What happened
Original notice title
Arco Globus Trading LLC 12/11/17
From the archived source record
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)]. 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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 9ba3fffe8332
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →