At the SupplySide West show in late October, Vasilios Frankos, PhD, director, Division of Dietary Supplement Programs, Office of Nutrition Labeling & Dietary Supplements, Center for Food Safety & Applied Nutrition (CFSAN), provided an update on where FDA stands with respect to dietary supplements and functional foods. First, he discussed nano-materials, which continue to make their way into many functional food and dietary supplement applications. At the same time, Dr. Frankos says, they are posing regulatory problems for FDA on the safety front. To get a better handle on these materials the agency intends to hold a public meeting to discuss their status and future in the coming year.

In his presentation Dr. Frankos also raised the issue of contamination in supplements, particularly as it relates to lead in multivitamins and heavy metals in botanicals. In its latest multivitamin report, Dr. Frankos said 324 products did not pass the agency’s testing. With respect to botanicals, he said, “These products tend to have higher amounts of heavy metals so the onus is on the manufacturer to set limits for them. The message is to work with your supplier and qualify them according to the GMPs.” He added, “For the future, we will continue the vigorous sampling of dietary supplements for contaminants.”

As for the industry’s first round of GMP inspections, Dr. Frankos noted they are well underway and that those interested in their status could view this information online. However, it was later learned that the only way to find out how inspections are going is to fill out a Freedom of Information Request. “Inspections are a huge part of the GMP regulation. And in addition to conducting inspections here, we will be conducting them overseas as well.”

So what types of inspectors can companies expect at their door? Dr. Frankos said it depends on the location of the company. “On the East Coast, for example, the field offices may have a higher amount of drug inspectors due to the high concentration of pharmaceutical companies in that area,” he said.

With nearly a full year of reporting adverse events under the industry’s belt, Dr. Frankos emphasized how important it is for companies to file AERs using the MedWatch 3500A forms. So far, throughout this first year of reporting, he said the agency is seeing a lot more AERs than in the past, and that those reports are now being analyzed for signals. He cautioned, however, that one report does not make the case for taking action against a product. To offer companies more clarity around this new law, he said, “We should have a finalized guidance on AERs by the end of the year.”

New Dietary Ingredient (NDI) notifications continue to present some complex issues for both industry and FDA. For example, does a company have to file an NDI notification for every new probiotic strain discovered? This is just one of many questions FDA is trying to answer with respect to NDIs. In discussing the status of the requirements, Dr. Frankos said, “We have to know what data are necessary for an NDI if a history of safe use is not enough.” He also assured the audience that FDA/CFSAN would soon provide more guidance about how to fill out NDI forms and how much and what type of information companies need to include in their submissions.

In other developments, FDA has scheduled a Nutrition Roundtable Discussion for Friday, December 12th, to be held at CFSAN. The purpose of the roundtable is to communicate FDA’s nutrition activities and provide status updates on the following tentative list of topics: foods referred to as functional foods, health claims and evidence-based review guidance, along with many other issues. The roundtable format will consist of a panel of experts led by Stephen Sundlof, DVM, PhD, CFSAN director, with remarks from David Acheson, MD, FDA associate commissioner, as well as a question and answer session.