In its 98-page comments on FDA’s New Dietary Ingredients draft guidance, the group spent much time on delving into the kind of testing protocols the agency called and the underlying assumptions it relied upon. These are more appropriate to food additive and create a costly and potentially risky situation for small businesses that are developing new ingredients or bringing finished products to market that include those ingredients, NPA asserts.
“We think this question of testing is potentially the most damaging to industry,” NPA CEO Daniel Fabricant, PhD told NutraIngredients-USA. “Our concern is that these sorts of guidance documents get used by plaintiffs bar attorneys. They could come back and say, FDA says you should do this you didn’t do it.”
Food vs supplement standard
In its comments, NPA asserts that FDA is blurring the line between a food additive and a dietary ingredient meant for a supplement. The agency relies on testing protocols taken from the Redbook, which apply to the higher food additive standard of “reasonable certainty of safety,” rather than the statutory NDI standard of “reasonably expected to be safe.” This has always been something of a gray area, but was supposed to elucidate the notion that consumers have no choice about whether to eat, and food is supposed to be safe to consume at all times and under almost all circumstances. With supplements, consumers are actively choosing whether to consume the product and so can accept some small level of risk and there may be situations in which consumption of a given supplement is inappropriate. While this is a fine distinction it’s an important one, NPA asserts, because the greater cost of this level of proof and the uncertainty with how this standard is applied has led to situation in which an NDI notification is seen as something to be avoided.
“Clarity with greater distinction between the lesser and higher safety standards without linking NDI safety to the scope of testing detailed in the Redbook would make the NDI notification process a more attractive alternative than is presently the case. FDA’s current thinking has driven present day practices to favor preparing self-determined GRAS dossiers over NDI notifications because of higher success rates with self-determined GRAS filings,” the comments state.
Uncertainty harms compliance
Fabricant noted that in addition to driving new ingredient developers in the direction of GRAS submissions, the draft guidance could also actually spur the proliferation of the sort of bad actors it is meant to help weed out.
“The way it stands now, the guidance could actually result in more bad actors skirting the law entirely, which is the opposite of what a sensible regulatory regime should be. This economic burden to industry in following the food additive-level toxicology tests proposed in this draft guidance could harm small businesses and create a chilling effect on innovation, and lead to fewer submissions from legitimate firms,” Fabricant said.
In its comments NPA said that in the latest draft of the NDI guidance the agency was calling for the following tests, which mimic a food additive testing protocol and which NPA believes to be excessive:
- two-study genetic toxicity battery
- three-study genetic toxicity battery
- one-generation rodent reproductive study
- multi-generation rodent reproductive study
- teratology study in no defined animal model (rodent or otherwise)
- one-year chronic toxicity study
- two-year carcinogenesis study
- single-dose tolerability.
“Outside the 14-day range-finding oral study, 90-day sub chronic oral study, and repeat-dose tolerability studies, NPA is not sure of the usefulness of these other OFAS Redbook testing recommendations,” NPA said. In the past, few if any of these additional tests have been included in NDI notifications and so have not determined whether the agency agreed in effect that the ingredient in question was safe.
Synthetics, ODI list
In addition to the emphasis on what kind of testing should be done, NPA renewed its call for the agency to not require a NDI notification on every new product that contains a new ingredient. In addition, the group says that synthetic copies of naturally-occurring substances should be allowed.
NPA also called for FDA to accept as authoritative its list of ODI ingredients. The list was developed based upon evidence collected from past media reports, advertising, and other public sources.
“The most common question we get from our members is whether something is an old ingredient and therefore off-limits to FDA or a new dietary ingredient, which triggers the NDI notification process. We are developing a safe harbor list now for greater clarity as to exactly what ingredients fall safely into the already-approved category and can be used in products today,” Fabricant said.