advertising as litigation continues.16,17
The no-money settlement and little additional enforcement beyond warnings at
the time prompted criticism that the FTC was failing to do enough to combat
fraud around COVID-19. Subsequently, one of the federal relief bills granted the
agency temporary civil penalty authority with regard to marketing claims to
treat or prevent COVID-19.18 The civil penalty authority will remain in place as
long as the federally declared public health emergency remains in place. 19 The
current maximum civil penalty per violation of the Federal Trade Commission
Act is $43,280, and FTC staff has signaled the agency will interpret each ad and
each day an ad runs as separate violations – meaning monetary amounts could
accumulate very quickly.20,21
In April 2021, the FTC flexed its new authority, filing a lawsuit seeking an
unspecified amount of civil penalties against a chiropractor in Missouri who
allegedly touted vitamin and zinc supplements as something that should be
used instead of vaccination.22 According to the FTC, it had issued a warning
letter to the chiropractor about a year earlier but had not received an adequate
response.23 FDA and FTC enforcement action is likely to continue along similar
lines as long as the pandemic continues, with the FTC seeking civil penalties in
its actions.
Apart from the FDA and FTC, the Department of Justice (DoJ) has been actively
pursuing criminal charges against similar alleged fraud schemes around
products promoted for treating or preventing COVID-19 infection.24 For
instance, a Utah man was indicted, and is currently being criminally prosecuted,
based on allegations that he posed as a doctor to sell ingestible silver products
as a COVID-19 cure.25
Similar to federal regulators, states have been active in policing largely clearly
violative COVID-19 marketing for foods, supplements, and many other types of
products. For instance, in June 2020, the Oregon attorney general announced
settlements with 6 companies and medical practitioners advertising products or
June 2021services as a “so-called Covid-19 ‘cure[s]” or able “to boost immunity and keep
people healthy from the disease.”26 As another example, the New York attorney
general issued numerous cease-and-desist letters to businesses making claims
around COVID-19.27 One letter targeted a beverage product, Sacramental
Cleansing Water, which the company promoted as having “the 20-20-20
essentials that can kill the coronavirus.”28 The state’s attorney general also
targeted Craigslist, ordering it to remove posts “attempt[ing] to sell fake items
that purportedly claim to provide ‘immunity’ to the coronavirus or allow
individuals to test for the disease.”29
Regulators in states, including Arkansas and California, have also launched high-
profile investigations into COVID-related marketing for Silver Solutions, a
purported dietary supplement, sold by televangelist Jim Bakker, a church and
for-profit company.30,31 A court in Missouri refused to grant an injunction sought
by Bakker and the groups to prohibit two of the investigations, and all
investigations (normally conducted in a nonpublic manner) are presumably
ongoing.32 As with the federal enforcement, such DOJ and state actions will
likely continue as the pandemic continues.
NAD cases
The National Advertising Division (NAD) is a self-regulatory body offering an
alternative forum where private actors or the NAD itself may challenge
advertising and labeling claims.33 The NAD is not able to order monetary relief,
but it regularly issues decisions upholding advertising claims or recommending
modifications or discontinuation. If an advertiser refuses to participate or abide
by a decision, the NAD will forward its case file to the appropriate federal
regulator, such as the FTC or FDA.34 The FTC prioritizes cases referred by the
NAD and routinely encourages companies choosing not to participate in NAD
proceedings to reconsider.
