Five major trade organizations jointly requested today that the U.S. Food and Drug Administration extend the comment period for the agency's New Dietary Ingredients (NDIs) guidance by an additional 45 days (to Nov. 17, 2011).
The FDA originally gave 90 days for comment, but the organizations cited the draft guidance's "thorough and complex" nature as the reason for the extension request. The associations that sent the letter include the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA).
Harry Rice, vice president of regulatory and scientific affairs for UNPA, said that CHPA, CRN and UNPA discussed the idea of an extension during a regular teleconference held by the groups. "It was clear that we should submit for an extension," Rice said. "We reached out to NPA and AHPA to see if they would like to join in, and they did."
Summer vacations and holidays contributed to the need for an extension, added Duffy MacKay, ND, vice president of scientific and regulatory affairs for CRN. "The draft guidance is very long and comprehensive and has different meanings for different stakeholders," he said. "We wanted to take some time to let the industry digest all the interpretations of what's been said," including comments made during industry webinars and events such as AHPA's NDI seminar last week.
Collaboration is common among the trades
When was the last time the trade associations collaborated on a document like this? "We do it all the time," said Michael McGuffin, president of AHPA. "We often speak with a single, unified voice and it's not a soloist—it's a choir."
"Quite frankly it's more ordinary than not," echoed Rice. "A lot of times it's not publicly seen. It's behind the scenes."
For example, when FDA issued its Good Manufacturing Practices (GMP) draft guidance in 2003, each of the associations filed comments, and then AHPA, CRN and NPA came back together to restate commonalities and resolve conflicting ideas.
The associations are hopeful for the extension because FDA's Dan Fabricant, PhD, director of the agency's Division of Dietary Supplement Programs, has mentioned the importance of hearing from all of them. The associations have diverse opinions about NDI guidance, marked by their diverse membership. Some associations have representatives that have been around since the Dietary Supplement Health and Education Act (DSHEA) passed in 1994. Some have smaller memberships, while others specialize in botanicals or over the counter medicines.
This rally cry is beneficial for the dietary supplements industry and helpful for efficiently shaping the regulation. Will collaboration continue when it comes time to submit the final comments? "We'll definitely have some dialogue with all the trades and share ideas," said MacKay. "If in that process it starts to surface that it makes sense for us to collaborate, then I think that'll happen, but it's too soon to tell."
For now, the associations wait. "The guidance was 16-and-a-half years in the making," said Rice. "I really don't think it's any burden to grant a 45-day extension."