Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 1 of 28 PageID #: 1
`
`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF NEW YORK
`
`COMPLAINT FOR CIVIL
`PENALTIES, PERMANENT
`INJUNCTION, MONETARY
`RELIEF, AND OTHER RELIEF
`
`Civil Action No.:
`
`22-CV-1159
`
`UNITED STATES OF AMERICA
`
`Plaintiff,
`
`v.
`
`B4B EARTH TEA LLC, a limited liability
`company;
`
`B4B CORP., a corporation; and
`
`ANDREW MARTIN SINCLAIR, individually
`and as an officer of B4B EARTH TEA LLC and
`B4B CORP.,
`
`Defendants.
`
`Plaintiff, the United States of America, acting upon notification and authorization to the
`
`Attorney General by the Federal Trade Commission (“FTC”), pursuant to Section 16(a)(1) of the
`
`Federal Trade Commission Act (“FTC Act”), 15 U.S.C. § 56(a)(1), and on behalf of the United
`
`States Food and Drug Administration (“FDA”), alleges:
`
`NATURE OF THE CASE
`
`1.
`
`The United States brings this action for permanent injunctive relief, civil
`
`penalties, and other remedies pursuant to the FTC Act, 15 U.S.C. § 45(a), § 45(m)(1)(A), § 52,
`
`and § 57a(a)(1)(B), the COVID-19 Consumer Protection Act, Pub. L. No. 116-260, Title XIV,
`
`§ 1401(b)(1), and the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 331(d),
`
`against B4B Earth Tea LLC, B4B Corp., and Andrew Martin Sinclair (“Defendants”). The
`
`1
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 2 of 28 PageID #: 2
`
`Defendants manufacture and sell an herbal tea product called B4B Earth Tea Extra Strength
`
`(“Earth Tea”). Defendants sell Earth Tea for $60 per 16-ounce bottle. Defendants have been
`
`advertising Earth Tea on social media and the internet as a product capable of preventing and
`
`treating the Coronavirus Disease 2019 (“COVID-19”), even claiming that it is more effective
`
`than the available COVID-19 vaccines. Defendants lack competent and reliable scientific bases
`
`for these claims, and their use of deceptive advertising and misinformation, exploiting fears in
`
`the midst of a pandemic to sell their product to concerned consumers, poses a significant risk to
`
`public health and safety.
`
`2.
`
`The Federal Trade Commission (“FTC”) has repeatedly warned Defendants that
`
`their deceptive advertising and misrepresentations violate the FTC Act and the COVID-19
`
`Consumer Protection Act. The U.S. Food and Drug Administration (“FDA”) has similarly
`
`warned Defendants that as currently marketed, Earth Tea is an unapproved new drug, and its
`
`sale into interstate commerce a violation of the FDCA, 21 U.S.C. § 331(d). Despite these
`
`warnings, Defendants continue to make deceptive and misleading statements about the ability of
`
`Earth Tea to prevent and treat COVID-19. The United States therefore brings this suit seeking
`
`permanent injunctive relief, civil penalties, and other remedies in order to prevent the harms
`
`caused by Defendants’ ongoing misrepresentations.
`
`JURISDICTION AND VENUE
`
`3.
`
`This Court has subject matter jurisdiction over this action pursuant to (1) 28
`
`U.S.C. § 1331, because it arises under the law of the United States; (2) 28 U.S.C. § 1337(a),
`
`because it arises under an Act of Congress regulating interstate commerce or protecting trade
`
`and commerce against restraints and monopolies; (3) 28 U.S.C. § 1345, because the United
`
`States is the Plaintiff; (4) 28 U.S.C. §1355, because the United States seeks a civil penalty; and
`2
`
`
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 3 of 28 PageID #: 3
`
`(5) 21 U.S.C. 332(a) for violations of Section 331 of the FDCA.
`
`4.
`
`At all times relevant to this Complaint, Defendants have maintained a substantial
`
`course of trade in or affecting commerce, as “commerce” is defined in Section 4 of the FTC Act,
`
`15 U.S.C. § 44.
`
`5.
`
`The Court has personal jurisdiction over the defendants because the majority of
`
`Defendants reside in this district and because the alleged acts giving rise to the claims occurred
`
`in this District.