Throughout the pandemic, the NAD has focused primarily on implied claims,
flagging advertising that may not mention “COVID-19” but that the NAD
nevertheless believes conveys messages about treating or preventing the
disease. In each case, the advertiser has agreed to discontinue the identified
advertising, which has been mostly advertising on social media. Below are
representative examples of social media posts that the NAD has challenged:
• An image of a woman wearing a mask, accompanied by the claims
“Strong IMMUNITY needs glutathione” and “Building your immunity
during these times is more important than ever;”
• An image of an elderberry syrup, accompanied by the claims “Potent
Immune Support During a Severe Season” and “[Product] is highly
concentrated to deliver antioxidant action for immune defense;”
• An image of a company’s dietary supplement, accompanied by the
claims, “As restrictions are gradually lifting, it’s more important than
ever to keep your immune system strong. Our [product] keeps you
protected with vitamin C, zinc, elderberries, garlic, echinacea; a
powerful immune-boosting combo”; and
• Claims such as “Twenty-three hospitals alone in New York are now
treating patients who test positive for COVID-19 with large doses of
June 2021vitamin C. While this is an extraordinary breakthrough in the medical
world, high Vitamin C foods have proven for millennia to do far more for
our health than just fighting off the winter bug. Infinity-C works by
delivering 1000mg of real Vitamin C per serving purely from plant foods
for a 100% absorption rate, making it a superior upgrade from the all-
too-common ascorbic acid.”35
Class actions
Although few class actions have targeted COVID-19 advertising or labeling
claims, immune claims, generally, have been a perennial class action target. The
following are examples of cases in the last 13 years.
• A class action filed in January 2021 in which plaintiffs allege the
following claims for a line of elderberry supplements lack adequate
substantiation: “Stress can wreak havoc on our immune system. This
leaves us open to the possibility of more frequently catching a virus or
other illness. Sambucol Black Elderberry helps to support a healthy
immune system so even on my most hectic days, I am giving my body
the immune support it needs.”36
• In 2018, a class action targeted claims, such as the following, for
Barlean’s Greens Supplement Powders: “Promote a healthy immune
system,” “Aid the body’s natural detoxification,” and “Help improve
digestion.”37 In July 2021, the case was voluntarily dismissed, suggesting
that the parties may have reached an individual settlement.38
• In 2014, the makers of Emergen-C agreed to a $6.45-million settlement
over allegations that claims such as the following were deceptive: “The
powerful blend of vitamins, antioxidants, and minerals boost your
immunity, increase your metabolic function and ignite your energy level
without caffeine.”39
• In 2013, Kellogg’s entered a $5-million settlement over allegations that
it misled consumers with claims such as “Kellogg's Cocoa Krispies has
been improved to include antioxidants and nutrients that your family
needs to help them stay healthy;” and “Enjoy this wholesome breakfast
and help keep your family healthy.”40 This case followed a settlement
with the FTC over the same claims.41
• In 2008, the makers of Airborne entered a $30-million joint FTC and
class action settlement over allegations that the product was promoted
with deceptive claims for preventing colds and reducing the severity or
duration of colds.42
Such cases will likely continue to be filed throughout and following the
pandemic, as they have been for years.
COVID-related class actions
COVID-19 has spurred a wave of class action lawsuits in many other areas. There
were class actions relating to confidentiality issues on the Zoom platform and
plaintiffs suing China for causing the coronavirus. There were also refund cases
for everything from tuition to vacations to concerts to monthly gym
memberships; insurance coverage cases from all types of businesses;
employment based claims for alleged unsafe working environments resulting
June 2021from potential virus exposure; claims against financial institutions for the way
they distributed pandemic relief loans; the inevitable stock drop cases; and
some virus exposure or risk of exposure cases for having large gatherings in
confined spaces. Grocery stores and other entities in the food chain were hit
with price gouging cases on products, including protective masks, toilet paper,
sanitizers, and even flour and eggs.
The most notable advertising or labeling cases involved cleaning and
disinfectant products and the products’ effectiveness against viruses. At the
core of these cases was whether the product satisfied what was stated on the
label. Hand sanitizer cases were likely the most publicized of such cases. The
Center for Disease Control and Prevention advised that alcohol-based hand
sanitizers inactivate viruses related to the coronavirus and recommended their
use. The FDA, however, sent warning letters to manufacturers Vi-Jon and Gojo,
noting that label claims about effectiveness were insufficiently supported and
had many flaws. Class action lawsuits ensued.43
As already noted, other than the cases on cleaning and disinfectant products,
we have not seen advertising or labelling cases relating to food or dietary
supplements and COVID-19. If they were to arise, the defenses would be those
prevalent in many advertising and labeling cases, beginning with “truth” – the
claims are not false, and certainly not to all or the majority of the purported
class. Individualized issues may also be prevalent in certain labelling cases,
giving rise under some state laws to arguments to defeat class certification.
