Ryan Harris

 

 
U.S. Food & Drug Administration
Office of Pharmaceutical Quality Operations, Division II
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

December 11, 2017

CMS Case # 538080

WARNING LETTER

VIA UPS EXPRESS

Abe Citron, Chairman & CEO
Arco Globus Trading LLC (dba Arco Globus International)
1998 Overseas Highway, 44A
Marathon, Florida 33050

Markquez Santiago
Legal Lean LLC
6324 Raleigh Street, Apt#703
Orlando, Florida 32835

Ryan Harris
Legalleanstore.com
10151 University Boulevard, #328
Orlando, Florida 32817

Messieurs Citron, Santiago and Harris:                                                                                

This letter concerns your firm’s marketing and distribution of Legal Lean Syrup and Coco Loko.  The U.S. Food and Drug Administration (FDA) has reviewed your websites at the internet addresses http://legallean.com and www.legalleanstore.com, where you take orders for your Legal Lean Syrup and Coco Loko products.  Based on the review of your websites and other product labeling, we have determined that your firm causes the introduction of unapproved new drugs for sale in interstate commerce in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(d) and 355(a)].  Furthermore, these drugs are misbranded under sections 502(f)(1) and 502(a) of the FD&C Act [21 U.S.C. §§ 352(f)(1), 352(a)], and by introducing or delivering these products for introduction into interstate commerce, you are in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].  FDA requests that you immediately cease marketing violative drug products to U.S. consumers. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

As set forth in more detail below, the claims made in your promotional materials for Legal Lean Syrup and Coco Loko demonstrate that these products are intended to be used as alternatives to illicit street drugs.  Drug abuse is a serious public health issue, and the Agency is concerned that products such as the ones mentioned above encourage drug abuse in individuals, including minors.  Additionally, your Legal Lean Syrup product contains the active pharmaceutical ingredient (API) doxylamine, which is not present in the product labeling.  FDA-approved products containing doxylamine warn against its concomitant use with alcoholic beverages and also warn that a physician should be consulted prior to use by people with glaucoma, by individuals with breathing problems such as asthma, emphysema, or chronic bronchitis, and by men with trouble urinating due to enlarged prostate glands.  For these patient populations, as well as those who have had adverse reactions to doxylamine in the past and have been advised by their physicians to avoid it, the inclusion of undeclared doxylamine in Legal Lean Syrup poses a potentially serious risk.  With respect to Coco Loko, a powder substance, you describe it in your labeling as a “snuff” and you promote it to be “snorted” (inhaled intranasally).  Intranasal administration of a powder substance can trigger laryngospasm or bronchospasm and induce or exacerbate an episode of asthma.  Furthermore, the ingredients listed on the product label for Coco Loko include taurine and guarana.  The safety of these ingredients for intranasal administration has not been evaluated. 

Unapproved New Drugs

As labeled, certain products offered for sale through your websites are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body.  These products, as marketed through your websites, are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)].  No approved applications pursuant to section 505 of the FD&C Act [21 U.S.C § 355] are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C §§ 331(d) and 355(a)].

Examples of some of the website claims that provide evidence that your Legal Lean Syrup and Coco Loko products are intended for use as drugs include:

Legal Lean Syrup

• Name of product: “Legal Lean Syrup” [1]
• “Legal Lean is just like prometh[a]zine and codeine, but . . . can be legally bought without a prescription.” [2] 
• “The balanced formula of herbs and nutrients promote a state of extended relaxation and euphoria.”
• “Our mixture of herbs and nutrients promotes a state of enhanced rest and bliss.”
• “Legal Lean uses a special blend of natural ingredients to achieve its relaxing and calming effects.”  Among the ingredients are “valerian root . . . used as a treatment for nervous conditions and insomnia …” and “St. John’s Wort [, which] is a very common non-prescription alternative for depression. It promotes normal mental health function and stability.”

Coco Loko

• “Endorphin rush . . . it triggers a positive feeling of well being in your body similar to morphine.”
• “Serotonin rush . . . will produce an elevated mood and a state of euphoria similar to the feeling of ecstasy.”
• “Euphoric energy . . . Raw cacao will give you a steady rush of euphoric energy . . ..”
• “Raw cacao . . . is also known to help with anxiety and to reduce stress.”
• Coco Loko Review by I Suck At Talking (Youtube video on your website): “Raw cacao is linked to numerous health benefits . . . lower blood pressure and improved blood circulation . . ..” (1:04 – 1:13)

Legal Lean Syrup is labeled as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)].  FDA confirmed through laboratory analysis that your Legal Lean Syrup product contains undeclared doxylamine, the API in Unisom, an FDA-approved over-the-counter (OTC) drug for use as a nighttime sleep-aid.  According to section 201(ff)(3)(B)(i) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(i)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug.  FDA approved Unisom as a new drug on October 18, 1978.  Doxylamine was not marketed as a dietary supplement or as a food before this date.  Therefore, Legal Lean Syrup is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act. 

Coco Loko is labeled as a conventional food and is also marketed as a dietary supplement on your website at http://legallean.com; however, Coco Loko is intended for intranasal administration.  Because your product is intended to enter the body directly through the mucosal tissues, it is not a conventional food or dietary supplement.  Your product also fails to meet the definition of dietary supplement in section 201(ff)(2)(A)(i) of the FD&C Act because it is not “a product . . . intended for ingestion.”

Additionally, both Legal Lean Syrup and Coco Loko are marketed with claims demonstrating that they are intended for use as alternatives to illicit street drugs.   In addition to the fact that Legal Lean Syrup and Coco Loko do not meet the definition of dietary supplements for the reasons explained above, FDA does not consider Legal Lean Syrup and Coco Loko to be dietary supplements because they are street drug alternatives.  Street drug alternatives, i.e., products that claim to mimic the effects of recreational drugs, are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations).  The term “dietary supplement” is defined in section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)], in part, as a product "intended to supplement the diet."  As explained in our March 2000 guidance on this topic, [3] street drug alternatives do not meet this element of the dietary supplement definition.

