Arco Globus Trading LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

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

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 5

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:

Potential Health Risks

• “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)

Sincerely,/s/Monica R. MaxwellActing Program Division DirectorOffice of Pharmaceutical Quality Operations, Division II

Mary MaylebenPharmaceutical Program ManagerFlorida Department of Business & Professional Regulation2601 Blair Stone RoadTallahassee, Florida 32399-1027Mary.Mayleben@dbpr.state.fl.us

Regulatory Context

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

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

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.”