“I hope the guidance respects the basic goal of establishing the concept of NDIs—a mechanism to assess safety of dietary ingredients. What this would accomplish, if properly implemented, is a renewed commitment by industry to build into their product development and budgets a review and assessment of their ingredients’ safety. This would include, in my judgment, looking at solvents and manufacturing methods, adulterants likely to be encountered, and using competent analytical tools to establish identity methods for the ingredient. My biggest fear? That FDA lacks the resources to put well-focused attention on compliance, resulting in no net improvement of the status quo. I also hope FDA would not use the NDI process as a secondary enforcement tool to go after claims or other issues not involving safety per se, particularly relating to imported ingredients.”— Loren Israelsen, United Natural Products Alliance
“I hope FDA’s document provides practical guidance to assist supplement companies in better understanding when NDI notification is required, and to more successfully complete those notifications. Such guidance should have the effect of clarifying that most herbal ingredients and many herbal extracts are not NDIs, and of increasing the likelihood that submitted notifications will be filed by FDA without any substantive comments or objections. My biggest fear is that FDA will confuse its obligation to issue guidance as an opportunity to reinterpret DSHEA in a manner that narrows the intent of Congress with regard to the breadth of ingredients allowed to be sold in dietary supplements.”—Michael McGuffin, American Herbal Products Association
“I hope it provides clarity to the industry and also clears the air. FDA has taken varied approaches to submissions that have left many parties justifiably confused. The concerns remain that the agency is understaffed and may not have the adequate resources to tackle these issues without sacrificing enforcement of the cGMP requirements for the dietary supplement industry. The recent passage of FSMA increases the workload at FDA. Without better management practices and risk-based priority setting, bolstered by adequate resources, I fear the guidance document will be difficult to manage by the agency and the industry.”—Mark LeDoux, Natural Alternatives International
“My biggest hope is that it provides guidance to effectively determine whether an ingredient is actually a new dietary ingredient, as well as the level of data necessary to establish its safety. My greatest concern is that, after almost 17 years of nonenforcement, the agency will view the term ‘new dietary ingredient’ expansively, to the extent that at least 65% of the ingredients presently marketed would be considered NDIs subject to notification, and thus adulterated as a matter of law because that notification has never been filed.”—Todd Harrison, Venable LLP
“The NDI process to date has become frustrating and feared, as the FDA has objected far more applications than it has approved. As a result, fewer companies are electing to enter into the NDI process, instead seeking alternatives such as GRAS submission, non-compliance, or simply avoiding innovation until it becomes more clear what the guidance will be. The industry hope is that FDA will remain true to the broad intent of the NDI requirement and focus on the safety of the ingredient in an effort to better protect consumers. There exists a wide chasm of ‘worst-case scenarios,’ so it’s possible to imagine a broad-stroke focus on the minute and specific details of the most literal interpretation of DSHEA. If this were to happen, any ingredient that has undergone even process efficiency improvement could be subject to an expensive and time-consuming NDI submission requirement. This seems unlikely, in my opinion. My biggest fear is the NDI guidance will not give the definitive answers which reopen the door for innovation.”—Scott Steinford, ZMC-USA
“Our single biggest hope is for the revised language to provide manufacturers with greater clarity in knowing whether or not they are required to submit an NDI. We also hope the guidance will provide greater transparency on FDA’s requirements for a reasonable expectation of safety. With a clearer sense of what the agency requires, we hope to dramatically improve the ‘no objection’ response rate for NDIs. The guidance could potentially draw attention from FDA to the fringe players marketing products that are unquestionably NDIs, or not even dietary ingredients at all. Hopefully it will empower the agency to go after these products and get them off the market. Our biggest fear is that we will get an overly narrow definition of a dietary ingredient, and an overly expansive definition of what constitutes an NDI, without any instruction for the industry on how FDA plans to transition or how it would handle the backlog of NDI notices that would result.”—Steve Mister, Council for Responsible Nutrition
What’s your biggest hope for NDI guidance? Your biggest fear?
Loren Israelsen with United Natural Products Alliance, Michael McGuffin from American Herbal Products Association, Mark LeDoux with Natural Alternatives International, Venable LLP's Todd Harrison, ZMC-USA's Scott Steinford and Steve Mister with Council for Responsible Nutrition discuss their biggest expectations for NDI Guidance, along with their biggest fears.