NDIs, GRAS & GMOs: CFSAN outlines priorities for 2013-14
The list, which is available in full here, has numerous issues for companies active in the dietary supplements industry, such as finalizing the guidance for new dietary ingredients (NDIs), modernizing the post-market surveillance system for dietary supplements, publishing final guidance to help determine if a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement, and publishing guidance for manufacturers who want to voluntarily label foods made without genetically modified organisms (GMOs).
Commenting on the priority list, Duffy MacKay, ND, vice president, scientific and regulatory affairs, for the Council for Responsible Nutrition (CRN) told us that seeing so many priorities are relevant to dietary supplement manufacturers and ingredient suppliers is “somewhat surprising because so many of the FSMA proposed rules will be finalized in this time period and one would assume that FDA resources would be tied up focusing on implementing new rules and providing training and guidance for all of the new rules and regulations that will come into effect under FSMA.
“It is clear that CFSAN will continue to focus significant resources on dietary supplements, which is a good thing because a strong industry needs a strong regulatory body to support it.”
NDIs
Dr MacKay added that it is noteworthy that the second NDI draft guidance and the final guidance are both scheduled to be completed in 2014.
“CRN is encouraged that FDA has made the NDI guidance a high priority and is optimistic that a final guidance could be issued in 2014, but if the second draft guidance does not address the many concerns that the industry outlined in its many comments, then it is not helpful if FDA focuses on meeting this deadline, rather than providing meaningful guidance that is within the parameters of DSHEA,” he said.
Michael McGuffin, President of the American Herbal Products Association (AHPA), said the NDI issue is, “clearly an area where guidance is needed by the regulated supplement industry.
"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."
CRN’s Dr MacKay added that, within the NDI issue, CRN has argued that the current draft guidance titled,‘Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives’, is a very appropriate framework to help determine when an ingredient is “chemically altered” with regard to when an NDI notification would be needed.
“However it is noteworthy that they have removed ‘and Regulatory Status’ from the title of the document,” he noted: The final guidance title is now: 1.1.7: [Publish final guidance on assessing the effects of significant manufacturing process changes, including emerging technologies (e.g., nanotechnology) on the safety of food ingredients (including color additives) and food contact substances.].
GRAS panels – “one for industry to watch closely”
Of the other noteworthy priorities from CFSAN, Dr MacKay picked out program goal 1.1.13: Publish draft guidance on conflict of interest for experts participating on GRAS panels
“This is one for industry to watch closely,” he said. “Pew Charitable Trust recently submitted extensive comments and suggestions to FDA that would remove many individuals with perceived conflicts of interest from participating in GRAS panels.”
Other goals of note included:
1.1.10: Increase environmental sampling and targeted surveillance to identify violative products.
“This could help to identify drugs and other adulterated products masquerading as dietary supplements,” said Dr MacKay.
2.1.9: Publish final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics.
“This will have an impact on certain dietary ingredient like desiccated thyroid gland, and other animal derived glandulars,” he said
2.3.2: Develop 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
“This is an interesting one and will likely be supported by the ODS Dietary Supplement Database,” said Dr MacKay. “However, the submission of labels to this database is voluntary so it is hard to determine how this will be complete, accurate, and up to date for supplements.”
2.1.4: Publish proposed rule for intentional contamination.
Dr MacKay said that CRN is optimistic that this proposed rule will reduce the availability of spiked products masquerading as dietary supplements.
4.1.11: Publish final guidance to help manufacturers who wish to voluntarily label their foods as being made with our without the use of bioengineered ingredients.
“This is significant because it sounds like FDA will provide a definition of what is and is not GMO,” he said.
4.1.4: Publish guidance on medical foods.
“FDA has ignored this category for years and now appears to be ready to enforce in this category,” explained Dr MacKay.
Missing
Despite the long list of priorities, Dr MacKay noted that one thing that seems to missing is that, “if FDA plans to define what is ‘GMO free’, then they should also consider defining what is ‘natural’. Both of these terms are used and mis-used, and are the subjects of much debate.
“It would be helpful to stakeholders on all sides of the discussion to have them defined using science as the basis.”
