Washington, D.C. — Dietary supplement industry leaders got the chance to go face-to-face with members of the Food and Drug Administration this week and encouraged movement on developing the list of ingredients that can be considered to pre-date the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Loren Israelsen, president of the United Natural Products Alliance (UNPA), reminded the FDA that the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA, then NNFA) and UNPA had compiled an “old dietary ingredient” list shortly after the bill’s passage.
FDA chose not to act on that list and has yet to define what it will consider acceptable evidence that an ingredient was on the market pre-Oct. 15, 1994. Meanwhile, whether or not companies even have the information FDA might require remains a question. Among the pieces of evidence Israelsen suggested FDA look at is menus. He demonstrated with an old menu from a Chinese restaurant that identified the herbs included in the dishes that had been deemed suitable for consumption pre-DSHEA.
When surveying the industry, Israelsen said, the lack of movement in defining what constitutes an NDI “new dietary ingredient” is hampering business progress. In September 2016, it polled attendees at a conference and found 43% said they would hold for now because things were too unclear. A repeat of that poll last February revealed things getting worse, not better, as 71% said they were on hold until things cleared up.
“We thank FDA for giving industry the opportunity to participate in discussion surrounding the planned development of a list of pre-DSHEA ingredients. We have consistently advocated for collaboration between industry and FDA to establish this list, and hope the agency will continue to include us in future conversation,” said Duffy MacKay, svp, scientific and regulatory affairs, at CRN.
“We thought it was a valuable meeting,” MacKay added. “FDA, the dietary supplement industry, and consumer groups have the shared value of consumer safety, and establishing a list of pre-DSHEA ingredients would allow FDA to then spend more of its time, focus and resources on other crucial areas of work, such as cGMP inspections and going after bad actors who tarnish the reputation of the industry and its products.”
NPA’s Dan Fabricant, who presented on the panel about which process should be used to develop the list of pre-DSHEA ingredients, described the meeting as “excellent.”
Michael McGuffin, president of AHPA, also presented. Among his suggestions were that the FDA accept widely available records such as those early industry lists, AHPA’s two editions of “Herbs of Commerce,” and other publications like herbal ingredient catalogs and pharmacopoeial references.
In addition, he said FDA should abandon any quest for absolute proof of pre-DSHEA marketing and move toward exercising enforcement discretion for dietary ingredients that are acknowledged as very likely to have been marketed in the U.S. as of Oct. 15, 1994.