FDA warns of sexual enhancement products and sends yet more letters for GMP violations
FDA issued public notifications on May 16th against three sexual enhancement products: "VMaxx Rx"; “Firminite”; and “Boost — Ultra Sexual Enhancement Formula” for containing undeclared drug ingredients.
According to FDA, “VMaxx Rx” is said to the undeclared ingredient sulfoaildenafil, an analog of sildenafil, an FDA approved prescription drug used to treat Erectile Dysfunction (ED). “Firminite” contains tadalafil, while “Boost - Ultra Sexual Enhancement Formula” contains sildenafil, said the Agency.
Consumers are advised to stop using the products and throw them away.
Label claims GMP violations… again
FDA also issued a warning letter to Naprodis Inc. for making disease claims on many products on its website, causing the products to be considered drugs.
The letter, which can be found here, also notes that since these products are dietary supplements, the company must comply with “21 CFR Part 111 Current Good Manufacturing Practices (CGMPs) regulations for dietary supplements”.
FDA also sent a warning letter to Dallas-based Dark Cyde Supplements and its contract manufacturer for the manufacture of products without compliance with certain cGMPs.
The letter also states that FDA found numerous disease claims and labeling violations. FDA was not finished there, however, and noted that “the only substances listed as dietary ingredients on the REIGN label are 4-chloro-17a-methyl-androst-1, 4-dien 3-17b-diol and 2a,17a dimethyl-etiocholan-3-one, 17b-ol.
“These compounds are steroids and are not vitamins, minerals, amino acids, herbs or other botanicals, or dietary substances for use by man to supplement the diet by increasing the total dietary intake,” said FDA.
Test the finished product…
Carnegie, PA-based Reaction Nutrition, LLC., also received a warning letter about deficiencies in its cGMP documentation (master manufacturing records and manufacturing operations). FDA also said that the company had failed to “verify that [the] finished batches of dietary supplements meet finished product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c).
“You may verify that these specifications are met by testing or examining (1) every finished batch or (2) a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical plan [21 CFR 111.75(c)].
“Because you did not identify such a subset of finished batches, you must test every finished batch of the dietary supplements manufactured at your firm.
“However, during the inspection you verbally confirmed to our investigators that you do not perform any finished product testing to verify the identity, purity, strength and composition of your dietary supplement products.”
The company responded to FDA on January 4, 2012, but the agency deemed the response to be inadequate because the company “did not provide any supporting documentation of [its] corrective action or specify what procedures you would follow during the first quarter of 2012.”