Other areas for tainted products raising red flags for the agency included statements like “works like” or “better than” an Rx drug, labels in a foreign language or ‘broken’ English, and label contradictions or warnings, said Michael Landa, Director of the Center for Food Safety and Applied Nutrition, FDA.
Landa was speaking to attendees at the CRN’s Annual Symposium for the Dietary Supplements Industry in Laguna Beach, CA.
NDI
On the topic of the NDI draft guidance, Landa said: “FDA is planning to issue a revised draft guidance with additional Q&As addressing issues raised in the comments. This is not a withdrawal of the draft guidance, rather address where more clarity or more information is needed.”
The next meeting with industry to further discuss the document is set for October 16th, he added.
Steve Mister, president and CEO, CRN, told attendees that the association would adopt a “spirit of compromise, where possible, if it brings predictability and certainty”.
However, he said that the synthetic botanicals issue is “an area where we will not compromise”.
“CRN has an unwavering commitment to protect the industry where compromise is not possible.”
GMPs
Good Manufacturing Practices (GMPs) continues to be a vital focus for the industry and the agency. FDA data as of September 1, 2012, showed that there had been 289 inspections in the program activity code. Of these, there were 85 NAIs (no action indicated), 103 VAIs (voluntary action indicated), and 101 OAIs (official action indicated).
“We are now 4 or 5 years after GMPs and the numbers are discouraging,” said Landa.
Claims
Warning letters have also been issued for claims, with more agency activity in the claims area recently, he said.
Of note, the number of warning letters has increased in 2012, with STD claims, and concussion-prevention claims highlighted by the CFSAN chief.
“The greatest concern is claims that have an impact on public health , for example claims that may lead to a delay in treatment,” said Landa.