This article was originally published in the October 2020 edition of the NAGTRI Consumer Protection Monthly newsletter. 

Stephanie N. Guyon, Deputy Attorney General,

Idaho Attorney General’s Office[1]

“Life is pain. Anybody that says different is selling something.”[2]

If you browsed a newspaper during the 1918 flu pandemic, you would have found ads for Owl’s throat gargle,[3] Dr. McKenzie’s smelling bottle,[4] J.W. Gardocky’s onions,[5] Horlick’s malted milk,[6] and Boyer’s massages.[7] From miracle water to sensible shoes, sellers offered dozens of fake treatments to capitalize on a deadly disease that gripped the world between 1918 and 1920.[8] Reading these outrageous health claims now is both laughable and ominous.

The COVID-19 pandemic has awakened a similar breed of miracle-cure charlatans. The Internet’s reach far exceeds that of 1918 newspapers, allowing scammers worldwide to bombard the public through social media and email with false or misleading health claims. The sheer number of sellers advertising bogus COVID-19 treatments and cures is daunting for regulators, but the Federal Trade Commission (FTC), state attorneys general, and other regulators are meeting this challenge.

As of September 1, 2020, the FTC has filed multiple deceptive advertising lawsuits and issued hundreds of warning letters to sellers about false or misleading COVID-19 health claims. Attorneys general throughout the country have issued joint and separate warning letters and filed their own actions to prohibit the marketing of ineffective and potentially dangerous treatments for COVID-19.

This article summarizes the history of unsubstantiated health claim regulation, tracing the path of legislation, case law, and policies that regulators—primarily the FTC—have employed to combat false claims. While sellers generally must substantiate health claims, what constitutes adequate “substantiation” has evolved in the past 100 years and continues to develop depending on the claim made and the court evaluating it.

The Great American Fraud

East coast retailers, manufacturers, newspaper and magazine publishers, and advertising agencies formed an advocacy group in the late 1800s to express concern about the increasing problem of false advertising. Advocating that one false advertisement could ruin the reputation of all advertisers, the group lobbied through articles in its primary trade publication, Printers’ Ink, for more truth-in-advertising regulation.[9] Advertising clubs formed in the early 1900s to educate their members about advertising standards and to discourage publishers from accepting misleading ads.[10]

In 1905, the Journal of the American Medical Association published a collection of essays that Samuel Hopkins Adams originally wrote for Collier’s Weekly. Collectively titled The Great American Fraud, Adams’ essays exposed manufacturers’ pervasive use of alcohol, opioids, and known poisons in the medicinal compounds they sold as treatments and cures for various diseases and illnesses. Druggists and others sold these addictive and often lethal remedies without disclosing their dangers or having any proof of their effectiveness.[11]

Congress had been investigating problems with food and drug purity for decades before Adams’ essays were published. But by exposing the fraudulent practices of the patent-medicine industry in such detail, Adams and his fellow muckrakers helped influence the passage of the federal Pure Food and Drug Act of 1906.[12] The Act, enforced by the federal Bureau of Chemistry,[13] prohibited “the manufacture, sale, or transportation of adulterated, misbranded, poisonous, or deleterious foods, drugs, medicines, and liquors”[14] and laid the foundation for stricter regulation of false health claims.

In 1911, Printers’ Ink retained a lawyer to draft a model law that criminalized false advertising.[15]  Most states, including Idaho,[16] enacted the law by 1931. Local advertising groups (e.g., Better Business Bureaus) received and investigated advertising complaints and, with the threat of criminal prosecution, obtained advertisers’ voluntary compliance.[17]

The FTC Begins

Congress established the FTC[18] in 1914 primarily to combat anti-competitive conduct. Soon, however, the FTC began scrutinizing deceptive advertising practices that both inhibited competition and harmed consumers. In the agency’s first full year of operations, three of the five[19] complaints it issued involved deceptive advertising. The Seventh Circuit, affirming a 1919 cease and desist order against Sears, Roebuck & Co. for deceptively advertising that it sold its products for “less than wholesale price,” made it clear that the FTC’s authority extended to “all those trade practices that have a capacity or a tendency to injure competitors directly or through deception of purchasers.”[20]

A year after the Sears, Roebuck & Co. decision, however, the U.S. Supreme Court issued a decision that impeded the FTC’s ability to stop false advertising. In FTC v. Gratz,[21] a case involving tie-in sales, the Supreme Court appeared to restrict the FTC’s activities to those that were “illegal at common law.”[22] This pronouncement eliminated the “flexibility” of the FTC Act and, because the illegality of false advertising at common law was undetermined, impaired the FTC’s authority to pursue false advertising cases.[23]

The FTC experienced another, albeit minor, setback in the early 1930s when the Supreme Court declined to uphold an FTC cease and desist order against the seller of a suspect weight-loss preparation.[24] Raladam Co. advertised that its weight-loss product, which purportedly contained desiccated thyroid, was a scientific method for treating obesity.[25] The FTC argued that Raladam’s claims were misleading because the company failed to disclose that consuming the product was unsafe without “medical advice and direction.”[26] The Supreme Court, despite acknowledging evidence of the product’s dangerousness, held that the FTC failed to show the company’s misleading advertising harmed the company’s competition.[27] This failure, according to the Court, prevented the FTC from exercising jurisdiction over Raladam’s business practices.[28] The Raladam decision did not restrict the FTC’s authority to bring false advertising cases, but it did require the FTC to vigilantly demonstrate in future cases that a seller’s false advertising was anti-competitive.[29]

Questions about the FTC’s authority over false advertising and its role as a consumer protection agency[30] ended in 1938 with enactment of the Wheeler-Lea Act.[31] That act amended the FTC Act to prohibit “unfair or deceptive acts or practices,”[32] as well as the false advertising of “food, drugs, devices, or cosmetics.”[33] With the FTC overseeing food and drug advertising and the FDA enforcing food and drug labeling laws, the two agencies achieved complementary oversight of the food and drug industries and helped to better protect consumers and the marketplace from false health claims.[34]

Expanding FTC Oversight

The FTC had no shortage of false health claim matters to pursue after President Roosevelt signed the Wheeler-Lea Act into law in 1938.[35] Many of those cases ended with the FTC, pursuant to its administrative authority under 15 U.S.C.A. § 45(b), issuing cease and desist orders and effectively stopping the deceptive advertising. Recipients of such orders could file a petition for review with the circuit appellate courts, which evaluated whether the evidence presented at the administrative hearing supported the order.[36] The courts deferred to the Commission’s findings of fact and did not evaluate the credibility of witnesses or the weight of the evidence presented at the administrative hearings.[37]

For example, in Koch v. FTC, the petitioner—Koch Laboratories, Inc.,—advertised in pamphlets it published and distributed to both doctors and the public that its three products—Glyoxylide, B-Q, and Malonide Ketene Solution—treated, among dozens of other conditions, diabetes, cancer, leprosy, malaria, multiple sclerosis, syphilis, and even infantile paralysis.[38] The company asserted that its pamphlets included “statements of scientific theories or opinions, which were in fact their honest and well-considered theories, and the therapeutic value of the drugs was shown by the experience of physicians who used them.”[39]