`
`6.
`
`Venue is proper in this District under 28 U.S.C. § 1391(b) and (c), and 15
`
`U.S.C. § 53(b), because the majority of Defendants reside in this District and because a
`
`substantial part of the events or omissions giving rise to the claims occurred in this District.
`
`
`
`7.
`
`8.
`
`PARTIES
`
`Plaintiff is the United States of America.
`
`Defendant B4B Earth Tea LLC is a New York limited liability company with its
`
`principal place of business at 40 Remsen Ave., Brooklyn, New York 11212. B4B Earth Tea
`
`LLC transacts or has transacted business in this District and throughout the United States. At all
`
`times relevant to this Complaint, acting alone or in concert with others, Defendant B4B Earth
`
`Tea LLC has manufactured, advertised, marketed, distributed, or sold Earth Tea, an herbal tea
`
`containing water, honey, aloe vera, and herbs, to consumers throughout the United States.
`
`9.
`
`Defendant B4B Corp. is a Michigan corporation with the address of the
`
`incorporator listed at 19179 Ilene St., Detroit, Michigan 28221. On information and belief, B4B
`
`Corp. conducts business at 40 Remsen Ave., Brooklyn, New York 11212, and transacts or has
`
`transacted business in this District and throughout the United States. At all times relevant to this
`3
`
`
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 4 of 28 PageID #: 4
`
`Complaint, acting alone or in concert with others, B4B Corp. has manufactured, advertised,
`
`marketed, distributed, or sold Earth Tea, an herbal tea containing water, honey, aloe vera, and
`
`herbs, to consumers throughout the United States.
`
`10. Defendant Andrew Martin Sinclair, who also calls himself “Busta Sinclair,” is the
`
`sole individual identified as founder, owner, agent, or principal officer of B4B Earth Tea LLC
`
`and B4B Corp. (jointly, “Corporate Defendants”). At all times relevant to this Complaint, acting
`
`alone or in concert with others, Defendant Sinclair has formulated, directed, controlled, had the
`
`authority to control, or participated in the acts and practices of the Corporate Defendants,
`
`including the acts and practices set forth in this Complaint. Defendant Sinclair is actively
`
`involved in Corporate Defendants’ business affairs. He created and manufactures Earth Tea and
`
`participates in promotions for Earth Tea through, among other things, posts on Facebook,
`
`TikTok, Twitter, Instagram, and YouTube accounts; personal appearances in videos posted on
`
`TikTok, Twitter, and YouTube; broadcasts on Instagram; and email communications with
`
`consumers who order Earth Tea. He has made representations in these online videos and social
`
`media posts about the purported efficacy of Earth Tea to prevent, mitigate, treat, or cure
`
`COVID-19. He also responded directly to a February 18, 2021 joint warning letter from the
`
`FTC and FDA to B4B Corp. about false or unsubstantiated advertising claims about Earth Tea
`
`and to subsequent communications from FTC staff. Defendant Sinclair resides in this District
`
`and, in connection with the matters alleged herein, transacts or has transacted business in this
`
`District and throughout the United States.
`
`THE FTC ACT
`
`11.
`
`Section 5(a) of the FTC Act, 15 U.S.C. § 45(a), prohibits “unfair or deceptive acts
`
`
`
`4
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 5 of 28 PageID #: 5
`
`or practices in or affecting commerce.”
`
`12. Misrepresentations or deceptive omissions of material fact constitute deceptive
`
`acts or practices prohibited by Section 5(a) of the FTC Act.
`
`13.
`
`Section 12 of the FTC Act, 15 U.S.C. § 52, prohibits the dissemination of any
`
`false advertisement in or affecting commerce for the purpose of inducing, or which is likely to
`
`induce, the purchase of food, drugs, devices, services, or cosmetics. For the purposes of Section
`
`12 of the FTC Act, 15 U.S.C. § 52, Earth Tea is a “drug” as defined in Section 15(c) of the FTC
`
`Act, 15 U.S.C. § 55(c).
`
`THE COVID-19 CONSUMER PROTECTION ACT
`
`14.
`
`On January 31, 2020, the Secretary of Health and Human Services declared that
`
`COVID-19 had caused a public health emergency. As of the date of the filing of this complaint,
`
`the public health emergency remains in effect.
`
`15.
`
`The COVID-19 Consumer Protection Act, signed into law on December 27, 2020,
`
`makes it unlawful, for the duration of the ongoing novel coronavirus (COVID-19) public health
`
`emergency, for any person, partnership, or corporation to engage in a deceptive act or practice in
`
`or affecting commerce in violation of Section 5(a) of the FTC Act, 15 U.S.C. § 45(a), that is
`
`associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19. COVID-
`
`19 Consumer Protection Act of the 2021 Consolidated Appropriations Act, Pub. L. No. 116-260,
`
`Title XIV, § 1401(b)(1).
`
`16.
`
`A violation of Section (b)(1) of the COVID-19 Consumer Protection Act is
`
`treated as a violation of a rule defining an unfair or deceptive act or practice proscribed under
`
`section 18(a)(1)(B) of the FTC Act, 15 U.S.C. § 57a(a)(1)(B). COVID-19 Act, § 1401(c)(1).
`
`
`
`5
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 6 of 28 PageID #: 6
`
`17.
`
`A violation of Section (b)(1) of the COVID-19 Consumer Protection Act made
`
`with the knowledge required by Section 5(m)(1)(A) of the FTC Act, 15 U.S.C. § 45(m)(1)(A), is
`
`subject to monetary civil penalties of not more than $46,517 for each violation of the COVID-19
`
`Consumer Protection Act after January 13, 2021, including penalties whose associated violation
`
`predated January 13, 2021. See 15 U.S.C. § 45(m)(1)(A), as modified by Section 4 of the Federal
`
`Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. § 2461, the Federal Civil Penalties
`
`Inflation Adjustment Act Improvements Act of 2015, Public Law 114-74, sec. 701, 129 Stat. 599
`
`(2015); see also 16 C.F.R. § 1.98(d).
`
`THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
`
`18.
`
`A product is a drug within the meaning of the FDCA if, among other things, it is
`
`“intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.”
`
`21 U.S.C. § 321(g)(1)(B).
`
`19.
`
`The intended use of a product “refer[s] to the objective intent of the persons
`
`legally responsible for the labeling of drugs” and may be determined from any relevant source,
`
`including the circumstances surrounding the distribution of the article, product labeling,
`
`advertising, promotional material, or oral or written statements by such persons or their
`
`representatives. See 21 C.F.R. § 201.128.
`
`20.
`
`The FDCA defines labeling as “all labels and other written, printed, or graphic
`
`matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such
`
`article.” 21 U.S.C. § 321(m). The term “accompanying” in the second clause of 21 U.S.C. §
`
`321(m) is not restricted to labels that are on or in the article at issue; physical attachment to the
`
`article is not necessary. See Kordel v. United States, 335 U.S. 345, 349-50 (1948). It is the
`
`
`
`6
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 7 of 28 PageID #: 7
`
`textual relationship and integrated nature of the transaction that is significant. See id. at 350.
`
`21.
`
`A “new drug” is defined as any drug “the composition of which is such that such
`
`drug is not generally recognized, among experts qualified by scientific training and experience to
`
`evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions
`
`prescribed, recommended, or suggested in the labeling thereof. . . . ; or any drug . . . the
`
`composition of which is such that such drug, as a result of investigations to determine its safety
`
`and effectiveness for use under such conditions, has become so recognized, but which has not,
`
`otherwise than in such investigations, been used to a material extent or for a material time under
`
`such conditions.” 21 U.S.C. § 321(p).
`
`22.
`
`The FDCA prohibits doing or causing the introduction or delivery for introduction
`
`into interstate commerce of any new drug unless FDA has approved a new drug application
`
`(“NDA”) or an abbreviated new drug application (“ANDA”) with respect to such drug, or such
`
`drug is exempt from approval because, for example, it is the subject of an approved
`
`investigational new drug application (“IND”). 21 U.S.C. §§ 331(d) and 355(a), (b), (i), and (j). It
`
`is a violation of the Act to introduce or deliver, or cause to be introduced or delivered, into
`
`interstate commerce a new drug that is neither approved nor exempt from approval. 21 U.S.C. §
`
`331(d).
