Men and women suffering from hair loss might be tempted to use any product that claims to cure hair loss regardless of the cause, but using products that have not been approved by the U.S. Food and Drug Administration, like Aminexil, might be unwise. Without FDA approval, an absence of side effects may be misrepresented by foreign companies, potentially endangering American consumers.
Aminexil (Diaminopyrimidine Oxide) is a drug originally developed by a French company named Vichy, according to the online website Antiaging-systems.com. It is an ingredient in a hair loss product produced under the name Dercos by L’Oreal laboratories in France. However, aminexil is not an approved drug by the U.S. Food and Drug Administration.
Aminexil is currently being used by L’Oreal in a shampoo product treatment of perifollicular fibrosis—a condition that, according to Antiaging-systems.com, occurs regardless of cause of hair loss (genetics, stress). Perifollicular fibrosis is premature hair root aging that occurs due to collagen overproduction near the hair root.
According to Antiaging-systems.com, the Dercos Aminexil hair shampoo product is hypoallergenic and pH neutral, and the only known possible side effect is itching. But since the FDA has not approved aminexil use in the United States, it is unknown if any side effects for the drug exist.
FDA and Import Refusal
On Oct. 13, 2009, the FDA refused a UPS shipment containing Dercos’ Aminexil hair loss treatment for two reasons: One, it was misbranded—the product was not on a required FDA listing—and two, there was no “new drug approval” application made prior to the shipments arrival in the United States.
While the FDA has not tested or approved the drug aminexil, an international patent has been obtained and the product carries a guarantee of “no unpleasant side effects”, according to the online website All Nations Pharmacy.com. But without FDA approval and testing, actual side effects remain unknown to U.S. consumers.
International patents do not supersede American authority over products and the ingredients they contain. And foreign product guarantees are just that: foreign guarantees; not necessarily enforceable by American courts or laws and not a legitimate gauge of potential harm to consumers. So use of foreign products not approved of by the U.S. FDA—and actually refused by them recently—carries a potential risk to consumers.