On the guidances, Prochnow said both have been a long time coming.
“It remains to be seen whether we are going to see them this year or not because FDA continues to say soon, and soon can be all in the eyes of the beholder,” Prochnow, who is a shareholder in the firm Greenberg Traurig, told NutraIngredients-USA.
NDI draft guidance
The NDI draft guidance was first released in July 2011. After a firestorm of strident criticism on the guidance that culminated in a couple of meetings between Senators Orrin Hatch, R-UT and Tom Harkin, D-IA and top-level FDA officials, the agency agreed to review the guidance with industry stakeholders with an aim toward issuing a revised version. A series of high-level meetings took place with little information released as to what transpired at those sessions. But the key lines of disagreement with the initial guidance still seem to be bones of contention, among them the nature of what extraction processes or manufacturing steps would cause an Old Dietary Ingredient to become an new one requiring the submission of new safety data, the question of whether the submission process is based on ingredients solely or on products that contain those new ingredients and the status of probiotics and so-called synthetic botanicals.
The existing guidance was not withdrawn, however, and FDA has applied some of the thinking contained therein in recent enforcement actions, including its campaign to get DMAA off the market. A number of warning letters to manufacturers of sports nutrition products containing DMAA have mentioned the idea the ingredient—the missing NDI notifications aside—is not a lawful dietary ingredient in the first place because it is wholly synthetic in origin. With the trend in the industry toward chemical synthesis of molecules that might have interesting properties but can’t be found in nature in commercially relevant quantities, or looking at synthesis as a more cost-effective way to get to the same result or a way to achieve higher purity, this will be an interesting development to watch, Prochnow said.
“The revised guidance on New Dietary Ingredients is one that industry is waiting for with great interest,” he said. “Regardless of whether the draft guidance comes out or not, the obligation to file NDI notifications is still out there and companies should still be doing it.”
The guidance on liquid dietary supplements has languished in draft form for quite a bit longer than has the NDI guidance. The idea of making it final has received renewed impetus from the controversy surrounding energy beverages. Senators Dick Durbin, D-IL and Richard Blumenthal, D-CT have made the marketing and labeling of energy beverages and their ingredients—how much caffeine and other ‘stimulant like’ ingredients they might contain—into a high profile issue. On several occasions Durbin and Blumenthal have sent letters to FDA requesting among other things that the draft guidance on liquid dietary supplements be made final.
If that happens in 2014, it’s unlikely to change much in the way things are done now, Prochnow said. Even though it’s just a draft version, just as with the NDI guidance FDA has been applying the ideas expressed there in its regulation of the sector. Whether in draft or final form, guidances are after all an expression of FDA’s most current thinking on a given topic, Prochnow said.
“I don’t expect it to be anything earth-shattering and (the guidance being made final) probably will not change the way things are looked at all that much,” Prochnow said.
“The guidance as it is currently out there identifies five or six different factors. The packaging size, the recommendations for use, the statement about identity, other statements about the product. These will all be used to determine whether a product that is labeled as a supplement is actually being represented as a conventional food.
“That’s not going to change. There’s not going to be anything (in the final version) that says something like, anything over 16 oz is now going to be a beverage and not a supplement,” he said.
The guidances mentioned above are really window dressing on FDA’s main concern, which is bringing the industry up to speed on manufacturing practices. The GMP rule has been in place for a number of years now, and from FDA’s point of view, the dietary supplement industry still has a long way to go to achieve adequate compliance.
“Clearly GMPs are still their No.1 concern and focus,” Prochnow said.
A developing trend, one that has been reinforced in both warning letters and public pronouncements by FDA officials, is the idea that brand holders bear the ultimate responsibility for the GMP compliance of the products marketed under their imprimatur.
“FDA will continue to focus on aspects of the GMPs including the responsibility private label manufacturers have to ensure their contract manufacturers are manufacturing products in compliance with the GMPs,” Prochnow said.
Now that many manufacturers have been inspected at least once, the second go-round on GMP enforcement will drill down to more detailed aspects of the rule, including whether the identity tests manufacturers are performing are fit for purpose. The regulation is written in such a way that companies have flexibility in what tests they choose to perform, but must have scientifically valid reasons for using certain tests.
“It’s clear that FDA is going to do more than a cursory look to see whether you are doing the testing. They are going to want evidence that the tests you are doing are appropriate for the ingredients and products you have,” Prochnow said.