`
`DEFENDANTS’ UNLAWFUL CONDUCT
`
`Defendants Deceptively Advertise Earth Tea as a Drug That Prevents or Treats
`COVID-19
`
`I.
`
`
`
`23.
`
`Defendants are the sole manufacturers of Earth Tea. Defendants sell Earth Tea for
`
`$60 per 16-ounce bottle, and consumers can purchase Earth Tea through the Corporate
`
`Defendants’ website, b4bearthteallc.com (formerly b4bcorp.com).
`7
`
`
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 8 of 28 PageID #: 8
`
`24.
`
`Since at least April 2020, Defendants have advertised Earth Tea to prevent,
`
`mitigate, treat, or cure COVID-19. Defendants advertise, label, or promote Earth Tea on the
`
`Internet, including on the website b4bearthteallc.com (formerly b4bcorp.com), and through
`
`social media posts and videos, including on Facebook, Instagram, Twitter, TikTok, and
`
`YouTube.
`
`25.
`
`Through the websites b4bearthteallc.com and b4bcorp.com, and postings on
`
`TikTok, Twitter, Instagram, and YouTube, Defendants disseminated or caused to be
`
`disseminated advertisements for Earth Tea, including but not necessarily limited to the following
`
`statements and depictions.
`
`
`
`A. Claims that Earth Tea Prevents or Treats COVID-19
`
`26.
`
`Defendants have posted on social media multiple claims that Earth Tea prevents
`
`or treats COVID-19, as illustrated by the following screenshots:
`
`Twitter b4bcorpusa Aug. 4, 2020 (captured 01.28.2021)
`
`“Covid 19 Stopper Movement
`EARTH TEA PROVEN
`NATURAL TREATMENT FOR
`COVID-19.. BY B4B CORP
`WORK IN MINUTES GET U
`FEELING NORMAL WITHIN
`24HRS.. EARTHTEA.US
`#COVID19 #CORONAVIRUS”
`
`“EARTH TEA PROVEN
`TREATMENT FOR COVID-19
`WORKS WITHIN MINUTES
`GET OUT OF QUARANTINE
`WITHIN 24HRS
`GUARANTEED
`EARTHTEA.US”
`
`
`
`8
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 9 of 28 PageID #: 9
`
`
`
`Twitter b4bcorpusa Oct. 9, 2020 (captured 1.28.21)
`
`
`“Covid 19 Stopper Movement
`To this day.. Earth Tea is the
`most effective Treatment
`against#COVID19 as
`Treatment and Prevention..All
`NaturAl..#TRYEARTHTEA
`Get well in 28-48 Hours..72
`Hours MAX..”
`
`[Embedded TikTok Video
`narrated by Defendant Sinclair
`demonstrating how to consume
`Earth Tea to “get rid of Covid-
`19.” Video superscript appears
`through duration of video “One
`Bottle is all it Takes! Earth Tea
`Covid-19 Stopper”]
`
`
`
`Facebook HGmotorcorp with TikTok Video (captured 9.16.21)
`
`
`
`
`9
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 10 of 28 PageID #: 10
`
`YouTube Earthtea.US Feb. 8, 2021 (captured 10.18.21)
`
`
`[Defendant Sinclair discusses how he
`was cured of Covid-19, and how 48
`consumers who tried Earth Tea were
`cured.]
`“[W]e’re up to 48 out of 48. That’s 48
`people who called and said they have
`symptoms or they tested positive and
`they tried Earth Tea…. They get a bottle.
`Drink half cold and then half hot before
`they go to bed, wake up the next
`morning, the symptoms gone.”
`“I understand the skepticism…. But I’ll
`say you don’t have to die, you don’t
`have to suffer…. You get this tea, you
`drink it, you go to sleep and wake up
`tomorrow…you’re good to go.”
`
`[Defendant Sinclair appears in
`and narrates “COVID19
`CHALLENGE” demonstrating
`how to consume Earth Tea to get
`rid of Covid-19.]
`“Pour half the bottle in a cup cold
`and then you drink the other half
`hot before you go to sleep, all
`right? Simple…. And then guess
`what? COVID-19, gone.”
