FDA warns companies marketing dietary supplements that contain methylsynephrine.

  • As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients in dietary supplements.  In the last year, FDA has taken action against beta-methylphenethylamine (BMPEA), 1,3-Dimethylbutylamine (DMBA), and kratom, to name a few prominent examples.
  • FDA recently sent Warning Letters to seven companies marketing dietary supplements that contain the stimulant, methylsynephrine (also called oxilofrine).  FDA’s position is that methylsynephrine does not meet the statutory definition of a “dietary ingredient” permitted for use in dietary supplements.  By law, a dietary supplement is defined as a product intended to supplement the diet that bears or contains one of the following dietary ingredients:  a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.
  • Although the Warning Letters do not cite the potential health risks associated with methylsynephrine consumption, the substance is known to be a powerful stimulant and has been banned by the World Anti-Doping Agency, Major League Baseball, National Football League, and other sports organizations.  An FDA spokesperson indicated that the Agency had learned of 47 adverse reactions associated with the stimulant.  Some media reports are characterizing methylsynephrine as the latest in a string of stimulants intended to replace ephedrine, which was banned in 2004 due to its serious side effects.

The Daily Intake will be on hiatus during our Practical Food Law Seminar — we will return on Monday, April 18.