The Agency also alleges that the company has labeling for other products that are promoted for conditions that cause the products to be drugs. The letter also alleges that an inspection by the Agency revealed a number of significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements.
According to a Legal Alert from the American Herbal Products Association (AHPA), the warning letter "is a good teaching tool for supplement labeling and responding to cGMP observations.
“Comparing a supplement to Viagra or Cialis is a drug claim according to FDA's long standing position,” said the AHPA alert. “FDA also declares again that DMAA is not a dietary ingredient.”
In the letter, dated Sept 6 and available to read here, FDA stated: “During the inspection [October 10 through October 19, 2012], our investigator noted that you distribute obestrim, which declares 1,3-dimethylamylamine [ab1] as a dietary ingredient…Dimethylamylamine does not qualify as a dietary ingredient under section 201(ff)(1)(C) or (F) because dimethylamylamine is not an herb or other botanical, nor is it a constituent of a botanical.
“Although some marketers of dimethylamylamine products have asserted that dimethylamylamine is present as a constituent of the geranium P. graveolens, FDA has reviewed the scientific literature on this subject and has concluded that the totality of the scientific evidence does not demonstrate the presence of dimethylamylamine in P. graveolens.”
The letter also alleges that the company promotes its Vivetra product as “[t]he Ultimate Viagra alternative”; its Cialafil (tiadalis) product as “the most effective and safest natural erection producing natural drug”, its Phentrazine 37.5 product as “a nutriceutical Alternative to Phentermine”, the Intensa product as “[w]omen’s Viagra”; and the Zirex product as “the most effective and safest natural erection producing natural drug”, among other claims for these products.
The letter also details 11 alleged GMP violations observed during the inspection, which were ‘inadequately’ addressed by the company following the inspection.
To read the full warning letter, please click here.