`
`
`
`
`TikTok B4BEarthtea Aug. 28, 2021 (captured 10.13.21)
`
`
`
`
`
`
`10
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 11 of 28 PageID #: 11
`
`Facebook b4bcorpUSA Sep. 3, 2021 (captured 10.20.21)
`
`
`“Vax or Not Grab 2 bottles keep
`it in your freezer in case
`Covid19hits. Frozen will last for
`1 year. DON’T DIE FROM
`COVID19. Protect yourself and
`your family. We are 100% sure
`we can save you!”
`
`
`
`
`
`
`
`B. Claims That Scientific Research Proves Earth Tea Prevents or Treats
`COVID-19
`
`27.
`
`Defendants compound their misrepresentations that Earth Tea prevents or treats
`
`COVID-19, with unsubstantiated claims that there is competent and reliable scientific research
`
`that supports these misrepresentations. In fact, at present, there is no published report of any
`
`well-controlled human clinical study to substantiate that Earth Tea can treat, prevent, or cure
`
`COVID-19. Defendants purport to possess anecdotal evidence from customers, and they also
`
`rely on a 15-person purported study that Defendants state was conducted in India. Neither the
`
`purported anecdotal reports nor this small, unpublished study suffices as competent and reliable
`
`scientific evidence to substantiate the claimed health benefits.
`
`28.
`
`The study, as described in a report on Defendants’ b4bearthteallc.com website,
`
`purportedly consisted of a single group of 15 adults with “mild COVID-19” who were evaluated
`
`for symptoms, given two 8-ounce doses of Earth Tea and evaluated again four to five days later.
`
`
`
`11
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 12 of 28 PageID #: 12
`
`The report claims, without documentation or any supporting data analysis, that there was
`
`“statistically significant efficacy” of the product including “a significant result” in RT-PCR lab
`
`tests for the COVID-19 infection. The unpublished results of this study, even if accurately
`
`presented in the report on Defendants’ website, do not comprise competent and reliable scientific
`
`evidence of any benefit of Earth Tea relating to COVID-19. Among other reasons, there was no
`
`control group to establish that Earth Tea performed any better than a placebo. The anecdotal
`
`reports are not documented, and even if accurate, do not constitute competent and reliable human
`
`clinical evidence that consuming Earth Tea caused any improvement in COVID-19 symptoms.
`
`29.
`
`Notwithstanding this, Defendants disseminated or caused to be disseminated
`
`statements claiming that the clinical trial establishes that Earth Tea is effective at preventing or
`
`treating COVID-19, including the following:
`
`Facebook b4bcorpUSA July 13, 2021 (captured 10.20.21)
`
`
`“B4BCorp is sharing a COVID-
`19 Update….Earth Tea works!!
`The all natural instant immune
`booster clinical trial proves its
`effective against Covid19.”
`
`
`
`
`
`12
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 13 of 28 PageID #: 13
`
`Website b4bcorp.com (captured 09.16.21)
`
`
`“Our Clinical Trial was
`successful. So successful we
`are offering Money Back
`Guarantee against covid-19 if 2
`bottles do not get you negative
`you will get your money back!”
`
`“Our First clinical trial was done
`in India in July of 2021 sixteen
`months after our first success
`against Covid-19… to prove Earth
`Tea Extra Strength is safe and
`effective and works against
`Covid-19. We had 15 people who
`was tested positive for Covid-19
`tried one bottle of Earth Tea Extra
`Strength…. They were then tested
`48 hrs after, here’s the result. 14
`came back Negative and 1 came
`back Positive…. The great news
`is all survived and all 15 avoided
`any need for help.”
`
`13
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 14 of 28 PageID #: 14
`
`Facebook b4bcorpUSA Aug. 3, 2021 (captured 10.20.21)
`
`
`“Covid19NEWS! We are on a
`Mission to Unmask the World!!
`Trial documents to be shared
`soon!! 15 people who tested
`positive tried Earth Tea Extra
`Strength 16 oz bottle they took 8
`oz cold during the day and then 8
`oz hot before bed. They were
`tested 48 hours after and the
`result is 14 came back with
`Negative and 1 came back
`positive.”
