DSHEA Expert Says FDA’s “Misreading” of the Term “Dietary Substance” in NDI Draft Guidance Is Biggest Hurdle for Synthetic Botanicals, Probiotics

Photo © iStockphoto.com/ScantyNebula

As FDA seeks to move forward on its draft guidance for new dietary ingredients (NDIs), one expert reports that the agency could reach out as soon as this fall to encourage further dialogue with the dietary supplements industry on a number of key issues related to the draft guidance. The last public move the agency made on the NDI draft guidance was officially closing the comment period last December on its August 2016 version of the draft guidance. Attorney Scott Bass, who helped draft the Dietary Supplement Health and Education Act of 1994 (DSHEA), says that the most important issue industry needs to get addressed relates to FDA’s interpretation of the term dietary substance within the draft guidance. According to Bass, the agency’s misinterpretation that dietary substances must be nutritional substances is incorrectly causing the agency to exclude non-nutritional ingredients, such as synthetic botanicals and probiotics, from its definition of a dietary ingredient-and potentially putting those ingredients out of the running for use in dietary supplements.

In an interview this week with Nutritional Outlook, Bass, a partner at law firm Sidley Austin LLP, reiterated concerns that he had expressed in public comments that he had helped draft on behalf of the Consumer Healthcare Products Association (CHPA; Washington, DC) to FDA last December. In the CHPA comments, Bass and his coauthors wrote that “FDA must correct its continued misreading” of Section 201 (ff)(1)(e) of the Federal Food Drug and Cosmetic Act (FFDCA). The authors pointed out that in FDA’s latest draft guidance discussion of synthetic botanicals, the agency stated that it considers dietary substances to be those that are “food or food components that humans eat as part of their usual diet” and that have been “used as a lawfully marketed ingredient in the conventional food supply.” FDA also clarified in the draft guidance that synthetic vitamins, minerals, and amino acids, for instance, “are recognized as dietary ingredients because a vitamin, mineral, or amino acid is defined by its nutrition function (its ability to provide nutrients to the human body), not by its state of matter like a botanical.”

By contrast, the agency said, synthetic botanicals do not qualify as dietary ingredients. As Bass and his coauthors wrote in CHPA’s comments back in December: “As part of its discussion of synthetic herbs, FDA reiterates a position that it had internally rejected in 2003: that the DSHEA definition of dietary ingredient in Section 201(ff)(1)(e)-‘dietary substance’-only means substances that are already present in ‘food or food components that humans eat as part of their usual diet’ and that have been ‘used as a lawfully marketed ingredient in the conventional food supply.’”

“For FDA,” they wrote, “this section acts a de facto exclusion of new synthetic versions of botanical ingredients and other new synthetic ingredients intended to supplement the diet.”

FDA’s interpretation of the term dietary substance is incorrect, Bass says. According to Bass, who participated in drafting the DSHEA statute, lawmakers at the time purposely chose not to define a “dietary ingredient” as one that is nutritional, meaning that dietary substances are not restricted to those that are consumed for nutritional purposes. Rather, he says, lawmakers used the term dietary ingredient instead of nutritional ingredient so that ingredients like synthetic CoQ10 or synthetic conjugated linoleic acid-or even probiotics or synthetic botanicals-would be considered dietary ingredients even if they are not consumed strictly for their nutritional value.

“Originally, what Congress first said was nutritional substance, but they took that word out and made it dietary substance so that it wouldn’t be bound by any definition of nutrients,” and so that the law would not limit innovation and progress in the supplements industry, Bass tells Nutritional Outlook.

“The point of Congress’ insertion of a separate definition for non-food ingredients was to anticipate expansion and innovation in dietary supplement development,” wrote Bass and his colleagues back in December. “Section 201(ff)(1)(e) should instead open the door to innovative dietary supplements, including synthetic ingredients and probiotics,” they wrote, concluding that “The Congressional intent is clear: there is no rationale for FDA to take the position that Section 201(ff)(1)(e) of the FFDCA precludes synthetics or probiotics as dietary ingredients.”

By contrast, Bass says, in FDA’s draft guidance, the agency is “interpreting it to mean only things with recognized nutritional value. It’s the opposite of what the statute says,” he says. And if this incorrect interpretation precludes ingredients like synthetic botanicals and probiotics-and, in fact, any ingredient that is “obviously synthetic or changes to traditional products”-from being considered dietary ingredients, the effect would be to stymie innovation in the dietary supplement industry. As Bass and his colleagues wrote in their CHPA comments, “there are...proposals in [FDA’s draft guidance] that may impede product/ingredient innovation by responsible companies and make it difficult to introduce new products. Some of the 2016 draft guidance content thus runs counter to the essence and intent of the Dietary Supplement Health and Education Act (“DSHEA”).”

They continued, “FDA should withdraw its effort to eliminate all innovative products, including synthetics and probiotics, that are not traditional vitamins, minerals or herbs under section 201(ff)(1)(e) of the FFDCA. Other ‘dietary substance[s]’ does not mean other ‘nutritional substances.’ Congress made that clear. This provision in FDA’s 2016 draft guidance will all but eliminate innovation.”

Bass says that FDA’s misreading “has implications across everything, not just synthetic herbs. It has implications for all dietary supplements and dietary ingredients.” So far, he says, this issue has not received much attention-although, he says, it is on FDA’s radar now because CHPA included discussion on the topic in its public comments. Still, he says, “I think that’s the biggest issue that everyone’s missing, because industry is based on innovation,” and FDA’s misreading will prevent certain innovative ingredients from moving forward as supplement ingredients.

Could FDA change its interpretation? It’s possible. Bass says that this year the agency has been very receptive to dialoguing with industry as it prepares to move forward on the draft guidance. (Some originally predicted that the agency could issue a final version of its draft guidance by the end of 2017.)

Bass speaks from experience. Just this June, he and Cara Welch, PhD, FDA’s senior advisor at FDA’s Office of Dietary Supplement Programs, were co-presenters at a conference titled, “The Revised FDA Draft NDI Guidance: Assessments, Interpretations, and Ambiguities.” Bass says he has heard FDA say it plans to reach out to industry this fall to further discussion. “They will be discussing how to deal with the whole NDI process from the standpoint of master files and other things,” he says. “So I think FDA is really showing a lot of willingness to move forward and to move forward with the proper input from industry.”

In general, he says, “I think there’s a new attitude at FDA. They’re much more willing to engage with industry and try to figure out a path that works.” Whether this includes amending the agency’s interpretation of a “dietary substance” remains to be seen.
 

Read more of Nutritional Outlook's extensive reporting on FDA's NDI draft guidance.