A united response from industry on the new dietary ingredient draft guidance could help prevent FDA from creating an even more burdensome policy, say representatives of the American Herbal Products Association.

AHPA President Michael McGuffin said the group has communicated with the Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance and Consumer Healthcare Products Association about writing comments on the draft guidance.

Trade groups are discussing “how do we make sure that FDA doesn’t try to turn subtle differences in our comments into some kind of evidence of lack of agreement,” McGuffin said Sept. 8 at AHPA’s NDI Congress in Chicago.

He observed that the agency likely would argue that differences among stakeholders show that FDA should determine the final guidance.

Contradictions among industry comments are “the primary thing we want to guard against.” – AHPA President McGuffin

The groups may submit a joint comment in addition to each association’s individual comment, or submit separate comments with a single preamble written by all the groups, McGuffin said.

Steve Mister, president of CRN, said each group will address points of agreement, like opposition to the ban on synthetic botanical ingredients without NDI notifications.

“We would make it very clear to FDA that there is solidarity on that point,” he said. “How we might choose to address it might differ, but at least we could not be said to be inconsistent among the associations.”

He pointed out that FDA in 2004 told trade groups that industry’s response to questions the agency presented in developing the draft guidance was not consistent.

“We don’t think that characterizes what happened in 2004, but in order to be sure that we are very clear with the agency this time … we do agree there is a need for consistency among our comments,” Mister said.

McGuffin said although he would not discourage firms from submitting comments individually, “I tend to think we’re actually stronger by focusing our efforts” on clear, concise comments from trade groups.

He is concerned that with scores of comments submitted, FDA will “look for the differences among all of those and pick the ones that they like” or “they’ll say ‘industry can’t agree.’”

During a webinar AHPA hosted soon after FDA published the draft guidance in July, McGuffin and Herbalife regulatory affairs executive Bill Frankos, formerly in charge of FDA’s dietary supplement program, argued for the trade groups coordinating industry’s response (Also see "NDI Notification Enforcement Ramp-Up Likely To Target “Low-Hanging Fruit”" - Pink Sheet, 25 July, 2011.).

Although trade groups stress consistency, they emphasize firms should submit comments on every concern to make FDA fully aware of industry’s questions.

Mister noted that FDA, unlike a member of Congress who must win re-election every two years, is “less responsive” to a flood of identical comments.

“I would urge those who want to comment to be constructive and thoughtful,” he said.

Be Careful What You Ask For

Tony Young, general counsel to AHPA, also advised firms to be careful about what they state in their comments. Statements intended to oppose FDA’s proposals could be inferred to instead support the agency’s thinking.

For instance, starting a comment saying the guidance will cause a firm to have to submit hundreds of NDI notifications “might not be a wise thing to say and might come back against the industry,” Young warned.

“We need to be cautious about how we frame the issues here, and we need to be careful what we ask for,” he said.

Firms should have trade associations or attorneys review the comments, Young suggested.

McGuffin offered to review comments from firms, not in any depth but to warn if any portions contradict those presented by AHPA or the other trade groups.

“That’s the primary thing we want to guard against,” he said.

Mister said CRN also will review comments from members.

“We need to be cautious about how we frame the issues here, and we need to be careful what we ask for.” – Tony Young, AHPA general counsel

Cara Welch, VP of scientific and regulatory affairs at NPA, agreed trade groups presenting a united front is important and said NPA would review members’ comments.

Even if members do not want their comments reviewed, the group still would like to receive what firms submit to FDA to help NPA write the comment it will submit, she added.

Alan Feldstein, an attorney of counsel to Collins, McDonald & Gann, said firms should use comments not only to point out where FDA’s interpretation is wrong, but also explain why and how to correct it.

“I think it resonates if we pose solutions to the problem, give [FDA] sort of a face-saving measure to amend the guidance,” Feldstein said at the AHPA event.

Stakeholders’ primary concerns are that the draft requires an NDI notification for every supplement that contains a new dietary ingredient, rather than only for new ingredients and the economic impact from the requirement; and whether the guidance prohibits the use of synthetic botanicals without NDI notifications (Also see "NDI Guidance Sparks Questions Even From Firms Ready To Comply" - Pink Sheet, 18 July, 2011.).

FDA on Sept. 9 extended the time to comment on the draft guidance by 45 days to Dec. 2 (Also see "In Brief" - Pink Sheet, 12 September, 2011., In Brief).

The Next GMP Preamble?

Young said while the guidance currently is a draft published for comment, “the next step might be a final guidance document accompanied by the preamble from hell.”

A preamble “will be used by FDA, sentence by sentence, footnote by footnote, to stick it to us,” he added.

The agency has taken such steps before and then treated the language of a preamble as if it were a Supreme Court pronouncement, Young said.

The preamble FDA published with the 2007 final rule on supplement good manufacturing practices quickly became an integral tool for understanding the agency’s thinking (Also see "Israelsen GMP Tips: Watch “Wild Card” Law, Use CoA As Legal Documents" - Pink Sheet, 1 October, 2007.).

Further, a preamble could sway a judge if the guidance is challenged in court, Young noted.

He said when judges remember bits of information about the industry reported in the news media, including product safety issues, they are likely to default to FDA’s language, which could be “something that is really going to hurt us.”

“This is a process that really needs to be dealt with carefully.”

By Carolyn B. Phenicie

Supplement Industry Must Make United Response To NDI Guidance – AHPA

More from Archive

More from Pink Sheet