`
`“Our Goal is Zero Death, Zero
`Ventilator, Zero Suffering, Zero
`Hospitalization, Zero Long
`Haulers. Is that possible? Our
`first Clinical Trial Report will
`show that Nature Rules! Watch
`us lead the fight against
`#Covid19 with the world’s most
`powerful natural Supplement!”
`
`
`
`Facebook b4bcorpUSA April 26, 2021 (captured 10.8.21)
`
`
`
`
`
`
`
`
`
`
`14
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 15 of 28 PageID #: 15
`
`Instagram b4bearthteallc Aug. 3, 2021 (captured 10.13.2021)
`
`
`“Our clinical Trials documents to
`be published soon! Stay
`Tuned!!...15 people who was
`tested positive tried Earth Tea
`Extra Strength 16 oz
`bottle….They were then tested 48
`hrs after and the result is 14 came
`back with Negative and 1 came
`back positive….From internal
`study if 1 bottle won’t do 2 or 3
`will get rid of COVID19
`‘guaranteed’…”
`
`
`
`
`
`
`
`
`C. Claims That Earth Tea Is More Effective at Preventing and Treating
`
`COVID-19 than Vaccination
`
`30.
`
`Defendants also disseminated or caused to be disseminated claims, including the
`
`following, that Earth Tea is more effective than vaccination at preventing or treating
`
`COVID-19.
`
`Instagram b4bearthteallc Oct. 31, 2021 (captured 11.03.2021)
`
`
`
`
`
`
`
`
`
`
`
`
`
`[Picture of vial labeled
`“COVID-19 Vaccine” and a
`bottle of Earth Tea]
`
`
`“Which one is 100% effective
`with 0 Side effects”
`
`“#COVID19 TRIALS
`REPORT IS THE ANSWER
`NOT WHAT LEADERS
`WANT.. COMPARE
`BOTH..”
`
`15
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 16 of 28 PageID #: 16
`
`Instagram b4bearthteallc Sept. 10, 2021 (captured 10.13.21)
`
`
`“#vaccines
`#EARTHTEAEXTRASTRENGTH
`Vaccines trial shows preventing
`hospitalization is 85%-96% while
`so far Earth Tea Extra Strength is
`100% we have helped people who
`are vaccinated. No one who was
`positive and used Earth Tea went
`to the hospital.”
`
`
`II. Defendants’ Deceptive Health Claims about Their Product are Harming Consumers
`
`31.
`
`Defendants deceptively advertise that Earth Tea prevents or treats COVID-19,
`
`and that its efficacy is superior to the current COVID-19 vaccines.
`
`32.
`
`Such baseless claims of health benefits are material, because, as prominent
`
`claimed benefits of Earth Tea, they are plainly a primary reason that anyone would pay $60 to
`
`purchase a bottle of Earth Tea.
`
`33.
`
`Upon information and belief, Defendants have earned a substantial amount of
`
`money from sales of its Earth Tea product during the pandemic, indicating that Defendants’
`
`unsubstantiated claims of efficacy against COVID-19 have led to consumers buying the product.
`
`34.
`
`In addition, Defendants’ claims may cause consumers to ingest Earth Tea in lieu
`
`of other measures to prevent COVID-19, such as getting vaccinated, social distancing, and
`16
`
`
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 17 of 28 PageID #: 17
`
`wearing a mask. In fact, the following statements, excerpted from the examples of Defendants’
`
`advertising provided above, appear to encourage this:
`
`“Vax [vaccinated] or Not . . . . DON’T DIE FROM COVID19. Protect yourself and your
`
`family. We are 100% sure we can save you!” (Facebook b4bcorpUSA posted Sept. 3,
`
`2021);
`
`“COVID19 POSITIVE? VAX OR NO VAX GRAB 2 BOTTLES OF EARTH TEA
`
`EXTRA STRENGTH AND GET OVER IT WITHIN 48HRS” (Instagram b4bearthteallc
`
`posted Sept. 10, 2021);
`
`“COVID19NEWS! We are on a Mission to Unmask the World!!” (Facebook
`
`b4bcorpUSA posted Aug. 3, 2021);
`
`“Vaccines trial shows preventing hospitalization is 85%-96% while so far Earth Tea
`
`Extra Strength is 100%” (Instagram b4bearthteallc posted Sept. 10, 2021).
