FDA’s publication of the New Dietary Ingredient Guidance (NDIG) in July 2011 has prompted a strong reaction from the dietary supplement industry as well as from long-time critics of DSHEA who believe the Guidance did not go far enough. With the benefit of eight months to reflect on where the matter now stands, the following perspectives may be of some use as we consider our path forward.
First, is there a need for an NDI policy? Unequivocally, yes. The concept of a safety review for new ingredients as part of an overall quality system for dietary supplements is a sound idea. That’s why it is in DSHEA. The safety elements found in DSHEA include recognition that dietary ingredients on the market before 1994 did not, as a general rule, warrant an expensive and disruptive reassessment of their safety. This concept of “grandfathering” classes of products or ingredients is well entrenched in US food, drug, cosmetic and medical device legislation and policy. There is a good reason for this. New legislation often involves revised standards of one sort or another. If those standards are retroactively applied to all existing products, the commercial effect is a shut-down of entire product categories, which is not only hugely expensive but also unacceptable to consumers who rely on such products for current needs. Thus, the idea of distinguishing old from new ingredients and setting different rules for each is based in long experience and practical realities.
The NDI provision is not a stand-alone safety measure for dietary supplements. It is part of a “package” of safety and quality directives that include GMPs and an imminent hazard provision to remove a supplement from the market under exceptional conditions.
To these safety and quality provisions in DSHEA have been added a number of other statutory requirements to which dietary supplement companies are subject, in whole or in part. They include:
- The Public Health, Security and Bioterrorism Preparedness and Response Act of 2002 (required registration of food facilities)
- The Anabolic Steroid Control Act Amendments of 2004 (banned specific steroid precursors)
- The Food Allergen Labeling and Consumer Protection Act of 2004 (requires label disclosure of eight major allergen sources)
- The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (requiring serious adverse event reporting for dietary supplements and OTC drugs)
- The Food Safety Modernization Act of 2010 (enhances mandatory recall authority for foods and supplements, expands facility registration and quality management systems, supplier verification responsibilities and more).
From the perspective of a dietary supplement (DS) business owner or executive, it is hard to hear that dietary supplements are unregulated, given the scope and depth of statutory and regulatory mandates covering GMPs, quality management, supply chain verification, facility registration, AER reporting and so on.
Having said that, the level of compliance within the DS industry is uneven. Areas of focus should be nondomestic ingredient identity and quality, contract manufacturing, contract analytical lab competence, and structure/function claim documentation. In each case, there is a road map to meaningful improvement, assuming FDA and industry continue to focus on these areas of concern.
This is where we return to the NDI Guidance. FDA’s position is that the best way to achieve dietary supplement safety is via an NDI review process based on finished products rather than ingredients. This is now referred to as the “DS vs. DI issue.” The industry and DSHEA’s authors believe the NDI mechanism is ingredient based. The strong reaction from industry to FDA’s interpretation of this specific issue is the primary point of contention.
So, where do we go from here? FDA is reviewing a lot of NDIG comments, which will take time. Senators Hatch and Harkin have expressed their concerns to FDA, as have other members of Congress. Many in industry have asked FDA to withdraw the guidance and reissue a revised guidance, one that takes the concerns expressed into account.
And while industry and FDA find themselves in disagreement, it should be noted that FDA has made itself available on a number of occasions to speak about the guidance and to explain its thinking and views.
So, 18 years after passage of DSHEA, we find ourselves revisiting these very same issues once again. There is, however, one big difference. This time, the public debate will focus on whether FDA has overstepped its authority—a similar debate to the one that preceded the passage of DSHEA. But the other issue will be, has the industry underperformed in meeting the safety and quality provisions laid out in DSHEA? Dietary supplement consumers are upset about the prospect of FDA overreaching. But they are also unsettled to hear that FDA’s reasons for doing so are based on a lack of compliance.
So, as the debate carries on, we would be advised as an industry to keep our eye on the real prize—steady and consistent improvement in overall quality and GMP compliance and, as appropriate, NDI notifications. The most convincing way to argue that the current NDI Guidance is overly aggressive is to demonstrate that the other elements of the dietary supplement safety package are all operating at acceptable and demonstrable levels of compliance. All sides are best served with this as a common objective.