At the administrative hearing on the cease and desist order, the FTC had 33 doctors and scientists testify that Koch Labs’ products had no therapeutic value in treating any of the advertised conditions or diseases.[40] Koch Laboratories attempted to rebut the expert witnesses’ testimony by introducing 150 case histories and calling 29 doctors to testify about “every kind of disease claimed to be cured by Koch’s treatments.”[41] On cross-examination, however, it was determined that Koch Labs’ clinical data was “inaccurate” or based on an “insufficient diagnosis.”[42] The witnesses testified that Glyoxylide was an effective treatment for tumors, but also admitted to not conducting any lab tests or biopsies on patients to confirm their cancer diagnosis.[43]

The Sixth Circuit found that substantial evidence presented at the administrative hearing established the misleading, deceptive and false character” of Koch Labs’ advertised health claims.[44] In affirming the cease and desist order against Koch Labs, the court explained:

Extensive expert testimony was introduced in support of the charge of the complaint. Physicians of long experience and high standing with reference to diabetes and cancer testified that the drugs involved had no therapeutic value for these diseases. Testimony was given by a number of physicians that these drugs had no therapeutic value with reference to any disease. While it was conceded that the drugs in the dilutions described were harmless, extensive positive testimony was given in support of the complaint. Whether the petitioners rebutted the Commission’s case is a question of fact primarily for the Commission to decide.[45]

These early opinions do not use the term “substantiation.” However, they do illustrate courts’ deference to the FTC’s position on what constitutes legitimate “substantiation” of health claims versus sellers’ standards. For example, courts acknowledge the value of evidence from experts with specialized training or experience, but consistently dismiss customer satisfaction testimonials and testing results obtained through illegitimate methods.[46]

The Pfizer Factors and FTC Policy Statements

The “baseline requirements for substantiation” arrived in 1972[47] when the FTC filed a complaint against Pfizer, Inc., the manufacturer of “Un-Burn.”[48] In its television and radio advertisements, Pfizer claimed Un-Burn anesthetized nerves and quickly relieved pain.[49] The FTC’s complaint charged that Pfizer violated section 5 of the FTC Act because the company falsely implied it had substantiated the product’s performance claims through unperformed scientific studies.[50]

The hearing examiner dismissed both the deception and unfairness charges,[51] and the Commission upheld the decision on appeal.[52] It warned, however, that an affirmative advertising claim made without a “reasonable basis” violated section 5 whether or not the claim was true.[53]

The Commission explained its “reasonable basis” standard as “a factual issue . . . affected by the interplay of overlapping considerations” (the Pfizer factors), including:

(1) the type and specificity of the claim made—e.g., safety, efficacy, dietary, health, medical; (2) the type of product—e.g., food, drug, potentially hazardous consumer product, other consumer product; (3) the possible consequences of a false claim—e.g., personal injury, property damage; (4) the degree of reliance by consumers on the claim; [and] (5) the type, and accessibility, of evidence adequate to form a reasonable basis for making the particular claim. More specifically, there may be some types of claims for some types of products for which the only reasonable basis, in fairness and in the expectations of consumers, would be a valid scientific or medical basis. The precise formulation of the “reasonable basis” standard, however, is an issue to be determined at this time on a case-by-case basis. This standard is determined by the circumstances at the time the claim was made, and further depends on both those facts known to the advertiser, and those which a reasonably prudent advertiser should have discovered.[54]

In 1984, the FTC issued a Policy Statement Regarding Advertising Substantiation (“FTC Advertising Policy”) that continued Pfizer’s case-by-case evaluation while specifying the type of support required for “express and implied claims, however conveyed, that make objective assertions.”[55] Advertising claims, including those concerning health, generally fall within two categories—“establishment” claims and “non-establishment” claims.

Pursuant to the FTC Advertising Policy, establishment claims—those that claim a product’s superiority or effectiveness is scientifically established—may be express or implied. To substantiate an express establishment claim, an advertiser needs to possess at least the level of substantiation it advertises.[56]

Non-establishment claims or simple efficacy claims are those where the advertiser claims a product successfully performs the advertised function or has the advertised benefit.[57] The FTC Advertising Policy defines six factors, adopted from Pfizer, that it uses as guidelines to evaluate efficacy claims:

(1) the type of claim;

(2) the product;

(3) the consequences of a false claim;

(4) the benefits of a truthful claim;

(5) the cost of developing substantiation for the claim; and

(6) the amount of substantiation experts in the field believe is reasonable.[58]

 

The last factor—the amount of substantiation experts in the field believe is reasonable—is particularly relevant to health claims. Claims specific to health benefits, safety, performance, or the efficacy of foods, OTC drugs, dietary supplements, devices, or cosmetics require “competent and reliable scientific evidence,” [59] which means:

tests, analyses, research, studies, or other evidence based upon the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted to yield accurate and reliable results.[60]

Additional advertising substantiation policies followed the FTC’s Advertising Policy. In 1994, the FTC issued its standard for substantiation of health claims in food advertising (“FTC Food Policy Statement”).[61] As previously defined in its orders, the FTC reiterated in its Food Policy Statement that health claims in food advertising requires “competent and reliable scientific evidence.”

The FTC issued its Dietary Supplements Advertising Guide (“FTC Supplements Guide”) in 2001, providing guidelines for advertising dietary supplements like vitamins and herbs.[62] In addition to outlining the Pfizer factors and reiterating the importance of advertisers possessing “competent and reliable scientific evidence,” the FTC Supplements Guide emphasizes that substantiation of health benefit claims requires a well-controlled human clinical study.[63] The FTC also will consider animal and in vitro studies where human studies are infeasible.[64] Replicating study results is important, but the FTC values a study’s quality over the number of studies performed.[65] When clinical studies are not possible, the FTC may accept “epidemiological evidence.”[66] “[R]esearch explaining the biological mechanism underlying the claimed effect” bolsters such evidence.[67]

Advertisers may not use anecdotal evidence about a consumer’s experience, which may have resulted from the placebo effect, “as competent and reliable scientific evidence” or rely on expert endorsements or traditional use claims[68] to substantiate dietary supplement health claims.[69] Additionally, including the two-part Dietary and Supplement Health Education Act disclaimer,[70] while valuable in some instances, does not “cure an otherwise deceptive ad, particularly where the deception concerns claims about the disease benefits of a product.”[71]

Throughout the 1990s and 2000s, the FTC regularly included the “competent and reliable scientific evidence” standard in consent orders arising from cases involving false health claims.[72] Such cases involved products marketed to improve brain function,[73] speed weight loss,[74] and prevent or treat diseases.[75]

In 2010, however, the FTC announced through a series of cases a heightened definition of “competent and reliable scientific evidence” for disease and weight loss claims. Resulting from Nestle Healthcare Nutrition’s representations that its BOOST Kid Essentials drink strengthened kid’s immunity[76] and Iovate Health Sciences’ claims that its pills promoted weight loss and cold/flu prevention,[77] the FTC included the following substantiation requirement in consent orders with the companies:

[A]t least two adequate and well-controlled human clinical studies[78] of the covered product, or of an essentially equivalent product, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true.[79]

The FTC previously issued orders requiring two randomized, well-controlled clinical human studies (RCTs),[80] but the requirements of Nestle Healthcare Nutrition and Iovate Health Sciences foreshadowed a shift in FTC substantiation policy—demanding RCTs up front rather than tailoring substantiation requirements to “specific claim[s].”[81] Some practitioners posited that the FTC’s “addition” of this up-front standard suggested an intent to require FDA pre-approval for certain disease claims.[82]

Pomegranates and Publications

Following the consent orders with Nestle Healthcare Nutrition and Iovate Health Sciences, “the FTC filed an administrative complaint against POM Wonderful, LLC, alleging the company made deceptive efficacy claims about its pomegranate juice’s ability to treat “heart disease, prostate cancer, and erectile dysfunction.”[83] The complaint included a proposed order requiring POM Wonderful to obtain FDA pre-approval before making future claims that its products prevented or treated serious diseases.[84] POM Wonderful declined to settle on the FTC’s terms.

While the FTC’s administrative complaint alleged 43 of POM Wonderful’s advertisements violated sections 5 and 12 of the FTC Act, [85] the administrative law judge (ALJ) found only 19 of the ads were deceptive. The Commission agreed the 19 ads, plus additional ones, violated sections 5 and 12[86] and entered an order prohibiting POM Wonderful from making disease-related claims unless it had “competent and reliable scientific evidence that, when considered in light of the entire body of relevant and reliable scientific evidence, is sufficient to substantiate that the representation is true.”[87] The Commission defined “competent and reliable scientific evidence” as at least two RCTs.[88]

For health-related claims, the order required POM Wonderful to possess “competent and reliable scientific evidence sufficient in quality and quantity when considered in the light of the entire body of relevant and reliable scientific evidence.”[89] The order did not specify the number of RCTs needed to substantiate health-related claims.

Neither the ALJ nor the Commission believed it was necessary for POM Wonderful to obtain FDA pre-approval before making future disease-related claims about its products. In its opinion, the Commission explained that the two RCT requirement sufficiently prevented POM Wonderful from again advertising that its products “treated, prevented, or reduced the risk of a disease.” [90]

POM Wonderful appealed the Commission’s order to the D.C. Circuit Court of Appeals, arguing that requiring two RCTs exceeded what was necessary to prevent consumer confusion and violated the commercial speech doctrine of the First Amendment.[91] The appellate court agreed, but restricted its holding to POM Wonderful, acknowledging in the future that the FTC may justify an “across the board” two RCT requirement.[92]

The commercial speech doctrine of the First Amendment continues to play a part in health claim substantiation cases. In 2018, the FTC filed a complaint seeking a permanent injunction against NewMarket Health, LLC, a Maryland publishing company and subsidiary of Agora Publishing.[93] NewMarket Health published a newsletter—The Doctors’ Guide—that included various health claims about Type 2 diabetes and advertised a protocol for “eat[ing] away your diabetes.”[94]

The FTC alleged false efficacy and establishment claims in its complaint, and NewMarket Health argued it was not subject to health claim advertising restrictions because it did not sell “medical supplements, devices, or services” and did not sell a product that customers consumed for any “particular benefits.”[95] Instead, NewMarket Health contended it advertised a publication that merely included advice about reducing “the risks and symptoms associated with Type 2 diabetes.”[96] The court’s first question was whether the publication constituted commercial speech.

The U.S. Supreme Court defines “commercial speech,” which enjoys First Amendment protection, as “expression related solely to the economic interests of the speaker and its audience.”[97] This protection, however, does not include false advertising, and “[a]dvertisers [are not] permitted to immunize false or misleading product information from government regulation simply by including references to public issues.”[98]

The NewMarket court concluded the content of The Doctors’ Guide did not constitute commercial speech and was “outside of the FTC’s jurisdiction.”[99]  Because the company was not selling a health care product, the court had no reason to “apply the standard for health-related efficacy claims” or venture into the “fray” of expert witness testimony.[100] NewMarket Health was not off the hook, however, and instead of requiring the company to substantiate the health claims within The Doctors’ Guide, the court focused on NewMarket’s advertising for its publication. Referencing a 1948 U.S. Supreme Court decision involving the Postmaster General,[101] the court ruled the advertising included material misrepresentations, including, for example that the protocol in the guide “had nothing to do with dieting” and that they were likely to mislead consumers.[102] The guide, in fact, had an entire module that focused on dieting and the recommendation of a low-carb diet.[103]

Attorneys General in Action

When faced with deceptive health claims, state attorneys general use their respective consumer protection laws to stop them. Provisions in the Uniform Deceptive Trade Practices Act, which several states have enacted, include provisions that specifically apply to health claims, for example, those that prohibit sellers from (a) misrepresenting the benefits, qualities, or ingredients of their products,[104] (b) omitting material facts concerning their products,[105] and, of course, (c) failing to possess written substantiation of their advertised claims.[106]

Many state consumer protection laws specifically direct that the statute must be construed “uniformly with” or in a manner that gives “due consideration and great weight” to federal law, including FTC orders, regulations, guidance, and federal court interpretations of the Federal Trade Commission Act. [107] Certainly, the FTC’s well-developed advertising substantiation law and policy leaves little reason for regulators or courts to reinvent this area of the law.

For example, in State ex rel. Slatery v. HRC Med. Ctrs.,[108] the Tennessee Attorney General sued a corporation that operated approximately 50 bio-identical hormone replacement therapy centers throughout the state.[109] The attorney general alleged, under the Tennessee Consumer Protection Act, that the corporation falsely advertised its hormone replacement therapy would give patients the identical hormones they had in their twenties or thirties.[110] Citing the FTC Advertising Policy, the trial court found, and the court of appeals agreed, that the company’s statement was an express representation for which the corporation lacked any reasonable basis.[111]

In T-Up, Inc., v. Consumer Prot. Div.,[112] the Maryland Court of Appeals reviewed an administrative cease and desist order issued against a company that falsely advertised its products as treatments and cures for cancer, AIDS, and HIV. In a brochure entitled “Boost Your Immune System” and an audio tape entitled “There is Hope,” the company marketed a concentrated aloe vera extract called T-Up and cesium chloride.[113] The advertisements included wild claims about the products’ ability to destroy malignant cancer cells in 10 days with a 100% success rate.[114]

The Maryland Consumer Protection Division’s cease and desist order prohibited the company from misrepresenting the efficacy, performance, safety, or benefits of its products unless it possessed competent and reliable scientific evidence, specifically “at least two adequate, and well-controlled, double-blinded clinical studies.”[115] The appellate court discussed multiple cases where the FTC required two clinical studies to substantiate health claims concerning products taken internally and found the Consumer Protection Division’s order, given the company’s product formulations and disease-treatment claims, proper.[116]

