New York, NY—At the American Conference Institute’s Forum on Dietary Supplements, several important topics of importance to the dietary supplement industry were discussed, among them being several upcoming rules potentially being introduced by the U.S. Food and Drug Administration (FDA).
The “FDA Rulemaking and Other Agency Activity Impacting the Dietary Supplements Industry” panel began with American Herbal Products Association (AHPA) president Michael McGuffin discussing the FDA’s New Dietary Ingredient (NDI) Guidance and whether or not revisions to the guidance would be a possibility at the end of the year. In his overview of the current status, McGuffin noted that a substantial amount of problems that companies encounter with NDIs are not due to safety problems, but due to omissions or technical issues in the filing process.
He anticipated one of two outcomes when trying to predict FDA’s next move on the Draft Guidance; either leaving it largely unchanged, which he described as a “missed opportunity,” or issuing a standalone guidance specifically targeting the information needed to accurately describe the identity of an NDI, a more favorable and significantly more useful outcome.
Marc Ullman, partner at Ullman, Ullman, and Shapiro, steered the conversation toward the Food Safety Modernization Act, pointing out that “the regulatory framework for the food industry is going to fundamentally change.” Of particular interest to supplement companies is the fact that importers previously exempt under Part 111 may now be subject to regulation under the new Part 117, requiring detailed food safety plans regarding items classified as food that may be part of supplements. There is also some question as to how these new rules will interact with current Good Manufacturing Practices (GMPs). The Foreign Supplier Verification Program under FSMA is also something to consider, with the U.S.-based party—be they the purchaser, importer, or simply the U.S. agent of a company being held more responsible for safety issues with items being brought into the country. Rules will differ between finished supplements and dietary supplement components as well, something else for industry to consider.
With these additional considerations for importers, though, come potential benefits. The Volunteer Qualified Importer Program (VQIP), can serve a purpose McGuffin equated to the TSA pre-check in, in that companies can volunteer themselves for participation and enjoy benefits such as access to a helpdesk, identification on the FDA’s website, and avoiding import alerts if unwanted alterations are found mid-trip. This program will require three years of good imports with no alerts, but McGuffin says that active participation in opportunities like these is ultimately best for industry.
Another upcoming change that will be visible on the shelf is the proposed revision of the Nutrition and Supplement Facts label. With a current potential final ruling time of March 2016, micronutrients will be featured on the label for the first time, along with a revised definition of dietary fiber. For supplements in particular, the older concept of “number of servings” in a bottle will be replaced with the new statistic of “how much to take.” The two proposed new labels will also be more distinct from each other visually.
The panel concluded with Ullman noting some trends in FDA warning letter and inspection activities. With the time to respond to a 483 form being 15 business days, it is important that companies have an established plan to respond, similar to how should they approach FSMA rules. In 2014, when looking over a sample size of FDA warning letters, “failure to respond adequately to a 483” was the number one cause. Ullman emphasized that not having a plan in place can be costly in multiple ways, mentioning that companies with multiple failures to respond properly to 483s may have to compensate FDA inspectors who repeatedly have to visit their facilities.