`
`IV. Defendants Refuse to Cease Deceptive Advertising Despite Notice from FTC and
` FDA
`
`
`35.
`
`Defendants have continued to make these and other deceptive and unsubstantiated
`
`claims about Earth Tea despite multiple written warnings from FTC and FDA that such conduct
`
`violates the law and may lead to legal action by the government.
`
`36.
`
`A February 18, 2021 warning letter issued jointly by the FTC and the FDA
`
`informed Defendant B4B Corp. that its b4bcorp.com website and its b4bcorpusa Twitter account
`
`were unlawfully advertising Earth Tea for the mitigation, prevention, treatment, diagnosis or
`
`cure of COVID-19, including by making the following claims about Earth Tea: “confirmed to
`
`stop coughing from Covid-19 100%”; “#1 choice to get people off the #ventilator not only for
`
`
`
`17
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 18 of 28 PageID #: 18
`
`covid19 but in general”; “our official formula now 100% guarantee to get rid of #Covid19”; and
`
`“the most effective Treatment against #COVID19.” Complaint, Ex. A (Feb. 18, 2021 warning
`
`ltr.) at 4. The warning letter stated, in part:
`
`It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a
`product or service can prevent, treat, or cure human disease unless you
`possess competent and reliable scientific evidence, including, when
`appropriate, well-controlled human clinical studies, substantiating that the
`claims are true at the time they are made. For COVID-19, no such study is
`currently known to exist for the product identified above [Earth Tea]. Thus,
`any coronavirus-related prevention claims regarding such products are not
`supported by competent and reliable scientific evidence. You must
`immediately cease making all such claims.
`
`
`37.
`
`In the warning letter, FDA also informed Defendants that the Earth Tea “product
`
`is an unapproved new drug” and “a misbranded drug” in violation of the FDCA. Ex. A at 2. The
`
`Warning Letter explained: “FDA considers your product(s) referenced above to be unapproved
`
`and misbranded products that cannot be legally sold to consumers in the United States.” Ex. A at
`
`4. The warning letter further stated that failure to correct the violations could result in legal
`
`action, including an injunction. Ex. A at 3.
`
`38.
`
`Defendant Sinclair responded to the February 18, 2021 warning letter on February
`
`19, 2021 and to subsequent communications with FTC staff. Subsequently, Defendants removed
`
`their claims of Earth Tea’s efficacy against COVID-19 from their websites and social media
`
`accounts. In March 2021, FDA and FTC indicated to Defendants that it appeared that Defendants
`
`had addressed the violations included in the warning letter. FDA’s letter to this effect also
`
`reminded Defendants that they had a continuing responsibility to comply with the FDCA and
`
`other relevant legal authority.
`
`39.
`
`By April 2021, however, Defendants had resumed making claims that Earth Tea
`
`
`
`18
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 19 of 28 PageID #: 19
`
`could prevent, mitigate, treat and cure COVID-19 and added claims that these health benefits
`
`were purportedly backed by a clinical trial. On September 29, 2021, FTC staff emailed
`
`Defendant Sinclair to inform him that Defendants’ express and implied claims about the benefits
`
`of Earth Tea for COVID-19 were unsubstantiated and violated both the FTC Act and the
`
`COVID-19 Consumer Protection Act (“CCPA”). Defendants kept making such claims despite
`
`this warning.
`
`40.
`
`To date, Defendants have not received approval for a NDA, ANDA, or IND
`
`Application1 for Earth Tea, and they continue to cause the distribution of this unapproved new
`
`drug in interstate commerce. Accordingly, unless restrained by this Court, Defendants will
`
`continue to violate the FDCA, 21 U.S.C. § 331(d), in the manner set forth above.
`
`41.
`
`Based on the facts and violations of law alleged in this Complaint, the United
`
`States has reason to believe that Defendants are violating or are about to violate FTC and FDA
`
`laws enforced by the United States. Among other reasons, Defendants have engaged in their
`
`unlawful acts and practices willfully and knowingly despite being clearly advised of their
`
`illegality in the joint FDA/FTC warning letter and in subsequent communications with FTC staff
`
`in February and March of 2021. Although Defendants may have briefly discontinued deceptive
`
`and false claims about the benefits of Earth Tea for COVID-19, they have resumed their
`
`unlawful acts and practices and continue such practices despite additional communications from
`
`
`1 An NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new
`pharmaceutical for sale and marketing in the United States. An ANDA contains data which is submitted to
`FDA for the review and potential approval of a generic drug product. An IND application is submitted by
`applicants who propose to study an unapproved drug or an approved product for a new indication or in a
`new patient population, or who seek authorization for the use of an experimental drug in an emergency
`situation or for serious or immediately life-threatening conditions.
