Although many dietary supplement industry members have feared that the July release of the New Dietary Ingredient (NDI) guidance document by the Food and Drug Administration (FDA) will upend the world of supplement ingredients, the word today is industry can breathe a sigh of relief.
"Today, as of 6 a.m. this morning, the word is there's some suggestion that the chief counsel's office trimmed [the NDI guidance] down," said Michael McGuffin, president of the American Herbal Products Association (AHPA). "The guidance is intended for clarifying current rules, not to change rules. Rulemaking is game-changing. This will be a guidance document. It's hearsay as of today; but if it's accurate, it should relieve some of the concerns that FDA was going to reinterpret the NDI sections of DSHEA. We'll wait and see."
This week krill ingredient supplier Aker BioMarine announced it received a "no-objection" letter from FDA for its NDI filing for Superba Krill Oil. It's clear the company wanted to get its filing in before any new interpretation of NDIs is released.
According to the Food Safety Modernization Act, the NDI guidance document is required to be released by this July. "I hear it's at the printer as we speak," said Dan Murray, vice president of business development at ingredient representative Xsto Solutions, told NewHope360 on Wednesday.
"We felt it was important to validate that Superba brand krill oil is backed by a safety dossier with animal and human studies," said Eric Anderson, Aker BioMarine's vice president of sales and marketing. "Our process is unique to our product. We use only ethanol and heat–a minimally processed extract. [Other krill suppliers] use acetone, a more potent solvent, which is not acceptable in some countries. Ethanol is recognized in most international markets as safe."
Aker BioMarine had its NDI filing conducted by Sony & Associates. Last year, its krill was approved as a Novel Food in Europe.
If GRAS, then NDI?
"There's an argument that you don't need to do NDI because you are GRAS," said Anderson. Indeed, an NDI clause states if a new ingredient has GRAS status, whether by self-affirmation or via a no-objection letter, and has been sold on the market as an ingredient in foods, it can be used in supplements without going through an NDI filing. "But a strict interpretation of simply being GRAS does not remove the requirement to do an NDI ingredient submission," said Anderson.
Functional Ingredients reported that the most basic definition of an NDI is an ingredient that came into the market after Oct. 15, 1994. Ingredients previously in commerce were grandfathered in under the Dietary Supplements Health and Education Act (DSHEA) and are considered safe.
For Aker BioMarine, getting a stamp of approval from FDA for NDIs serves as a validation that krill is a safe source of omega-3s. For the safety of consumers, companies that introduce a new ingredient – or that have introduced one since 1994 – should make it a priority to demonstrate its safety. The requirements to do so will become clearer when NDI guidance is published.
"NDIs and the implementation of cGMPs is going to clean up the supply chain," said Anderson. "The outliers, the cheaters and the fraudulent players are going to have to clean up their acts."
Even so, the prospect of a tightly defined NDI document is having a chilling effect on even the responsible members of the supplements industry. The industry will have an opportunity to comment on the NDI document, but that seems to be cold comfort against a regulatory apparatus that could fundamentally alter the supplements world. At worst, it would spell significant reformulation if not outright removal from the market for up to 60 to 80 percent of products.
McGuffin, however, said that the document will not be that onerous. The most comprehensive database of NDI filings has been produced by AHPA, and is co-hosted by NPIcenter.