Attorneys general working jointly with the FTC to stop deceptive health claims expands states’ enforcement reach and helps consistently develop substantiation-related case law. In 2010, the Florida Attorney General and the FTC filed a joint complaint against the Alcoholism Cure Corporation, which advertised a permanent cure for alcoholism.[117] The “Permanent Cure Program” included various supplements and herbs that, according to the company, acted as a blocker for alcohol cravings.[118]

The company made multiple false establishment and efficacy claims in its promotional materials. Establishment claims included statements that its cure was “scientifically proved to cure alcoholism” and developed by Harvard Medical School.[119] The corporation also advertised that the Permanent Cure Program cured alcoholism while allowing alcoholics to drink socially.[120]

The appellate court, based on a detailed review of the evidence and applicable FTC law, upheld the lower court’s award of summary judgment in favor of Florida and the FTC.[121] The court held that what constituted competent and reliable scientific evidence in the case was a question of fact for expert interpretation, and the court agreed with the government’s expert who testified that:

adequate scientific evidence providing the efficacy of intervention agents . . . for treating or curing alcohol dependence should, at minimum, consist of two or more studies that are double-blinded and placebo-controlled involving 150-1,000 human participants and lasting at least 12 weeks, with standard measures and data analysis, and follow-up three to six months later.[122]

Cases like HRC Med. Ctrs., T-Up, and Alcoholism Cure Corp. represent instances where state attorneys general have utilized well-developed FTC law to hold advertisers accountable for false health claims. These cases also involve products marketed as treatments or cures for serious and sometimes fatal diseases. Desperate circumstances create desperate consumers, which is why today’s most prominent and fast-moving health issue—COVID-19—demands state and federal vigilance.

 

Pills, Potions, and Pandemics

COVID-19[123] first presented itself in the United States on January 20, 2020.[124] Recent data from the New York Times shows 7.1 million total confirmed and probable COVID-19 cases in the United States since March 1, 2020, and over 204,330 deaths.[125] There is no known vaccine or preventative treatment for COVID-19.[126]

Faced with a highly contagious and potentially fatal disease, a frightened citizenry has become an inviting target for unscrupulous sellers pushing fake COVID-19 treatments and cures. On March 7, 2020, the FTC and FDA first sent warning letters to seven companies, including an Idaho company, about deceptive COVID-19 health claims on their websites, Facebook pages, and Instagram feeds.[127] The warning letters inform companies that they may not claim their products prevent, treat, or cure COVID-19 because they lack competent and reliable scientific evidence, emphasizing that no well-controlled human clinical study currently exists to show the companies’ products effectively treat COVID-19.[128]

A Nampa, Idaho, company advertised on its website and Facebook page that its “Coronavirus Protocol,” comprised of an herbal tea and tinctures, was exceptionally potent in preventing “acute infections” and even “work[ed] well” on SARS.[129]  The company claimed that Stephen Buhner, a prolific writer who promotes “herbal antibiotics,”[130] analyzed coronaviruses and found that certain herbs effectively interrupted the infection process and both prevented and treated coronaviruses.[131] The FTC and FDA sent a warning letter to the Idaho company on March 6, 2020, instructing it to immediately correct its advertising and inform the FTC and FDA via separate emails of the company’s remedial actions.[132] It appears the company complied, as the health claims outlined in the warning letter no longer appear on the company’s website.[133]

Multiple regulators took quick action against Jim Bakker and his television show for promoting “Silver Solution”—a colloidal silver product that had the potential to “eliminate,” “kill,” and “deactivate” strains of the coronavirus.[134] The show also advertised that the product had “been proven by the government to kill every pathogen it [was] tested on, including SARS and HIV.”[135] The New York Attorney General issued a cease and desist notice to Bakker on March 3, 2020.[136] Bakker then received a warning letter from the FTC and FDA on March 6, 2020.[137] Soon after, Bakker pulled his products from his website.[138] Actions for temporary restraining orders subsequently filed by the Missouri and Arkansas attorneys general remain pending.[139]

At the end of April, the FTC issued an administrative complaint and sued an online store that advertised its CBD/herb capsules as an anti-viral wellness booster.[140] Called “Thrive,” the capsules supposedly strengthened users’ “immunity against pathogens” and treated “ailments [like] the flu, colds, bronchial infections, fungal and yeast based issues, as well as the coronavirus.”[141] The complaint alleged, among other things, (a) false and unsubstantiated COVID-19 health claims (i.e., Thrive treats, prevents, or reduces the risk of COVID-19); and (b) false proof claims (i.e., Thrive is clinically or scientifically proven to treat, prevent, or reduce the risk of COVID-19).[142] The matter was resolved through an administrative settlement on July 10, 2020.[143]

More recently, the FTC filed a complaint against Golden Sunrise Nutraceutical, Inc., which, since 2016, has marketed dietary supplements for the treatment of serious diseases, including cancer.[144] In March 2020, the corporation began advertising a cure for COVID-19—a combination of common herbs and spices, including turmeric, cayenne, eucalyptus extract, goldenseal, and mistletoe.[145]

Before filing its complaint, the FTC sent a warning letter to the corporation, instructing it to stop falsely representing its product as a cure for COVID-19.[146] The corporation simply changed its COVID-19 references to “the virus” and continued to advertise its product as a medicinal cure despite having no reasonable basis for its claim.[147] The court granted a temporary restraining order, citing the FTC’s expert testimony that the corporation’s health claims required “validation from controlled, scientific trials establishing the product’s ability to treat, mitigate the symptoms of, or cure COVID-19.”[148]

Regulators have issued hundreds of warning letters to companies advertising fake cures and preventative treatments for the coronavirus. Some of these ineffective treatments include acupuncture, air purifiers, chiropractic treatment, horse milk, Kratom, music therapy, oral peroxide gel, sonic silicone face brushes, and toothpaste.[149]

Generally, upon receipt of warning letters, sellers remove references to COVID-19 from their advertising but may fail to address other questionable health claims. To protect consumers from any lingering deceptive health claims and stop the marketing of potentially dangerous products, regulators may want to review these sellers’ websites and social media feeds for additional unlawful statements. Attorneys who represent health product sellers, on the other hand, should consult with their clients about regulators’ heightened vigilance concerning unsubstantiated COVID-19 health claims.

In addition to sending warning letters and filing lawsuits, attorneys general have entered into settlements with companies selling fake COVID-19 treatments. For example, on June 26, 2020, the Oregon Attorney General announced assurances of voluntary compliance with six herbal remedy sellers falsely advertising that their products boosted immunity or treated COVID-19.[150] The assurances prohibit the companies from marketing their unproven cures using claims that the Oregon Attorney General noted were not “supported by competent and reliable scientific evidence.”[151]

 Moving Forward

We all want to believe in miracle fixes—that there really are pills, potions, and protocols that cure our illnesses, keep us young, and fix our everyday problems. It is the fantastical promises and the public’s eagerness to believe that helps sustain a bogus healthcare industry, injuring consumers and damaging the marketplace. While regulators cannot stop consumers from believing in and buying miracle cures, they can provide increased enforcement and consumer education.

