April 30, 2020

Bookmark and Share

Federal Efforts to Prevent Fraudulent COVID-19 Products

By Susan D. Brienza. Ph.D., Esq., Ryley Carlock & Applewhite

Introduction
While many Americans have used the COVID-19 pandemic as an opportunity to come together, some unscrupulous businesses have sought to turn pandemonium into profit. As of today, no prevention, remedy, or vaccine is known to exist for COVID-19. Therefore, any coronavirus-related “treatment” or other medical products and claims are not substantiated by competent and reliable scientific evidence. Moreover, any future COVID-19 drugs must be first approved by the Food and Drug Administration (FDA). In an attempt to prevent deception and fraud during these confusing and stressful times, the FDA, the Federal Trade Commission (FTC), and the Environmental Protection Agency (EPA) have cracked down on unfair business and marketing practices at an unprecedented rate. This article analyzes numerous examples of recent warning letters regarding unapproved and/or unsupported products and claims related to COVID-19, and emphasizes the need for all companies to adhere to FDA/FTC/EPA regulations.

Agency Teamwork to Tackle Fraud
Since the beginning of the COVID-19 pandemic in the U.S. in March, the FTC and FDA have partnered in sending more than 40 warning letters to companies regarding fraudulent claims that their products can prevent, treat, or cure COVID-19.  The agencies have cited extensive language on the companies’ websites and social media channels as evidence of these deceptive claims. Most dietary supplement companies are “good players,” with only a small minority of bad and opportunistic apples. With confidence in the majority’s desire for compliance, the four leading trade associations1 (Coalition) for the supplement industry jointly released a unified advisory statement in February as a proactive measure.2 This statement cautioned marketers to refrain from promoting any dietary supplement as a cure, treatment, or prevention for COVID-19, and cautioned retailers not to stock or sell supplements presented as treating, curing, or preventing COVID-19.3 The statement further advised consumers of supplements to avoid any product that claims to treat, cure, or prevent COVID-19 and also to report such products to the FDA.

In a joint press release issued April 6, 2020, this Coalition commended the FDA “for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19.”4 The following day, there was a record-setting 24 warning letters posted on the FDA website. Then, completing a 1-2 punch, on April 14 the FTC issued 10 more warning letters to companies making false COVID-19 related claims.5 Typically, the FDA provides companies up to 15 days to respond (usually via letter) with how they plan to address violations raised against them. That the FDA and FTC currently give companies only 48 hours to answer warning letters—and via email—illustrates agency urgency to decisively end such fraudulent claims.

Why do government agencies spend so much time and resources pursuing such companies and claims? Because, as the Coalition noted in its February statement, illegal and unsubstantiated drug claims seriously misdirect consumers toward ineffective products, divert them from seeking critical medical care, and endanger the public health.6 Moreover, even if research is conducted and published on COVID-19, the law that regulates dietary supplements in the U.S., the Dietary Supplement Health and Education Act of 1994, prohibits marketers from promoting any dietary supplement product with any disease or drug claims.7 With its first enforcement letters on March 9, the FTC presented its rationale for such forceful action: “There already is a high level of anxiety over the potential spread of coronavirus,” said FTC Chairman Joe Simons. “What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”

More recently, the FTC has been acting unilaterally. On April 23, the FTC sent out 21 additional warning letters in the following 4 categories: vitamins and supplements, intravenous (IV) therapy and related treatments, ozone therapy, and stem cell therapy.8 This third group of warning letters differed from previous letters in that the FTC specifically targeted products that may appear more medically sophisticated to consumers. Thus, IV therapy incorporating high-dose Vitamin C, stem cell therapy, ozone therapy, and regenerative cell medicine were all among the unsupported products that defendant companies deceitfully marketed. On the other hand, some of the methodologies marketed were as simple as acupuncture—which can indeed be effective for pain and other issues, when professionally performed, though not to prevent or cure any virus, and certainly not a novel one. The 21 recent warning letters remind recipients that under the FTC statute, it is illegal to advertise that a product can prevent, treat, or cure any disease unless the company has “competent and reliable scientific evidence” to support what they claim–which usually means well-controlled human clinical studies.  However, “For COVID-19, no such study is currently known to exist” for the products and services cited in the letters. 

