FDA is expected to issue a revised draft document governing new dietary ingredient (NDI) notifications to the agency.
Industry sources described release of the document as “imminent" and said it could be unveiled in the coming weeks in response to criticisms that the July 2011 guidance poses undue burdens to companies and is contrary to the 1994 Dietary Supplement Health and Education Act (DSHEA).
While FDA had no comment on the timing of the new guidance, an agency spokesperson reiterated a previous statement that issuing a revised draft “remains a priority for the FDA."
Before the guidance is finalized and publicly released, it must go through a review at the White House’s Office of Management and Budget (OMB). OMB did not respond to requests for comment, but the guidance does not appear on its website among U.S. Department of Health and Human Services (HHS) documents that are pending review. FDA is an agency within HHS.
In an interview this year with INSIDER, one of the principal architects of DSHEA—former Sen. Tom Harkin, a Democrat from Iowa—described the 2011 guidance as “awful" and contrary to the intent of members of Congress who drafted the law. Harkin said he and Sen. Orrin Hatch (R-Utah) called FDA’s commissioner regarding the guidance. Margaret Hamburg, M.D., lead FDA at the time the draft guidance was released.
“We laid this out for her and said, ‘We wrote the bill. It’s not our intent,’" recalled Harkin in the interview, which the American Herbal Products Association (AHPA) arranged. “Plus, what you outlined there is in violation of the law."
In reflecting on the NDI provision in DSHEA, Harkin said lawmakers possibly should have included more guidance in the bill.
“I just didn’t think it was going to be that big of a problem," he said.
Under DSHEA, dietary supplement manufacturers bringing new ingredients to market must notify FDA 75 days in advance. As INSIDER reported in January, the notification system—and FDA’s interpretation of it—has divided the dietary supplement industry and regulators, causing disagreements about the scope of the requirements and when they are triggered. Since the law was passed, three out of four NDI notifications have been met with some type of an objection by FDA, such as a finding that there is inadequate safety data or the company failed to sufficiently describe the ingredient.
Many issues surrounding NDIs remain unresolved five years after FDA issued its draft guidance, noted Rend Al-Mondhiry, associate general counsel with the Council for Responsible Nutrition.
“I believe that the Food and Drug Administration could provide guidance that would lead to improvement," said Michael McGuffin, president of AHPA, in a phone interview. “And by improvement, what I mean is better quality submissions for a broad representation of ingredients that are actually new as defined by the law."
Such improvements, McGuffin proclaimed, will require FDA adopt a “significantly different" draft guidance than the 2011 version. “As we said in our comments, our concern with the 2011 draft was that FDA viewed it as an opportunity to reinterpret the law," he explained.
Asked what he would like to see in the revised guidelines, Harkin said, “They have to be clear, understandable, comport with our intentions, and [be] legal."
Daniel Fabricant, Ph.D., who leads the Natural Products Association (NPA), said it was important for the agency to have a consistent policy with regard to the NDI guidance.
“It’s also important to know … if there are areas where there are inconsistencies, why," observed Fabricant, FDA’s former director of the Division of Dietary Supplement Programs, in a phone interview. “And there may be justifications for inconsistencies."
For example, he indicated regulators may view more skeptically an ingredient that is new to the human diet.
While industry has argued some of FDA’s positions in the guidance create undue burdens on companies and fail to comport with DSHEA, the specific issues in contention are nuanced and rarely black and white.
Take, for example, the question of whether a dietary supplement company must submit an NDI notification even if another manufacturer or distributor already made a submission for the same ingredient. (In its guidance, FDA answered the question in the affirmative).
“What the question really should be is, is my ingredient lawful if the ingredient that I’m selling has been the subject of an NDI notification?" McGuffin asked. “Is my ingredient lawful even if it was somebody else that submitted the NDI notification? I don’t believe this is a yes-no question."
For instance, McGuffin cited a hypothetical in which an ingredient company submitted an NDI notification, received a positive letter from FDA in which the agency had no objections, and sold the ingredient to 30 brands.
“Those 30 brands are covered by that ingredient supplier’s submission," declared McGuffin, whose organization closely tracks NDI submissions. “That’s what the law says."
FDA’s draft guidance, he conceded, implies each brand would need to submit a notification.
McGuffin agreed a company taking a supplement to market can’t rely on a previous NDI notification if, for example, the described conditions of use for the new product—such as the serving size—are vastly different than the conditions of use specified in the original submission to FDA. FDA mandates in its NDI regulation that the submission describe, among other things, the recommended or ordinary conditions of use such as serving size.
Al-Mondhiry said CRN is looking forward to hearing FDA’s position on various NDI issues, such as those relating to synthetic botanicals and a provision in the law that exempts an ingredient from an NDI submission if the substance has been present in the food supply and not “chemically altered."
“Industry really needs this guidance from FDA, even if we might not agree with FDA on some of these points," she said in a phone interview. “We need to hear from FDA."
Others outside the industry also have been clamoring for FDA to issue the revised guidance, including Rep. Jason Chaffetz, a Republican from Utah, home to a number of dietary supplement companies. (FDA confirmed it responded to Chaffetz in March in a letter to him, but as of deadline, INSIDER was unable to obtain the letter from the congressman’s office or the agency).
“Institutionally, and I mean the industry and FDA, have an unsolved problem," McGuffin said. “Could we see some guidance from the Food and Drug Administration that would move towards solving the problem?"
That remains to be seen.
Editor's note: Interested in learning more about what’s happening at FDA around dietary supplements? Join FDA’s Cara Welch, Ph.D., senior advisor in the Office of Dietary Supplement Programs, in the SupplySide West Featured Speaker session on Thursday, Oct. 6, at SupplySide West 2016.