The U.S. Food and Drug Administration received almost a thousand comments relating to a public meeting in late March that was meant to tackle the definitional issue of what constitutes a “dietary substance.” A general thread in the comments has been that FDA’s current interpretation is too restrictive.
The public docket for comments closed Monday at midnight, by which time 955 comments had been received. As of the publication date of this article, only nine of those comments had been made public. Publication of the remainder will take at least a week, sources said.
The meeting was held to address the question of what exactly was meant by the clause in the original Dietary Supplement Health and Education Act of 1994 (DSHEA) that reads; “a dietary substance for use by man to supplement the diet by increasing the total dietary intake.” (DSHEA is the law that created the modern dietary supplement marketplace in the United States.)
The clause was originally included to allow for future innovation in health and nutrition. Industry observers have long held that this was meant to be an expansive category, focusing on the intended use of new ingredients, not on their provenance. FDA, on the other hand, has viewed this as pertaining to ingredients that are derived from foods already consumed by man.
One of the comments that has been made public came from Scott Bass — an attorney who is a significant figure in this debate, as he was one of the lead negotiators with Congress and FDA at the time DSHEA was written. This makes him one of the heavy hitters when it comes to questions of the legislative intent of the lawmakers and staff members who wrote the original legislation.
Bass: Definition should be broad, but that doesn’t mean safety will be compromised
In his comments, Bass noted that the original wording in DSHEA was criticized as being too broad. In response, the language of law was changed to incorporate multiple filters to ensure the safety of new ingredients and to arm FDA with enforcement capabilities to quickly deal with new products that did not meet those standards.
Bass said safety, not source, is the main criterion for limiting what can be called a dietary ingredient, and he said DSHEA has adequate safety protocols built in. He noted that in the past such well-researched ingredients such as CoQ10 — which now has a decades-long history of safe use — had been attacked by FDA as not meeting the definition.
“‘Dietary substance’ means innovation. Assuming that FDA is now willing to open the innovation door and abandon the current interpretation, the real key is
getting adequate funding for FDA to enforce the entire safety regime developed by DSHEA,” Bass commented.
Israelsen: Industry priorities will become clearer
Another DSHEA-era heavy hitter is Loren Israelsen, president of the United Natural Products Alliance (UNPA). In 1994, Israelsen was on the staff of the late Sen. Orrin Hatch (R-Utah), who, along with Sen. Tom Harkin (D-Iowa), cosponsored the legislation. Israelsen told SupplySide Supplement Journal that he had anticipated the flood of comments that inundated the docket.
“It didn’t surprise me,” Israelsen said. “It will take about a week for them to be posted up, and then after we’ve had time to read the most relevant ones, we’ll be able to get a clear ranking of what is considered most important by the industry.”
In UNPA’s comments, Israelsen excerpted some statements made by Cara Welch, Ph.D., head of FDA’s Office of Dietary Supplement Programs (OSP) during the meeting which took place on March 27 in Washington, D.C. These illustrate the agency’s long held belief that a “dietary substance” must by definition be sourced from a food.
But UNPA’s comments raise the point that the American diet has changed almost beyond recognition when compared to 1994, replete with new foods and ingredients sourced from around the globe … So whose food are we talking about, anyway?
UNPA’s comments said that a legislative fix for this impasse — considering the current state of national politics — is unlikely. So, the organization noted, an FDA administrative procedure is the way to go to resolve this impasse once and for all in favor of innovative new ingredients.
Trade associations weigh in
Other trade associations weighed in, too. The Council for Responsible Nutrition echoed Bass’ assertion that FDA’s restrictive definition runs counter to the intent of DSHEA. CRN also observed that stance helped to discourage some ingredient developers away from filing new dietary ingredient notifications (NDINs) for fear that their ingredients wouldn’t even get through the door because FDA would rule that they didn’t qualify as dietary ingredients. Thus some new products were diverted into the self-affirmed GRAS (generally recognized as safe) pathway, which was less than ideal from a safety review standpoint.
The comments filed by the Natural Products Alliance (NPA) noted that the restrictive definition by FDA has made innovation more difficult. The group’s comments mentioned that probiotics — a massive field of research and product development — weren’t even defined as a product category until 2001, years after DSHEA took effect.
“This creates an impediment to innovation and undermines the clear intent of Congress to make a wide variety of safe supplements available to consumers,” the NPA comments stated.
The comments filed by the Consumer Healthcare Products Association (CHPA) included a blow-by-blow response to the questions raised by FDA during the meeting. CHPA advocated that FDA take a more expansive view of the definition of a dietary substance and that the agency should adopt a risk-based approach when evaluating ingredients made via new technologies, such as chemical synthesis, cell tissue culture or precision fermentation.
In addition, CHPA advocated that FDA establish clear expectations for the kind of safety information necessary for a successful NDIN.