Then on April 24, the FTC turned its focus to Multilevel Marketing (MLM) companies, based on the social media and online video posts of their participants/distributors. Of the 10 such warning letters, 7 concerned “spurious health claims” made for illegal supplements, cosmetics, essential oils, and other personal care products. In addition, this time the FTC was emphasizing that MLM companies are responsible for the claims made by their distributors as well as directly on company promotions.9 As with earlier COVID-19 enforcement letters since early March, the FTC required a response from all 31 recently cited companies within 48 hours with a description of the specific actions the recipients have taken to address these serious concerns. Again, penalties for failing to respond adequately to a warning letter can be swift and severe.

Types of Fraud: Let Us Count the Ways
Recent warning letters cover the gamut from supplements (including CBD products) to facial brushes, homeopathic drugs, essential oils, mushroom sprays, Vitamin C infusions, and even pet products.10 Again, significantly both agencies examine social media platforms as well as promotional websites, links and hyperlinks. Of the many warning letters issued, one was addressed to the California-based, CBD Online Store.11 The letter states that after the FDA and FTC reviewed the company’s website and social media pages, they discovered multiple violations of the Federal Food, Drug, and Cosmetic Act.12 As previously stated, there is no reliable and substantiated scientific evidence for any cure, remedy, or treatment of COVID-19. However, CBD Online Store’s website attempted to deceive customers into thinking that its product would combat COVID-19. “Can CBD Help With The Corona Virus?...We have been saying on our blog since the beginning about the powerful anti-inflammatory effects of CBD…CBD has been found to decrease inflammations naturally, and through communicating with your endocannabinoid system.”13 The website continued: “Can CBD help with Corona Virus? Possibly! But one thing is for sure, it will help you relax when everyone else is panicking.” By posting such misleading content, CBD Online Store sought to encourage customers to purchase its products (often at higher-than-usual prices) to treat—or at least mitigate—COVID-19. Consequently, the resulting warning letter demanded that immediate action be taken to correct the violations. And as all FDA warning letters do, this one concluded that failure to do so may result in legal action, including, without limitation, seizure of products and injunction against further sales.14 

Herbs of Kedem, an herbal beauty company, was issued a warning letter after making several deceptive claims that their products were safe and/or effective for the treatment or prevention of COVID-19.15 The company’s website asserts, “Corona Virus Prevention…As long as there is no vaccine for this new virus, it is recommended to consider using natural substances…Since plants deal with plant viruses, they sometimes produce substances that can be effective against other viruses as well.” [Pause here to consider the simplistic scientific reasoning and “logic” of this statement.] The Herbs of Kedem website then links to a study about Withania somnifera, an ingredient in the product Winter Companion, stating “Recent studies in India have shown that the vitamin [sic], an intoxicating plant, may inhibit the attachment of the new corona virus to cells in the body.” The warning letter concludes by clearly informing the defendant company that it is illegal to advertise that a product can prevent, treat, or cure human disease unless there is competent and reliable scientific evidence substantiating that the claims are true. As mentioned above, there is no such evidence currently known for COVID-19.

In yet another instance, a warning letter was sent to Holistic Animal Remedies, a marketer of pet products. According to the letter, the company had several federal violations for misleadingly representing their products as a treatment or prevention of COVID-19. The company described one product as “Corona viral immune support and/or active respiratory infection for all ages. Holistic Animal Remedies…For all species.” In promoting their Vitamin C products, the company claimed, “Vitamin C protects…against all virus [sic] e.g. CoronaVirus.” In another fraudulent claim, the company said, “China Oral Nosode is the homeopathic nosode called a homeoprophylasix of Corona Virus to assist immunity.” As in other warning letters, Holistic Animal Remedies was required to take immediate action to correct the multiple violations in order to avoid legal action. 