Primary jurisdiction and preemption defenses are also often available.
Take-aways and tips for crafting low-risk claims
Against the above regulatory background, the following are tips to craft low-risk
claims:
• Avoid claims, imagery, or other elements that reference any disease
including cold, flu, or COVID-19. As the federal and state enforcement,
in particular, demonstrates any express mention of COVID-19 – or any
other disease – in the context of promoting a dietary supplement or
food without question increases the chances of enforcement. As the
NAD cases demonstrate, imagery like people wearing masks or language
alluding to pandemic “restrictions” can be equally risky even if no
disease is expressly mentioned.
• Avoid claims for “boosting,” “building,” or “protecting” the immune
system, as opposed to “supporting” or “maintaining” the immune
system. Under FDA rules, claims to “support” or help “maintain” the
immune system are considered acceptable structure/function claims. 44
On the other hand, claims to “boost,” “build,” or “protect” the immune
system are normally considered unauthorized disease claims. As
discussed above, such claims have drawn not only governmental
enforcement but also class actions like the case involving Emergen-C.
• Confirm claims are substantiated. Even if a claim uses FDA-allowed
language, it will still normally present risk if not adequately
June 2021substantiated. Regulators have not generally required human clinical
data for claims to “support” or “maintain” the immune system versus
claims to boost immunity or prevent or treat colds or other disease. 45
Nevertheless, an immune “support” or “maintain” claim requires
reliable in vitro or other evidence demonstrating a positive effect on
immune function.
• Bear in mind that just because a statement is truthful, that does not
mean it is allowable. As reflected in both the governmental
enforcement and NAD cases discussed above, just because a statement
is truthful, that does not necessarily mean it is allowable or low risk.
Both an FDA warning letter and the NAD challenged social media posts
that shared truthful information about hospitals in New York treating
COVID-19 patients with vitamin C. Although such discussion outside of
the context of advertising or labeling is normally First Amendment
protected, it becomes fair game for regulation when integrated into
product promotion. Similarly, it may very well be true that “Colloidal
silver is an ancient remedy commonly utilized for its . . . anti-viral
activities,” but as reflected in the FTC and FDA warning letters, such
traditional use claims entail risk given the discussion of disease.
Conclusion
COVID-19 has raised the risk profile in the immune support category. However,
with careful execution and an eye to ongoing regulatory developments,
companies can continue to provide consumers the immune support products
they desire more than ever, while avoiding legal pitfalls.
About the authors
Katie Bond, JD, is a partner at Lathrop GPM. She provides regulatory counseling and litigation
support to national and global brands marketing a variety of consumer products. She focuses her
practice primarily on advertising and food and drug law, with an emphasis on risk analysis and a
deep knowledge of federal regulatory regimes affecting consumer product labeling and
marketing. Bond has extensive experience handling complex FTC and state investigations, in
addition to assisting clients with consumer class action defense and self-regulatory actions before
the NAD. She can be contacted at Katie.Bond@LathropGMP.com
Brian Fries, JD, is a partner at Lathrop GPM. He focuses his practice on class actions and complex
litigation and leads the firm’s class action group. He has extensive trial practice, arbitration, and
mediation experience in a variety of litigation matters throughout the US. His experience includes
disputes arising from general business transactions, class actions, single plaintiff claims,
healthcare litigation, business torts, accounting negligence claims, real estate transactions,
business ownership disputes, banking related claims, personal injury claims, and a variety of tort,
breach of contract and fraud claims. Fries can be contacted at Brian.Fries@LathropGMP.com
Citation Bond K, Fries B. ‘Immune’ claims and COVID-19. https://www.raps.org/news-and-
articles/news-articles/2021/6/immune-claims-and-covid-19. Regulatory Focus. Published online
30 June 2021.
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