`19
`
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 20 of 28 PageID #: 20
`
`FTC staff on September 29, 2021, showing that permanent injunctive relief is necessary and
`
`appropriate.
`
`42.
`
`43.
`
`COUNT ONE
`
`FTC Act Section 5(a) and Section 12 Violations
`
`Paragraphs 1 through 42 are incorporated as if set forth herein.
`
`In numerous instances in connection with the advertising, marketing, promotion,
`
`offering for sale, or sale of Earth Tea, including through the statements reflected above,
`
`Defendants have represented, directly or indirectly, expressly or by implication, that Earth Tea:
`
`a. prevents COVID-19;
`
`b. treats the symptoms of COVID-19;
`
`c. cures COVID-19;
`
`d. leads to recovery from COVID-19 within 48 hours;
`
`e. is 100% effective in preventing hospitalization from COVID-19;
`
`f.
`
`is more effective than a vaccine in preventing hospitalization from COVID-
`
`19;
`
`g. is clinically proven effective to treat and cure COVID-19; and
`
`h. is clinically proven to cure COVID-19 in 48 hours.
`
`44.
`
`The foregoing representations are false or misleading, or were not substantiated at
`
`the time the representations were made.
`
`45.
`
`In truth and in fact, Defendants have no competent and reliable scientific evidence
`
`that any of Defendants’ statements identified in Paragraph 43(a)-(h) are true.
`
`46.
`
`Therefore, the making of the representations as set forth in Paragraph 43 of this
`
`
`
`20
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 21 of 28 PageID #: 21
`
`Complaint constitutes a deceptive act or practice and the making of false advertisements in
`
`violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52.
`
`47.
`
`Defendants committed the violations set forth in Paragraph 43 with the
`
`knowledge required by Section 5(m)(1)(A) of the FTC Act, 15 U.S.C. § 45(m)(1)(A).
`
`48.
`
`Defendants’ representations are material to consumers because they relate to
`
`COVID-19 prevention and treatment, subjects that are very important to many consumers.
`
`49.
`
`Upon information and belief, Defendants continue to make similar
`
`misrepresentations regarding the efficacy of Earth Tea for preventing or treating COVID-19.
`
`50.
`
`Upon information and belief, consumers are suffering, have suffered, and will
`
`continue to suffer substantial injury as a result of Defendants’ violations of the FTC Act. Upon
`
`information and belief, absent injunctive relief by this Court, Defendants are likely to continue to
`
`injure consumers and harm the public interest.
`
`COUNT TWO
`
`COVID-19 Consumer Protection Act Violations
`
`Paragraphs 1 through 51 are incorporated as if set forth herein.
`
`In numerous instances since December 27, 2020, Defendants have made false,
`
`51.
`
`52.
`
`misleading, or unsubstantiated representations that Earth Tea is effective for the prevention or
`
`treatment of COVID-19.
`
`53.
`
`In support of their advertising, marketing, promotion, offering for sale, or sale of
`
`Earth Tea, Defendants have represented, directly or indirectly, expressly or by implication, that
`
`there is a causal connection between Earth Tea and the prevention or treatment of COVID-19,
`
`including claims that Earth Tea:
`
`
`
`21
`
`

`

`Case 1:22-cv-01159-ENV-RML Document 1 Filed 03/03/22 Page 22 of 28 PageID #: 22
`
`a. prevents COVID-19;
`
`b. treats the symptoms of COVID-19;
`
`c. cures COVID-19;
`
`d. leads to recovery from COVID-19 within 48 hours;
`
`e. is 100% effective in preventing hospitalization from COVID-19;
`
`f.
`
`is more effective than a vaccine in preventing hospitalization from
`
`COVID-19;
`
`g. i