Enzolytics Inc (ENZC)

[suny66]

IPF is not a med and it is not subject to approval. Only drugs are subject to approval. IPF Immune is a dietary food supplement registered with the FDA, reg. 1083. We are OK here. Harry did his homework. Dietary food supplements are dealt with differently than drugs.They require registration with the FDA. After that they are required to complete a lengthy computer generated form with data to indicate that the product is safe for human consumption. The form must be submitted to the FDA at least 75 days before the product enters into interstate commerce. According to the FDA some companies in the past have not followed the 75 day ruling and the FDA did not do anything about it.
Now, on May 19, all of a sudden the FDA announces that they are temporarily enforcing the 75 day ruling and also that dietary supplements can be subject to inspection. If they don't find discrepancies they can hold the shipment no more than 30 days. However, if they suspect noncompliance they can pull representative samples for testing which can take weeks. They also indicated that they will be checking labels, company websites, and social media for false claims.
Again, it is very unusual to see this "temporary" action during the same timeframe that IPF Immune entered the US. This is the first time since 1994 that FDA has tightened requirements for dietary supplements. IMHO