Joshua Sharfstein, MD, principal deputy commissioner of FDA, offered remarks at the Council for Responsible Nutrition Annual Conference, saying the agency and the industry must continue working together to protect consumers. He noted several issues on which the agency has collaborated with the industry. “We have worked together to implement new provisions mandating reporting of serious adverse events,” he said. “Implementation of these provisions will help the agency identify unsafe products, warn the public about them and remove them from the market. We also worked together to develop dietary supplement current good manufacturing practice (GMP) requirements. These requirements will enhance the quality of the products provided to consumers.”

However, much more work needs to be done, he added. “There are products marketed as dietary supplements today that pose serious risks to consumers—in some cases, life-threatening risks. Addressing this problem is critical for consumer health and for consumer confidence in the dietary supplement industry.” Dr. Sharfstein said the issue of dietary supplements spiked with potentially dangerous pharmaceuticals remains one of FDA’s biggest concerns. “The steroid problem is the most high profile safety issue facing the nation’s supplement supply,” he stated. “Recently, at a hearing before the Senate Judiciary Committee, the chief executive officer of the U.S. Anti-Doping agency testified that elite athletes are ‘testing positive for banned drugs because they were taking products that were either accidentally contaminated or purposefully spiked by manufacturers with designer steroids, stimulants or other drugs’.”

The agency has committed substantial resources to confront the situation, according to Dr. Sharfstein, and intends to continue its aggressive enforcement and education. However, these steps alone will not be enough, he added. “We must develop new tools and approaches to succeed. An important step is to develop all the tools DSHEA gives us for improving the safety and quality of dietary supplements. One such tool is the agency’s ability to review new dietary ingredients, or NDIs.

“Although DSHEA excludes from premarket notification ‘grandfathered’ dietary ingredients that were marketed before DSHEA became law, dietary supplements that contain new dietary ingredients must submit a 75-day pre-market notification to FDA,” he continued. “So far, we have been hampered by the fact that no verified list of grandfathered ingredients exists. But here’s what we can do. We can set out guidance explaining how to demonstrate that a product is in fact grandfathered in. Then, when we see concerning products we do not believe were marketed prior to October 15, 1994 on the market, we can ask companies to provide evidence of prior marketing, or to voluntarily pull the product until an NDI premarket notification is filed.”

Looking forward, Dr. Sharfstein said the safety of the supply chain in an increasingly globalized world is a top concern. “Because you are ultimately responsible for the product you put on the market and its impact on consumers, every company in the supplement industry should be responsible for where you are purchasing their ingredients,” he said. “When you find problems, you should notify the FDA, so we can take action to prevent these ingredients from being sold by other companies in your industry.”