Supplement Industry Stained By Criticism Due Irresponsible Firms
This article was originally published in The Rose Sheet
Executive Summary
FDA's warnings to industry "about safety have not always been met adequately or even uniformly accepted," says Steve Tave, director of the agency's dietary supplement programs.
Steve Tave chooses his words carefully on how FDA and the industry reached a point of needing a pre-DSHEA ingredient list, but still offers a sharp reminder that some criticism of the industry is justified.
"Although we know responsible industry members share our concern for consumer safety, in practice our warnings [to industry] about safety have not always been met adequately or even uniformly accepted," said the director of FDA's Office of Dietary Supplement Programs during his opening remarks at an Oct. 3 public meeting on identifying ingredients available when Congress passed the Dietary Supplement Health & Education Act. (Also see "FDA Expects Safety As Ticket To Enter 'Pre-DSHEA' Dietary Ingredient List" - HBW Insight, 4 Oct, 2017.)
Tave noted some firms' response to FDA's warnings about using ephedra as a supplement ingredient. Rather than all firms' voluntarily removing ephedra-containing products and ceasing use of the ingredient, FDA was forced to conduct a rulemaking to ban the ingredient's use in supplements and to defend its action against litigation questioning the process.
Despite the ban imposed in 2004, ephedra and substances of similar chemical makeup still periodically are found in supplements available in the US. (Also see "FDA List Of Supplement Formulation Taboos Adds Ephedra-Like Ingredient" - HBW Insight, 11 Apr, 2016.)
Pointing out that "ephedra was unambiguously marketed in the US before Oct. 15, 1994, so it would be on a pre-DSHEA list" except for the ban, Tave said ODSP expects that other "old" dietary ingredients are unsafe but still available in supplements.
"I think all of us would acknowledge that there are ingredients now being marketed in dietary supplements s that shouldn't be considered lawful," he said. While FDA has enforced to prevent use of some potentially dangerous ingredients, "in other cases we may not have acted yet, whether because of resource or other constraints."
The potential for ingredients considered pre-DSHEA, or for variations of those substances that currently are commonly used in supplements, to be unsafe makes the NDI notification requirement all the more important for consumers.
"This NDI notification is an extremely important part of FDA's regulation of dietary supplements in the United States. It's our only opportunity to identify potentially dangerous products before they become available to consumers," the ODSP director said.
At the same time, a determination that is acknowledged as authoritative of whether an ingredient is pre-DSHEA would help FDA identify supplement formulations that should be notified to the agency as NDIs. (Also see "Lack Of Supplement NDI Notification Guidance Not A Market Pass For Industry" - HBW Insight, 29 Jun, 2017.)
"Some people call them old ingredients, some call them grandfathered, others call them pre-DSHEA. But no matter what you call them, here's the $64,000 question: what ingredients does this category include?" Tave said.
From the editors of The Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the Rose Sheet website.