COVID-19 will continue to occupy regulators’ attention and stretch their resources as new testing protocols and vaccine innovations ignite the imaginations of profiteers willing to risk consumers’ health for a fast buck. Stopping these and future deceptive health claims requires regulators’ constant vigilance and commitment. Over 100 years of well-developed substantiation law and policy, however, give regulators a solid foundation on which to move forward and better protect consumers, businesses, and the marketplace.

 

[1] The opinions expressed in this article reflect those of the author, not the Idaho Attorney General’s Office or the State of Idaho.

[2] William Goldman, The Princess Bride: S. Morgenstern’s Classic Tale of True Love & High Adventure Chap. 5 (Harcourt Brace Jovanovich 1973).

[3] Peter Hartlaub, Long Before the Coronavirus, SF Faced the 1918 Spanish Flu. It Was Horrifying, S.F. Chron., Mar. 6, 2020, https://www.sfchronicle.com/oursf/article/Long-before-coronavirus-SF-faced-the-1918-15109879.php (last visited Sept. 11, 2020).

[4] Rachel M. Williams, Dual Threat: The Spanish Influenza and World War I (2014) (unpublished Honors Thesis Project, U. of Tenn.) at 16, https://trace.tennessee.edu/utk_chanhonoproj/1742 (last visited Sept. 11, 2020).

[5]Kevin Simpson, Colorado’s Other Pandemic, Colorado Sun, Mar. 5, 2020, https://coloradosun.com/2020/03/05/colorado-influenza-pandemic-1918/ (last visited Sept. 11, 2020).

[6] Suyin Haynes, ‘You Must Wash Properly:’ Newspaper Ads from the 1918 Flu Pandemic Show Some Things Never Change, Time, Mar. 27, 2020, https://time.com/5810695/spanish-flu-pandemic-coronavirus-ads/ (last visited Sept. 11, 2020).

[7] Id.

[8] The 1918 influenza pandemic, caused by an H1N1 virus, spread worldwide, infecting 500 million people and killing 50 million. Centers for Disease Control, Influenza (Flu), 1918 Pandemic, https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html (last visited Sept. 11, 2020).

[9]See, e.g., Printers’ Ink, Oct. 1, 1902, at 26 https://babel.hathitrust.org/cgi/pt?id=nnc1.cu03993523&view=1up&seq=32 (last visited Sept. 26, 2020) (“The ideal advertisement may not tell the whole, cold truth, but what it does set forth must be accurate as far as it goes, or the purchaser, though persuaded to buy once, will not buy again. Don’t expect to reap good business from bad advertising.”)

[10] Zeynep Hansen & Marc Law, The Political Economy of “Truth-in-Advertising” Regulation During the Progressive Era, (Nat’l Bureau of Econ. Research, Working Paper No. 11927, 2006).

[11] Samuel Hopkins Adams, The Great American Fraud 23 (1905). Liquozone, for example, was a concoction of sulfuric acid, sulfurous acid, and, primarily, water, that Douglas Smith, a former piano dealer, advertised as “liquid oxygen.”  Smith used fake endorsements to support his claim that Liquozone treated or cured everything from asthma to tumors. A laboratory tested Liquozone on guinea pigs infected with anthrax, diphtheria, or tuberculosis and found the product had no curative effect. Rather, according to the laboratory, Liquozone appeared to lower the guinea pigs’ natural immunity, causing them to die faster than the animals that did not receive the treatment.

[12] Elizabeth Fee, M.D., Samuel Hopkins Adams (1871-1958): Journalist and Muckraker, 100 Amer. J. of Pub. Health 1390-91 (2010). This is not to suggest that the 1906 act was America’s first attempt to regulate food or drug purity. Massachusetts and Virginia enacted laws in the 17th Century requiring bakers to identify their bread with special markings, and the federal government passed legislation in 1813 concerning the purity of the smallpox vaccine. U.S. Food & Drug Admin., Milestones in U.S. Food and Drug Law History, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history (last visited Sept. 14, 2020).

[13] Establishment of the Food and Drug Administration dates back to President Lincoln’s 1862 appointment of a chemist “to head the Chemical Division of the new U.S. Department of Agriculture.” U.S. Food & Drug Admin., Background: Research Tools on FDA History, https://www.fda.gov/about-fda/research-tools-fda-history/background-research-tools-fda-historyy (last visited Sept. 14, 2020). In 1901, the Chemical Division became the Bureau of Chemistry and was charged with enforcing the 1906 Act. The Food, Drug, and Insecticide Administration, which was established in 1927, abbreviated its name in 1930 to the Food and Drug Administration (FDA).

[14] U.S. Food & Drug Admin., Part I: The 1906 Food and Drugs Act and its Enforcement, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-i-1906-food-and-drugs-act-and-its-enforcement (last visited Sept. 25, 2020).

[15] Hansen, et al., supra note 10, at 8.

[16] I.C.A. § 17-3915 (1915) (repealed by S.L. 1972, ch. 381, § 17, 1972).

[17] According to Printers’ Ink, of the 6,815 cases the local BBBs handled between May 1920 and May 1921, only 51 required prosecution. Hansen, et al., supra note 10 at 9.

[18] As a reference note, this article uses the acronym “FTC” when referencing (a) the Federal Trade Commission in general and (b) the Federal Trade Commission’s enforcement actions, including administrative and court actions. This article uses the term “the Commission” when referencing the FTC commissioners’ decisions in administrative enforcement actions.

[19] In Re Circle Cilk Co., 1 F.T.C. 13 (1916); In Re A. Theo Abbott & Co., 1 F.T.C. 16 (1916); In Re Golden Bros., 1 F.T.C. 538 (1916). These matters concerned the mislabeling of cotton as silk.

[20] Sears, Roebuck & Co. v. FTC, 258 F. 307, 311 (7th Cir. 1919).

[21] 253 U.S. 421 (1920).

[22] Ira M. Millstein, The Federal Trade Commission and False Advertising, 64 Colum. L. Rev. 439, 452 (1964).

[23] Id.

[24] FTC v. Raladam Co., 283 U.S. 643 (1931).

[25] Id. at 644-45.

[26] Id. at 646.

[27] Id.

[28] Id. at 653-54.

[29] Millstein, supra note 22, at 453. The FTC took a second run at Raladam in 1935. This time, the FTC established substantial evidence that Raladam’s false advertising violated the FTC Act’s prohibition against unfair methods of competition. FTC v. Raladam Co., 316 U.S. 149 (1942). The Supreme Court upheld the FTC’s cease and desist order and found the agency showed with “meticulous particularity” that Raladam used deceptive advertising to promote the sale of its product over its competitors. Id. at 151, 153. See also Electro Thermal Co. v. FTC, 91 F.2d 477, 480 (9th Cir. 1937), cert. denied, 302 U.S. 748 (1937) (upholding the FTC’s cease and desist order based on the FTC’s findings that Electro Thermal Co.’s deceptive advertising of its Thermalaid device gave the company an unfair advantage over competitors who marketed a similar product).

[30] See Pep Boys-Manny, Moe & Jack, Inc. v. FTC, 122 F.2d 158, 161 (3d Cir. 1941) (finding that Congress’s exclusion of any reference to “competition” in the law’s language showed “a legislative intent to remove the procedural requirement” established in Raladam and directing the FTC to focus “its attention on the direct protection of the consumer”).