To my mind, the most bizarre claim is the following, as cited by the FTC in the April 23 letters, and described by the Commission’s Leslie Fair in a recent article for consumers: 

TRULYHEAL Pty. Ltd. The Australian business has promoted its products by claiming, “Ozone plays a fundamental role in the treatment of viral infections including the Coronavirus (COVID-19) . . . .” According to the company, “To prevent and protect the body from a coronavirus infection at HOME with ozone, it is administered via rectal insufflation,” and it’s “the easiest, most inexpensive, safe, and effective protection solution that everyone should have available to them, their family and loves [sic] ones.”  [Emphasis added.]

This company website (accessed on April 25) still claims that ozone will treat many other serious diseases, such as HIV-1, Epstein Barr virus, Hepatitis B,C,  Papillomavirus infections, Lyme Disease, etc. 

Separation of Church and Science
The FTC’s and FDA’s efforts to protect consumers have gone so far as to alert consumers about seemingly harmless groups, such as churches.16 On April 8, a warning letter was issued to The Genesis II Church of Health & Healing, based on “unapproved products related to COVID-19.” The letter was centered on material published on the church’s website that sold “Miracle Mineral Solution” (MMS) intended to “cure, mitigate, treat, prevent, or diagnose Coronavirus and/or COVID-19 in people.”17 The website added that “14 people that tested positive for COVID-19 in Europe took MMS and recovered their health.” Finally, the website instructed individuals to “let MMS be your first line of defense.” When combined with the included activator, MMS has a chlorine dioxide content equivalent to industrial bleach. The church’s claims epitomize the FDA and FTC’s fear—that illegal and unsubstantiated claims for ineffective products divert individuals from seeking critical medical care and endanger public health.

In response to the warning letter, Genesis II made clear that they had no intention of taking the required corrective action and would continue to sell MMS in direct violation of the law.18 As a result of the Church’s defiance, on April 17, U.S. District Judge Kathleen M. Williams entered a temporary restraining order against the Church and four individuals associated with the entity. The order lasts until May 1, 2020, after which a hearing will take place on the government’s behalf to extend the injunction. The complaint, filed by the U.S. Department of Justice, seeks to permanently restrain and enjoin defendants from labeling, holding, and distributing unapproved new and/or misbranded drugs, including MMS, in interstate commerce.

Don’t Forget About the EPA
Although the FDA and FTC enforcements have received the most coverage in headlines, the EPA has been making waves of its own. While the general public was in a frenzy to hoard large amounts of legitimate and effective hand sanitizer, the Environmental Protection Agency has been taking steps to eliminate unverified COVID-19 cleansers.19 Officials report that the EPA intends to issue enforcement measures that would force companies to end the sale of fake products. Additionally, the EPA has begun coordinating with the Department of Justice “to bring the full force of law” against anyone who continues to sell fake products.20 The administrator of the EPA, Andrew Wheeler, declared, “We will work diligently to ensure that consumers have access to EPA-approved and verified disinfectant products—products that we know to be effective against the novel coronavirus.”21

Among the bogus products are: lanyards containing chlorine dioxide, “sanitization cards,” unregistered wipes, sprays, air purifiers, and a wearable sticker that purportedly provides 30 days of protection against COVID-19. Although the products themselves may be harmless if intended solely for cleaning purposes, they nevertheless provide the public a hazardous false sense of protection that could potentially deter social distancing and other well-substantiated methods of potentially reducing COVID-19, including the purchase of valid and effective sanitizers. Last week, the EPA added sprays and wipes that claim to kill “99 percent of germs” to the list of unregistered products that should not be sold. Additionally, the agency has reached out to Amazon to remove all such unregistered products from its online marketplace.

