Once the dust has settled and stakeholders have had a chance to re-read the document in question, they may calm down a little, predicted Frankos, senior vice president of product compliance and safety at supplements giant Herbalife and a former director of the FDA’s dietary supplements division.
He added: “I think everyone has to take a deep breath, read this guidance again more carefully and then look at their product lines and ask how much will this really impact my business?”
If you sell mostly vitamins, minerals, amino acids, this will not have a big impact
The one area that was potentially going to present difficulties to industry was the issue of NDI notifications for products that had been ‘chemically altered’ owing to a change in the manufacturing process or the use of a novel solvent or extraction process, he said.
“This is where we are going to see the most controversy. Congress did not provide a definition of ‘chemically altered’, only what was NOT considered chemically altered, so I expect there will now be a dialogue over what the intent of Congress was on this.
“If your product line is mostly vitamins, minerals and amino acids, really, this draft guidance may have very little impact. If you are supplying botanicals, it may have a bigger impact. But even then, if your botanicals are simple water or alcohol extracts then you are not affected.
“The NDI is triggered if you are using novel extraction techniques. But even then, this doesn’t necessarily mean you have to do multi-million-dollar new safety studies, it may just be a case of saying ‘I extracted it using this method, which gives me this much of the substance, which gives you the same amount as if you were to eat a cup of broccoli.”
‘You don’t need to spend millions on new tox studies…’
As for fears that the amount of safety data the FDA now says it requires to prove NDIs are safe goes well beyond what Congress envisaged when it ratified DSHEA, they were largely unfounded, argued Frankos.
“I think there may have been some overreaction about the safety requirements. If you read the guidance carefully, I don’t believe that the FDA is saying that we all need to go out and spend millions on new tox studies for an NDI notification.
“The important thing is history of use; the majority of ingredients will have to have little to no additional human or animal studies [to support an NDI notification].
“You need to look at traditional use. What have people historically been exposed to? Just ensure that the amount you’re putting in your supplement does not exceed what people have historically been exposed to.”
Grandfathered ingredients
Meanwhile, the news that industry lists of ‘grandfathered’ ingredients are not considered by the FDA to be authoritative should come as no surprise, he said.
And while collating evidence to demonstrate that ingredients assumed to be grandfathered were on the market prior to 1994 was onerous, it was not an impossible task, he said. And it was also something that companies should have been doing anyway.
“This pushes industry to come up with the evidence to support the grandfathered status of their ingredients. But they should have been doing this anyway, contacting their suppliers to get the evidence that these products were marketed before 1994 and getting information about their history of use.
“But there are also many other sources of information that have not been tapped that we have been able to find, adverts in women’s magazines and so on.”
Be careful what you wish for
On the plus side, the guidance also gave the FDA the power to take tough action against firms selling potentially unsafe and untested ingredients, he said.
Indeed, responsible players in the industry had long complained that rogue players were selling dodgy products without NDI notifications but the FDA had not pursued them very aggressively because of the lack of clarity over the NDI process, he said.
“Well, now we have it, and it’s to the benefit of everyone that the NDI process is clarified. The problem is it provides answers that people didn’t want to hear.”
He added: “It’s too easy just to trash this guidance; it is actually very helpful, and it’s what we have been asking for. Everything you need to do to make an NDI submission is laid out very clearly and it should make the submissions process a lot easier.”
FDA estimates that around 1,000 new dietary supplements are introduced every year. However, it has only received approximately 700 NDI notifications since 1995, claimed Hyman, Phelps & McNamara attorney Riëtte van Laack, who was writing in the FDA law blog this week.
While the draft guidance helped to clarify what an NDI was and what evidence regulators required to demonstrate it was safe, the FDA's "interpretation of the statutory requirements applicable to NDIs is more restrictive than the statutory language contemplates and would create substantial hurdles for manufacturers”, she argued.
Click here to read the draft guidance.