Responding to FDA’s recently released NDI Guidance, Cara Welch, Natural Products Association (NPA) vice president of scientific and regulatory affairs, offered the following statement:
 
“The Natural Products Association thanks the FDA for meeting the deadline set by Congress for the release of the NDI guidance. The draft guidance answers a lot of questions for the industry, but it also raises concerns about its overall impact. It could profoundly affect the ability of Americans to get the supplements they want and need.
 
“We believe the draft guidance does not match Congress’s clear intent that products made from ingredients on the market prior to DSHEA should remain on the market. The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce. That was not the intent of DSHEA. These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.
 
“The draft guidance also addresses a number of situations when a premarket safety notification is required. NDI notifications are required for: components of food marketed before 1994; a change in solvent when processing an ingredient; a change in manufacturing that produces nanoscale particles; and each manufacturer of each supplement containing an NDI. The agency further clarified that synthetic versions of dietary ingredients require an NDI notification, with the exception of synthetic botanical constituents that FDA has declared are not considered dietary ingredients. These situations have the potential to impact dietary supplement manufacturers far and wide.
 
“In addition, the safety testing requirements for NDIs are raised to a level well above what was contemplated in DSHEA. These requirements will be harder for manufacturers to meet, inevitably leading to fewer new products in the marketplace.
 
“We said this could be a game-changer for the industry and it is. NPA will monitor and report on how this guidance affects the industry, and develop comments representing these concerns to be submitted to FDA. Today, half of all Americans trust dietary supplements and use them as part of a healthy lifestyle. For them and for our industry, it’s vital that we make sure consumers continue to have access to popular, safe dietary supplements.”