[31] Pub. L. No. 75-447, 52 Stat. 111 (1938).

[32] 15 U.S.C.A. § 45(a)(1).

[33] 15 U.S.C.A. § 52.

[34] See Fresh Grown Preserve Corp. v. FTC, 125 F.2d 917, 919 (2d Cir. 1942) (explaining that the 1938 amendments “give the Commission greater control over the advertising of food, drugs, cosmetics and the like by providing for criminal action as well as injunction; and only in proceedings under such sections is the definition of false advertisement in Sec. 15 relevant, not in a proceeding like this under Sec. 5”).

[35] See e.g., Dr. W.B. Caldwell, Inc., v. FTC, 111 F.2d 889, 891 (7th Cir. 1940) (affirming a cease and desist order based on testimony from 10 doctors that petitioner’s constipation treatment—Dr. Caldwell’s Syrup Pepsin—had no therapeutic value); Charles of the Ritz Dist. Corp. v. FTC, 143 F.2d 676, 678-79 (2d Cir. 1944) (holding the FTC showed through medical expert testimony, which petitioners failed to rebut, that nothing known to medical science, including petitioner’s Rejuvenescence Cream, could restore consumers’ skin to the “petal-like quality and texture of youth” as petitioner advertised); Irwin v. FTC, 143 F.2d 316, 323-24 (8th Cir. 1944) (deferring to the knowledge and experience of the FTC’s physician experts that the Gordon Detoxifer, a rectal irrigator, was an unsafe and ineffective treatment for asthma, bad breath, ulcers, and dozens of other conditions, despite petitioner’s evidence that thousands of people benefitted from the device without “injurious consequences”); Erickson v. FTC, 272 F.2d 318 (7th Cir. 1959) (affirming the cease and desist order against Erickson Hair and Scalp Specialists, which claimed its preparations treated baldness, based on medical evidence and despite consumer satisfaction testimony).

[36] 15 U.S.C.A. § 45(c).

[37] 15 U.S.C.A. § 45(c). See Aronberg v. FTC, 132 F.2d 165, 170 (7th Cir. 1942) (affirming a cease and desist order based on the substantial evidence presented at the administrative hearing and noting the court’s “lack of authority to pass upon the credibility or weight of the evidence”).  

[38] Koch v. FTC, 206 F.2d 311, 314 (6th Cir. 1953).

[39] Id. at 315.

[40] Id.

[41] Id. at 319. In its findings of fact, the Commission noted its doubts as to the existence of certain conditions about which Koch Labs’ witnesses testified. Id. at 318.

[42] Id. at 315.

[43] Id. at 316.

[44] Id. at 318-19.

[45] Id. at 319.

[46] See, e.g., Erickson, 272 F.2d at 322 (customer testimonials); Dr. W.B. Caldwell, Inc., 111 F.2d at 891 (testing).

[47] Randal Shaheen & Amy Ralph Mudge, Has the FTC Changed the Game on Advertising Substantiation?, 25 Antitrust 65 (2010).

[48] In Re Pfizer, Inc., 81 F.T.C. 23 (1972).

[49] Id. at 24.

[50] Id. at 24-25.

[51] The hearing examiner dismissed both claims because the ingredients (benzocaine and menthol) used in Un-Burn “had been considered efficacious by [dermatologists for decades] and it was reasonable for [Pfizer] . . . to make claims based on such historical and clinical proof and to test only for safety.”  Id. at 54, 56

[52] Id. at 73.

[53] Id. at 63.

[54] Id. at 64.

[55] FTC Policy Statement Regarding Advertising Substantiation, appended to Thompson Medical Co., 104 F.T.C. 648, 839 (1984), aff’d, 791 F.2d 189 (D.C. Cir. 1986), cert. denied, 479 U.S. 1086 (1987) (hereinafter cited as “FTC Advertising Policy”). The FTC Advertising Policy is available on the FTC’s website at https://www.ftc.gov/public-statements/1984/11/ftc-policy-statement-regarding-advertising-substantiation (last visited Sept. 26, 2020).

[56] Bristol-Myers Co. v. FTC, 738 F.2d 554 (2d Cir. 1984).

[57] Thompson Medical Company v. FTC, 791 F.2d 189, 194 (1986).

[58] FTC Advertising Policy, supra note 55.

[59] Anne W. Maher & Lesley Fair, The FTC’s Regulation of Advertising, 65 Food & Drug L.J. 589, 607 (2010).

[60] Shaheen, et al., supra note 47 at 66.

[61] FTC Enforcement Policy Statement on Food Advertising (May 13, 1994), https://www.ftc.gov/public-statements/1994/05/enforcement-policy-statement-food-advertising (last visited Sept. 16, 2020).

[62] Bureau of Consumer Prot., Fed. Trade Comm’n, Dietary Supplements: An Advertising Guide for Industry (Apr. 2001), https://www.ftc.gov/system/files/documents/plain-language/bus09-dietary-supplements-advertising-guide-industry.pdf  [hereinafter FTC Supplements Guide].

[63] Id.

[64] Id. The FTC’s Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs (“OTC Homeopathic Drugs Policy”) joined the FTC’s previous health-related advertising policies in 2016. The policy allows unsubstantiated claims for OTC homeopathic drugs that treat self-resolving conditions if the advertisement informs consumers that: (1) “no scientific evidence” supports the product’s efficacy; and (2) “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” Marketers of OTC homeopathic drugs that make “health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms,” must provide competent and reliable scientific evidence to substantiate their claims. The OTC Homeopathic Drugs Policy is available on the FTC’s website at https://www.ftc.gov/system/files/documents/public_statements/996984/p114505_otc_homeopathic_drug_enforcement_policy_statement.pdf (last downloaded Sept. 16, 2020).

[65] FTC Supplements Guide, supra note 62.

[66] Id.

[67] Id.

[68] A “traditional use” claim is a claim based on an ingredient’s or product’s historical use for a particular purpose. Id.

[69] Id.

[70] Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-418, 108 Stat. 4325. The DSHEA disclaimer reads: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

[71] FTC Advertising Policy, supra note 55.

[72] Eric Berman, FTC Orders in Health-Related Advertising Cases: From a New Approach to the New Normal, 29 Antitrust 98, 98-99 (2015).

[73] See, e.g., In Re Nutramax Laboratories, Inc., 138 F.T.C. 380 (2004) (consent order requiring seller of dietary supplement to possess competent and reliable scientific evidence to substantiate claims about product’s ability to restore memory function or prevent memory loss).

[74] See, e.g., In Re Venegas, Inc., 125 F.T.C. 266 (1998) (consent order prohibiting seller of nutritional supplement from claiming the product treats or cures numerous illnesses or diseases unless seller has competent and reliable scientific evidence to support such claims).

[75] See, e.g., In Re Nutrition 21, 124 F.T.C. 1 (1997) (consent order prohibiting seller of chromium picolinate from advertising the supplement allows people to lose fat, but keep muscle and look leaner and firmer unless seller has competent and reliable scientific evidence).