Conclusion
In March, President Trump declared a national emergency in response to COVID-19. Subsequently, government agencies have taken urgent measures to protect consumers from certain products that, without approval or scientific support, claim to prevent, treat, or prevent COVID-19 in people. This is especially significant because many consumers are more susceptible to unscrupulous business practices—practices designed to unconscionably deceive in an opportunistic effort to profit—during a time of panic or anxiety. 

By contrast, during this pandemic, many responsible dietary supplement companies are making proper, legal, and well-substantiated claims that ingredients such as zinc, Vitamin C, probiotics, and certain herbs can strengthen the immune system. To police the fraudulent companies, however, fortunately the FDA, FTC, and EPA are well aware of the egregious COVID-19 products and claims and have sent a record-setting number of warning letters to such companies requiring them to cease and desist such practices.

During these times, companies should carefully consider their implied as well as express (direct) claims, as well as claims made on social media and by distributors—especially regarding products even remotely related to COVID-19. They should consult with a regulatory compliance attorney to stay fully compliant with FTC/FDA/EPA regulations. General questions on these cases and issues may be addressed to author Susan Brienza at sbrienza@rcalaw.com.

About the Author
Susan Brienza helps clients navigate complex federal laws relating to the manufacture, labeling,   marketing, and sales of conventional/organic foods, dietary supplements, pet supplements, “functional foods,” cosmetics, “cosmeceuticals,” over-the-counter and homeopathic drugs, and much more.  Her experience includes: label claims, substantiation and risk assessment; hemp/CBD; new dietary ingredient (NDI) opinion letters; self-affirmed GRAS status and panels; and formal comments to the FDA on Draft Guidances and Proposed Rules. Ms. Brienza also counsels clients in advertising law under FTC regulations in all types of marketing, including social. Ms. Brienza writes and speaks frequently on these issues. She can be reached at sbrienza@rcalaw.com.

Disclaimer: This article is not intended as, and does not constitute, legal advice. If further analysis is required, an experienced attorney can help ensure you avoid the aforementioned pitfalls and stay in full compliance with current FDA and FTC requirements.

References:
1 This joint coalition includes 1) American Herbal Products Association 2) Consumer Healthcare Products Association 3) Council for Responsible Nutrition and 4) United Natural Products Alliance.
2 Council for Responsible Nutrition, “Industry Coalition Reminds Consumers, Retailers that Dietary Supplements May Not Claim to Cure, Prevent Coronavirus” (February 2020).
3 Id.
4 United Natural Products Alliance, “Supplement Industry Associations Applaud FDA Actions to Protect Consumers from Fraudulent Products Related to Coronavirus Disease” (April 2020).
5 Federal Trade Commission: Thinking about making Coronavirus claims? Read the latest FTC warning letters first (April 14, 2020).
6 Id.
7 Id.
8 Federal Trade Commission, FTC Sends 21 Letters Warning Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Treat Coronavirus (April 23, 2020).
9 In addition to the illegal disease claims about the virus, 9 of the 10 companies targeted people stuck working at home to entice them with false, inflated claims about how much they could earn as MLM distributors.
10 Due to the unusually large number of warning letters, this article serves as merely a selective representation of recent cases and is by no means a complete survey.
11 Food and Drug Administration, Warning Letter: CBD Online Store (April 07, 2020).
12 Id.
13 Id.
14 Id.
15 Food and Drug Administration, Warning Letter: Herbs of Kedem (April 10, 2020).
16 Food and Drug Administration, Warning Letter: Genesis 2 Church (April 08, 2020).
17 Id.
18 Food and Drug Administration, Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19.” (April 17, 2020).
19 Environmental Protection Agency, EPA Administrator Wheeler Talks with Retailers and Third-Party Marketplace Platforms to Discuss Steps to Protect American Consumers from Fraudulent Coronavirus Disinfectant Claims. (April 2020).
20 Id.
21 Id.

Publications

Related Attorneys

Solutions

COPYRIGHT © 2020 - RYLEY CARLOCK & APPLEWHITE. A PROFESSIONAL CORPORATION. ALL RIGHTS RESERVED.