The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has posted its Plan for Program Priorities, 2013 to 2014.
The plan includes several priorities that may be of interest to the herbal supplement industry, including:
- Guidance for new dietary ingredients (NDIs)
- Modernizing the postmarket surveillance system for dietary supplements
- Developing and implementing risk-based compliance and regulatory strategies to address dietary supplement safety issues
- Final guidance to help determine if a liquid food product (such as an energy drink) may be labeled and marketed as a dietary supplement
- Guidance for manufacturers who want to voluntarily label foods made without genetically modified organisms (GMOs)
- Guidance on medical foods
- Develop policy/regulatory options for energy drinks
- Draft guidance on conflicts of interest for experts participating on generally recognized as safe (GRAS) panels
- Use FDA's Substance Registration System to create a standardized, all-inclusive "catalog" of foods, agrochemicals, food additives, food ingredients, dietary supplements, and cosmetics
CFSAN's plans include publishing in 2013 revised draft guidance on new NDIs "to increase premarket oversight of dietary supplements." Under the plan, final NDI guidance will be issued in 2014.
In May, AHPA and four other supplement associations asked FDA to issue revised draft NDI notification guidance, with a specific focus on what information FDA needs to identify an NDI. AHPA maintains an online database that catalogues nearly 700 NDI notifications submitted to FDA along with the agency's responses. A review of the AHPA NDI Database shows that FDA frequently responds to NDI notifications by saying it is "unable to establish the identity" of the NDI.
"This is clearly an area where guidance is needed by the regulated supplement industry," said American Herbal Products Association (AHPA) President Michael McGuffin. "AHPA appreciates that CFSAN's plans include publishing revised draft NDI guidance. CFSAN should make this issue a priority to provide the industry with clarity on this matter."
Addressing safety of dietary supplements
CFSAN describes an initiative to modernize the postmarket surveillance system for dietary supplements, developing and implementing "risk-based compliance and regulatory strategies to address dietary supplement safety issues."
CFSAN intends to publish final guidance regarding the circumstances under which a liquid food product (such as an energy drink) may be labeled and marketed as a dietary supplement. FDA also states that it will issue guidance in 2014 for manufacturers that want to voluntarily label their foods as being made without the use of bioengineered ingredients/GMOs. This is another initiative to publish guidance on when products may be labeled as medical foods.
Another initiative that may be of interest to dietary supplement companies is CFSAN's plan to publish draft guidance in 2014 on "conflict of interest for experts participating on GRAS panels."
Scientific computing capability
Another goal outlined in the plan is to develop and maintain leading-edge scientific computing capability. The plan outlines several initiatives to accomplish this goal, including a comprehensive database and related tools that will provide a new approach for creating a standardized, all-inclusive "catalog" of foods, agrochemicals used for growing foods, food additives, food ingredients, dietary supplements, and cosmetics using the FDA's Substance Registration System