[76] Complaint at 2-6, In Re Nestle Healthcare Nutrition, Inc., No. C-4312, 2010 WL 2811203 (F.T.C. Jan. 11, 2011).

[77] Complaint at 4, FTC v. Iovate Health Sciences USA, No. 10-CV-587 (W.D.N.Y. Jul. 14, 2010).

[78] The consent orders require adequate and well-controlled human clinical studies that are “randomized and, unless it can be demonstrated that blinding or placebo control cannot be effectively or ethically implemented given the nature of the intervention, . . . be double blind and placebo controlled.” Agreement Containing Consent Order at 2, In Re Nestle Healthcare Nutrition, Inc., No. 092-3087, 2010 WL 2811203 (F.T.C. May 18, 2010). The Iovate Health Sciences settlement does not include any exceptions to the double-blind, placebo-controlled requirement. Stipulated Final Judgment and Order for Permanent Injunction and Other Equitable Relief at 4, FTC v. Iovate Health Sciences USA, No. 10-CV-587 (W.D.N.Y. Jul. 29, 2010).

[79] Agreement Containing Consent Order at 4, In Re Nestle Healthcare Nutrition, Inc., No. 092-3087, 2010 WL 2811203 (F.T.C. May 18, 2010). The same provision with capitalization modifications appears in the Iovate Health Sciences settlement. Stipulated Final Judgment and Order for Permanent Injunction and Other Equitable Relief at 7, FTC v. Iovate Health Sciences USA, No. 10-CV-587 (W.D.N.Y. Jul. 29, 2010).

[80] See generally cases involving substantiation of comparative efficacy claims for OTC analgesics, including In Re Thompson Med. Co., 104 F.T.C. 648 (1984) and In Re American Home Prods. Corp., 98 F.T.C. 136 (1981).

[81] Ryan McCarthy, Did the FTC Actually Lose POM Wonderful? Health Claims, Prior Substantiation, and the First Amendment, 35 Rev. Litig. 353, 360-61 (2016).

[82] Shaheen, et al., supra note 47 at 67. The authors, antitrust and consumer protection attorneys, hypothesized that the orders in Nestle Healthcare Nutrition and Iovate Health Sciences demonstrated the FTC’s belief that “certain disease prevention claims relating to cold and flu, hay fever, and allergies may only be made if they are approved by the FDA.” Indicating the FTC conferred with the FDA about this new requirement, the authors cite to a 2009 advertising webinar where an FTC representative discussed the FTC’s intent to include “new injunctive language in future orders” to better define “competent and reliable scientific evidence” and “better harmonize with [FDA] laws and regulations.” Mary K. Engle, Assoc. Dir. for Adver. Practices, FTC, Remarks Before False Adver. Disputes Roundtable Webinar, The FTC’s Priorities (Oct. 22, 2009). The presentation is on file with the author.

[83] Berman, supra note 72 at 99.

[84] Id.

[85] POM Wonderful, LLC v. FTC, 777 F.3d 478, 488 (D.C. Cir. 2015).

[86] Id. at 489.

[87] In Re POM Wonderful, LLC, 155 F.T.C. 1, 192 (Jan. 10, 2013).

[88] Id.

[89] Id. at 193.

[90] Id. at 192.

[91] POM Wonderful, LLC, 777 F.3d at 500.

[92] Id. at 505.

[93] FTC v. Agora Financial, LLC, 447 F.Supp.3d 350 (D. Md. 2020).

[94] Id. at 356.

[95] Id. at 360.

[96] Id. at 361. In granting the FTC’s motion for preliminary injunction, the court noted the FTC was unable to identify another case where a court “applied the health-related efficacy standard in such” circumstances.

[97] Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n, 447 U.S. 557, 561 (1980).

[98] Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60, 69 (1983).

[99] Agora Financial, LLC, 447 F.Supp.3d at 364.

[100] Id.

[101] In Donaldson v. Read Magazine, 333 U.S. 178, 188 (1948), the Supreme Court noted, “[a]dvertisements as a whole may be completely misleading although every sentence separately considered is literally true.”

[102] Agora Financial, LLC, 447 F.Supp.3d at 366.

[103] Id.

[104] See, e.g., Idaho Code § 48-603(5) (2020).

[105] See, e.g., Idaho Admin. Code 04.02.01.30 (2019).

[106] See, e.g., Idaho Admin. Code 04.02.01.31 (2019).

[107] See Lovett, Louisiana Civil Code of 1808: State Deceptive Trade Practice Legislation, 46 Tul. L. Rev. 724, 733-34 (1972). See also ORC Ann. 1345.02 (C) (“In construing division (A) [unfairness and deception prohibition] of this section, the court shall give due consideration and great weight to federal trade commission orders, trade regulation rules and guides, and the federal courts’ interpretations of subsection 45 (a)(1) of the ‘Federal Trade Commission Act,’ ….”), Idaho Code § 48-618 (2020) (This act is to be construed uniformly with federal law and regulations.)

[108] 603 S.W.3d 1 (Tenn. Ct. App. 2019).

[109] Id. at 7.

[110] Id. at 18.

[111] Id. at 23, 27.

[112] 801 A.2d 173 (Md. Ct. App. 2002).

[113] Id. at 180.

[114] Id. at 181.

[115] Id. at 184-85.

[116] Id. at 185-86.

[117] FTC v. Alcoholism Cure Corp., 2011 WL 13137951 (M.D. Fl. Sept. 16, 2011).

[118] Id. at *2-3.

[119] Id. at *41.

[120] Id. at *33.

[121] Id. at *58.

[122] Id. at *38 (internal quotations omitted).

[123] A coronavirus called SARS-CoV-2 causes COVID-19. Like MERS-CoV and SARS-CoV, SARS-CoV-2 is an animal coronavirus that spreads to humans. The World Health Organization officially named the disease on February 11, 2020, which initially was identified in Wuhan, China. The abbreviation “COVID-19” stands for: corona (CO); VI (virus); D (disease); and 2019 (year of appearance). U.S. Centers for Disease Control and Prevention, Coronavirus Disease 2019, https://www.cdc.gov/coronavirus/2019-ncov/faq.html (last visited Sept. 1, 2020).

[124] Tamin J. Harcourt, et al., Emerging Infectious Diseases, Severe Acute Respiratory Syndrome Coronavirus 2 from Patient Coronavirus Disease, United States, 26 Emerg. Infect. Dis. 1266 (May 18, 2020), https://wwwnc.cdc.gov/eid/article/26/6/20-0516_article (last visited Sept. 1, 2020).

[125]Covid in the U.S.: Latest Map and Case Count, N.Y. Times, https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html (last visited Sept. 27, 2020).

[126] World Health Org., Coronavirus Disease (COVID-19) Advice for the Public: Mythbusters, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters (last visited Sept. 26, 2020).

[127] The FTC’s COVID-19 website is available at https://www.ftc.gov/coronavirus. Its consumer protection enforcement activities, including a link to its warning letters, are collected at https://www.ftc.gov/coronavirus/enforcement (last visited Sept. 26, 2020).