Based on the representations on your websites and social media accounts (including www.facebook.com/LegalLeanCocoSnuff and www.facebook.com/LegalleanstoreTexas), you intend for Legal Lean Syrup and Coco Loko to be used to affect the structure or function of the mind through their use for recreational purposes (i.e. for euphoria and sedation).  This is made clear by the suggestion in the labeling and marketing materials that these products mimic the effects of controlled substances. A product makes a claim about its effect on the structure and/or function of the body when labeling shows that it is “intended to affect the function or structure of the mind by elevating the psychological condition of users.”  United States v. Undetermined Quantities of Articles of Drug, 145 F. Supp. 2d 692, 700 (D. Md. 2001). For these reasons, and consistent with our guidance on street drug alternatives, FDA considers these products marketed as street drug alternatives to be unapproved new drugs and misbranded drugs under sections 505 and 502 of the FD&C Act. [4]

Misbranded Drugs

Legal Lean Syrup and Coco Loko are also misbranded drugs under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].  A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s).  “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription products, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them.   [FD&C Act 503(b)(1)(A)].  Legal Lean Syrup and Coco Loko are prescription products that are intended to treat conditions such as hypertension, depression, and insomnia that are not amenable to self-diagnosis and treatment by persons who are not medical practitioners.  Therefore, adequate directions for use cannot be written for these drug products, and they must qualify for one of the exemptions to 502(f)(1) to avoid being misbranded. 

The exemption to 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] found at 21 CFR 201.100 does not apply to unapproved new drugs, such as Legal Lean Syrup and Coco Loko, because that exemption requires that such drugs bear “the labeling authorized by the approved new drug application.”  Furthermore, unapproved new prescription drugs also do not qualify for the exemption set forth at 21 CFR 201.115, which also requires an approved new drug application (NDA) or active investigational new drug application (IND). Consequently, a prescription drug that is a new drug and has not been approved by FDA or is not subject to an exemption from the premarketing approval requirements under the FD&C Act cannot qualify for the exemptions to 502(f)(1).  Because none of the exemptions to 502(f)(1) apply, the labeling for Legal Lean Syrup and Coco Loko fails to bear adequate directions for their intended uses, and the products are therefore misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. By shipping these products to U.S. consumers, you are causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. 

A drug is also misbranded under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)] if its labeling is false or misleading in any particular.  Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations . . . .” The labeling for Legal Lean Syrup does not declare that it contains doxylamine.  The failure to disclose the presence of doxylamine in the product’s labeling renders it misbranded under section 502(a) of the FD&C Act.  The introduction or delivery for introduction into interstate commerce of a misbranded drug violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

This letter is not intended to identify all the ways in which your activities might be in violation of law.  It is your responsibility to ensure that all products you market are in compliance with the FD&C Act and its implementing regulations.  You should take prompt action to correct the violations noted above as well as any other violations of the FD&C Act (which would include the offer for sale of all unapproved and/or misbranded drug products by your websites, not just the products noted above).  Failure to correct violations may result in FDA enforcement action, including seizure or injunction, without further notice.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.

Your written notification should refer to the Warning Letter Number above (CMS Case #538080).

Please address your reply to John W. Diehl, Acting Director, Compliance Branch, at the FDA address provided. In addition, please submit a signed copy of your response to john.diehl@fda.hhs.gov.

If you have questions regarding the contents of this letter, you may contact Mr. Diehl at (214) 253-5288.


Sincerely,
/s/ 
Monica R. Maxwell
Acting Program Division Director
Office of Pharmaceutical Quality Operations, Division II

Cc:

Mary Mayleben
Pharmaceutical Program Manager
Florida Department of Business & Professional Regulation
2601 Blair Stone Road
Tallahassee, Florida 32399-1027
Mary.Mayleben@dbpr.state.fl.us

Christopher Ferguson, Chief
Florida Department of Health
4052 Bald Cypress Way Bin C-04
Tallahassee, Florida 32399-3258
Christopher.ferguson@flhealth.gov

ARCO GLOBUS NY, INC.
407 Henderson Avenue
Staten Island, New York 10301

[1] “Lean” and “Syrup” are alternative street names used to describe “Purple Drank,” a street name for a drink mixture typically containing a prescription cough syrup (promethazine and codeine), carbonated lemon-lime soda, and pieces of hard candy. See “Resurgence in Abuse of ‘Purple Drank.’” Retrieved from the Department of Justice Web site: https://www.justice.gov/archive/ndic/pubs43/43924/sw0008p.pdf.

[2] Additionally, the product label for Legal Lean Syrup resembles the labeling for FDA-approved prescription drug Promethazine with Codeine Cough Syrup, which is a Scheduled V controlled substance containing active pharmaceutical ingredients promethazine hydrochloride and codeine phosphate. The background colors and layout, including the positioning of the text, on Additionally, the product label for Legal Lean Syrup resembles the labeling for FDA-approved prescription drug Promethazine with Codeine Cough Syrup, which is a Scheduled V controlled substance containing active pharmaceutical ingredients promethazine hydrochloride and codeine phosphate. The background colors and layout, including the positioning of the text, on the Legal Lean Syrup product label have a likeness to the prescription drug product label.

[3] See Guidance for Industry:  Street Drug Alternatives, March 2000, available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070343.pdf; 62 Fed. Reg. 30678, 30699-700 (June 4, 1997). 

[4] See id.

This page was posted on April 30, 2019.

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