While many industry stakeholders are still digesting the details of the new draft guidance for new dietary ingredient notifications, released last week, the preliminary reaction seems to be one of acceptance and respectful requests for more clarity on certain topics.
This marks a significant difference from the reaction that greeted the first one released in 2011 (Senator Orrin Hatch even said he was “alarmed” by the 2011 version). So what’s different? On the NDI side, not an awful lot – there has been the addition of Master Files (widely welcomed by the industry), and talk of developing a grandfathered list of ingredients (no small task), and some clarification on topics such as piggybacking (when it is and isn’t acceptable), but on the whole the draft guidance is similar to its predecessor.
The document clearly shows FDA’s thinking is relatively consistent about new dietary ingredients and this is certainly not the extensive overhaul the industry demanded five years ago. And don’t forget that the agency has been using the previous one to assess NDI notifications in the interim, and it would seem that those five years may have slowly led to some kind of acceptance within some industry circles that this is just the way it is. These are the rules of the game, so let’s just get on with it.
The big changes are on the industry side: We’ve seen Attorneys General wade in and start sending out cease and desist letters and more; we’ve experienced incredible levels of negative press; industry critics have become more visible and vocal; and the FDA now has an Office to enforce the regulations. In response, the industry has had a cold hard look at the current reality.
As I wrote earlier this year, the conversations the industry is now having need to happen. We need to be talking about transparency, about supply chain integrity and management, about improved testing techniques, and about removing ingredients and products from the market because they shouldn’t be there.
While product registries such as the Dietary Supplement Label Database have been available for years, many would not have welcomed talk of an industry-led product registry five years ago that would be searchable by the public. And yet we have the Council for Responsible Nutrition aiming to launch one before the end of 2016, and the Natural Products Association telling me that it is working on opening up its TruLabel Program to complement its enforcement and warning letter database. (TruLabel was launched in 1990 as a label registration and random-testing program, but to-date has been an internal oversight program.)
The mentality of the industry has changed. I don’t doubt that there will be extensive comments submitted to the Agency before October 11 on the new draft guidance, but I do not expect any “back to the drawing board” comments like last time. There’s no evidence to suggest that the FDA would change it significantly anyway, and is industry willing to live with uncertainty again while awaiting another version?
If you’re in the space you should be already looking at your products, working with your suppliers, and dotting all your i’s and crossing your t’s. A grandfathered list of approved old dietary ingredients (ODIs), a list of accepted NDIs, and a registry of finished products will make for a quick and easy way to cross reference whether the ingredients should be there, and that will be a magnet for both regulators and class action lawyers.
This will require investments from the industry, and many are asking the Agency to take that into consideration. But the times they are a-changing. The cost of doing business is going up. If you cannot afford a parachute, don’t go skydiving.
Editor's note: This article has been updated from its original to include details of the NPA's TruLabel Program, in response to the comment submitted below. We apologize for the oversight.