[128] For example, GuruNanda, LLC, a Buena Park, California, company advertised on its website and social media sites that its essential oils prevented the COVID-19 virus. Warning Letter from Federal Trade Comm’n & U.S. Food & Drug Admin. to GuruNanda, LLC (Mar. 6, 2020), https://www.ftc.gov/system/files/warning-letters/fda-covid-19-letter-gurunanda.pdf (last downloaded Sept. 27, 2020).

[129] Warning Letter from Federal Trade Comm’n & U.S. Food & Drug Admin. to Amy Weidner, Herbal Amy, Inc. (Mar. 6, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter-to-herbal-amy.pdf (last downloaded Sept. 11, 2020).

[130] Buhner has written several articles about herbal protocols for treating COVID-19. Stephen H. Buhner, Articles, Stephen Harrod Buhner, https://www.stephenharrodbuhner.com/  (last visited Sept. 29, 2020).

[131] Warning Letter from Federal Trade Comm’n & U.S. Food & Drug Admin. to Amy Weidner, Herbal Amy, Inc. (Mar. 6, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter-to-herbal-amy.pdf (last downloaded Sept. 11, 2020).

[132] Id.

[133] Clicking on the link identified in the warning letter (www.herbalamy.com/product-page/corona-virus-protocol) brings up Herbal Amy’s website with the following statement: “This product couldn’t be found.” While the company no longer offers Buhner’s herbal tinctures, it continues to sell the ingredients for the tinctures and advertises the ingredients as “herbal antivirals” that maintain “a healthy immune system.” Herbal Amy, LLC, Buhner Herbs, http://www.herbalamy.com/buhner-antivirals (last visited Sept. 26, 2020).

[134] Matthew S. Swartz, Missouri Sues Televangelist Jim Bakker for Selling Fake Coronavirus Cure, NPR, Mar. 11, 2020, https://www.npr.org/2020/03/11/814550474/missouri-sues-televangelist-jim-bakker-for-selling-fake-coronavirus-cure (last visited Sept. 26, 2020).

[135] Id.

[136] Cease and Desist Notification from New York Attorney General’s Office to James Orsen Bakker (Mar. 3, 2020), https://ag.ny.gov/sites/default/files/bakker_cease_and_desist_letter_notification.pdf (last downloaded Sept. 26, 2020).

[137] Warning Letter from Federal Trade Comm’n & U.S. Food & Drug Admin. to Jim Bakker Show (Mar. 6, 2020), https://www.ftc.gov/system/files/warning-letters/fda-covid-19-letter-jim-bakker.pdf (last downloaded Sept. 11, 2020).

[138] Swartz, supra note 134.

[139] Application for Temporary Restraining Order, Missouri v. Jim Bakker, No. 20SN-CC00084 (Mo. Cir. Ct., Stone County Mar. 10, 2020); Complaint, Arkansas v. Morningside Church Productions, Inc., et al., No. 60CV-20-3460 (Ark. Cir. Ct. Jun. 16, 2020).

[140] In Re Marc Ching, No. 9394 (F.T.C. Apr. 22, 2020); FTC v. Marc Ching, 2020 WL 2079985 (C.D. Cal. Apr. 29, 2020). All documents related to this matter are available on the FTC’s website at https://www.ftc.gov/enforcement/cases-proceedings/202-3110/marc-ching-matter (last visited Sept. 27, 2020).

[141] Id. at *1.

[142] Id.

[143] Agreement Containing Consent Order, In Re Marc Ching, No. 9394 (F.T.C. Jul. 31, 2020).

[144] FTC v. Golden Sunrise Nutraceutical, Inc., 2020 WL 4501968 at *1-2 (E.D. Cal. Aug. 5, 2020).

[145] Id. at *2.

[146] Id.

[147] Id. at *5.

[148] Id. at *6.

[149] See, e.g., Air Purifiers: Demand Letter from Arizona Attorney General to IONAER International Arizona, LLC (Jun. 25, 2020, https://www.azag.gov/sites/default/files/docs/press-releases/2020/letters/2020_06_25_CLEAN_AIR_EXP_WARNING_LETTER.pdf (last downloaded Sept. 27, 2020); Acupuncture: Warning Letter from Federal Trade Comm’n to Art of Wellness Acupuncture & Traditional Chinese Medicine (May 13, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_art_of_wellness_acupuncture_traditional_chinese_medicine.pdf (last downloaded Sept. 26, 2020); Chiropractic Treatment: Warning Letter from Federal Trade Comm’n to Fuller Life Chiropractic (Apr. 23, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_dap_fuller_life_chiropractic.pdf (last downloaded Sept. 26, 2020); Horse Milk: Warning Letter from Federal Trade Comm’n to OrganyLife (May 11, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_organylife.pdf (last downloaded Sept. 26, 2020); Kratom: People typically chew, smoke, or brew the leaves from the Southeast Asian Kratom tree to activate the leaves’ psychotropic compounds. Nat’l Institute on Drug Abuse, Kratom DrugFacts, https://www.drugabuse.gov/publications/drugfacts/kratom (last visited Sept. 26, 2020). Warning Letter from Federal Trade Comm’n to Ethos Natural Medicine, LLC (Apr. 15, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_ethos-natural-medicine.pdf (last downloaded Sept. 26, 2020); Music Therapy: Warning Letter from Federal Trade Comm’n to Musical Medicine (Apr. 20, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_dap_musical_medicine.pdf (last downloaded Sept. 26, 2020); Oral Peroxide Gel: Warning Letter from Federal Trade Comm’n to San Francisco Dental Wellness (Jun. 3, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_san_francisco_dental_wellness.pdf (last downloaded Sept. 26, 2020); Sonic Silicone Face Brushes: Warning Letter from Federal Trade Comm’n to Face Vital, LLC (Apr. 8, 2020), https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_nwrofacevital.pdf (last downloaded Sept. 26, 2020); Toothpaste: Cease and Desist Notification from New York Attorney General to Alex Jones (Mar. 12, 2020), https://ag.ny.gov/sites/default/files/jones_cease_and_desist_3.12.2020.pdf (last downloaded Sept. 27, 2020).

[150] Oregon Dept. of Justice, AG Rosenblum Settles with Six Companies and Medical Clinics Selling Unproven Covid-19 Treatments, https://www.doj.state.or.us/media-home/news-media-releases/ag-rosenblum-settles-with-six-companies-and-medical-clinics-selling-unproven-covid-19-treatments/ (last visited Sept. 27, 2020).

[151] Id. Another example is the Michigan Attorney General’s assurance of voluntary compliance with two companies that advertised a $49.99 “Coronavirus Defender” patch to “protect people from the coronavirus disease 2019.” The Attorney General alleged the companies misrepresented the “sponsorship, approval, characteristics, ingredients, uses, benefits or quantities” of their goods or services. Department of Attorney General, Businesses Agree to Stop Selling Fake “Coronavirus Defender” Patch (April 15, 2020), https://www.michigan.gov/ag/0,4534,7-359-92297_92299-525938–,00.html (last visited Sept. 27, 2020).

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