In comments filed with the Food and Drug Administration (FDA) about its controversial draft guidance on NDIs, Amin Talati partner Ashish Talati said the FDA’s stipulation that supplements - rather than ingredients - are subject to NDI filings, raised “significant intellectual property issues”.
Ingredients manufacturers may not wish to provide this information
He said: “The draft guidance would require each supplement manufacturer or distributor to seek manufacturing, safety and other relevant information from the ingredient suppliers/manufacturers.
“[But] this information is customarily held in strict confidence by the ingredient manufacturer… Ingredient manufacturers may not wish to provide such information that they have developed at great expense to finished product manufacturers.
“Without such information, finished product manufacturers cannot adequately submit their notification to FDA.”
FDA has re-interpreted the statute
Along with many other commentators, Talati also argues that the FDA’s focus on supplement- rather than ingredient-specific notifications is contrary to the intent of Congress when it passed the 1994 Dietary Supplement health and Education Act (DSHEA).
He added: “FDA has made a complete about-face in re-interpreting the statute… Although the statue requires the dietary supplement to be ‘reasonably be expected to be safe’, it does not require the notification for the dietary supplement.
“The notification is for the dietary ingredient. The draft guidance overrides Congressional intent and would not withstand judicial review.”
The FDA has always considered notifications to be ingredient-specific
Moreover, given that the FDA has spent the last 17 years processing ingredient-specific NDI filings, its sudden change of focus was baffling, he claimed.
“For 17 years the industry notified and FDA accepted new dietary ingredient notifications for ingredients and now FDA has reversed course by interpreting NDI regulations to be supplement-specific.
“We have not been able to locate any Agency document prior to the draft guidance that even suggests that NDI notifications are supplement specific. To the contrary, FDA‟s own documents show that the Agency itself has always considered notification to be ingredient specific.”
Chicago-based Amin Talati specializes in all fields of intellectual property, including patents, trademarks, copyrights and trade secrets and has several clients in the dietary supplements sector.