By John R. Endres, ND, Chief Scientific Officer, AIBMR Life Sciences
Over the past 20 years, the dietary supplements industry and FDA have learned how to work together to achieve the common goal of regulatory compliance to ensure that products are safe for consumers. My company, AIBMR, is approaching its 40th year as a scientific and regulatory consultant serving the natural products industry. I myself have had the mere pleasure of being part of this industry for 11 years. As we have worked together with our industry clients on regulatory compliance, we have experienced firsthand the benefits that come from working closely with FDA.
First, however, consider all the regulatory changes that have taken place in the 20 years that Nutritional Outlook has been publishing, and consider how the natural products industry’s relationship with FDA has had to evolve over that time. When Nutritional Outlook first published in 1998, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was only an infant at four years old. At the same time, as a result of scrutiny from public interest groups, FDA’s Office of Food Additive Safety finalized the proposed GRAS rule that went into effect in April 1997. Later, in 2007, FDA established Good Manufacturing Practices (GMPs) for dietary supplements. And just six months after the Food Safety Modernization Act (FSMA) was signed into law by President Obama in 2011, FDA issued the first of two draft guidance documents to help our industry understand how to properly prepare and submit a New Dietary Ingredient notification (NDIN); just last August, FDA issued its revised second NDI draft guidance.
Clearly, a lot has changed at FDA in the past 20 years. In fact, FDA’s dietary supplement division isn’t even a division anymore within FDA’s Center for Food Safety and Applied Nutrition; in 2015, the division became a full-fledged office, the Office of Dietary Supplement Programs.
It has taken time for the industry to digest and to understand FDA’s complicated set of regulations, and during that time, we have been honored to be able to provide guidance to industry on how to navigate the regulatory waters. And, while the regulatory realm may be second nature for us, we still continue to learn as new challenges present themselves.
An important lesson that AIBMR likes to communicate is that FDA is not the enemy. In most cases, FDA has been extremely helpful in terms of its availability, spirit of cooperation, and willingness to offer advice. For example, GRAS pre-notification meetings we have facilitated in person in College Park, MD, between GRAS notifiers and the agency have tended to result in enhanced cooperation between the two parties that FDA has ultimately said helps make the GRAS process more efficient by reducing the agency’s questions on the back end. These hour-long meetings are generally attended by 10–12 FDA senior staff, perhaps including the division director as well as senior supervisory toxicologists, chemists, and microbiologists.
From our perspective, maintaining this open dialogue with FDA is partly why our process has resulted in a high degree of success; it helps companies to understand questions and concerns that FDA might have on the front end, and it allows the agency the opportunity to preemptively provide very valuable advice.
The industry as a whole has realized over the past 20 years that it needs to self-regulate—that is, to move closer to full compliance with GMPs, label claims, and submitting NDINs and obtaining GRAS notifications when necessary. I believe that the majority of industry companies are chiefly trying to do the right thing and appreciates any help they can get to be completely compliant with FDA regulations. Companies that are unwilling or unable to comply will eventually be pushed out of business if they haven’t already been.
FDA has been very active and helpful—both the Office of Dietary Supplement Programs and the Office of Food Additive Safety—with giving presentations and participating in Q&A sessions at industry tradeshows (e.g., SupplySide West, Natural Products Expo, the Institute of Food Technologists’ Annual Meeting and Food Expo) and trade association meetings (e.g, the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, the American Herbal Products Association, etc.).
The future is bright as the industry continues to grow. Although we face many challenges, working together with FDA to make sure consumers are assured safe products to support their health is part of what will enable our industry to remain successful for many years to come.
John R. Endres, ND, is chief scientific officer at AIBMR Life Sciences (Seattle), a leading natural products and functional ingredients consulting firm.